PHARMACY AND POISONS REGULATIONS

PHARMACY AND POISONS REGULATIONS

PHARMACY AND POISONS REGULATIONS

ARRANGEMENT OF REGULATIONS

Regulation 0 age

PART I

PRELIMINARY

1 Citation.................................. ... ... ... ... ... . ... A 4

2. Interpretation ............................. ... ... A 4

3. Application of section 22 restricted to the First Schedule ... ... ... ... A 5
4. Extension of labelling provisions and relaxation with respect to poisons in the

Sixth Schedule ... ... ... ... ... ... . 1 . ... ... ... ... ... ... A 5

5. Extension of section 22 to sales wholesale etc. and relaxation of the section ... A 5
6. Relaxation of section 28(3) in the case of certain medicines ... ... ... - A 7
7. Exemption from the provisions relating solely to the First Schedule ... ... ... A 7
8. Complete exemption for articles and substances in the Second Schedule ... ... A 7

PART 11

ADDITIONAL RESTRICTIONS ON THE SALE OF POISONS

9.................................Additional restriction of sale of poisons in the Third Schedule ... ... ... A 7

10............................Restriction of sales by listed sellers of poisons .1 . ... ... ... ... A 8

10A.....................................Prohibition on dispensing of prescriptions by listed sellers of poisons A 8

11...................Restriction of sale of strychnine ... ... ... ... ... ... ... ... ... A 8

PART III

SUPPLEMENTARY PROVISIONS WITH RESPECT To
LABELLING
AND CONTAINERS

12...................Manner of labelling containers ... ... ... ... ... ... ... ... - A9

13.................Labelling of name of poison ... ... ... ... ... ... ... ... ... - A 9

14..............................Labelling of particulars as to proportions of the poison ... ... ... ... A 10

15.....................'Poison' to be in English and Chinese - . 1. .. 1 ... ... ... ... A10

16..........................Special precautions in the case of certain articles .. ... ... ... ... ... A 11

17.....................Name of seller and address of premises ... ... ... ... ... ... ... ... A 11

18.............Form of containers ...... ... ... ... .. ... ... ... ... ... ... ... A 12

PARTIV

STORAGE AND TRANSPORT

19.............Storage of poisons ........ ... ... ... . ... ... ... ... ... ... A 12
20.............Transport of poisons .... ... ... ... ... ... ... ... ... ... ... ... A 13

21. Special provisions with respect to the transport of poisons in the Seventh







Schedule................................ ... ... ... ... ... ... ... ... A
13





Regulation Page
PART V

SPECIAL PROVISIONS WITH RESPECT TO
INSTITUTIONS

22. Supply of medicines to out-patients from certain institutions, etc . ... ... ... A 13
23. Supply of medicines for use in institutions, etc . ... ... ... ... ... ... ... A 14
24. Storage of poisons in institutions ... ... ... ... ... ... ... ... ... ... A 14

PART VA

LISTED SELLERS OF
POISONS

24A...........................Applications to be entered on list under section 25 ... ... ... ... ... A 15

PARTVB

REGISTRATION OF
PREMISES

24B. Applications to register premises under section 13
24C.......................Certificate of registration under section 13 ... ... ... ... ... ... ... A 16

PART VI

WHOLESALE
DEALERS

25......................Sale and supply of poisons wholesale ... ... ...

26. Pharmacy and Poisons (Wholesale Licences) Committee

27.................Sales by wholesale dealers ... ... ... ... ...

28......................Records to be kept by wholesale dealer ... ... ... ... ... ... ... ... A 17

PART VII

MANUFACTURERS

29.................Licensing of manufacturers ... ... ... ... ... ... ... ... ... ... A 19

30. Manufacture to be under supervision of a registered pharmacist ... ... ... A 19

31.................Labelling by manufacturers ... ... ... ... ... ... ... ... ... ... A 20

32..........................Manufacturing workers not to infect products ... ... ... ... ... ... A 21

33...............Duties of manufacturers .... ... ... ... ... ... ... ... ... ... ... A 21
34...............Manufacturer's premises .... ... ... ... ... ... ... ... ... ... ... A 21

35......................Records to be kept by manufacturers ... ... ... ... ... ... ... ... A 22

PART VIII

REGISTRATION OF PHARMACEUTICAL PRODUCTS AND
SUBSTANCES

36..............................Registration of pharmaceutical products and substances ... ... ... ... A 22

36A.....[Spent] .......................... ... ... ... ... ... ... ... ... ... A 24

36B..................Clinical trials and medicinal tests ... ... ... ... ... ... ... ... ... A 24











Regulation.................................. Page

36C. Definition of 'pharmaceutical product and 'substance' for the purposes of this

Part ................................ ... ... ... ... ... ... ... ... A 24

36D. Duplicate certificates ... ... ... ... . ... ... ... ... ... ... ... ... ... A 24

37. Factors relevant to determination of application for registration ... ... ... A 25

PART VIIIA

REGISTRATION OF IMPORTERS AND EXPORTERS

37A.........................Application for registration under section 28A ... ... ... ... ... ... A 26

PART IX

SALE OF MEDICINES

38......................Disclosure of composition of medicines ... ... ... ... ... ... ... ... A26

PART X

MISCELLANEOUS

39...................Period of keeping of records . ~ . ... ... ... ... ... ... ... ... ... A 28

40........Penalties ...................... ... ... ... ... ... ... ... ... ... A 28

41.................Certificates, forms and fees ... ... ... ... ... ... ... ... ... ... A 29

42...............Transitional provisions .... ... ... ... ... ... ... ... ... ... ... A 29

SCHEDULES

First Schedule. Substances failing within the Poisons List to which special restrictions

apply under regulations 3 and 5 ... ... ... ... ... ... ... ... A 29

Second Schedule.Articles exempted by regulation 8 from the provisions of the Ordinance

and of these regulations ........ ... ... ... ... ... ... A43

Third Schedule.Substances required by regulation 9 to be sold by retail only upon a
prescription given by a registered medical practitioner, registered

dentist or duly qualified veterinary surgeon ... ... ... ... ... A 48

Fourth Schedule. Statement of particulars as to proportion of poison in certain cases

permitted by regulation 14(a) ... ... ... ... ... ... ... ... A 57

Fifth Schedule. Indication of statement prescribed by regulation 15 for the purposes of

section 27(c) of the Ordinance ... ... ... ... ... ... ... ... A 60

Sixth Schedule. Poisons exempted by regulation 4 from labelling provisions when sold

or supplied in certain circumstances ... ... ... ... ... ... A 62

Seventh Schedule.Poisons required by regulation 21 to be specially labelled for

transport ...................... ... ... ... ... ... ... ... A 62







Eighth Schedule..Forms ..................... ... ... ... ... ... ... ... ... A 63

Ninth Schedule...Fees ............................ ... ... ... ... ... A 81





PHARMACY AND POISONS REGULATIONS

(Cap. 138, section 29)

[1 July 1978.]

PART 1

PRELIMINARY

1. These regulations may be cited as the Pharmacy and Poisons
Regulations.

2. (1) In these regulations, unless the context otherwise requires

'antimonial poisons- means organic and inorganic compounds of
antimony;

'arsenicsl poisons' means organic and inorganic compounds of
arsenic;

'British Pharmaceutical Codex', 'British Pharmacopoeia', 'British
National Formulary' and 'British Veterinary Codex' include the
supplements thereto;

'food' includes a beverage;

'medicine for the internal treatment of human and animal ailments'
includes any medicine to be administered by injection, but does
not include any mouth-wash, eye-drops, eye-lotion, ear-drops,
nasal drops, douche or similar article;

'Tribunal' means the Pharmacy and Poisons Appeal Tribunal
established by section 30 of the Ordinance;

veterinary institution' means a veterinary hospital, veterinary clinic or
other premises where sick animals are treated.

(2) In these regulations any reference to an alkaloid shall include a
reference to any salt of that alkaloid, and, in a case where the esters of
an alkaloid are included in the Poisons List by virtue of the words 'its
esters', to any esters of that alkaloid.

(3) Any reference in the Schedules to these regulations to the
percentage of a poison contained in any substance or preparation shall,
unless otherwise expressly provided, be construed in the following
manner, that is to say, a reference to a substance or preparation
containing 1 per cent of any poison means

(a)in the case of a solid, that 1 gramme of the poison is
contained in every 100 grammes of the substance or
preparation;





(b)in the case of a liquid, that 1 millilitre of the poison, or, if the
poison itself is a solid, 1 gramme of the poison, is contained in
every 100 millilitres of the substance or preparation,

and so in proportion for any greater or less percentage.

(4) Substances listed under the headings 'A' in the Schedules to
these regulations are those whose uses are essentially medicinal, whilst
substances listed under the headings 'B' are not normally used
medicinally.

(5) Where in these regulations reference is made to a numbered
section the reference shall be a reference to that section of the
Ordinance.

(6) Where functions are conferred on a committee by any provision
of these regulations, references in such provision to 'the Committee'
shall be construed as references to the executive committee established
under section 4A of the Ordinance for the purpose of performing such
functions.

3. Section 22 (which sets out the person to whom poisons included
in Part 1 of the Poisons List may be sold and which requires the making
of entries in the poisons book) shall apply to substances included in
the First Schedule other than those substances included in the Third
Schedule.

4. (1) Subject to paragraph (2), the provisions of section 27 and
regulations 12 to 17 (which provisions relate to the labelling of poisons)
shall apply to sales exempted by section 32, and shall also apply to the
supply of poisons (otherwise than on sale) and references in those
provisions to the sale and the seller of poisons shall be deemed to refer
to the supply and the supplier of poisons respectively.

(2) In the case of the sale or supply of any of the poisons included
in the Sixth Schedule to a person who

(a)carries on a business in the course of which poisons are
regularly sold by way of wholesale dealing or are regularly
used in the manufacture of other articles; and

(b) requires the poison for the purpose of that business,

if the outside of the package in which the poison is sold or supplied is
labelled conspicuously with words indicating the dangerous properties
of the poison, it shall be necessary to comply only with regulation 15
and section 27(a) and section 27(d) (as modified by regulation 17).

5. (1) Section 22 shall apply to sales exempted by section 32, except
sales of poisons to be exported to purchasers outside Hong Kong, and
shall also apply to the supply in the form of a commercial sample,
otherwise than on sale, of any substance included in the First Schedule
in like manner as if references in section 22 to the sale and seller of
poisons respectively included references to the supply and the supplier
of poisons in the form of commercial samples:





Provided that section 22 shall not apply to the sale or supply of
any article by the manufacturer thereof or by a person carrying on a
business in the course of which poisons are regularly sold by way of
wholesale dealing, if

(a)the article is sold or supplied to a person carrying on a
business in the course of which poisons are regularly sold or
are regularly used in the manufacture of other articles; and

(b)the seller or supplier is reasonably satisfied that the purchaser
requires the article for the purpose of that business.

(2) Section 22(1) shall, in its application to sales exempted by
section 32 and to the supply in the form of commercial samples of
substances included in the First Schedule, be deemed to be satisfied if
the person to whom the poison or sample is sold or supplied is known
by the person in charge of the department of the business through
which the sale or supply is effected to be a person to whom the poison
or sample may properly be sold or supplied.

(3) Subject to paragraph (4), so much of section 22(3)(b) as requires
an entry in the poisons book to be signed by the purchaser of a poison
shall not, as respects the sale of a poison to a person for the purpose of
his trade, business or profession, apply if the following requirements are
satisfied

(a)the seller shall obtain before the completion of the sale an
order in writing signed by the purchaser stating his name and
address, trade, business or profession, the name and quantity
of the article to be purchased, and the purpose for which it is
required;

(b)the seller shall be reasonably satisfied that the signature is
that of the person purporting to have signed the order, and
that that person carries on the trade, business or profession
stated in the order, being one in which the poison to be
purchased is used; and

(c)if the article sold is sent by post, it shall be sent by registered
post.

(4) Where a person represents that he urgently requires a poison
for the purpose of his trade, business or profession, the seller may, if he
is reasonably satisfied that the person so requires the poison and is, by
reason of some emergency, unable before delivery either to furnish to
the seller an order in writing duly signed or to attend and sign the entry
in the book, deliver the poison to the purchaser on an undertaking by
the purchaser to furnish such an order within 48 hours next following.

(5) Any purchaser by whom an undertaking under paragraph (4)
has been given who fails to deliver to the seller a signed order in
accordance with the undertaking, or any person who for the purpose of
obtaining delivery of any poison makes a statement which is to his
knowledge false in any material particular shall be guilty of an offence
and shall be liable on conviction to a fine of $10,000 and to
imprisonment for 12 months.





(6) In the case of a sale or the supplying of a poison included
in the First Schedule to an institution such of the provisions of this
regulation as require the purchaser to state his trade, business or
profession and the seller to be satisfied with respect thereto shall not
apply and for the reference in paragraph (4) to the purposes of the
purchaser's trade, business or profession there shall be substituted in
the case of any such sale a reference to the name of the institution
and the full name and rank or position held at the institution of the
person making the order.

6. The requirements of section 28(3) (which requires particu-
lars of medicines supplied or dispensed under that section to be
entered in a book) shall be satisfied in respect of medicines included
in the First Schedule, but need not be satisfied in respect of other
medicines which are supplied by-
(a)a registered medical practitioner for the purposes of medi-
cal treatment; or
(b)an authorized seller of poisons on and in accordance with a
prescription given by a registered medical practitioner.

7. The provisions of these regulations and of the Ordinance
(as modified by these regulations) which apply solely to the sub-
stances in the First Schedule shall not apply to-
(a) machine-spread plasters;
(b) surgical dressings;
(e)articles containing barium carbonate or zinc phosphide
prepared for the destruction of rats and mice; or
(d)corn paints in which the only poison is a poison included in
the Poisons List under the heading 'Cannabis'.

8. (1) Subject to paragraph (2), nothing in the Ordinance or
these regulations shall apply---
(a) to any article in Group 1 of the Second Schedule; or
(b)to any of the articles or substances specified in the second
column of Group 11 of the Second Schedule opposite the
description of the poison specified in the first column
thereof.
(2) Notwithstanding paragraph (1)(b), Parts VII, VIII, VIIIA,
IX and X of these regulations shall apply to every article or sub-
stance referred to in that paragraph, that is a pharmaceutical pro-
duct within the meaning of the Ordinance.

PART II

ADDITIONAL RESTRICTIONS ON THE SALE OF POISONS

9. (1) No person shall sell any poison included in the Third
Schedule, except on and in accordance with a prescription given by
a registered medical practitioner, registered dentist or duly qualified
veterinary surgeon.





(2) This regulation shall apply to the sale of any such poison,
including a medicine exempted by section 28, but shall not apply to any
sale exempted by section 32.

(3) For the purposes of this regulation a prescription shall-

(a)be in writing and be signed by the person giving it with his
usual signature and be dated by him;

(b) specify the address of the person giving it;

(e)specify the name and address of the person for whose
treatment it is given or, if the prescription is given by a duly
qualified veterinary surgeon, of the person to whom the
medicine is to be delivered;

(d) have written thereon, if given by a dentist, the words 'For
dental treatment only or, if given by a duly
qualified veterinary surgeon, the words 'For animal treat-
ment only and

(e)indicate the total amount of the medicine to be supplied and
the dose to be taken or administered.

(4) The person dispensing the prescription shall comply with the
following requirements

(a)the prescription shall not be dispensed more than once unless
the prescriber has directed either

(i) that it may be dispensed a stated number of times; or

(ii) that it may be dispensed at stated intervals;

(b)if the prescription contains a direction that it may be dispensed
a stated number of times or at stated intervals, it shall not be
dispensed otherwise than in accordance with the direction;

(e)at the time of dispensing there shall be noted on the
prescription above the signature of the prescriber the name and
address of the seller and the date on which the prescription is
dispensed; and

(d)except in the case of a prescription which may be dispensed
again, the prescription shall, for a period of 2 years, be retained
and kept on the premises on which it was dispensed in such
manner as to be readily available for inspection.

10. No listed seller of poisons shall sell any poison other than a
solution of ammonia, hydrochloric acid, nitric acid, potassium
quadroxalate or sulphuric acid, except in a closed container as closed by
the manufacturer or other person from whom the poison was obtained.

10A. No listed seller of poisons shall dispense any prescription for
medicine.

11. (1) No person shall sell or supply strychnine except as an
ingredient in a medicine.





(2) This regulation shall extend to transactions exempted by
section 32, but shall not apply to the sale of strychnine

(a) by way of wholesale dealing;

(b) to be exported to purchasers outside Hong Kong;

(c)for the purpose of being compounded in medicines prescribed
or administered by a registered medical practitioner or duly
qualified veterinary surgeon; or

(d)to a person or institution concerned with education, scientific
research or chemical analysis, for the purpose of that
education, research or analysis.

