Vous êtes sur la page 1sur 208

PERUNDANGAN FARMASI

PHARMACY LIGISLATIONS
The are 5 types of Malaysian Pharmacy
Legislations.
It consist of 5 Main Acts and several regulation
made under each Act.
Each Act stand by itself and are specific in its own
way and control.
Certain requirement can be different or
overlapping between the Acts but the public have
to satisfy and abide to the requirement of every
Act.

ORDINANCE,
ACT,
REGULATION &
GUIDELINE

ORDINANCE
Laws before Merdeka Day
For Federal they are called

ORDINANCE
For State they are known as

ENACTMENT

ACT (AKTA)
Laws after Merdeka Day
Written Laws
***Federal
Constitution
***Constitution of State
***Act of
Parliament
Common Laws

REGULATION
Subsidiary Legislation
Form a subsidiary to the Act with
the criteria of supervisional
Regulation only need to be
approved by the Minister who will
be empowered by the Parent Act.
Do not go to Parliament for
approval

GUIDELINES
More for the purpose of Administrative
Mostly no legal standing
May have legal implication when the Parent
Act or the regulations have provision for
certain bodies to issues guidelines
***eg.
The DCA who are
promulgated under the Control of Drug
and Cosmetic Regulations is given
power under Regulations 20(1), 22.

BASIC FORMAT OF AN ACT OR


A REGULATION

Tittle of the Act/Regulation


Short title and application ........Sec 1/Reg 1.
Interpretation (Definition).........Sec 2/Reg 1.
Content:
**********appointments,
**********powers of authorised officers,
**********what you must do,
**********what you must not do,
**********what contributes to an Offence
**********Offence Sections,
**********Penalty Sections,
**********Powers of Minister to make Regs./Exam.

ADA
SOALA
N TAK?

AKTA UBAT
(IKLAN DAN PENJUALAN) 1956
MEDICINE
(ADVETISMENT & SALE)
ACT 1956

PREAMBLE OR THE SPIRIT


OF THE ACT

It is an Act to
prohibit certain
advertisments
relating to medical
matters and to
regulate the sale of
substances
recommended as a

INTERPRETATION &
DEFINITION OF CERTAIN
IMPORTANT WORDS AND
PHRASES

SECTION 2

Advertisment
Definition;
*advertisment includes any notice,
circular, report, comentary, pemphlet,
label, wrapper or other document or
any announcement made orally or by
any means of producing or transmitting
light or sound;
*
the inclusive definition of advertisment
means that it take into consideration the
traditional meaning (as in the dictionaries) of
and advertisment and it include..............

OTHER IMPORTANT
SECTIONS

PRODUCT

Sec. 3
Sec. 4
Sec. 4A
Sec. 4B
Sec. 5
Sec. 6

SKILL & SERVICES

TREATMENT

SECTION 3
Prohibition of advertisment relating to certain
diseases.
Paragraph 3(1)(a) prohibition of advertisment
relating to diseases in Schedule
Paragraph 3(1)(b) prohibition of advertisment
relating to contraception among human beings
Paragraph 3(1)(c) prohibition of advertisment
relating to improving condition or function of
human kidney, heart, sexual function or sexual
performance of human
Paragraph 3(1)(d) prohibition of advertisment
relating to diagnosis of disease as specified in
schedule

Subsection 3(1A); give power to the minister to


amend the schedule
Subsection 3(2) give examption for such prohibited
advertisment ion the manner so far as was
reasonably necessary to bring to the notice of person
of the following classes;
*
- public or local authorities
* public hospital governing bodies
* registered medical practitioners
* registered dentist
* registered nurses and midwives
* registered Pharmacist, Chemist or
*
poison licence holder
* person undergoing training

SECTION 4
Prohibition of advertisment relating to
abortion
this section relates to advertisment for article
used for procuring the miscarriage of woman

SECTION 4A
This section prohibit advertisment relating to skill or
service
Paragraph 4A(a) refer to skill or service relating to
treatment, prevention or diagnosis of disease, injury,
infirmity or condition effecting the human body
Paragraph 4A(b) added that the advertisment which is
capable of inducing, contain an invitation to any person
to seek the advive of the advertiser or any person
referred to in the advertisment
Paragraph 4A(aa) is an examption for advertisment of
such nature by pfofessional body
Paragraph 4A(bb) approval from MAB needed for such
advertisment for private hosp., clinic, radiology or lab.

SECTION 4B
Avertisment of medicines to be approved by
the Medicines Advertisment Board (MAB)
established by the Minister
This approval given by the MAB do not
include the advertisment of medicine for the
treatment and prevention the diseases listed
under the Schedule (because those in the
schedule are totaly prohibited for layman
advertisment)
Subsection 4 (2) stated that the advertisment to
be publish have to be submitted to MAB in the
manner as regulated

SECTION 5: Offence, penalty, defence


Subsection 5(1), provides the penalty for
contravention of S.3, S.4, S.4A, and 4B.
Subsection 5(2) provide a presumption on
person taking part in the publication of an
offensive advertisment of medicines or article
as a medicine (S.3(1), S.4, S.4B)
Subsection 5(2A) provide a presumption on
person taking part in the publication of an
offensive advertisment on skill and service
for treatment , prevention or diagnosis (S.4A)

Subsection 5(3) provide a defence for the person


charge to prove;
*
paragraph 5(3)(a) to prove that he do *
not
know and had no reason to
*
believe
that he was taking part in the *
publication
*
- paragraph
5(3)(b) to prove that the *
advertisment
was publish only in a
*
publication of
technical character
*
intended for
professional circulation

SECTIONS 6
Disclosure of composition of
medicines
Such information have to be
written in English or national
language and clearly legible
Information includes ingredient,
quantity, poison (as in the
Poison Act 1952 and its
regulations), ..........

SEC. 6A:

Powers of authorised officers

The Minister may


authorised in writting
any Pharmacist in the
public service to execise
the power of authorised
officers

SECTION 6B
Power of Officer to
investigate offences under
the Act
Power of officer with the
cooperation of the court to
secure attendance of
witness for the purpose of
investigation

SECTION 6C
Examination of witness
Recording statement of
who ever is acquainted with
the fact and circumstances
of the case
Proviso for caution and the
right of the person
investigated upon

SECTION 6D
Power of officer to enter,
search and examine premises
related with the offence under
the Act
power of officer to inspect,
remove, detain any related
item with the offence under
the Act.

SECTION 6E
Penalty for
obstructing or
impeding an
authorised
officer

SECTION 6F
Sanction by the Public
Prosecutor before a
case under this Act can
be taken to court
Authorised Officer to
conduct prosecution

SEC. 7:

The Minister may make Regulations

Regulation to establish MAB


Manner of submitting
advertisment for approval under
Sec. 4A and 4B
Procedure to be followed by the
MAB
Manner of appeal against the
dicision of MAB

MEDICINE ADVERTISMENT
BOARD REGULATION 1976

ANY
QUESTION?

POISON ACT 1952


AKTA RACUN 1952

PREAMBLE

An act to regulate the


importation, possession,
manufacture, compounding,
storage, transport, sale and
use of poisons.
This Act apply throught
Malaysia

Generally
For over 40 years this Act and its regulations provided
the chief source of law relating to the sale and supply
of medicines and other chemicals.
A Poison Board was created under the Act, to advice
the Health Minister on substances to be controlled
and various restriction to be imposed upon.
The expression Poison was defined as any
substance specified by name in the first column of the
poison list order under the Act.

The Health Minister after consultation with the Poison


Board has power to amend or vary the Poison List.
However some of the substances listed as poison were
not really toxic but were included in the List because
there were no other means of controlling their
distribution and use.
The poison Act only allow a licensed Pharmacist to deal
in all the substances listed in the poison list where this
include importation, possession for sale, manufacture,
compounding and retailing.
A registered Medical Practitioner, registered Dentist are
allowed to use the substances in the poison list for their
own particular patient treatment only.