PART III

SUPPLEMENTARY PROVISIONS WITH RESPECT To
LABELLING
AND CONTAINERS

12. (1) Subject to paragraphs (2) and (3), the particulars with which
the container of a poison is required to be labelled under section 27 and
under these regulations, shall appear in a conspicuous position on the
container in which the poison is sold and on every box or other
covering of whatever nature enclosing the container, and the particulars
shall be clearly and distinctly set out and not in any way obscured or
obliterated.

(2) Where the poison is contained in a cachet or similar article it
shall not be necessary to label the article itself, if evey box or other
covering in which the article is enclosed is labelled in accordance with
paragraph (1).

(3) Nothing in section 27 or in this regulation or regulations 13 to
17 shall be deemed to require the labelling of any transparent cover or
any wrapper, hamper, packing case, crate or other covering used solely
for the purposes of transport or delivery.

13. (1) For the purposes of section 27(a) and regulation 22(3)(a), the
name of a poison shall be the term under which it is included in the
Poisons List:

Provided that, where the term describes a group of poisons and
not the poison specifically, the name of the poison shall be

(a)if the poison is the subject of a monograph in either the British
Pharmacopoeia, the British Pharmaceutical Codex or the British
Veterinary Codex, one of the names or synonyms or
abbreviated names set out at the head of the monograph; or

(b) in any other case, the accepted scientific name or the name
descriptive of the true nature and origin of the poison.

(2) For the purposes of the proviso to paragraph (1), where-

(a)a substance is the subject of a monograph in the British
Pharmacopoeia, the British Pharmaceutical Codex or the





British Veterinary Codex, or any dilution, concentration or
admixture of such substance; or

(b)a preparation is contained in the British Pharmacopoeia, the
British Pharmaceutical Codex, the British National Formulary
or the British Veterinary Codex, or any dilution, concentration
or admixture of such preparation; or

(c)a surgical dressing of a type for which a standard is
prescribed in the British Pharmaceutical Codex,

it shall be sufficient to state the name, synonym or abbreviated name
used to describe the substance, preparation or surgical dressing with
the addition of the letters B.P., B.P.C., B.N.F. or B. Vet. C., as the case
may be.

14. For the purpose of section 27(b) (which requires preparation
containing poisons to be labelled with particulars as to the proportion
of each poison therein)

(a)in the case of a preparation containing a poison specified in
the first column of the Fourth Schedule, it shall be sufficient to
state on the label the particulars specified in the second
column of that Schedule against the description of the poison;

(b)in the case of a substance, preparation or surgical dressing
which is named in accordance with regulation 13(2), it shall
not be necessary to state on the label the proportion of the
poison contained in the substance, preparation or surgical
dressing, and in the case of any dilution, concentration or
admixture of such substance or preparation it shall be
sufficient to state the proportion which the substance or
preparation bears to the total ingredients of that dilution,
concentration or admixture;

(c)where the poison is in tablets, pills, cachets, capsules,
lozenges or similar articles, it shall be sufficient to state on the
label of the box or other covering in which the articles are
enclosed the number of the articles and the amount of the
poison, or in the case of a preparation or substance mentioned
in paragraph (b), the amount of the preparation or substance,
contained in each article;

(d)where the poison is in ampoules it shall be sufficient to show
the name of the poison contained in it together with, either its
concentration (if in solution or in emulsified form), or the
quantity (if in solid form); and

(e)where any proportion is stated as a percentage, the statement
shall indicate whether the percentage is calculated on the
basis of weight in weight, weight in volume, or volume in
volume.

15. (1) The word 'poison' or other statement as specified in the
Fifth Schedule with which a container of a poison is required to be
labelled pursuant to section 27(c) shall be printed clearly in both English
and Chinese.





(2) The container of any article specified in the Fifth Schedule shall,
instead of being labelled with the word 'Poison *M' be labelled with
the words specified in that Schedule as applicable to that article.

(3) The words referred to in paragraph (2) or the word 'Poison **',
as the case may be, shall not be modified in meaning by the addition of
any other words or marks, and

(a)in the case of a substance included in the First Schedule, shall
either be in red lettering or be set against a red background;
and

(b)in all cases shall either be on a separate label or be surrounded
by a line within which there shall be no other words except
words with which the container of the poison is required to be
labelled under the Ordinance or these regulations.

16. (1) No person shall sell or supply any poison-

(a)in the case of a liquid other than a medicine, in a container of a
capacity of not more than 2 litres, unless the container is
labelled with the words 'Not to be taken and

(b)in the case of an embrocation, liniment, lotion, liquid
antiseptic, or other liquid medicine for external application,
unless the container is labelled with the type of preparation
and the words 'For external use only

(2) No person shall sell or supply any compressed hydrocyanic
acid, unless the container thereof is labelled with the words ' Warning.
This container holds poisonous gas and should only be opened and
used by persons having expert knowledge of the precautions to be
taken in its use.

(3) This regulation shall be in addition to the other requirements of
the Ordinance and of these regulations with respect to labelling and
shall apply to the transactions referred to in sections 28 and 32, but shall
not apply to the sale or supply of poisons to be exported to purchasers
outside Hong Kong.

17. (1) Section 27(d) (which requires the container of a poison to
be labelled with the name of the seller and the address of the premises
on which it was sold) shall apply to the transactions referred to in
section 32, but shall not apply

(a)in the case of an article sold for the purpose of being sold
again in the same container; or

(b)to poisons to be exported to purchasers outside Hong Kong.

(2) The requirements of section 27(d) shall be deemed to be
satisfied, in the case of a poison supplied from a warehouse or depot, if
the container of the poison is labelled with the address of the supplier's
principal place of business.





(3) Where any poison (other than a substance included in the First
Schedule) is sold in a container and outer covering, being the container
and covering in which it was obtained by the seller, it shall be sufficient
if the name of the seller and the address of the premises on which it was
sold appear only on the outer covering.

(4) Where the names of more than one person or more than one
address appear on any label, there shall also be words on the label
indicating clearly which person is the seller and at which of the
addresses the poison was sold.

18. (1) No person shall sell, whether wholesale or retail, or supply
any poison unless

(a)it is contained in a container impervious to the poison and
sufficiently stout to prevent leakage arising from the ordinary
risks of handling and transport; and

(b)in the case of a liquid contained in a glass bottle or plastic
container containing not more than 2 litres, not being a
medicine made up ready to be taken for the internal treatment
of human or animal ailments, the outer surface of the bottle or
container is fluted vertically with ribs or grooves recognizable
by touch.

(2) Paragraph (1)(a) shall apply to the transactions referred to in
section 28, and paragraph (1)(b) shall apply to the transactions
exempted by section 32 but shall not apply to the sale or supply of
poisons to be exported to purchasers outside Hong Kong.

PART IV

STORAGE AND TRANSPORT

19. (1) No person shall store any poison except in a container
impervious to the poison and sufficiently stout to prevent leakage from
the container arising from the ordinary risks of handling.

(2) No person shall store any substance included in the First
Schedule in any retail shop or premises used in connexion therewith
unless the sub substance A

(a) in a a capboard ------ reserved solely for the storage of
poisons, which cupboard or drawer shall be fitted with an
adequate lock the key for which shall be retained by the
registered pharmacist; or '

(b)in a part of the premises to which customers are not permitted
to have access and which is partitioned off or otherwise
separated from the remainder of the premises.

(3) No food shall be stored in the part of the premises where such
poison or substance is stored.





20. No person shall consign any poison for transport unless it is
sufficiently stoutly packed to avoid leakage arising from the ordinary
risks of handling and transport.

21. (1) No person shall consign for transport by carrier any poison
included in the Seventh Schedule unless the outside of the package
containing the article is labelled conspicuously with the name or
description of the poison as set forth in that Schedule and a notice
indicating that it is to be kept separate from food and from empty
containers in which food has been contained.

(2) No person shall knowingly transport any poison included in the
Seventh Schedule, either on his own behalf or for another person, in any
vehicle in which food is being transported, unless the food is carried in a
part of the vehicle effectively separated from that containing the poison,
or is otherwise adequately protected from the risk of contamination.

(3) This regulation shall not apply to medicines.

PART V

SPECIAL PROVISIONS WITH RESPECT TO
INSTITUTIONS

22. (1) Nothing in the Ordinance or in these regulations, except
regulation 16, shall apply with respect to

(a)any medicine dispensed in an institution where the dispensing
is under the supervision of a registered pharmacist or other
person as may be approved by the Director of Medical an
Health Services; or

(b)any medicine for the treatment of animals supplied from a
veterinary institution which is under the superintendence of a
duly qualified veterinary surgeon,

if the requirements of this regulation are satisfied in relation thereto.

(2) The medicine shall not be supplied except by, or on and in
accordance with a prescription of, a duly registered medical practitioner
for the purposes of medical treatment, or a registered dentist for the p
purposes of dental treatment, or a duly qualified veterinary surgeon for
the purposes of animal treatment.

(3) In a case where a substance included in the First Schedule is
supplied, a record shall be kept on the premises in such a way that there
can readily be traced at any time during a period of 2 years after the date
on which the substance was supplied the following particulars--

(a) the name and quantity of the poison supplied;

(b) the date on which the poison was supplied;





(c)the name and address of the person to whom the poison was
supplied; and

(d)the name of the person who supplied the poison or who gave
the prescription upon which it was supplied.

(4) The container of the medicine shall be labelled-

(a)with a designation sufficient to identify the institution or
veterinary institution from which it was supplied;

(b)except in the case of a medicine made up ready for treatment,
with the word 'Poison';

(c)in the case of a poison supplied from a veterinary institution,
with the words 'For animal treatment only'.

(5) The medicine shall be clearly labelled with instructions for use
in English and in Chinese.

(6) In the case of a medicine to which regulation 16 applies the
requirements of that regulation shall be satisfied in addition to the
requirements of this regulation.

23. (1) In any institution in which medicines are dispensed in a
dispensing or pharmaceutical department in charge of a registered
pharmacist or any other person approved by the Director of Medical
and Health Services for that purpose, no medicine containing a poison
shall be supplied from that department, except in cases of emergency,
for use in the wards, operating theatres or other sections of the
institution, except in accordance with paragraphs (2) and (3).

(2) Subject to paragraph (4), the medicines shall not be supplied
except upon a written order signed by a duly registered medical
practitioner, registered dentist, or by a person authorized to be in charge
of a ward, theatre or other section of the institution.

(3) The container of the medicine shall be labelled-

(a) with words describing its contents;

(b)in the case of substances included in the First Schedule, with
a distinguishing mark or other indication indicating that the
poison is to be stored in a cupboard reserved solely for the
storage of poisons.

(4) In the case of an emergency, a medicine containing a poison
may be supplied without a written order if the person ordering the
medicine undertakes to furnish a written order in respect of that
medicine within the next 24 hours.

24. (1) In any institution in which medicines are dispensed in a
dispensing or pharmaceutical department in the charge of a person
appointed for the purpose, all poisons other than those issued for use
within the institution shall be stored in that department.





(2) In any institution to which paragraph (1) does not apply all
poisons other than those issued for use within the institution shall be
stored

(a)in the charge of a person appointed for the purpose by the
governing body or person in control of the institution; and

(b)in the case of substances included in the First Schedule either
in a cupboard or drawer, or on a shelf, reserved solely for the
storage of poisons.

(3) No poison shall be stored on an open shelf, unless the
container of the poison is distinguishable by touch from the containers
of any other substances stored in the same premises.

(4) In every institution, every substance in the First Schedule
which is stored in the wards shall be stored in a locked cupboard
reserved for the storage of poisons.

(5) All places in which poisons are required by this regulation to be
stored shall be inspected at regular intervals of time not exceeding three
months by a registered pharmacist or registered medical practitioner
appointed for the purpose by the governing body of the institution and
a record of all inspections shall be made in a book kept at the institution.

PART VA

LISTED SELLERS OF
POISONS

24A. (1) Any application under section 25(1) shall be made in
writing to the Committee and shall be accompanied by the fee specified
in the Ninth Schedule.

(2) The Committee may grant or refuse any application under this
regulation and shall notify the applicant of its decision:

Provided that if the Committee intends to refuse an application the
Committee shall first notify the applicant and the applicant may, not
later than 14 days after the date of such notification, submit
representations in writing to the Committee in support of his
application.

(3) Where the Committee grants an application under this
regulation the Committee shall notify the Board of its decision and shall
state whether the applicant has paid the prescribed fee.

(4) Any person aggrieved by a decision of the Committee under
this regulation may, in the prescribed manner, appeal to the Tribunal
against that decision.





PART VB

REGISTRATION OF PREMISES

24B. An application to register premises under section 13 shall
be-

(a)made to the Board in the form prescribed in the Eighth
Schedule; and

(b)submitted together with a copy of the certificate of registra-
tion of the registered pharmacist in whose presence or
under whose supervision the actual sale of poisons will be
conducted under section 11(1) of the Ordinance.

24C. A certificate of registration under section 13 shall be in
the form prescribed in the Eighth Schedule.

PART VI

WHOLESALE DEALERS

25. No person other than an authorized seller of poisons or a
licensed manufacturer selling pharmaceutical products of his own
manufacture only shall, by way of wholesale dealing, sell or supply
at or from any premises any substance or article consisting of or
containing any poison unless he is the holder of a wholesale poisons
licence issued to him by the Committee in respect of those premises.

26. (1) There shall be for the purposes of this Part a Com-
mittee to be called the Pharmacy and Poisons (Wholesale Licences)
Committee.

(2) [Deleted, L.N. 369180]

(3) The Committee may issue a wholesale poisons licence on
payment of the fee prescribed in the Ninth Schedule.

(4) The issue of a wholesale poisons licence shall be at the
discretion of the Committee and shall be in the form prescribed in
the Eighth Schedule.

(5) The Committee may revoke a wholesale poisons licence or
suspend it for such period as it thinks fit, if in its opinion the holder
has failed to comply with the conditions subject to which the licence
was issued or with any of these regulations, or has been convicted of
an offence under the Ordinance.

(6) Any person aggrieved by a decision of the Committee
under this regulation may, in the prescribed manner, appeal to the
Tribunal against that decision.

(7) [Deleted, L.N. 369180]





(8) An applicant for a wholesale poisons licence-

(a)shall nominate in writing a responsible person to be in
charge of poisons; and

(b)may nominate in writing a deputy to act during the
temporary absence of the responsible person.

(9) An applicant shall at the time of his application submit to
the Secretary of the Board the name of the person so nominated and
of any deputy, and shall advise the Secretary of any change within 7
days of its occurrence.

27. No person holding a wholesale poisons licence or a licence
to manufacture pharmaceutical products shall sell or supply any
poisons except to-

(a)another wholesale dealer duly licensed to sell poisons
wholesale;

(b) an authorized seller of poisons;

(c) a registered pharmacist;

(d)a registered medical practitioner, a registered dentist or a
duly qualified veterinary surgeon;

(e)persons who require the poison for the purpose of their
trade or business;

a Government department or public officer requiring the
article for the purposes of the public service;

(g)a person or an establishment concerned with education or
scientific research, if the article is required for the purposes
of such education or research;

(h) an institution;

(i) purchasers outside Hong Kong; or

(j) a listed seller of poisons:

Provided that only such poisons shall be supplied to a
listed seller of poisons as are included in the classes of
poisons in Part 11 of the Poisons List that the listed seller is
licensed to sell.

28. (1) The holder of a wholesale poisons licence or a licence
to manufacture pharmaceutical products shall record the following
particulars of all transactions whereby poisons included in Part 1 of
the Poisons List are acquired by him whether by way of import,
purchase, gift or otherwise-

(a) the date of the transaction;

(b) the name of the supplier;

(c) the name of the poison and unit of quantity;





(d) the total quantity of the poison;

(e) the nature of the transaction; and

(f)a reference to the invoice or other documents supporting the
transaction.

(2) The holder of a wholesale poisons licence or a licence to
manufacture pharmaceutical products shall record the following
particulars of all transactions for the disposition of poisons included in
Part 1 of the Poisons List, whether uncompounded or as part of a
pharmaceutical product and whether such disposition is by way of
export, sale, gift or otherwise

(a) the date of the transaction;

(b) the nature of the transaction;

(e) the name of the person to whom the poison is supplied;

(d)the quantity of the poison or pharmaceutical product, as the
case may be;

(e)a reference to the invoice or other documents supporting the
transaction;

(f)the name of the poison or pharmaceutical product, as the case
may be, and the unit of quantity;

(g)the balance of the poison remaining in his possession after
the transaction.

(3) For each poison in Part 1 of the Poisons List there shall be a
separate entry in the records and all transactions involving that poison
shall be entered in a part of the records reserved for that poison.

(4) Unless the Committee approves another system of recording, all
records of transactions involving poisons in Part 1 of the Poisons List
shall be made in the form prescribed in the Eighth Schedule.

(5) Every transaction to which these regulations relate shall be
recorded within 72 hours after the time it took place.

(6) Records of sales or supplies maintained under this regulation
shall be supported by documents signed by the purchaser.

(7) In the case of an export transaction the holder of a wholesale
poisons licence or a licence to manufacture pharmaceutical products
shall retain all shipping and other documents supporting the
transaction.

(8) A holder of a wholesale poisons licence or a wholesale dealer in
medicines not containing poisons shall set up and maintain a system of
control that will enable the rapid and, so far as practicable, complete
recall of any lot or batch of a pharmaceutical substance or product from
sale to the public in the event of the pharmaceutical substance or
product being found to be dangerous or injurious to health.





PART VII

MANUFACTURERS

29. (1) Subject to paragraph (2), no person shall manufacture
any pharmaceutical product on any premises unless he is the holder
of a licence to manufacture pharmaceutical products on those
premises.

(2) Paragraph (1) and regulations 33 and 35 shall not apply to
an authorized seller of poisons, who in the course of his retail
business, manufactures any pharmaceutical product at any premises
registered by him under the Ordinance in quantities which in the
opinion of the Board, are consistent with the scope of his business
and the nature of the product.

(3) The Committee may issue a licence to manufacture phar-
maceutical products in such form as it may prescribe on payment of
the fee prescribed in the Ninth Schedule.

(4) The Committee may revoke the licence or suspend it for
such period as it thinks fit, if, in its opinion, the licensee has failed to
comply with the conditions subject to which the licence was issued or
with any of these regulations.

(5) For the purpose of certifying that a manufacturer is licen-
sed under this regulation, the Committee, subject to any conditions
it may impose and to the payment of the fee prescribed in the Ninth
Schedule. may issue to the manufacturer-

(a) a certificate for manufacture; or

(b)an interim-certificate for manufacture, in the forms pre-
scribed in the Eighth Schedule.

(6) For the purpose of exporting pharmaceutical products
manufactured by a manufacturer licensed under this regulation, the
Committee may issue a free sale certificate in the form prescribed in
the Eighth Schedule subject to such conditions as the Committee
may impose and upon payment of the fee prescribed in the Ninth
Schedule.

(7) Any person aggrieved by a decision of the Committee
under this regulation may, in the prescribed manner, appeal to the
Tribunal against that decision.

30. (1) In all premises in which pharmaceutical products are
manufactured such products shall be manufactured by or under the
supervision of---.

(a) a registered pharmacist;

(b)a Fellow or Associate of the Royal Institute of Chemistry;
or

(c)a person having such other qualifications or sufficient ex-
perience as may be approved by the Board.





(2) For the purposes of paragraph (1), 'supervision' means the
exercise by any of the persons referred to in paragraph (1) of control
over the process of manufacture and of the persons engaged therein.

31. (1) Subject to paragraph (4), a manufacturer or authorized seller
of poisons, supplying for distribution under regulation 29(2), shall label
or cause to be labelled the container of each pharmaceutical product,
with the following particulars

(a) the appropriate designation of-

(i) the substance or substances from which the
pharmaceutical product was manufactured;

(ii) each of the active constituents of the product; or

(iii) each of the ingredients from which the product was
compounded;

(b)in the case where the appropriate designation of each of the
active constituents or ingredients of a product is given, the
appropriate quantitative particulars of those constituents or
ingredients;

(c) the name and address of the manufacturer; and

(d)the number of the certificate of drug/product registration or
the provisional certificate of drug/product registration of the
pharmaceutical product issued by the Board.

(2) For the purposes of paragraph(1)
(a)the expression 'appropriate designation', in relation to a
substance, constituent or ingredient, means

(i) in the case of a poison included in the Poisons List, the
name with which the container of the poison is for the time
being required to be labelled in accordance with regulation
13;

(ii) in the case where a substance, constituent or ingredient
is not a poison and is described in any of the monographs
contained in the edition of the British Pharmacopoeia, the
British Pharmaceutical Codex or the British Veterinary Codex
which was last published before the date on which the article
was sold or supplied, the description set out at the head of
that monograph; and

(iii) in any other case the accepted scientific name or the
name descriptive of the true nature and origin of the
substance, constituent or ingredient;

(b)the expression 'appropriate quantitative particulars', in
relation to the active constituent or ingredient of a
pharmaceutical product, means

(i) the percentage or quantity of that constituent or
ingredient contained in the pharmaceutical product sold or
supplied;or

(ii) in the case of a pharmaceutical product which is in pill,
capsule, tablet or similar article, either the percentage





or quantity of the substance or substances comprising or
forming part of the pills, capsules, tablets or similar articles, or
the quantity of each constituent or ingredient in each pill,
capsule, tablet or article.

(3) For the purposes of paragraph (1) the container to be labelled
shall, where the pharmaceutical product is packed by the manufacturer
in more than one container, be the container which is likely to be sold or
distributed to the ultimate user of the product.

(4) In the case of a pharmaceutical product intended for export it
shall be a sufficient compliance with this regulation if the container of
the product is labelled with the following particulars

(a) the name and address of the manufacturer; and

(b) such other details as the importing country may require.

32. A manufacturer shall take adequate steps to ensure that every
person engaged in the manufacturing or packing of pharmaceutical
products does not contaminate or infect such products.

33. (1) Subject to paragraph (IA), a manufacturer shall test each lot
or batch of raw or bulk material intended to be used in the manufacture
of pharmaceutical products to ensure identity and purity.

(IA) Raw or bulk material the identity and purity of which the
manufacturer thereof has certified by a certificate of analysis does not
require a test by a manufacturer under paragraph (1).

(2) A manufacturer shall test each batch of pharmaceutical
products in a finished form to ensure identity and potency.

(3) Every parenteral product shall be manufactured in accordance
with the method of preparation of injections laid down by the British
Pharmacopoeia or other Pharmacopoeia with which the particular
product is intended to comply.

(4) A manufacturer shall maintain a control sample of each batch of
finished products under conditions of storage suitable to that product
for a period of not less than the normal shelf-life of the product or 2
years after the last transaction in that batch of products whichever is
the shorter period.

(5) A manufacturer shall set up and maintain a system of control
that will enable the rapid and, so far as practicable, complete recall of
any lot or batch of a pharmaceutical substance or product from sale to
the public in the event of the pharmaceutical substance or product being
found to be dangerous or injurious to health.

34. (1) No pharmaceutical product shall be manufactured unless the
premises and the fittings and machinery therein used in the
manufacturing and packaging of such product are of such construction,
materials and finish as to

(a) permit the ready and efficient cleaning of all surfaces; and





(b)avoid the contamination of the product during manufac-
ture and packing.

(2) All premises used in the manufacturing, testing, packing
and despatch of pharmaceutical products shall be-

(a) suitable for the purpose; and

(b) maintained in a clean and orderly condition.

(3) The temperature and humidity of the premises shall be
controlled as appropriate to the manufacture of the product or the
process being carried out therein.

(4) All parenteral products shall be manufactured and put into
containers in an enclosed area in which aseptic conditions can be
maintained.

(5) The enclosed area referred to in paragraph (4) shall be
separate from the areas used for the manufacture and packing of
other pharmaceutical products.

35. (1) A manufacturer shall maintain adequate records in
respect of each pharmaceutical product prepared by him, showing---

(a)the quantities of all substances used in the manufacture of
the product;

(b) the quantity of the product manufactured;

(c)the name and the address of the person to whom the phar-
maceutical product was sold or supplied;

(d)the nature and results of tests made on each lot or batch of
raw or bulk materials used in the product;

(e)the nature and results of tests made on each batch of
finished product;

any complaints received relating to the product and the
action taken thereon by him; and

(g)the nature and result of any tests made on the samples
retained.

(2) The records required to be maintained by paragraph (1)
shall be completed within 72 hours from the time the process or test
was carried out or the transaction took place.

PART VIII

REGISTRATION OF PHARMACEUTICAL PRODUCTS AND SUBSTANCES

36. (1) Subject to paragraph (IA), no person shall sell, offer
for sale or distribute or possess for the purposes of sale, distribution
or other use any pharmaceutical product or substance unless the
product or substance is registered with the Board-





(a)by the manufacturer, if the pharmaceutical product or
substance is manufactured in Hong Kong;

(b)by the importer, if the pharmaceutical product or substance is
manufactured outside Hong Kong; or

(c)by the local branch, subsidiary, representative, agent or
distributor of an overseas manufacturer.

(IA) Nothing in paragraph (1) shall apply in the case of possession
or use where the pharmaceutical product or substance

(a) has been imported into Hong Kong-

(i) to be exported outside Hong Kong;

(ii) by a pharmaceutical manufacturer for the purpose of
manufacture or the compounding of pharmaceutical
preparations;

(iii) for the purpose of treatment by a registered medical
practitioner or a registered dentist, of a particular patient or,
for the purpose of treatment by a duly qualified veterinary
surgeon of a particular animal; or

(b)has been manufactured in Hong Kong to be exported outside
Hong Kong.

(2) Application for the initial registration of a pharmaceutical
product or substance shall be made in the form prescribed in the Eighth
Schedule and shall be accompanied by the fee prescribed in the Ninth
Schedule.

(3) The particulars to be registered shall include-

(a)the trivial, proprietary or approved name of the product or
substance;

(b)the chemical name in the case of a substance which has no
trivial, proprietary or approved name;

(c) details of the composition in the case of a product;

(d) the name and address of the manufacturer;

(e)the name and address of the person who applies for
registration; and

the quantity or quantities of the dose form contained in a unit
package or unit packages in the case of a product.

(4) Representative specimen sales packs of the product or
representative samples of the substance shall be made available for
inspection by the Committee. In the case of products not yet marketed
the Committee may accept prototypes of the packs and proposed
wordings of the labels on the understanding that these will be replaced
by actual sale packs not later than 6 months after registration of the
product or substance.

(5) The Committee may issue to an applicant a registration
certificate in the form prescribed in the Eighth Schedule valid for a
period of 5 years from the date of registration on payment of the fee
prescribed in the Ninth Schedule.





(6) The Committee shall advise the applicant whether the
pharmaceutical product or substance appears in the Poisons List and if
so, under which classification.

(7) A registration certificate issued under paragraph (5) shall be
renewable on payment of the fee prescribed in the Ninth Schedule.

(8) The Committee may deregister a pharmaceutical product or
substance if it considers it to be in the public interest to do so.

(8A) Where the Committee refuses to register or deregisters a
pharmaceutical product or substance it shall forward to the applicant or
permit holder, as the case may be, a notice of refusal or of deregistration
and shall state in such notice its reasons for refusal to register or for
deregistration.

(9) Any person aggrieved by a decision of the Committee under
this regulation may, in the prescribed manner, appeal to the Tribunal
against that decision.

(10) [Deleted, L.N. 369180]

(11) Any change in the particulars referred to in paragraph (3) shall
be reported to the Committee within 14 days.

36A. [Spent]

36B. (1) For the purpose of conducting a clinical trial on human
beings or a medicinal test on animals application shall be made in
writing to the Committee and shall be accompanied by the fee
prescribed in the Ninth Schedule.

(2) A sample of the product or substance and a copy of the
protocol for the trial or test shall accompany the application.

(3) The Committee may issue a clinical trial certificate or medicinal
test certificate in the form prescribed in the Eighth Schedule valid for a
period not exceeding 2 years on payment of the fee prescribed in the
Ninth Schedule.

(4) Any person aggrieved by a decision of the Committee under
this regulation may, in the prescribed manner, appeal to the Tribunal
against that decision.

36C. For the purposes of this Part 'pharmaceutical product' and
'substance' have the meaning assigned to 'pharmaceutical product'
and 'medicine' in the Ordinance.

36D. (1) The Committee may issue a duplicate of any certificate
issued under this Part if the Committee is satisfied that the original
certificate has been lost or destroyed or that for other good reason such
duplicate ought to be issued.





(2) A duplicate certificate issued under this regulation shall be
certified in such manner as the Committee may determine.

(3) There shall be payable in respect of any duplicate certificate
issued under this regulation the fee prescribed in respect thereof in the
Ninth Schedule.

37. (1) In dealing with an application for initial registration of a
pharmaceutical product or substance the Committee shall in particular
take into consideration

(a)the safety of the pharmaceutical product or substance to
which the application relates;

(b)the efficacy of the pharmaceutical product or substance for
the purposes for which the product or substance is proposed
to be administered; and

(c)the quality of the pharmaceutical product or substance
according to the specification and the method or proposed
method of manufacture of the product or substance, and the
provisions proposed for securing that the product or
substance as sold or supplied will be of that quality.

(2) In taking into consideration the efficacy for a particular purpose
of a pharmaceutical product or substance to which such an application
relates, the Committee shall leave out of account any question whether
a pharmaceutical product or substance of another description would or
might be equally or more efficacious for that purpose:

Provided that nothing in the paragraph shall be construed as
requiring the Committee, in considering the safety of a pharmaceutical
product or substance of a particular description, in relation to a purpose
for which it is proposed to be administered, to leave out of account any
question whether a pharmaceutical product or substance of another
description, being equally or more efficacious for that purpose, would or
might be safer in relation to that purpose.

(3) In dealing with an application by an importer the Committee
shall also take into consideration in particular the methods, standards
and conditions of manufacture of the pharmaceutical product or
substance in respect of which application is made and may, if it thinks
fit, require the production by the applicant of one or both of the
following

(a)an undertaking, given by the manufacturer of any such
products or substances, to permit the premises where they are
to be manufactured, and the operations carried on or to be
carried on in the course of manufacturing them, to be
inspected by or on behalf of the Committee;

(b)a declaration, given by or on behalf of the manufacturer of any
such products or substances, that, in relation to the
manufacture of these products any requirements imposed





by or under the law of the country in which they are or are to
be manufactured have been or will be complied with.

(4) The Committee shall make arrangements for the separate
processing of an application for the registration of a new pharmaceutical
product or new substance so that its registration shall not be unduly
delayed.

(5) For the purposes of paragraph (4) 'new pharmaceutical
product' and 'new substance' means a medicine containing an active
ingredient, or a substance, having a chemical formula which has not
previously been marketed or registered in Hong Kong under some other
name or description.

PART VIIIA

REGISTRATION OF IMPORTERS AND
EXPORTERS

37A. (1) Any application for registration under section 28A as an
importer or exporter of pharmaceutical products shall be made to the
Committee in Form 13 in the Eighth Schedule and shall be accompanied
by the fee specified in the Ninth Schedule.

(2) The Committee may require any applicant under this regulation
to furnish such information and to permit such inspection of premises
and storage facilities used by the applicant for the purposes of his
business as the Committee may specify by notice to the applicant.

(3) The Committee may grant or refuse any application under this
regulation as the Committee may deem fit.

(4) The Committee shall furnish any person whose application is
granted with a certificate in Form 14 in the Eighth Schedule.

(5) Any person aggrieved by a decision of the Committee under
this regulation may, in the prescribed manner, appeal to the Tribunal
against that decision.

PART IX

SALE OF MEDICINES

38. (1) Subject to these regulations, no person shall-

(a)sell any article consisting of or comprising a substance
recommended as a medicine; or

(b)supply any such article as a sample for the purpose of
inducing persons to buy the substances of which it consist
or which it comprises,

unless-

(i) the article is labelled as required under regulation 31; or





(ii) the particulars specified under regulation 3 1 (1) are printed
so as to be clearly legible in English or Chinese on the
article or a label affixed thereto.

(2) Nothing in this regulation shall apply to any article-

(a)made up and supplied for the use of a particular person,
being an article prescribed by reference to the needs of that
person; or

(b) consisting wholly of either-
(i) a product resulting solely from the pharmaceutical
treatment of natural products as referred to by the Chinese
Herbal Materia Medica;
(ii) a mixture the sole ingredients of which are two or
more of such products; or
(iii) a natural mineral water or an artificial imitation
thereof.

(3) For the purposes of this regulation-

'advertisement' includes any notice, circular, pamphlet, label,
wrapper or other document, and any announcement made
orally or by any means of producing or transmitting light or
sound;

'proprietary designation', in relation to the sale of an article
consisting of or comprising a substance recommended as a
medicine, means words used or proposed to be used in con-
nexion with the sale of articles consisting of or comprising the
substance, for the purpose of indicating that they are the goods
of a particular person by virtue of manufacture, selection,
certification, dealing with or offering for sale; and 'proprietor'
in relation to such a designation means the person whose goods
are indicated or intended to be indicated by the designation;

'substance' includes a preparation;

'substance recommended as a medicine', in relation to the sale of an
article consisting or comprising a substance so recommended,
means a substance which is referred to-

(a)on the article, or on any wrapper or container in which the
article is sold, or on any label affixed to, or in any
document enclosed in, the article or such wrapper or
container; or

(b)in any placard or other document exhibited at the place
where the article is sold; or

(c)in any advertisement published after the coming into
operation of these regulations by or on behalf of the
manufacturer of the article, or the person carrying on the
business in the course of which the article was sold, or, in a
case where the article was under a proprietary designation,
the proprietor of the designation,





in terms which are calculated to lead to the use of the substance for
the prevention or treatment of any ailment, infirmity or injury
affecting the human body, not being terms which give a definite
indication that the substance is intended to be used as, or as part
of, a food or drink, and not as, or as part of, a medicine.