A veterinary Doctor is allow to use the same


substances for animal treatment.
There are several Regulations being made
under this Act to supervise matters
pertaining to Poison.

Regulations

The Poison Regulation 1952, regulate the matters


pertaining to importation, storage, supply, transport,
labelling, recording, colouring of poison and provide a
special provisions relating to manufacture, import,
sale and possession of Lead Tetra Ethyl.
The Poison (Sodium Hydroxide) Regulations 1952
regulate the purchase, store and use of NaOH.
The Poison (Exemption) Regulation 1980 allow the
Minister to issue an exemption to persons who in the
course of his work use Part II Poisons in substantial
quantity. An authorization may be granted subject to
restrictions and conditions as may be specified.

The Poisons (Psychotropic Substances)


Regulation 1989 is an outcome of the signing of
the Single Convention on Psychotropic
Substances 1971. After becoming a signatory to
the said convention there seem to be a need to
regulate a more standardise control tuned
towards the convention. This Regulation
regulate the possession, import and export, sale
and supply, purchase and use, administration,
dispensing, compounding mixing and
manufacturing, storage, disposal and labelling of
Psychotropic Substances.

SECTION 2
INTERPRETATION,
DEFINITION
Some important definition

Interpretation and Definition of certain


important words and phrases
The Act define poison as any substance
specified by name in the first column of the
poison list and include any preparation,
solution, compound, mixture or natural
substance containing such substance, other
than an exempted preparation or any or
preparation included for the time being in
the second schedule of the Act

Part I Poisons are Group A, B, C, D, E and F


Poison as specified in the Poison List Order
Part II Poison are those substances listed under
the Part II column of the Poison List Order.
dispensed medicine means a medicine
supplied by a registered medical practitioner,
registered dentist or veterinary surgeon under
and in accordance with sec. 19 or supplied, for
the purpose of medical, dental or animal
treatment, of a particular individual by a
licensed pharmacist on the premises specified in
his licence;

The Act define the term possession for sale as to


also include having in possession knowing that the
article possessed is likely to be sold or expose for
sale.
Sell or Sale, include barter, offering or attempting
to sell in the traditional meaning as sell or sale.
definition of supply include the supply of
commercial sample and dispense med. but it does
not include the direct administration by or under
the immediate supervision of a reg. med.
practitioner or reg. dentist to his patient in the
course of that patient treatment.

Wholesale, the meaning of wholesale in this


Act is, a sale to a person who intent to sell
again and any sale by a wholesaler
authorised under this Act.

Immediate Personal Supervision


Subsection 2(2) of this Act give the presumption for
the term immediate personal supervision, where it is
deem to have been so done if such person was at the
time it was done upon the premises where it was
done and available for immediate consultation by the
person doing such thing.
Provided that, where for compounding, mixing and
dispensing, it shall not be deem to have been so done
unless such person has himself checked such
compounding, mixing and dispensing.

The Poison Board

Section 3 laid out the establishment of the poisons


Board, appointment of member of the Board, who to be
appointed and from which office.
Section provide that the Board may regulate its own
procedure and action.
The Board must advice the Minister on matter
concerning poisons and this is also provided under
section 6 where the Minister have to consult the Board
before amending or varying the Poison List Order and
section 7 where the Minister can exempt any
substance or preparation and put them in the Second
schedule after consultation with the Poisons Board

constituent of the Board


outlined in Section 3 of the Act. It consist of 13
members, where 12 member are appointed by
the Minister.
The Director General shall be the an ex-officio
member and section 4 laid that he shall be the
chairman of the Board and preside at all meeting
that he attends.
In his absent one member shall be elected to
preside. The chairman shall have an original
vote and a casting vote and he may also decide
the place where the Board may meet.

The 12 member appointed by the Minister

a) one pharmacist holding office in the Government service,


b) one officer of the Chemistry Department,
c) one officer from the Agriculture Department,
d) one officer from the Veterinary Department,
e) eight person who is resident of Malaysia and not in the
Government service,
who shall be nominated as follows;
i) one by Malaysian Medical Association,
ii) one by the Malaysian Medical Council,
iii) one by the Malaysian International Chamber of Commerce & Industry,
iv) one by the Association of Chinese Chamber of Commerce and Industry
of Malaysia,
v) one by the Malay Chamber of Commerce,
vi) one by the Association of Indian Chamber of Commerce, Malaysia,

vii) one by the Malaysian Pharmaceutical Association,


viii) one by the Malaysian Rubber Producer's Council.

All members other than the ex-officio member shall hold


office for a period of three years and the can be
reappointed by the Minister. The Minister may also
appoint a similar qualified person to be a temporary
member during illness or absence from Malaysia of any
member other than the Ex-officio member. Four members
including the Chairman or member presiding shall form a
quorum.
Section 5(2) provides the procedure of the Board cannot
be question on the ground of vacancy in membership,
constitution of the Board or omission, defect or
irregularities in procedure not effecting the merits of the
case.

Poison List Order


The Poison List Order is illustrated in the First Schedule
of the Act.
This list divide Poisons into Part I and Part II
Part I Poisons are further divided into Group A, Group
B, Group C, Group D, Group E and Group F.
There is also a column in the list specifying items which
are exempted from all the requirement of the Act, where
these items are usually those with a low concentration
or in the form that could not be use as medicine and not
in any way be a hazard or a threat to human health.
The Poisons List can be amended from time to time in
the manner set in Section 6.

The Minister may from time to time amend


by adding, removing, reinstating,
transferring or including in any column of
the Poisons List.
The Minister have to consult the Poison
Board Before amending this List and all the
amendment have to be gazetted by
notification in an Order.
Amendment also include the exemption of
any preparation or amendment of any
definition of any poison in the Poisons List.
(Sec.6)

The Second Schedule


The second schedule in the Act list articles and preparations
which are exempted from the provisions of this Act.
Most of the article listed are poisons or class of poisons used in
industrial or those use in trade which does not involve them to
be consumed as a medicine.
It is interesting to note that items like machine spread plaster
(with lead content) and surgical dressing are also listed in this
second schedule.
Section 7 confirm that the Act shall not apply to item listed in this
second schedule and the Minister may by Order notified in the
Gazette add to or remove from the second schedule any article
or preparation after consultation with the Poison Board.

General control on all Poison


Since this Act divided Poison in various
grouping and each of these group have
specific control, it is important to discuss
the control of all poison in general before
going into each specific group.

Control of import of poisons


All importation of poisons are prohibited
except by person licensed under this Act
(s.8(1)).
Under section 8(3), it is an offence for any
person to import poison without a valid
licence issued under this Act.

Exemption are given for import of poison by;


i) person arriving in Malaysia with poison as part of their
personal luggage solely for his personal use or for the use of
his family, in the form of prepared medicine for one month use
for one person (s.8(2));
ii) person importing poison by parcel post and solely for his
personal use or for the use of his family, in the form of prepared
medicine for one month use for one person (s.8(2)). Reg. 4 of
the Poisons Regulation 1952 further regulate that the parcel
should have the name of the person to whom it is consigned,
the name of poison, the quantity and the date of posting;
iii) any government officer importing any poison in the course
of his duties (s.8(2));
iv) any person who the Minister may absolutely or conditionally
exempt (s.8(2)).

Packaging , Labelling &


Storing of Poison.