PART X

MISCELLANEOUS

39. All-

(a) poisons books;

(b) books kept under section 28(3);

(c)certificates given under section 22(1)(a) kept by authorized
sellers of poisons;

(d)books or other form of records and documents required to be
kept or retained by holders of wholesale poisons licences
under regulation 28; and

(e)all records and documents required to be kept or retained by
manufacturers under regulation 35,

shall be preserved by the authorized seller of poisons, holder of
wholesale poison licence or manufacturer, as the case may be, in the
premises in which the transaction recorded took place

(i)for a period of 2 years from the date of the last entry therein;
or

(ii) in relation to a certificate or document, for a period of 2 years
from the date of the transaction.

40. (1) Any person who contravenes any of the provisions of
regulation 9(1) or (4), 10, 10A, 11, 12, 15, 16(1) or (2), 18, 19, 20, 2 1(1) or
(1), 22(2), (3), (4) or (5), 23(1), (2) or (3), 24, 25, 28, 30(1), 31(1), 32, 33(1),
(2), (3), (4) or (5), 34, 35, 36(1) or (11), 38(1) or 39 commits an offence and
is liable on conviction

(a) for a first offence to a fine of $2,500;

(b) for a second offence to a fine of $5,000;

(c)for a third or subsequent offence to a fine of $ 10,000 and to
imprisonment for 12 months; and

(d)to a further fine of $1,000 for every day during which any
offence continues subsequent to the date of the conviction
for the offence.

(2) Any person who contravenes regulation 27 commits an offence
and is liable on conviction to a fine of $10,000 and to imprisonment for
12 months.





(3) Any person who contravenes regulation 29(1) commits an
offence and is liable on conviction to a fine of $10.000 and to
imprisonment for 12 months, and to a further fine of $1,000 for every day
during which the offence continues subsequent to the date of the
conviction for the offence.

41. (1) The certificate referred to in section 22(1)(a) may be given by
any person known both to the intending purchaser and the intending
seller and shall be in the form prescribed in the Eighth Schedule.

(2) A certificate of registration issued under section 9 of the
Ordinance shall be in the form prescribed in the Eighth Schedule.

(M) The logo referred to in section 13A(1) shall be in the form
prescribed in the Eighth Schedule.

(3) The particulars of sales of poisons which are required by
section 22(3) to be entered in a book shall be entered in the form
prescribed in the Eighth Schedule.

(4) The fees to be paid under the Ordinance and these regulations
shall be those prescribed in the Ninth Schedule.

42. Where a person would, but for this regulation, be liable to a
penalty for not holding a licence to manufacture pharmaceutical
products, he shall not be so liable

(a) until the expiry of a period of 3 months immediately
following the commencement of these regulations; or

(b)where, before the expiry of that period, he applies for a licence,
until

(i) he obtains a licence; or

(ii) his application is refused.

FIRST SCHEDULE [regs. 3, 5(1), 6, 7,
15(3),17(3),19(2),
22(3), 23(3)(b),
24(2)(b), (4).]

SUBSTANCES FALLING WITHIN THE POISONS LIST TO WHICH
SPECIAL
RESTRICTIONS APPLY UNDER REGULATIONS 3 AND 5

A

Acebutolol; its salts Acetanilide; alkyl acetanilides
Acetohexamide Acctorphine; its salts; its esters and ethers; their
salts Acetylcarbromal Acetyldihydrocodeine; its salts
Alc)ofenae; its complexes A lcuronium; its salts





Alkaloids, the following; their quaternary compounds; any salts, simple or complex,
of any substance falling within the following-

Aconite, alkaloids of, except substances containing less than 0.02% of the
alkaloids of aconite

Atropine, except substances containing less than 0. 15% of atropine or not
more than 1 % of atropine methonitrate

Belladonna, alkaloids of, except substances containing less than 0.15% of the
alkaloids of belladonna calculated as hyoscyarnine

Brucine, except substances containing less than 0.2% of brucine
Calabar bean, alkaloids of

Coca, alkaloids of, except substances containing less than 0. 1 % of the alkaloids
of coca

Cocaine, except substances containing less than 0. 1 % of cocaine
Codeine, except substances containing less than 1.5% of codeine
Colchicum, alkaloids of
Coniine, except substances containing less than 0. 1 % of coniine
Cotarnine, except substances containing less than 0.2% of cotarnine
Curare, alkaloids of, curare bases

Ecgonine; its esters and ethers; except substances containing less than the
equivalent of 0.1% of ecgonine

Emetine, except substances containing less than 1 % of emetine
Ephedrine; its optical isomers; their salts; when contained in aerosol dispensers
Ergot, alkaloids of

Gelsemium, alkaloids of, except substances containing less than 0.1% of the
alkaloids of gelsemium

Homatropine, except substances containing less than 0. 15% of
homatropine
Hyoscine, except substances containing less than 0. 15% of hyoscine
Hyoscyarnine, except substances containing less than 0. 15% of hyoscine

Lobelia, alkaloids of, except substances containing less than 0.5% of the
alkaloids of lobelia

Morphine; its esters and ethers; except substances containing less than 0.2% of
morphine calculated as anhydrous morphine

Nicotine

Nux Vomica, alkaloids of, except substances containing less than 0.2% of
strychnine

Papaverine, except substances containing less than 1 % of papaverine

Pilocarpus, alkaloids of, except substances containing less than 0.5% of the
alkaloids of pilocarpus

Pomegranate, alkaloids of, except substances containing less than 0.5% of the
alkaloids of pomegranate

Quebracho, alkaloids of
Rauwolfia, alkaloids of., their derivatives

Sabadilla, alkaloids of, except substances containing less than 1 % of the
alkaloids of sabadilla







Stavesacre, alkaloids of, except substances containing less than 0.2% of the
alkaloids of stavesacre

Strychnine, except substances containing less than 0.2% of
strychnine
Thebaine, except substances containing less than 1 % of thebaine

Veratrum, alkaloids of, except substances containing less than 1 % of the
alkaloids of veratrum

Vinca, alkaloids of
Yohimba, alkaloids of

Allylisopropylacetylurea

Allylprodine; its salts

Almitrine; its salts

Alphadolone; its esters

Alphaxalone

Alprenolol; its salts





Alufibrate
Amantadine; its salts
Amidopyrine; its salts
Amiloride; its salts
Amineptine; its salts

Amino-alcohols esterified with benzoic acid, phenylacctic acid, phenylpropionic
acid, cinnamic acid or the derivatives of these acids; their salts (except
substances containing less than 10% of esterified amino-alcohols and except
procaine when in a preparation containing any substance to which the
Antibiotics Ordinance for the time being applies)

para-Aminobenzenesulphonamide; its salts; derivatives of para-
aminobenzenesulphonamide having any of the hydrogen atoms of the para-
amino group or of the sulphonamide group substituted by another radical; their
salts, except when contained in ointments or surgical dressings or in preparations
for the prevention and treatment of diseases in poultry

Aminoglutethirnide
Aminopterin; its derivatives
Aminorex; its salts

para-Aminosalicylic acid; its salts; its derivatives; their salts; any compound with
any substance falling within this item

Amitriptyline; its salts
Arnrinone
Amsacrine; its salts
Anrylene hydrate

Androgenic, oestrogenic and progestational substances, the
followingBenzoestrol

Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their
esters

Steroid compounds with androgenic or oestrogenic or progestational activity;
their esters

Anileridine; its salts

Antihistamine substances, the following; their salts; any compound with any
substance falling within this item

Antazoline
Doxylamine
Mebhydrolin

Tripelennamine

Antimonial poisons, except substances containing less than the equivalent of 1 %
of antimony trioxide

Antithymocyte Immunoglobulin

Apomorphine; its salts; its quaternary compounds; except substances containing
less than 0.2% of apomorphine

Aprindine; its salts

Arsenical poisons, except substances containing less than the equivalent of 0.0 1 %
of arsenic trioxide and except dentifrices containing less than 0.5% of acetarsol

Atenolol; its salts
Atracurium Besylate






Auranofin
Azacyclonal; its salts
Azapropazone





Azauridine; its derivatives
Aziridine; its derivatives
Baclofen
Barbituric acid; its salts; its derivatives; their salts; any compound with any substance
falling within this item
3Genactyzine; its salts
Benoxaprofen; its salts
Benzethidine; its salts
Benzhexol; its salts
Benzquinarnide
Benzoylmorphine; its salts
Benztropine and its homologues; their salts
Benzydamine; its salts
BenzyImorphine; its salts
Betaxolol; its salts
Bethanidine; its salts
Bezalibrate
Bezitramide; its salts
N-[4,4-Bis(para-fluorophenyl)butyllpiperidine, 4-substituted derivatives of, their
salts
Bitolterol and its salts when contained in aerosol dispensers
Bromocriptine; its salts
Bromvaletone
Bucolome
Buflexamac
Buformin; its salts
Bumadizone; its salts
Bumetanide; its salts; its derivatives; their salts
Bupranolol; its salts
Buprenorphine; its salts
Buserelin; its salts
Busulphan; its salts
Butorphanol; its salts
--3~c-annabinol and its tetrahydro derivatives; their 3-alkyl homologues; any ester or
ether of any substance falling within this item
Cannabis; the resin of cannabis; extracts of cannabis; tinctures of cannabis; cannabin
tennate
Cantharidin, except substances containing less than 0.01 % of cantharidin
Cantharidates, except substances containing less than the equivalent of 0.01% of
cantharidin
Captodiarnine; its salts
Captopril
Caramiphen; its salts
Carbachol
Carbamazepine





Carboplatin
Carbromal
Carbutamide
Carisoprodol
Carmustine
Carperidine; its salts
Carprofen; its salts
Carteolol; its salts
Chloral; its addition and its condensation products other than alphachloralose; any
compound with any substance falling within this item, except when contained, in
the form of chloral hydrate, in preparations intended for external application only
Chlordiazepoxide; its salts
Chlormethiazole; its salts
Chlormezanone
Chloroform, except substances containing not more than 5% of chloroform or when
in preparations not intended for the internal treatment of human ailments
Chlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonamide 1,
1-dioxide, whether hydrogenated or not; their salts
Chlorphenoxamine; its salts
Chlorphentermine; its salts
Chlorpropamide; its salts
Chlorprothixene and other derivatives of 9-methylenethiaxanthen; their salts
Chlorthalidone and other derivatives of ortho-chlorobenzene-sulphonamide
Chlorzoxazone
Chymopapain
Cisplatin
Clioquinol
Clobazam.
Clofibrate
Clomiphene; its salts
Clomipramine; its salts; its derivatives; their salts
Clonidine; its salts
Clonitazene; its salts
Clorexolone
Clorprenaline and its salts when contained in aerosol dispensers
Clothiapine
Colaspase
Collagen, purified
Corticotrophins
Corynebacterium parvum
4-Cyano-2-dimethylamino-4,4-diphenylbutane; its salts
4-Cyano-1-methyi-4-phenylpiperidine; its salts
Cyclarbamate
Cyclobenzaprine; its salts





Cyclofenil
Cyclosporin A
Cycrimine; its salts
Cytarabine; its salts
Dacarbazine
Deanol acetamidobenzoate
Debrisoquine; its salts
Dehydroemetine; its salts
Demecarium bromide
Desipramine; its salts
Desomorphine; its salts; its esters and ethers; their salts
DiacetyInalorphine; its salts
Diampromide; its salts
Diazepam and other compounds containing the chemical structure of dihydro-1,
4-benzodiazepine substituted to any degree; their salts
Diazoxide
Diclofenac; its salts
Diethyl para-nitrophenyl phosphate
Difenoxin; its salts
Diflunisal
DigitN#7glycosides and other active principles of, except substances containing less
than,6ne xinit of activity (as defined in the British Pharmacopoeia) in 2 grammes of
the ScbgrTn-ce
Dihydrallazine; its salts
Dihydrocodeine; its salts; its esters and ethers; their salts
Dihydrocodeinonc; its salts
Dihydrocodeinone 0-carboxymethyloximc; its salts; its esters; their salts
Dihydrocodeinone enol acetate; its salts
Dihydromorphine; its salts; its esters and ethers; their salts
3-(3,4-Dihydroxyphenyl)alanine; its salts
Dimenoxadole; its salts
Dimepheptanol; its salts; its esters and ethers; their salts
Dioxaphetyl butyrate; its salts
Diphenoxylate; its salts
Dipipanone; its salts
Disopyramide; its salts
Disulfiram
Dithienylallylamines; dithienylaikylallylamines; their salts
Dothiepin; its salts
Doxapram; its salts
Doxepin; its salts; its derivatives; their salts
Droperidol
Dyftos
Ecothiopate iodide





Ectylurea
Embutramide
Emylcamate
Enalapril; its salts
Ethacrynic acid; its salts
Ethambutol; its salts
Etlichlorvynol
Ethinamate
Ethionamide
Ethoglucid
Ethoheptazine; its salts
Ethylmorphine; its salts; its esters and ethers; their salts; except substances containing
less than 0.2% of ethyimorphine
EthyInoradrenaline; its salts
Etidronic acid; its salts
Etodolac
Etofibrate
Etomidate; its salts
Etonitazene; its salts
Etoposide
Etorphine; its salts; its esters and ethers; their salts
Etoxeridine; its salts

Fencarnfamin; its salts
Fenclofenac; its salts
Fendiline; its salts
Fenfluramine; its salts
Fenofibrate
Fenoprofen; its salts
Fenoterol and its salts when contained in aerosol dispensers
Fenoxazoline; its salts
Fentanyl; its salts
Fentiazac; its salts
Feprazone
Flecainide; its salts
Fluanisone
Flufenarnic acid; its salts; its esters; their salts
Fluorouracil; its derivatives
Flupenthixol; its salts
Flurbiprofen
Fluspirilene
Flutamide





Frusemide
Furethidine; its salts
Gallamine its salts; its quaternary compounds
Gemfibrozil
Glibenclamide
Glibornuride
Gliclazide
Glipizide
Gliquidone
Glutethimide; its salts
Glymidine
Guanabenz; its salts
Guanethidine; its salts
Guanfacine; its salts

Guanidines, the following Polymethylene diguanidines; di-para-anisyl-para-
phenetylguanidine; their salts

Halofuginone; its salts

Haloperidol and other 4-substituted derivatives of N-(3-parafluorobenzoyl-propyl)
piperidine

Hexachlorophane contained in medicinal products except (a) in the case of
medicinal products for human use substances containing 0. 1 % or less; and (b) in
the case of medicinal products for animal use (i) aerosols the contents of the
container of which contain 0. 1 % or less; (ii) soaps and shampoos containing
2% or less; (iii) other medicinal products containing 0.75% or less; and (c)
preparations for oral administration to sheep or cattle for liver fluke disease

Hexamethylmelamine
Hexapropyrnate
Hydiazines, the following and their alpha-rnethyl derivatives-

Benzyl hydrazine

Phenethyl hydrazine

Plienoxyethyl hydrazine

their salts; their acyl derivatives; their salts
Hydrallazine; its salts

Hydrocyanic acid, except substances containing less than 0.15%, weight in weight,
of hydrocyanic acid (HCN); cyanides, other than ferrocyanides and ferricyanides,
except substances containing less than the equivalent of 0. 1 % weight in weight,
of hydrocyanic acid (HCN)

Hydromorphinol; its salts; its esters and ethers; their salts
Hydromorphone; its salts'. its esters and ethers; their salts

Hydroxycinchoninic acids; derivatives of, their salts; their esters; except substances
containing less than 3% of hydroxycinchoninic acid or a derivative thereof

Hydroxy-N,N-dimethyltryptarnines; their esters and ethers; any salt of any
substance falling within this item

3-Hydroxy-N-methyimorphinan; its salts; its optical isomers; their salts

3-Hydroxymorphinan; its salts; its optical isomers; their salts; their esters and
ethers; their salts

3-Hydroxy-N-phenacylmorphinan; its salts; its optical isomers; their salts; their
esters and ethers; their salts