Section 9 prohibit the sale, supply, keeping or


having in possession or having under control or
store any poison, not in accordance with any
regulation made relating to the possession,
containers, packaging, labelling or storing.
This section in general make it an offence for
infringing any of the regulations pertaining to
packaging, labelling and storing as set out in the
Poison Regulation 1952. This regulation regulates
these matter as follows;

*Poison shall be stored in container impervious to the poison and


sufficiently stout to prevent leakage (r. 5)
*Regulation 6 further regulate the manner that poisons have to be
stored where it have to separated from non poison, distinguishable from
other preparation interm of container and kept under lock and key.
There is also a proviso under regulation 6 where it allows the storage of
poisons in dispensary, retail shop or premises to be kept in a part of the
premises which partition or separated from the remainder of the
premises and to which customer are not permitted access.
* Regulation 9 regulate that the poison have to be labelled with the
accepted name of the poison as in the Poisons List or as specify by
British Pharmacopoeia or British Pharmaceutical Codex and have to
also be labelled with the word "Poison" in red or red background.
Exemption is give for smaller packing such as ampoule or cachet if the
next larger packing have been labelled as such (r. 9(4). Labelling
requirement will be more specific for specific types of Poison (Part I or
Part II).

Transportation of Poison
Poisons have to be transported in accordance with
regulation made under this Act (s. 10). The
Poison Regulation set that the poison which are to
be transported have to be;
* pack in such a way to avoid leakage (r.8(1))
* to be labelled with the name of the poison and to
follow all the labelling requirement as being
mention in any of the regulation made under this Act
(r. *(2))
* to be transported on a vehicle separately from food
to avoid contamination (r. 8(3))

Compounding, Dispensing or Mixing of


Poisons for use in Med. Treatment.
Section 12 allows:
Registered Pharmacist and any person working under his
immediate supervision,
Registered Medical Practitioners and any body working
under his immediate supervision
any person employed in the government hospital in the
course of his duties.

This section also set out that any person doing


Compounding, Dispensing or Mixing have to do them in
accordance to the regulations made under this Act.

Supply of Poison for the purpose


of treatment by professional man.
In general all poison listed under the PLO are allowed to
be sold, supp. & admin. by the following professionals
for purpose of treatment except Group A Poison
a registered medical professional for his particular patient treatment
a registered Division I dentist for his particular patient dental
treatment, whereas a Division II dentist is allowed to sell, supply or
administered any poison except Group A and Group B poisons.
a veterinary officer for his client for the purpose of animal treatment

All Poison sold, supplied or administered by the these


professional man have to be done by them or under
their immediate supervision.

Sale of poison by Wholesale


Poison can only be wholesale by person who are
having a wholesale licence issued under this Act and
such sale have to be in accordance to the term and
condition as specified in the Licence (s. 15(1)). The Act
set that Poisons can only be Wholesale to (s. 15(2));
(a) a person licensed to retail such poison, so it is the responsibility
of the wholesaler to ascertain that the poison is sold to a genuine
license holder
(b) a purchase outside Malaysia, this mean that the poison is to be
exported out of Malaysia
(c) to another license wholesaler and it applies the same as
(a) where the first wholesaler have to make sure that the
person have a valid wholesale license

(d) to an estate manager or person on his behalf, where this sale is


for the purpose of estate hospital where it become the responsible
of the estate manager
(e) to a professional person or tradesman for their own use and not
for resale, for example the sale of Theophylline to a tradesman for
the use in the industry dealing with polishing
(f) to a registered medical practitioner, registered dentist and
registered veterinary surgeon for treatment of their own patient only
(g) to licensed Pharmacist for wholesale or for retail
(h) to a Government Department, Local Authorities or Public Body
(i) to any treatment institution run by government, public fund or a
charity body
(j) to any institute concern with scientific education and research
such as the Universities

Section 15(3) goes further into identifying the requirement on


documentation and recording for wholesale sale.
A Wholesaler should keep a wholesale record book where he should
enter the particular such as name and address of the purchaser, date
of sale, name and quantity of the poison sold and the purpose
A wholesaler can only deliver any poison after receiving a sign order
(SO) from the purchaser, the SO have to be retain by the seller and a
reference of the fail in which the SO is retained is entered in the earlier
mention record book in place of the purchaser signature.
If a poison is needed urgently and its SO cant be procured the seller
can deliver the poison after entry in the record book stating the reason
along with all the other particulars mention earlier. In such cases the
poison Act required the SO in respect of such sale to be obtain by the
seller within 7 days after the date of the delivery (15(3)).

The format of the poison wholesale sale record book is prescribed


in Form A of the First Schedule in the Poison Regulations 1952 (r.
26(1).

Sale of Poison By Retail.


Retail of Poisons can only be done by a person license to
retail such poison under the Act.
The Licensed retailer have to follow the term and condition
set in the license and can only the done upon the premises
stated in the licensed and by the person referred to in the
license or under his immediate supervision (s. 16).
Retailing poisons can be the act of filling up priscribtion by
medical practitioner, dentist or veterinary surgeon or it can
also be the sale of certain group poison by a licence
Pharmacist for a particular patient treatment The sale of
poison by retail have to be recorded either in the
"Priscribtion book" or "Poison book".

Priscibtion book (s. 24) is kept for the sale of poison by


filling up priscribtion (s. 21) or for recording the
dispensing of any poison as a "dispense medicine" or
an ingredient in a dispensed medicine (r. 12), (s. 22).
Poison book is kept for recording those poison which
are Group D poison and not a dispense medicine or
any ingredient in a dispensed medicines (s 23(2)). The
format for the poison book is being prescribed in the
First Schedule, Form A. (r. 26(2)) .

Prohibition of sale to persons


under 18 years old.
Section 17 make it an offence for anyone to
sell poison to person below 18 year old
otherwise only for the purpose of his
medical treatment.

Control of Part I Poisons


We have discuss the general control on
Poison these control applies also in general
for Part I poisons. In this Chapter we will
discuss the specific control on Part I
Poisons in order of their specific Groups, A,
B, C, and D;

Control of Group A Poisons


This group of poison have the strictest control in the
poison List.
It can also be assumed that any poison listed into this
Group is as good as being ban for use in human
treatment, where they can only be limited for use in other
trade or in scientific research.
This statement is true if we look back into the problem on
the use of Beta agonist in animal feed supplement in
1992. (Adrenaline and other substance structurally
derived from Phenethylamine .....(item 13 in the Poison
List order)).

Section 20 of the Act stated that Group A


Poisons shall be sold or supply by wholesale or
retail by a licensed wholesaler to a licensed
Pharmacist or another licensed Wholesaler or to
be exported to a purchaser outside Malaysia.
The retail of Group A Poison is allowed for other
purpose except for medical treatment where the
medical practitioners, the dentist or the
veterinary surgeon are not allowed to prescribed
Group A Poison for the purpose of treatment.

Control of Group B Poisons


Group B poison are those items in the Group B column
of the Poisons List.
This category of poison can only be supplied for the
purpose of treatment by a medical practitioner, division I
dentist or a veterinary surgeon.
All the supply by these professional have to be for a
specific or particular patient treatment (s. 21). This
means that these professional cannot supply poison to
a person who will then sell or supply again to another
person.

The Act also allows licensed Pharmacist to supply


Group B Poisons as a "dispensed medicine" and in
accordance with a priscribtion
Subsection 21(6) allow the supply of Group B Poison by
a licensed Pharmacist without a priscibtion for urgent
treatment upon request from a medical practitioner who
is personally known to him by verble or telephone. He
can dispense it by first recording in the priscribtion book
and the priscribtion have follow within one day of the
sale or supply. This Act regulate that both the medical
practitoner and the Pharmacist are responsible to
ensure that this requirement is followed.