Hydroxypethidine; its salts; its esters and ethers; their salts





Hydroxyphenamate
Hydroxyurea
Hydroxyzine; its salts
Ifosfamide
Imipramine; its salts
Indomethacin; its salts
Indoprofen; its salts
Indoramin; its salts
1prindole; its salts
Isoaminile; its salts
Isoetharine; its salts
Isomethadone; its salts
Isoniazid; its salts; its derivatives; their salts; any compound with any substance
falling within this item
Isoprenaline; its salts
Isopyrin; its salts
Isotretinoin
Isoxicam; its salts
Ketamine; its salts
Ketobemidone; its salts; its esters and ethers; their salts
Ketoconazole
Ketophenylbutazone
Labetalol; its salts
Laudexium; its salts
Lead, compounds of, with acids from fixed oils
Lithium carbonate
Lithium Sulphate
Lomustine
Lonazolac; its salts
Lorcainide; its salts
Loxapine; its salts
Lysuride; its salts
Mannomustine; its salts
Maprotiline; its salts
Mazindol
Mebezonium iodide
Mebutamate
Mecarnylamine; its salts
Meclofenamic Acid; its salts
Meclofenoxate; its salts
Mefenamic acid; its salts; its esters; their salts
Mefruside
Mephenesin; its esters; their salts





Mephenoxalone
Mepirizole
Meprobamate
alpha-Meprodine; its salts
beta-Meprodine; its salts
Mercaptopurine; its salts; its derivatives; their salts

Mercuric chloride, except substances containing less than 1% of mercuric chloride;
mercuric iodide, except substances containing less than 2% of mercuric iodide;
nitrates of mercury, except substances containing less than the equivalent of 3%,
weight in weight, of mercury (Hg); potassiomercuric iodides, except substances
containing less than the equivalent of 1 % of mercuric iodide; organic
compounds of mercury, except substances, not being aerosols, containing less
than the equivalent of 0. 3 %, weight in weight, of mercury (Hg)

Mescaline; its salts; other derivatives of phenethylamine formed by substitution in
the aromatic ring; their salts

Metaxalone
Metazoeine; its salts; its esters and ethers; their salts
Metergoline
Metformin; its salts
Methadone; its salts
Methadyl acetate; its salts
Methaqualone; its salts
Methixene; its salts
Methocarbamol

Methorphan; its salts; its optical isomers; their salts; except substances containing
less than 1.5% of dextromethorphan

Methoxsalen
Methoxyphenamine; its salts
Methylaminoheptane; its salts
MethyIdesorphine; its salts; its esters and ethers; their salts
MethyIdihydromorphine; its salts; its esters and ethers; their salts
MethyIdopa.; its esters; their salts
2-Methyl-3-morpholino- 1, I-diphenylpropanecarboxylic acid; its salts; its esters;
their

salts
Methylpentynol; its derivatives
alpha-Methylpenethylamine; beta-methylphenethylamine; alpha-ethylphenethylamine;
beta-ethylphenethylamine; their optical isomers; any synthetic
compound structurally derived from any of those substances by subsitution in the
aliphatic part or by ring closure therein (or by both such substitution and such
closure) or by substitution in the aromatic ring (with or without substitution at
the nitrogen atom), except hydroxyamphetamine, methoxyphenamine, phenylpropanolamine,
pholedrine, prenylamine and N-subsituted derivatives of ephedrine; any salt of any
substance falling within this item

Methylphenidate; its salts
1-Methyl-4-phenylpiperidine-4-carboxylic acid; its salts; its esters; their
salts

Methyprylone
&etoclopramide; its salts
Metolazone
Metopon; its salts; its esters and ethers; their salts
Metoprolol; its salts





Mexiletine; its salts
Mianserin; its salts
Minoxidil
Mitobronitol
Mitopodozide; its salts
Mitotane
Mitoxantrone; its salts
Mofebutazone; its salts
Molindone; its salts
Moramide; its salts; its optical isomers; their salts
Morpheridine; its salts
Mustine and any other N-substituted derivative of di-(2-chloroethyl)afnine; their salts
Muzolimine
Myrophine; its salts
Myrtecaine; its salts
Nadolol; its salts
Nalbuphine; its salts
Nalorphine; its salts
Naproxen; its salts
Nefopam; its salts
Niclofolan
Nicocodine; its salts
Nifenazone
Niflumic Acid; its salts
Nitromethaqualone; its salts
Nomifensine; its salts
Noracymethadol; its salts
Noramidopyrine methanesulphonate; its salts
Norcodeine; its salts; its esters and ethers; their salts
Norfloxacin; its salts; its esters
Normethadone; its salts
Normorphine; its salts; its esters and ethers; their salts
Norpipanone; its salts
Nortriptyline; its salts
Ofloxacin; its salts; its esters
Opipramol; its salts; its derivatives; their salts
Opium, except substances containing less than 0.2% of morphine calculated as
anhydrous morphine
Orciprenaline; its salts
Orphenadrine; its salts
Ouabain
Oxanamide
Oxethazaine; its salts





Oxprenolol; its salts
Oxycinchoninic acid; its derivatives; their salts; their esters
Oxycodone; its salts; its esters and ethers; their salts
Oxymorphone; its salts; its esters and ethers; their salts
Oxypertine
Oxyphenbutazone
Oxytocins
Pancuronium; its salts
Paraldehyde
Paramethadione
Pargyline; its salts
Pemoline; its salts
Pernpidine; its salts
Penbutolol; its salts
Penicillamine; its salts
Pentazocine; its salts
Pentolinium; its salts
Phenacemide
Phenacctin
Phenadoxone; its salts
Phenaglycodol
Phenampromide; its salts
Phenazoeine; its salts; its esters and ethers; their salts
Phenbutrazate
Phencyclidine; its salts
Phenetidylphenacctin
Phenformin; its salts
Phenomorphan; its salts; its esters and ethers; their salts
Phenoperidine; its salts; its esters and ethers; their salts
Phenothiazine; its salts; its derivatives (except dimethoxanate and promethazine);
their salts (except salts of dimethoxanate and promethazine); any compound with
any substance falling within this item
Phenprenazone
Phenprobarnate
Phenylbutazone; its salts
2-Phenyleinchoninic acid; 2-salicylcinchoninic acid; their salts; their esters
5-Phenyihydantoin; its alkyl and aryl derivatives; their salts
4-Phenylpiperidine-4-carboxylic acid ethyl ester; its salts
Pholcodine; its salts; its esters and ethers; their salts; except substances containing less
than 1.5% of pholcodine
Picrotoxin
Piminodine; its salts
Pipobroman
Piritramide; its salts





Piromidic acid; its salts
Piroxicam
Pirprofen; its salts
Pituitary gland, the active principles of, other than corticotrophins, oxytocins and
vasopressins
Polymethylenebistrimethylammoidum salts
Prazosin; its salts
Primidone
Prindolol; its salts
Probucol
Procainamide; its salts
Procarbazine; its salts
Procaterol and its salts when contained in aerosol dispensers
Procyclidine; its salts
alpha-Prodine; its salts
beta-Prodine; its salts
Proglumetacin; its salts
Proheptazine; its salts
Promoxolane
Propafenone; its salts
Propanidid
Propofol
Propoxyphene; its salts; its optical isomers; their salts
Propranolol; its salts; its derivatives; their salts
Propylhexedrine; its salts
Proquazone
Prostaglandins, the following and their derivatives-
Alprostadil
Dinoprost
Dinoprostotle
Misoprostol
their salts; their esters
Prothionamide
Prothipendyl; its salts
Protriptyline; its salts; its derivatives; their salts
Pyrazinamide
PyrithyIdione
Quinethazone
Quinidine; its salts
Quinine; its salts; its derivatives; their salts
Reproterof and its salts when contained in aerosol dispensers
Rimiterol and its salts when contained in aerosol dispensers
Rosoxacin; its salts
Salbutamol and its salts when contained in aerosol dispensers
Savin, oil of





Sotalol; its salts
Spironolactone
Strophanthus, glycosides of
Styramate
Sulindac
Sulphinpyrazone
Sulphonal; alkyl sulphonals
Sulpiride
Sultopride
Suprarenal gland, the active principles of, except adrenaline and noradrenaline
(other
than when contained in aerosol dispensers); their salts, except salts of adrenaline
(other than when contained in aerosol dispensers); their derivatives; their salts
Sutoprofen; its salts
Suxamethonium; its salts
Syrosingopine

Tamoxifen;.moxifen; its salts
Teniposide
Terbutaline and its salts when contained in aerosol dispensers
Tetrabenazine; its salts
Tetracosatrin; its salts
Thalidomide; its salts
Thallium, salts of
Theofibrate
Thiacetazone
Thiocarlide; its salts
Thiotepa
Thyroid gland, the active principles of., their salts
Tilidate; its salts
Timolol; its salts
Tinoridine; its salts
Todralazine; its salts
Tofenacin; its salts
Tolazamide
Tolbutamide
Tolfenamic Acid; its salts
Tolmetin; its salts
Tolperisone; its salts
Tranyleypromine; its salts
Trazodone; its salts
Tretamine; its salts
Triarnterene; its salts
Triaziquone
Tribromoethyl alcohol





2,2,2-Trichloroethyl alcohol, esters of, their salts
Trilostane
Trimeperidine; its salts
Trimetaphan; its salts
Trimethadione
Trimetozine
Trimipramine; its salts
Trioxsalen
Tybamate
Urapidil; its salts
Urethane
Valnoctamide
Valproic acid; its salts; its esters
Vasopressins
Vencuronium; its salts
Verapamil; its salts
Viloxazine; its salts
Vindesine; its salts
PC- melidine; its salts
zi
Zomepirac; its salts
Zoxazolarnine; its salts

B

Barium, salts of, except barium sulphate
alpha-Chlorohydrin Crimidine
Dimetilan
Dinitrocresols (DNOC), their compounds with a metal or a base, except preparations
for use in agriculture or horticulture
Dinitronaphthols; dinitrophenols; dinitrothymols
Fluoroacetamide; fluoroacetanilide
Monofluoroacetic acid; its salts
meta-Nitrophenol; ortho-nitrophenol; para-nitrophenol
Organo-tin compounds, the following-
Compounds of fentin
Phosmet
Pyriminil
Zinc phosphide

SECOND SCHEDULE [reg. S.]

ARTICLES EXEMPTED BY REGULATION 8 FROM THE PROVISIONS OF
TKE ORDINANCE AND OF THESE REGULATIONS

GROUP 1

GENERAL EXEMPTIONS

Adhesives; agricultural pesticides; anti-fouling compositions; builders' materials;
ceramics; distempers; electrical valves; enamels; explosives; fillers; fireworks; fluores-





cent lamps; glazes; glues; inks; lacquer solvents; loading materials; matches; motor
fuels and lubricants; paints other than pharmaceutical paints; photographic paper;
pigments; plastics; propellants; rubber; varnishes

GROUP 11

SPECIAL ExEmPTIONS

A

Poison Substance or article in which exempted

Alkaloids, the following-
Brucine Surgical spirit containing not more than 0.015%
of brucine

Emetine lpecacuanha; extracts and tinctures of ipeca-
cuanha; substances containing less than 0.05%
of emetine
Ephedra, alkaloids of Substances containing less than 1% of the alka-
loids of ephedra, their optical isomers
Lobelia, alkaloids of Preparations for the relief of asthma in the form
of cigarettes, smoking mixtures or fumigants;
substances containing less than 0. 1 % of the
alkaloids of lobelia
Pilocarpus, alkaloids of Substances containing less than 0.025% of the
alkaloids of pilocarpus, preparations contain-
ing not more than 2%, weight of the
sulphate salt of transpilosine
Pomegranate, alkaloids of Pomegranate bark
Stavesacre, alkaloids of Soaps; ointmentsl lotions for external use
para-Aminobenzenesulphona- Feeding stuffs containing not more than 0.5% of
mide; its salts; derivatives total sulphonamides
of para-aminobenzenesul-
phonamidehavinganyofthe
hydrogen atoms of the
para amino gropup of of
the sulphonamide group
substituted by another
radical; their salts
Androgenic, oestrogenic and Preparations intended for external application
progestational substances, only; except preparations containing more than
the following- 4 milligrammes of oestrogenic substance per
Benzoestrol 100 grammes of inert substance
Derivatives of stilbene,
dibenzyl or naphth-
alene with oestrogenic
activity; their esters
Steroid compounds with preparations intended to be taken orally for con-
androgenic or traceptive purposes only which contain not
oestrogenic or more than 50 microgrammes of oestrogenic
progestational substance and not more than 5 milligammes
activity; their esters of progestational substance; multivitamin
preparations with or without minerals contain-
ing not more than 0.01 Ing. ethinyloestradiol or
not more than 2.5 rng. Methyltestosterone or
both in each dosage form
Antihistamine substances; Preparations intended for external application
their salts; any compound only and preparations containing not more
with any substance failing than 1 % of anti-histamine substances for appli-
within this item cation in the nose or eye





Poison Substance or article in which exempted
Arsenical posions Poultry or pig feeding stuffs containing not more
than 0.005% of 4-hydroxy-3-nitrophenylarso-
nic acid and not containing any other arsenical
posion; animal feeding stuffs containing not
more than 0.01% of arsenilic acid and not
containing any other arsenical poison; poultry
feeding stuffs containing not more than
0.0375% of carbarsone and not containing any
other arsenical poison;
medicines containing arsenic in a non-assimilable
form
Barbituric acid; its salts; its Self-heating preparations, in aerosol dispensers
derivatives; their salts; any intended for external application only, contain-
compound with any sub- ing 1, 5-diethyl-2-thio-4, 6-pyrimidine-dione
stance falling within this and not containing any other substance men-
item tioned opposite hereto in the first column
Chloroform Substances containing less than 1 % of chloro-
form; solid preparations; toothpaste
Clioquinol Preparations intended for external application
only
Creosote obtained from wood Substances containing less than 50% of creosote
obtained from wood
Diperodon; its salts Preparations intended for external application
only, containing not more than 1 % of dipero-
don, calculated as anhydrous base
Hydrocyanic acid Preparations of wild cherry; in reagent kits sup-
plied for medical or veterinary purposes; sub-
stances containing less than the equivalent of
0.1%, weight in weight, of hydrocyanic acid
(HCN)
Lead acetate Substances containing less than 4% of lead
acetate
Lead, compounds of Machine-spread plasters
Lignocaine; its salts Preparations intended for external application
only, containing not more than 0.7% of Ligno-
caine or its salts
Mercury, nitrates of Ointments containing less than the equivalent of
3%, weight in weight, of mercury (Hg)
Mescaline; its salts Living plants
Phenols Butylated hydroxytoluene, carvacrol, creosote
obtained from coal tar;
essential oils in which phenols occur naturally;
medicines containing less than 1 % of phenols;
nasal sprays, mouth washes, pastilles, lozenges,
capsules, pessaries, ointments or suppositories
containing less than 2.5% of phenols, in reagent
kits supplied for medical or veterinary pur-
poses;
smelling bottles;
soaps for washing;
solid substances, other than pastilles, lozenges,
capsules, pessaries, ointments and supposi-
tories, containing less than 60% of phenols;
Tar (coal or wood), crude or refined;
para-tertiary amylphenol;
tertiary butylcresol;
para-tertiary butylphenol;
para-(1, 1, 3, 3-tetramethylbutyl) phenol;
thymol





Poison Substance or article in which exempted
Phenyl mercuric salts Toilet, cosmetic and therapeutic preparations
containing not more than 0.01% of phenyl
mercuric salts as preservative; antiseptic dress-
ings on toothbrushes; in textiles containing
not more than 0.01 % of phenyl mercuric salts
as a bacteriostat and fungicide
Picric acid Substances containing less than 5% of picric acid
Podophyllum resin Preparations containing not more than 1.5%,
weight in weight, of podophyllum resin
Procaine Feeding stuffs containing any substance to which
the Antibiotics Ordinance for the time being
applies
Quinine; its salts; its Preparations containing not more than 1% of
derivatives; their salts quinine, its salts, its derivatives or their salts;
soft drinks, wines or tonic wines; preparations
containing not more than 15% of quinine, its
salts, its derivatives or their salts for use in
the manufacture of soft drinks, wines, tonic
wines, or confectionery
Sodium ethyl mercurithio- Therapeutic substances containing less than 0. 1 %
salicylate of sodium ethyl mercurithiosalicylate as a
preservative
Sodium fluoride Substances containing less than 3% of sodium
fluoride as a prescrative; dentifrices contain-
ing not more than 0.3% of sodium fluoride;
mouth wash tables containing not more than
0.2% of sodium fluoride and liquid mouth
washes containing not more than 0.05% there-
of; tablets containing not more than 0.016%,
weight in weight, of sodium fluoride and
intended, when chewed to prevent tooth decay