Control of Group C Poisons


Group C Poisons are those item under the Group C column
of the PLO.
The specific control involving Group C poison is that they
can be sold or supplied by retail to any person as a
"dispense medicine" by a licensed Pharmacist or by any
person under the Pharmacist immediate supervision.
Every sale of Group C poisons have to be recorded in the
prescription book.
The labelling have to follow the requirement set in
regulation 12 of the Poison Regulation 1952 regarding the
labelling od "dispense medicine" (this requirement will be
discuss in the coming chapter)

Control of Group D Poisons


Group D poisons are those in the Group D column of the PLO.
This category of poison can only be sold by a licensed Pharmacist
to a person known personally to him or introduced to him
personally by another person known to him.
If this Group D poison is a dispense medicine or an ingredient in a
dispense medicine, the record of the sale have to be maintained in
the prescription book (s. 24). If not, the sale need to be recorded
into the Poison Book (s. 23(2)) (regulation 26(2) regulate the
format of the Poison Book where it should be as prescribed in
Form B of the First Schedule) and the purchaser have to put his
signature on the Poison Book.

If in this case the purchaser are not present to sign on


the poison book the he has to send a written sign order
before the delivery can be made. The Written sign
order have to be kept in a file and the reference to it
shall be use to replace the purchaser signiture.
If a Group D poison is needed urgenly and and it is
impossible to obtain the signature or its sign order can
be procured the seller can deliver the poison after
entery in the poison book stating the reason of his
action. In such cases the poison Act required the sign
order in respect of such sale to be obtain by the saler
within seven days after the date of the delivery (s. 23(3))

Control of Part II Poison

Part II Poison might be dangerous if their handling such as


storage, transport and labelling are not control.
So those tradesman who handle such poisons have to be
licensed so that the requirement of this Act and its Regulation
are being followed and can be enforce on them.
Any one who want to sell or supply a Part II poisons have to be
licensed (s. 25) under these Act. These applicant can apply for
either Type D License (to store and sell) where the name of
poison they can dealt with will stated in this license or a Type E
Licensed which is more specific for importation, storing and use
Sodium Hydroxide.

Control of Acetylating Substances


Acetylating substances such as Acetly-bromide or
Acetic-anhydride are control in a special manner
because these substances can be use in the acetylation
process on opiates.
Mere possession of acethylating agent without
authorisation is an offence (s. 14(1)) under this act
unless the possessor can prove that he is:
(a) that he is licensed under this Act;
(b) That he is authorised under this Act;
(c) That the acethylating substance is in his possession for a lawful
purpose

Acethylating Substances are also listed under the


custom prohibition list and their importation need to
be authorised by the Ministry of Health through the
issuence of Authorisation Permit (AP).
The penalty for infringing the control of acethylating
substances under this Act is very severe. An
offender shall be liable to be imprisoned for a term
not exceeding fourteen years and not less than three
years, and shall also be punished with whipping of
not less than six strokes (s. 14(3)). Any person
charged for this offence concerning acethylating
substances shall not be granted bail (s. 14(4)).

Control of Lead tetraethyl


Prohibition of manufacturing of lead tetraethyl in
Malaysia (r. 16).
Importation of lead tetraethyl by those who are licensed
by the licensing officer (r. 17 (this regulation also laid
down the fee of RM 100.00 and the terms and condition
of the license)).
Regulation 18 goes further in prohibiting the import,
sale or possession of ethyl petrol containing more than
1/750 in proportion of lead tetraethyl

Regulation 19 restrict the import, sale or have in possession of


ethyl petrol containing more than 1/150 in proportion of lead
tetraethyl with the following conditions;
for the used in aircraft or any other purpose authorised by the Director
of Medical services;
such ethyl petrol have to be distinctively coloured inaccodance with a
British Standard (r. 19);
all container and appliances use in dealing with such ethyl petrol have
to be conspicously and distinctively labelled or marked with the
words "This spirit contains LEAD to be used for aircraft or motor fuel
only" in English, Malay, Chinese and Tamil.