B
Acetanilide; alkyl acetanilides Substances not being preparations for the treat-
ment of human ailments
Ammonia Substances not being solutions of ammonia or
preparations containing solutions of ammonia;
substances containing less than 5%, weight
in weight, of ammonia (NH3); refrigerators;
smelling bottles
Antimony, chlorides of Polishes
Arsenical poisons Pyrites ores or sulphuric acid containing arsenical
poisons as natural impurities
Barium, salts of Witherite other than finely ground witherite;
barium carbonate bonded to charcoal for
case hardening; fire extinguishers containing
barium chloride
gamma-Benzene Substances containing not more than 5% by
hexachloride weight of gamma-benzene hexachloride; when
used in agriculture or horticulture
Chlordane Substances containing not more than 5% by
weight of chlordane; when used in agriculture
or horticulture
Dicophane Substances containing not more than 5% by
weight of dicophane; when used in agriculture
or horticulture
Diamines, the following; their Substances other than preparations for the dyeing
salts-phenylene diamines; of hair
toluene diamines; other
alkylated-benzenediamines





Poison Substance or article in which exempted
Dinitrophenols Substances not being preparations for the treat-
ment of human ailments
Disulfiram Substances not being preparations for the treat-
ment of human ailments
Formaldehyde Substances containing less than 5%, weight in
weight, of formaldehyde (H. CHO); photo-
graphic glazing or hardening solutions
Formic acid Substances containing less than 5%, weight in
weight, of formic acid (H. COOH)
Hydrochloric acid Substances containing less than 9%, weight in
weight, of hydrochloric acid (HCI)
Mercuric chloride Batteries
Mercuric chloride; mercuric Dressings on seeds or bulbs
iodide; organic compounds
of mercury
Mercury, oxides of Canker and wound paints (for trees) containing
riot more than 3%, weight in weight, of yellow
mercuric oxide
Nicotine Tobacco; preparations in aerosol dispensers con-
taining not more than 0.2% of nicotine, weight
in weight; other liquid preparations and solid
preparations with a soap base, containing not
more than 7.5 % of nicotine, weight in weight
Nitric acid Substances containing less than 9%, weight in
weight, of nitric acid (HN02)
Nitrobenzene Substances containing less than 0. 1 % of nitroben-
zene; soaps containing less than 1 % of nitroben-
zene; polishes
para-Nitrobenzyl cyanide Photographic solutions containing less than the
equivalent of 0. 1 %, weight in weight, of hydro-
cyanic acid (HCN)
para-Nitrophenol Preparations for use in agriculture or horticulture
containing not more than 0.5% of para-Nitro-
phenol as preservative
Oxalic acid; metallic oxalates Laundry blue; polishes; cleaning powders or
scouring products containing the equivalent of
not more than 10% of exalic acid dihydrate
Phosphoric acid Substances containing phosphoric acid, not being
descaling preparations containing more than
50%, weight in weight, of ortho-phosphoric
acid
Potassium hydroxide Substances containing the equivalent of less than
17% of total caustic alkalinity expressed as
potassium hydroxide; accumulators, batteries
Sodium hydroxide Substances containing the equivalent of less than
12% of total caustic alkalinity expressed as
sodium hydroxide
Sodium nitrite Substances other than preparations containing
more than 0. 1 % of sodium nitrite for the des-
truction of rats or mice
Sodium silicofluoride Substances containing less than 3% of sodium
silicofluoride as preservative
Sulphaquinoxaline; its salts Preparations for the destruction of mice and rats
containing not more than the equivalent of
0.5% of sulphaquinoxaline
Sulphuric acid Substances containing less than 9%, weight in
weight, of sulphuric acid (H2S04); accumula-
tors;
batteries and scaled containers in which sul-
phuric acid is packed together with car batter-
ies for use in those batteries; fire extinguishers





THIRD SCHEDULE [reg. 9(1)_]
A
SUBSTANCES REQUIRED BY REGULATION 9 TO BE SOLD BY RETAIL ONLY UPON
A PRESCRIPTION GIVEN BY A REGISTERED MEDICAL PRACTITIONER,
REGISTERED DENTIST OR DULY QUALIFIED VETERINARY SURGEON
Acebutolol; its salts
Acetanilide; alkyl acetanilides
Acetohexamide
Acetylcarbromal
Alclofenac; its complexes
curonium; its salts
VAIllylisopropylacetylurea
Almitrine; its salts
Alphadolone; its esters
Alphaxalone
Alprenolol; its salts
Alulibrate
Amantadine; its salts
Amidopyrine; its salts
Amiloride; its salts
Amineptine; its salts
para-Arninobenzenesulphonamide; its salts; derivatives of para-aminobenzene-
sulphonamide having any of the hydrogen atoms of the para-amino group or of the
sulphonamide group substituted by another radical; their salts; except when
contained in preparations intended for external application or surgical dressings or
in preparations for the prevention and treatment of diseases in poultry
Aminoglutethirnide
Arninopterin; its derivatives
Aminorex; its salts
para-Arninosalicylic acid; its salts; its derivatives; their salts; any compound with any
substance falling within this item
Amitriptyline; its salts
Amrinone
Amsacrine; its salts
Amyiene hydrate
Androgenic, oestrogenic and progestational substances, the following-
Benzoestrol
Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their
esters
Steroid compounds with androgenic or oestrogenic or progestational activity; their
esters
Antihistamine substances, the following; their salts; any compound with any sub-
stance falling within this item-
Antazoline
Doxylamine
Mebhydrolin
Tripelennamine
Antithymocyte Immunoglobulin
Aprindine; its salts
Atenolot; its salts
Atracurium. Besylate
Auranofin
Azacyclonol; its salts
Azapropazone





Azauridine; its derivatives
Aziridine; its derivatives
Baclofen
Barbituric acid; its salts; its derivatives; their salts; any compound with any substance
t;_' falling within this item
Renactyzine; its salts
Benoxaprofen; its salts
Bewquinamide
Betaxolol; its salts
Bethanidine; its salts
Bezafibrate
N-[4,4-Bis(para-fluorophenyl)butyllpiperidine,4-substituted derivatives of; their salts
Bitolterol and its salts when contained in aerosol dispensers
Bromocriptine; its salts
Bromvaletone
Bucolome
Bufexamac
Buformin; its salts
Bumadizone; its salts
Bumetanide; its salts; its derivatives; their salts
Bupranolol; its salts
Buprenorphine; its salts
Buserelin; its salts
Rusulphan; its salts
Butorphanol; its salts
Captodiamine; its salts
Captopril
Caramiphen; its salts; except tablets containing not more than the equivalent of 7.5
milligrammes of caramiphen base and liquid preparations containing not more
than the equivalent of 0. 1 % of caramiphen base
Carbamazepine
Carboplatin
Carbromal
Carbutamide
Carisoprodol
Carmustine
Carprofen; its salts
Carteolol; its salts
Chloral; its addition and its condensation products other than alphachloralose, any
compound with any substance failing within this item; except when contained, in
the form of chloral hydrate, in preparations intended for external application only
Chlordiazepoxide; its salts
Chlormethiazole; its salts
Chlormezanone
Chlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonaniide 1,
1-dioxide, whether hydrogenated or not; their salts
Chlorphentermine; its salts





Chlorproparnide; its salts
Chlorprothixene and other derivatives of 9-methylenethiaxanthen; their salts
Chlorthalidone and other derivatives of ortho-chlorobenzene sulphonamide
Chlorzoxazone
Chymopapain
Cisplatin
Clioquinol
Clobazam
Clofibrate
Clomiphene; its salts
Clomipramine; its salts; its derivatives; their salts
Clonidine; its salts
Clorexolone
Clorprenaline and its salts when contained in aerosol dispensers
Clothiapine
Colaspase
Colchicum, alkaloids of, their salts
Collagen, purified
Corticotrophins
Corynebacterium parvum
Cyclarbamate
Cyclobenzaprine; its salts
Cyclofenil
Cyclosporin A
Cytarabine; its salts
Dacarbazine
Deanol acetamidobenzoate
Debrisoquine; its salts
Demecarium bromide
Desipramine; its salts
Diazeparn and other compounds containing the chemical structure of dihydro-1,
4-benzodiazepine substituted to any degree; their salts
Diazoxide
Diclofenac; its salts
3-(3,4-Dihydroxyphenyl)alanine; its salts
Dihydrallazine; its salts
Disopyramide; its salts
Disulfiram
Dithienylallylamines; dithienylaikylailylamines; their salts; except diethylthiambut-
ene, dimethylthiarnbutene and ethyImethylthiambutene
Dothiepin; its salts
Doxapram; its salts
Doxepin; its salts; its derivatives; their salts
Droperidol
Ectylurea





Emylcamate
Enalapril; its salts
Ephedrine; its optical isomers; their salts; when contained in aerosol dispensers
Ethaerynic acid; its salts
Ethambutol; its salts
Ethchlorvynol
Ethinamate
Ethionamide
Ethoglucid
EthyInoradrenaline and its salts when contained in aerosol dispensers
Etidronic acid; its salts
Etodolac
Etofibrate
Etomidate; its salts
Etoposide
tretinate
enbufen
Fencarnfarnin; its salts
Fenclofenac; its salts
Fendiline; its salts
Fenofibrate
Fenoprofen; its salts
Fenoterol and its salts when contained in aerosol dispensers
Fenoxazoline; its salts
Fentiazac; its salts
Feprazone
Flecainide; its salts
Flufenamic acid; its salts; its esters; their salts
Fluorouracil; its derivatives
Flupenthixol; its salts
Flurbiprofen
Fluspirilene
Flutamide
Frusemide
Gallamine; its salts; its quaternary compounds
Gernfibrozil
Glibenclarnide
Glibornuride
Gliclazide
Glipizide
Gliquidone
Glutethimide; its salts





Glymidine
Guanabenz; its salts
Guanethidine; its salts
Guanfacine; its salts
fHalofuginone; its salts; except for incorporation in feed for chickens for fattening at
levels not exceeding 3 parts per million
Haloperidol and other 4-substituted derivatives of N-(3-para-fluoro-benzoyl-propyl)
piperidine
Hexamethylmelamine
Hexapropymate
Hydrallazine; its salts
Hydrazines, the following and their alpha-methyl derivatives-
Benzyl hydrazine
Phenethyl hydrazine
Phenoxyethyl hydrazine
their salts; their acyl derivatives; their salts
Hydroxy-N,N-dimethyltryptarnines; their esters and ethers; any salt of any substance
failing within this item
Hydroxyphenamate
Hydroxyurea
Hydroxyzine; its salts
Ifosfamide
lmipramine; its salts
Indomethacin; its salts
Indoprofen; its salts
Indoramin; its salts
-7prindole; Tits salts
Isoarninile; its salts
Isoetharine and its salts when contained in aerosol dispensers
Isoniazid; its salts; its derivatives; their salts; any compound with any substance
falling within this item
Isoprenaline and its salts when contained in aerosol dispensers
Isopyrin; its salts
Isotretinoin
Isoxicam; its salts
-'~Ketamine; its salts
Ketoconazole
Ketophenylbutazone
Ketoprofen; its salts
Labetalol; its salts
Lithium carbonate
Lithium Sulphate
Lomustine
Lonazolac; its salts
Lorcainide; its salts





Loxapine; its salts
Lysuride. its salts

--~annomustine; its salts
Maprotiline; its salts
Mazindol
Mebutamate
Mecarnylarnine; its salts
Meclofenamic acid; its salts
Meclofenoxate; its salts
Mefenamic acid; its salts; its esters; their salts
Mefruside
Mephenesin; its esters; their salts
Mephenoxalone
Mepirizole; its salts
Meprobamate
Mercaptopurine; its salts; its derivatives; their salts
Metaxalone
Metergoline
Metformin; its salts
Methaqualone; its salts
Methocarbamol

Methoxsalen
Methoxyphenamine and its salts when contained in aerosol dispensers
Methylaminoheptane and its salts when contained in aerosol dispensers
MethyIdopa; its esters; their salts

Methylpentynol; its derivatives
alpha-Methylphenethylaraine; beta-methylphenethylamine; alpha-ethylphene-
thylamine; beta-ethylphenethylamine; their optical isomers; any synthetic
compound structurally derived from any of those substances by substitution in the
aliphatic part or by ring closure therein (or by both such substitution and such
closure) or by substitution in the aromatic ring (with or without substitution at the
nitrogen atom), except hydroxyamphetamine, methoxy-phenamine, phenylpropa-
nolamine, pholedrine, prenyh~ and N-substituted derivatives of ephedrine; any
salt of any substance failing within this item
Methylphenidate; its salts
Methyprylone
t7Metolazone
Metoprolol; its salts
Mexiletine; its salts
Mianserin; its salts
Minoxidil
Mitobronitol
Mitopodozide; its salts
Mitotane
Mitoxantrone; its salts





Mofebutazone; its salts
Molindone; its salts
Mustine and any other N-substituted derivative of di-(2-chleroethyl) amine; their
salts
Muzolimine
Nadolol; its salts
Nalbuphine; its salts
Naproxen; its salts
rNifenazone
kiflumic acid; its salts
tromethaqualone; its salts
Nomifensine; its salts
Noramidopyrine methanesulphonate; its salts
Norfloxacin; its salts; its esters
Nortriptyline; its salts
Ofloxacin; its salts; its esters
Opipramol; its salts; its derivatives; their salts
Orciprenaline and its salts when contained in aerosol dispensers
Oxanamide
Oxprenolol; its salts
Oxypertine
Oxyphenbutazone
Oxytocins
Pancuronium; its salts
Paraldehyde
Paramethadione
Pargyline; its salts
Pernoline; its salts
Pempidine; its salts
Penbutolol; its salts
Penicillamine; its salts
Pentazocine; its salts
Pentolinium; its salts
--~pPhenacemide
Phenacetin
Phenaglycodol
Phenbutrazate
Phencyclidine; its salts
Phenetidylphenacetin
Phenformin; its salts
Phenothiazine; its salts; its derivatives (except dimethoxanate and promethazine);
their salts (except salts of dimethoxanate and promethazine); any compound with
any substance falling within this item





Phenprenazone
Phenprobamate
Phenylbutazone; its salts
2-Phenylcinchoninic acid; 2-salicylcinchoninic acid; their salts; their esters
5-Phenylhydantoin; its alkyl and aryl derivatives; their salts
Pipobroman
Piromidic acid; its salts
Piroxicam
Pirprofen; its salts
Pituitary gland, the active principles of, other than corticotrophins, oxytocins and
vasopressins, except when contained in inhalants or in preparations intended for
external application only
Polymethylenebistrimethylammonium salts
Prazosin; its salts
Primidone
Prindolol; its salts
Probucol
Procainamide; its salts
Procarbazine; its salts
Procaterol and its salts when contained in aerosol dispensers
Progiumetacin; its salts
Promoxolane
Propafenone; its salts
Propanidid
Propofol
Propranolol; its salts; its derivatives; their salts
Propylhexedrine and its salts, except when contained in inhalers
Proquazone
Prostaglandins, the following and their derivatives-
Alprostadil
Dinoprost
Dinoprostone
Misoprostol
their salts; their esters
Prothionamide
Prothipendyl; its salts
Protriptyline; its salts; its derivatives; their salts
Pyrazinamide
PyrithyIdione
Quinethazone
Quinidine; its salts
Quinine; its salts; its derivatives; their salts; except in preparations containing less
than 10% of quinine, its salts, its derivatives or their salts
Rauwolfia, alkaloids of, their salts; derivatives of the alkaloids of rauwolfia; their
salts





Reproterol and its salts when contained in aerosol dispensers
Rimiterol and its salts when contained in aerosol dispensers
Rosoxacin; its salts
--~s~butamol and its salts when contained in aerosol dispensers
Sotalol; its salts
Spironolactone
Styramate
Sulindac
Sulphinpyrazone
Sulphonal; alkyl sulphonals
Sulpiride
Sultopride
Suprarenal gland, the active principles of, except adrenaline and noradrenaline (other
than when contained in aerosol dispensers); their salts; except salts of adrenaline
(other than when contained in aerosol dispensers); their derivatives; their salts
Suxamethonium; its salts
Syrosingopine
Tamoxifen; its salts
Teniposide
Terbutaline and its salts when contained in aerosol dispensers
Tetrabenazine; its salts
Tetracosatrin; its salts
Thalidomide; its salts
Theofibrate
Thiacetazone
Thiocarlide; its salts
Thiotepa
Thyroid gland, the active principles of; their salts
Tilidate; its salts
Timolol; its salts
Tinoridine; its salts
Todralazine; its salts
---,,Tofenacin; its salts
Tolazamide
Tolbutainide
Tolfenarnic acid; its salts
Tolmetin; its salts
Tolperisone; its salts
VT1anyleypromine; its salts
Trazodone; its salts
Tretamine; its salts
Triamterene; its salts
Triaziquone





Tribromoethyl alcohol
2,2,2-Trichloroethyl alcohol, esters of., their salts
Trilostane
Trimetaphan; its salts
Trimethadione
Trimetozine
Trimipramine; its salts
Trioxsalen
Tybamate
Urapidil; its salts
Urethane
Valnoctamide
Valproic acid; its salts; its esters
Vasopressins
Vencuronium; its salts
Verapamil; its salts
Viloxazine; its salts
Vinca, alkaloids of
Vindesine; its salts
~7Zi.elid-ine; its salts
Zornepirac; its salts
Zoxazolarnine; its salts

B

Dinitrocresols (DNOC), their compounds with a metal or a base, except prepara-
tions for use in agriculture or horticulture
Dinitronaphthols; dinitrophenols; dinitrothymols
Hexachlorophane; preparations containing more than 0. 1 % for human or animal use
in aerosol containers; preparations in the form of a cake, tablet or bar of soap for
human use containing more than 2%; preparations in the form of soaps or
shampoos for animal use containing more than 2%; medicinal preparations for
human or animal use (except those for oral administration to sheep or cattle for
liver fluke disease) containing more than 0.75%.

FOURTH SCHEDULE [reg. 14.]

STATEMENT OF PARTICULARS AS TO PROPORTION OF POISON IN
CERTAIN CASES PERMITTED BY REGULATION 14(a)

A

Name ofPoison Particulars

Alkaloids The proportion of any one alkaloid of aconite
Aconite, alkaloids of that the preparation would be calculated to
contain on the assumption that all the alkaloids
of aconite in the preparation were that alkaloid.





Name of Poison Parliculars
Belladonna, alkaloids of
Calabar bean, alkaloids
of
Coca, alkaloids of
Colchicum, alkaloids of
Ephedra, alkaloids of
Ergot, alkaloids of
Gelsemium, alkaloids of The same as above, with the substitution for
Lobelia, alkaloids of the reference to aconite of a reference to balla-
Pilocarpus, alkaloids of donna, calabar bean or such other of the said
Pomegranate, alkaloids poisons as the case may require.
of
Quebracho, alkaloids of,
other than the alkaloids
of red quebracho
Sabadilla, alkaloids of
Stavesacre, alkaloids of
Veratrum, alkaloids of
Yohimba, alkaloids of
Antimonial poisons The proportion of antimony trioxide (Sb,03)
or antimony pentoxide (Sb20.) that the pre-
paration would be calculated to contain on the
assumption that the antimony (Sb) in the poison
had been wholly converted into antimony
trioxide or antimony pentoxide as the case may
be.
Arsenical poisons The proportion of arsenic trioxide (A5203) or
arsenic pentoxide (AS201) that the preparation
would be calculated to contain on the assump-
tion that the arsenic (As) in the poison had
been wholly converted into arsenic trioxide or
arsenic pentoxide as the case may be.
Digitalis, glycosides of, other The number of units of activity as defined in the
active principles of digitalis British Pharmacopoeia contained in a specified
quantity of the preparation.
Hydrocyanic acid; cyanides; The proportion of hydrocyanic acid (HCN) that
other than ferrocyanides the preparation would be calculated to con-
and ferricyanides tain on the assumption that the cyanides in the
poison had been wholly converted into hydro-
cyanic acid.
Insulin The number of units of activity as defined in the
British Pharmacopoeia contained in a specified
quantity of the preparation.
Lead, compounds of, with The proportion of lead oxide (PbO) that the
acids from fixed oils preparation would be calculated to contain on
the assumption that the lead in the poison had
been wholly converted into lead oxide.
Mercury, organic compounds The proportion of organically-combined mercury
of (Hg) contained in the preparation.
Nux Vomica The proportion of strychnine contained in the
preparation.
Opium The proportion of morphine contained in the
preparation.
Phenols The proportion of phenols (added together) con-
tained in the preparation.
Compounds of a phenol The proportion of phenols (added together) that
with a metal the preparation would be calculated to con-
tain on the assumption that the compounds of
phenols with a metal had been wholly con-
verted into the corresponding phenols.





Name of Poison Particulars

Pituitary gland, the active Either-
principles of (a) The number of units of activity as
defined in the British Pharmacopoeia
contained in a specified quantity of
the preparation; or
(b)the proportion of pituitary gland, or
of anterior or of posterior lobe of the
gland, as the case may be, contained
in the preparation; or
(e)the amount of pituitary gland, or of
anterior or of posterior lobe of the
gland, as the case may be, from which
a specified quantity of the preparation
was obtained, together with an indi~
cation whether the amount relates to
fresh or to dried gland substance.

Strophanthus, glycosides ofThe amount of Standard Tincture of Strophan-
thus as defined in the British Pharmacopoeia
1948 which possesses the same activity as a
specified quantity of the preparation when
assayed by the method described in the said
Pharmacopoeia.

Suprarenal gland, the active Either-
principles of, their salts; (a) the proportion of suprarenal gland or
their derivatives; their salts of the cortex or of the medulla of the
gland, as the case may be, contained
in the preparation; or
(b)the amount of suprarenal gland, or of
the cortex or of the medulla of the
gland, as the case may be, from which
a specified quantity of the preparation
was obtained, together with an indica-
tion whether the amount relates to
fresh or to dried gland substance.

Thyroid gland, the active Either-
principles of., their salts (a) the proportion of thyroid gland con-
tained in the preparation; or
(b)the amount of thyroid gland from
which a specified quantity of the pre-
paration was obtained together with
an indication whether the amount
relates to fresh or to dried gland.

B

Barium, salts of The proportion of one particular barium salt
which the preparation would be calculated to
contain on the assumption that the barium (Ba)
in the preparation had been wholly converted
into that salt.
Potassium hydroxideThe proportion of potassium monoxide (K20)
which the preparation would be calculated to
contain on the assumption that the potassium
hydroxide in the preparation had been wholly
converted into potassium monoxide.
Sodium hydroxide The proportion of sodium monoxide (Na20)
which the preparation would be calculated to
contain on the assumption that the sodium
hydroxide in the preparation had been wholly
converted into sodium monoxide.











FIFTH SCHEDULE [reg. 15(2)-1

INDICATION OF STATEMENT PRESCRIBED BY REGULATION 15 FOR
THE PURPOSES OF SECTION 27(c) OF THE ORDINANCE

1.To he labelled with the words 'Caution. It is dangerous to take this
preparation except under medical supervision.'

Medicines made up ready for the internal treatment of human ailments
and containing insulin

2.To be labelled with the words 'Caution. It is dangerous to exceed the stated
dose.

Medicines (other than medicines containing insulin and medicines
mentioned in paragraph 8 of this Schedule) made up ready for the
!nternal treatment of human ailments except in the case of a substance
included in the First Schedule

3. To be labelled with the words 'Poison. For animal treatment only.

Medicines made up ready for the treatment of animals

4.To be labelled with the words 'Caution. This preparation may cause serious
inflammation of the skin in certain persons and should be used only in accordance
with expert advice.'

Preparations for the dyeing of hair containing phenylene diamines, toluene
diamines or other alkylated-benzene diamines or their salts

5. To be labelled with the words 'Caution. This substance is caustic.'

Potassium hydroxide, sodium hydroxide, and articles containing either of
those substances

6.To be labelled with the words 'Caution. This substance is poisonous. The
inhalation of its vapour, mist, spray or dust may have harmful consequences- It
may also be dangerous to let it contact the skin or clothing.

Diethyl para-nitrophenyl phosphate
Fluoroacetamide; fluoroacetanilide
Monofluoroacetic acid; its salts
Organic compounds of mercury in aerosols

7. To be labelled with the words 'Caution. This preparation should be
administered only under medical supervision. The vapour is dangerous.

Medicines made up ready for the internal or external treatment of human
ailments and containing dyflos

8.To be labelled with the words 'Caution. This may cause drowsiness. If
affected, do not drive or operate machinery.

Medicines made up ready for the internal treatment of human ailments if
the poison is one of the antihistamine substances, their salts, or their
compounds with any other substance



9. To be labelled with the words 'Caution. Not to be taken internally.'

Preparations for external use containing mercuric ammonium chlorides
10. (a)To be labelled with the words 'Not to be usedfor babies' '&k%gffl o j
or 'This preparation should not be administered, except on medical advice,
to a child under 2 years of age.'


Hexachlorophane

(b)To be labelled with the words 'Not to be usedfor whole body bathing
except on medical advice.'
Soap for human use containing 2% or more of hexachlorophane

(c)To be labelled with the words 'For animal treatment only.

Medicine containing hexachlorophane for the treatment of animal

(d)To be labelled with the words 'Notfor usefor lactating cattle.
-
Medicine containing hexachlorophane for oral administration for the
prevention or treatment of liver fluke disease in cattle

(e)To be labelled with the words 'Protective clothing must be worn by the
operator when this product is being administered.

Medicine containing hexachlorophane for oral administration for the
prevention or treatment of liver fluke disease in sheep or cattle

11. To be labelled with-
(i) the words 'Rat Poison. Keep away from children, domestic animals and
pets. Obtain medical attention for poisoned persons. Destroy old con-
tainers and untaken baits.'


(ii) a description of relevant first aid treatment.

Preparations made up ready for the destruction of rats and mice containing-
alpha-Chlorohydrin
Chlorophacinone
Cournachlor
Cournaffiryl
Coumatetralyl
Crimidine
Difenacourn
Diphacinone
Pindone
Pyriminil
Valone
Warfarin
Zinc Phosphide





SIXTH SCHEDULE [reg. 4(2).]

POISONS EXEMPTED BY REGULATION 4 FROM LABELLING PROVISIONS
WHEN SOLD OR SUPPLIED IN CERTAIN CIRCUMSTANCES

A

Antimony, chlorides of; oxides of, sulphides of, antimonates; antimonites
Chloroform
Glyceryl trinitrate
Lead acetates; compounds of lead with acids from fixed oils
Mercuric chloride; mercuric iodide; organic compounds of mercury
Mercury, nitrates of; oxides of
Oxalic acid; metallic oxalates
Phenols; compounds of phenol with a metal
Picric acid

B

Ammonia
Alkali fluorides
Dinitrocresols
Dinitronaphthols; dinitrophenols; dinitrothymols
Formaldehyde
Formic acid
Hydrochloric acid
Hydrofluoric acid; sodium silicofluoride
Nitric acid
Nitrobenzene
meta-Nitrophenol; ortho-nitrophenol; para-nitrophenol
Phosphorus, yellow
Potassium hydroxide
Sodium hydroxide
Sulphuric acid

SEVENTH SCHEDULE [reg- 21

POISONS REQUIRED BY REGULATION 21 TO BE SPECIALLY
LABELLED FOR TRANSPORT

A

Arsenical poisons
Diethyl para-nitrophenyl phosphate
Hydrocyanic acid; cyanides, other than ferrocyanides and ferricyanides, except
preparations containing less than the equivalent of 0. 1 %, weight in weight, of
hydrocyanic acid (HCN)
Nicotine
Strychnine; its salts
Thallium, salts of





B

Barium, salts of, except barium sulphate
alpha-Chlorohydrin
Chlorophacinone
Cournachlor
Coumafuryl
Coumatetralyl
Crimidine
Difenacourn
Diphacinone
Fluoroacetarnide; fluoroacetanilide
Monofluoroacetic acid; its salts
Pindone
Pyriminil
Valone
Warfarin
Zinc Phosphide

EIGHTH SCHEDULE

FORM 1 [reg. 26(4)-1

PHARMACY AND POISONS ORDINANCE

(Chapter 138)
WHOLESALE POISONS LICENCE

................... of

is hereby licensed to deal in wholesale poisons at ........................................................

................... until the day of

........................ 19 inclusive, subject to the

conditions endorsed hereon.

Dated this .day of ..............19
A


for and Poisons Board.
CONDITIONS


. . .

.... 1
.............. 1





FORM 2 [reg. 28(4).
RAJ

PHARMACY AND POISONS ORDINANCE


(Chapter 138)


FORM OF RECORDS OF TRANSACTIONS INVOLVING POISONS IN PART 1 OF
THE POISONS LIST TO BE KEPT BY WHOLESALE DEALERS






FORM 3 [reg. 29(5).]

PHARMACY AND POISONS ORDINANCE


(Chapter 138)


CERTIFICATE FOR MANUFACTURER


It is hereby certified that ......................................................................................


............... 1
(Name of the pharmaceutical firm)

(1) is authorized to manufacture and market drugs and pharmaceutical

products;

(2) is subject to regular inspections which have shown that it follows the

requirements of good practices in manufacture and quality control of

drugs and pharmaceutical products as recommended by the World

Health Organization, and is included in the list established for that

purpose.

HONG KONG. ......................................(Date)




...............-- -- ................ ..........
for Pharmacy and Poisons Board.





FORM 4 [reg. 29(5).]

PHARMACY AND POISONS ORDINANCE


(Chapter 138)


INTERIM CERTIFICATE FOR MANUFACTURER


It is hereby certified that ...................................................................................


....................................
(Name and address of manufacturer)

(1) is authorized to manufacture and market drugs and pharmaceutical

products;

(2) is subject to regular inspections in respect of the manufacture of drugs

and pharmaceutical products in accordance with the requirements

recommended by the World Health Organization.

This certificate shall expire on ..............................................................................


Subject to the Pharmacy and Poisons Board being satisfied that the manu-

facturer complies with the requirements of good practices in manufacture and

quality control of drugs and pharmaceutical products as recommended by the

World Health Organization, a Certificate for Manufacturer may be issued on or

before the expiry of this certificate.


HONG KONG. ...................................... (Date)

for and Poisons Board.





FORM 5[reg. 29(6).]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

FREE SALE CERTIFICATE OF PHARMACEUTICAL PRODUCT


Name and dosage form of product: ............................................................................

Name and amount of each active ingredient: ..............................................................

..................
- ..........................................................................................................................
............. 1 .11
.........................

Manufacturer, and/or when applicable, the person responsible for placing the

product on the market: ........................................................................................


...................................

.................*---* .....**---*------ *-** *---* *---* **** ****
Address(es): .................................................................................................................

It is certified that:

This product has been authorized to be placed on the market for use in

Hong Kong.

Number of permit and date of issue .................................................................

.. .......................................................................................................................
This product has not been authorized to be placed on the market for use

in Hong Kong for the following reasons: .........................................................

..................................
..................................
It is also certified that (a) the manufacturing plant in which the product is
2, 2 R)] ( FP ) ñ
produced is subject to inspection at suitable intervals, and (b) the manufacturer

conforms to requirements for good practices in the manufacture and quality

control, as recommended by the World Health Organization, in respect of products

to be sold or distributed within the country of origin or to be exported.

HONG KONG. .........................(Date)


...............................................................
for Pharmacy and Poisons Board.





Form 6 [reg. 36(2).]


PHARMACY AND P01SONS ORDINANCE


(Chapter 138)

APPLICATION FOR REGISTRATION OF A DRUG/
PHARMACEUTICAL PRODUCT/SUBSTANCE


the relevant literature must be submitted together with the application.
Supplementary documentation and supporting documents issued by the
health authority in the Country of origin should be submitted if required.

Name of Drug/Product/Substance*:
(*Delete as appropriate)

Dose Form/Package Size(s):

Detailed Qualitative and Quantitative Composition:

Indications:


Names of Countries in which registered/marketed:

Name of Applicant:

Business Address of Applicant: Tei. No.

Name of Manufacturer:


Address of Manufacturer:






DECLARATION OF APPLICANT


I hereby declare that to the best of my knowledge and belief the information given
in this application is correct.

Date: .............Signature:


For Office Use Only






Form 7 [reg. 36(5).]


PHARMACY AND POISONS ORDINANCE

(Chapter 138)

CERTIFICATE OF DRUG/PRODUCT REGISTRATION

It is hereby certified that ......................................................................................


............ 1
(Name and address)

has been issued with a permit No . authorizing

.......... (Name of drug/product) to be

marketed for use within Hong Kong.

2. This certificate will be valid until ..................................................................

19 and thereafter for periods of 5 years at a time on renewal and subject

to the payment of the registration fee.

3. No change in the formulation and commercial presentation of this product

shall he made during the effectivity of this registration without the approval of the

Pharmacy and Poisons Board.


HONG KONG.




...................................... (Date)



for Pharmacy and Poisons Board.





FORM 8 [reg. 41(1).]

PHARMACY AND POISONS ORDINANCE


(Chapter 138)

CERTIFICATE

For the purposes of section 22(1)(a) of the Pharmacy and Poisons Ordinance,

I, the undersigned, occupying(a) ...................................................................................

........................... 1
hereby certify that 1 am acquainted with(b) ...................................................................

........ and with(c)

......................... 1 and that0)

..... is a fit and proper person to whom

(d) ........................may properly
(T)
be supplied by(c) ...........................................................................................................

1 further certify that(e) ...........................................................................................

................... is the signature of the said(h)

...................

. .................
Signature ofperson giving certificate.


(Name in block letters) ..................................................................

Date ..................

(a) Insert M postal address.
(b) Insert full narne of intending purchaser.

(c) Insert full name of intending seller.

(d) Insert narne of poison.
(e) Intending purchaser to sign here.





FORM 9 [reg. 41(2).]

PHARMACY AND POISONS BOARD


HONG KONG

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

CERTIFICATE OF REGISTRATION
(Section 9(1))

Number onRegister............................................

This is to certify that ............................................................................................
whose address is ..........................................................................................................

...........................

and whose photograph appears hereon was on the .....................................................

day of ................19 admitted to the register of

pharmacists.


Dated this ........day of ......19

............. 1
Secretary,
Pharmacy and Poisons Board.






FORM 10 [reg. 42(3).]


PHARMACY AND POISONS ORDINANCE


(Chapter 138)

FORM OF ENTRY TO BE MADE IN THE BOOK TO BE KEPT BY
SELLERS OF POISONS IN ACCORDANCE WITH SECTION 22(3)







FORM 11
[Spent]

FORM 12 [reg. 36B(3).]


PHARMACY AND POISONS ORDINANCE


(Chapter 139)

CERTIFICATE FOR CLINICAL TRIAL/MEDICINAL TEST*


It is hereby certified that .................................................................................


........... ..1
(Nante and address)

is authorized to establish a clinical trial on human beings/medicinal test on

animals in respect of


............................................................................................................. 1
(Nante ofproduct or substance)

to be conducted by ....................................................................................................
(Natne(s) ofperson(s) concerned)

at .................................................................................................................................
Rath MA (Nanze and address of instintlion where applicable)

.............................................................................................................................

2. This certificate will be valid until ..................................................................

...................

HONG KONG. ...................................... (Date)







FORM 13 [reg. 37A.]

PHARMACY AND POISONS ORDINANCE

(Chapter 138)

APPLICATION FOR REGISTRATION AS AN
IMPORTER/EXPORTER OF PHARMACEUTICAL PRODUCTS

We wish to apply for registration as an importer and exporter of pharma-
ceutical products under the Pharmacy and Poisons Ordinance, Cap. 138.

Name of pharmaceutical product(s)
registered by Applicant:

Name of manufacturer(s) represented by
Applicant, if any:

Description of storage room/cublele/receptacle*:
(* Delete as appropriate)

Name of Applicant:

Business Address of Applicant: Tel. No.

Name of person in charge:

Date ...........Signature






FoRm 14 [reg. 37A.]
PHARMACY AND POISONS ORDINANCE
(Chapter 138)
CERTIFICATE OF REGISTRATION AS AN IMPORTER
AND EXPORTER

It is hereby certified that ......................................................................................
.......................................
(Name and Address ofpharmaceuticaffirm)

has been registered as an importer and exporter of pharmaceutical products and is
entitled to import and export pharmaceutical products subject to the conditions
endorsed hereon.

Dated this .day of ............19

.. .. ...............................
.......for Phairmacy and Poisons Board.

CONDITIONS

.......................................






FORM 15 [reg. 24B(a).]
PHARMACY AND POISONS ORDINANCE
(Chapter 138)
APPLICATION FOR REGISTRATION OF PREMISES
UNDER SECTION 13

We .................of
(Name of business)
...................
(Address of business)
wish to apply for the registration under section 13 of the Pharmacy and Poisons
Ordinance of the premises as set out in paragraph 1 of this application to conduct
the retail sale of poisons at such premises.

1. Address of premises
2. Name of business at the premises
........................................................................
3. Business Registration No .
4.Telephone No. of the premises
5. Name of registered pharmacist in whose presence or under whose supervision
the retail sale of poisons is conducted under section 11 (1) of the Ordinance
...................................
...................................
In support of this application, we submit a copy of the certificate of registration
of the pharmacist named in paragraph 5.

Signature ..............................................

Full name of signatory .........................................

Signed on behalf of ..............................................
(Name of business)

Date ..........................................................






FORM 16 [reg. 24C.]

PHARMACY AND POISONS ORDINANCE
(Chapter 138)

CERTIFICATE FOR REGISTRATION OF PREMISES
UNDER SECTION 13

This is to certify that the premises known as .......................................................

...................................... and situated at

........... 1 ...................we, for the
(Address ofpremises)

period from the date of this certificate until ...........................................
(Date of expiryj ............
registered under section 13 of the Pharmacy and Poisons Ordinance as being premises
where the retail sale of poisons may be conducted, subject to the conditions endorsed
hereon.

Dated this ...................day of 19

or
CONDITIONS

.......................................





1987




FoRm 17

Form of logo which may be displayed under section 2A







NINTH S(HEDULE [regs. 26(5),
29(3),(5),
36(2), (5) &
FEES (7) & 41(4).]

1 . Registration as a student for a course of training specified by the Board $ 10

2. Examination in each subject prescribe( by the Board $ 50
3. Issue of a certificate of registration as ~ pharmacist 5100
4. Issue of a duplicate certificate of regist ation as a pharmacist 5 75
5. Registration of premises of an authori d seller of poisons $ 50
6. Retention of premises on the register ol premises, each year $ 50
7. Application for entry on the list of liste 1 sellers of poisons $ 50
8. Retention on the list of listed sellers of wisons, each year $ 50
9. Any alteration to the register of premi s or to the list of listed sellers $ 15
10. An annual licence for wholesale dealers in poisons $100

11. Annual licence for manufacturers ............. ...................................... $100

12. Application for registration of a prodw L 5 50
13. Certificate of registration of a product . 5200
14. Renewal of a certificate of registration a product $100

15-16. [Deleted, L.N. 1371781

17. Free Sale Certificate ............................................................. $100

18. Certificate and Interim Certificate for M mufacturer $200
19. Annual practising certificate for a regish red pharmacist-
(a) employed by the Government, a hc spital subvented by the Govern-
ment, a University or the Polytechr c $ 10
(b) in all other cases .............................................................. $ 75

20. [Spent]

2L Application for a clinical trial or medicill i 311 test $ 50
22. Certificate for clinical trial or medicinal t st $200

23. Application for registration as an impc rter or exporter of pharmaceu-
tical products .................................................... $100

24. Duplicate of any certificate specified in 13 or 22 above 5 75
L.N. 163/75. L.N. 228/75. 92 of 1975. L.N. 195/77. L.N. 311/77. L.N. 137/78. L.N. 369/80. L.N. 22/82. L.N. 415/84. L.N. 129/86. L.N. 85/87. L.N. 130/87. L.N. 145/78. Citation. Interpretation. L.N. 369/80. Schedules. L.N. 369/80. Application of section 22 restricted to the First Schedule. L.N. 85/87. Third Schedule. Extension of labelling provisions and relaxation with respect to poisons in the Sixth Schedule. Sixth Schedule. Extension of section 22 to sales wholesale etc. and relaxation of the section. First Schedule. Relaxation of section 28(3) in the case of certain medicines. First Schedule. Exemption from the provisions relating solely to the First Schedule. Complete exemption for articles and substances in the Second Schedule. L.N. 85/87. L.N. 85/87. Additional restriction of sale of poisons in the Third Schedule. Restriction of sales by listed sellers of poisons. Prohibition on dispensing of prescriptions by listed sellers of poisons. L.N. 85/87. Restriction of sale of strychnine. Manner of labelling containers. Labelling of name of poison. Labelling of particulars as to proportions of the poison. Fourth Schedule. 'Poison' to be in English and Chinese. L.N. 137/78. Fifth Schedule. First Schedule. Special precautions in the case of certain articles. L.N. 22/82. L.N. 137/78. Name of seller and address of premises. First Schedule. Form of containers. L.N. 22/82. Storage of poisons. First Schedule. Transport of poisons. Special provisions with respect to the transport of poisons in the Seventh Schedule. Supply of medicines to out-patients from certain institutions, etc. First Schedule. L.N. 137/78. Supply of medicines for use in institutions, etc. First Schedule. Storage of poisons in institutions. First Schedule. L.N. 137/78. L.N. 137/78. L.N. 369/80. Applications to be entered on list under section 25. Ninth Schedule. Applications to register premises under section 13. L.N. 85/87. Eighth Schedule, Form 15. Certificate of registration under section 13. L.N. 85/87. Eighth Schedule, Form 16. Sale and supply of poisons wholesale. L.N. 137/78. Pharmacy and Poisons (Wholesale Licences) Committee. Ninth Schedule. Eighth Schedule, Form 1. L.N. 369/80. Sales by wholesale dealers. L.N. 137/78. Records to be kept by wholesale dealer. L.N. 137/78. L.N. 137/78. Eighth Schedule, Form 2. L.N. 137/78. L.N. 137/78. Licensing of manufacturers. L.N. 369/80. Ninth Schedule. Ninth Schedule. Eighth Schedule, Forms 3 & 4. L.N. 137/78. Eighth Schedule, Form 5. L.N. 369/80. Manufacture to be under supervision of a registered pharmacist. L.N. 137/78. Labelling by manufacturers. L.N. 137/78. L.N. 137/78. Manufacturing workers not to infect products. Duties of manufacturers. L.N. 137/78. Manufacturer's premises. Records to be kept by manufacturers. L.N. 228/75. L.N. 137/78. Registration of pharmaceutical products and substances. L.N. 137/78. L.N. 369/80. L.N. 85/87. L.N. 85/87. Eighth Schedule, Form 6. Ninth Schedule. L.N. 137/78. L.N. 137/78. Eighth Schedule, Form 7. L.N. 137/78. Ninth Schedule. L.N. 137/78. Ninth Schedule. L.N. 137/78. L.N. 369/80. Clinical trials and medicinal tests. L.N. 137/78. L.N. 369/80. Ninth Schedule. Eighth Schedule, Form 12. Ninth Schedule. L.N. 369/80. Definition of 'pharmaceutical product' and 'substance' for the purposes of this Part. L.N. 137/78. Duplicate certificates. L.N. 369/80. Ninth Schedule. Factors relevant to determination of application for registration. L.N. 369/80. L.N. 137/78. L.N. 137/78. L.N. 369/80. Application for registration under section 28A. Eighth Schedule, Form 13. Ninth Schedule. Eighth Schedule, Form 14. Disclosure of composition of medicines. L.N. 137/78. Period of keeping of records. Penalties. L.N. 137/78. L.N. 85/87. L.N. 85/87. L.N. 85/87. Certificates, forms and fees. Eighth Schedule, Form 8. Eighth Schedule, Form 9. L.N. 85/87. Eighth Schedule, Form 17. Eighth Schedule, Form 10. Ninth Schedule. Transitional provisions. L.N. 137/78. L.N. 369/80. L.N. 415/84. L.N. 129/86. L.N. 130/87. L.N. 195/77. L.N. 137/78. L.N. 129/86. L.N. 195/77. L.N. 137/78. L.N. 415/84. L.N. 369/80. L.N. 137/78. L.N. 369/80. (Cap. 137.) L.N. 130/87. L.N. 137/78. L.N. 137/78. L.N. 369/80. L.N. 415/84. L.N. 129/86. L.N. 130/87. L.N. 369/80. L.N. 129/86. L.N. 137/78. L.N. 195/77. L.N. 129/86. L.N. 137/78. L.N. 195/77. L.N. 137/78. L.N. 85/87. L.N. 137/78. L.N. 137/78. L.N. 137/78. L.N. 369/80. L.N. 369/80. L.N. 85/87. L.N. 85/87. L.N. 85/87. L.N. 85/87. L.N. 311/77. L.N. 311/77. L.N. 369/80. L.N. 311/77. L.N. 369/80. L.N. 369/80.

L.N. 163/75. L.N. 228/75. 92 of 1975. L.N. 195/77. L.N. 311/77. L.N. 137/78. L.N. 369/80. L.N. 22/82. L.N. 415/84. L.N. 129/86. L.N. 85/87. L.N. 130/87. L.N. 145/78. Citation. Interpretation. L.N. 369/80. Schedules. L.N. 369/80. Application of section 22 restricted to the First Schedule. L.N. 85/87. Third Schedule. Extension of labelling provisions and relaxation with respect to poisons in the Sixth Schedule. Sixth Schedule. Extension of section 22 to sales wholesale etc. and relaxation of the section. First Schedule. Relaxation of section 28(3) in the case of certain medicines. First Schedule. Exemption from the provisions relating solely to the First Schedule. Complete exemption for articles and substances in the Second Schedule. L.N. 85/87. L.N. 85/87. Additional restriction of sale of poisons in the Third Schedule. Restriction of sales by listed sellers of poisons. Prohibition on dispensing of prescriptions by listed sellers of poisons. L.N. 85/87. Restriction of sale of strychnine. Manner of labelling containers. Labelling of name of poison. Labelling of particulars as to proportions of the poison. Fourth Schedule. 'Poison' to be in English and Chinese. L.N. 137/78. Fifth Schedule. First Schedule. Special precautions in the case of certain articles. L.N. 22/82. L.N. 137/78. Name of seller and address of premises. First Schedule. Form of containers. L.N. 22/82. Storage of poisons. First Schedule. Transport of poisons. Special provisions with respect to the transport of poisons in the Seventh Schedule. Supply of medicines to out-patients from certain institutions, etc. First Schedule. L.N. 137/78. Supply of medicines for use in institutions, etc. First Schedule. Storage of poisons in institutions. First Schedule. L.N. 137/78. L.N. 137/78. L.N. 369/80. Applications to be entered on list under section 25. Ninth Schedule. Applications to register premises under section 13. L.N. 85/87. Eighth Schedule, Form 15. Certificate of registration under section 13. L.N. 85/87. Eighth Schedule, Form 16. Sale and supply of poisons wholesale. L.N. 137/78. Pharmacy and Poisons (Wholesale Licences) Committee. Ninth Schedule. Eighth Schedule, Form 1. L.N. 369/80. Sales by wholesale dealers. L.N. 137/78. Records to be kept by wholesale dealer. L.N. 137/78. L.N. 137/78. Eighth Schedule, Form 2. L.N. 137/78. L.N. 137/78. Licensing of manufacturers. L.N. 369/80. Ninth Schedule. Ninth Schedule. Eighth Schedule, Forms 3 & 4. L.N. 137/78. Eighth Schedule, Form 5. L.N. 369/80. Manufacture to be under supervision of a registered pharmacist. L.N. 137/78. Labelling by manufacturers. L.N. 137/78. L.N. 137/78. Manufacturing workers not to infect products. Duties of manufacturers. L.N. 137/78. Manufacturer's premises. Records to be kept by manufacturers. L.N. 228/75. L.N. 137/78. Registration of pharmaceutical products and substances. L.N. 137/78. L.N. 369/80. L.N. 85/87. L.N. 85/87. Eighth Schedule, Form 6. Ninth Schedule. L.N. 137/78. L.N. 137/78. Eighth Schedule, Form 7. L.N. 137/78. Ninth Schedule. L.N. 137/78. Ninth Schedule. L.N. 137/78. L.N. 369/80. Clinical trials and medicinal tests. L.N. 137/78. L.N. 369/80. Ninth Schedule. Eighth Schedule, Form 12. Ninth Schedule. L.N. 369/80. Definition of 'pharmaceutical product' and 'substance' for the purposes of this Part. L.N. 137/78. Duplicate certificates. L.N. 369/80. Ninth Schedule. Factors relevant to determination of application for registration. L.N. 369/80. L.N. 137/78. L.N. 137/78. L.N. 369/80. Application for registration under section 28A. Eighth Schedule, Form 13. Ninth Schedule. Eighth Schedule, Form 14. Disclosure of composition of medicines. L.N. 137/78. Period of keeping of records. Penalties. L.N. 137/78. L.N. 85/87. L.N. 85/87. L.N. 85/87. Certificates, forms and fees. Eighth Schedule, Form 8. Eighth Schedule, Form 9. L.N. 85/87. Eighth Schedule, Form 17. Eighth Schedule, Form 10. Ninth Schedule. Transitional provisions. L.N. 137/78. L.N. 369/80. L.N. 415/84. L.N. 129/86. L.N. 130/87. L.N. 195/77. L.N. 137/78. L.N. 129/86. L.N. 195/77. L.N. 137/78. L.N. 415/84. L.N. 369/80. L.N. 137/78. L.N. 369/80. (Cap. 137.) L.N. 130/87. L.N. 137/78. L.N. 137/78. L.N. 369/80. L.N. 415/84. L.N. 129/86. L.N. 130/87. L.N. 369/80. L.N. 129/86. L.N. 137/78. L.N. 195/77. L.N. 129/86. L.N. 137/78. L.N. 195/77. L.N. 137/78. L.N. 85/87. L.N. 137/78. L.N. 137/78. L.N. 137/78. L.N. 369/80. L.N. 369/80. L.N. 85/87. L.N. 85/87. L.N. 85/87. L.N. 85/87. L.N. 311/77. L.N. 311/77. L.N. 369/80. L.N. 311/77. L.N. 369/80. L.N. 369/80.

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