Regulation 16 to 22 of the Poison Regulation 1952 is very specific


for lead tetraethyl and regulation 22 exempt all other requirement
(other than regulation 16 to 22) of the Act or Regulation relating to
import, possession, sale, supply, packing, storage, transport,
colouring or labelling of poisons to be applicable on lead tetraethyl.

Control of Colouring of Poison


Regulation 15 of the Poison Regulation 1952 stated
that a distinctive dye have to be added to poisons for
use in agriculture or horticulture for the destruction of
pests, fungi, or bacteria.
This dye have to be soluble in water is the poison is
needed to be diluted with water.
Regulation 15(2) specifically mention the need to
colour sodium arsenite or any other arsenic preparation
used in agriculture or horticulture but regulation 15(3)
exempt the need to colour lead arsenate paste or lead
arsenate powder along with poison which are already
distinct in colour or any such poison for the purpose or

Licences needed in dealing in Poison


One of the main function of this Act and its
Regulations is to control poison by way of
licensing.
This Act appointed the Director General of Health
or the Director of Pharmaceutical Services or the
Director of Medical Services of the state
appointed by the Director General of Health to be
the Licensing Officers(s. 26).
The type of license that can be issued under this
Act are as follows;

Type A Licence

This Licence is only issued to registered Pharmacist.


It allows the Pharmacist to deal in all poisons.
In general it allows poisons to be imported, stored
and sold.
In term of sale this licence can be specific for
wholesale only, retail only or for both wholesale or
retail depending on the application made by the
pharmacist to the licensing officer.

Type B Licence
This licence is issued to any person the Licensing Officer may
consider to be fit and proper person to hold such licence, or
issued to a responsible officer of a company incorperated
under the Companies Act 1965.
This type B licence allows a person to import, store and sell
by wholesale only such poison as may be specified in the
licence.
This licence is restricted only in dealing on specific poisons
excluding the Group A poison.
The Poison Act also have proviso which do not allow this type
B licence to be issued to any person or officer who is engaged
or concern in selling goods by retail.

Type C Licence
The Licensing Officer is issued to listed seller a Type C
Licence when there is no pharmacist in within a local
authority licensed to carry on a business in such area.
This license will allow the listed seller to sell by retail and
store Group F poisons.
As the number of licensed pharmacist increase
tremendously the Poison Board view that they should up
grade all Group F poisons.
Untill 1989 there is no more Group F poison in the Poison
List so there is no more Type C licence issued by the
Licensing Officer.

Type D Licence
This licence is issued to any person whom the
licensing may consider to be fit and proper to hold
such license to store and sell by retail such Part II
Poisons as may be specified(ususlly after an
inspection of the applicant premise by the
enforcement officer to acertain that the applicant
and their premises are fit to handler such poison in
term of storage and safety)

Type E Licence
This licence is for any person who uses Sodium
Hydroxide in the course of his business in a
substantial quantity where this licence allows the
holder to import, store and use.
The enforcement unit of the state will have to ensure
that the person and the premises is fit and proper for
such activity before this licence can be considered
by the Licensing Officer.

General: on license
All the format of licences are prescribed by the Act
Licensing Officer have freedom to instate terms and condition in
every licence where he deem it is fit, proper and which are not
inconsistent with this Act or its Regulations. If the terms and
condition stated in the licence is not aggreable by the applicant,
the applicant can appeal to the minister (s. 26(3) and 26(4)).
All licence is personal to the licensee named in the licence and are
not tranferable.
The person named in the licence have to be responsible for
authorising any sale of the poison and any dealing in such poison
have to be personally supervised by him.

Each licence is specific to the premise where the addresses are stated in the
lic. Any change of add. have to be made by application to the Licensing
Officer and he will amend the address as he see fit (s. 26(6).
Section 26(5) give powers to the Licensing Officer to refuse issuance any
such licence or he may may cancel a licence that had been issued. Anybody
aggrieved by such action may appeal to the Minister. The Minister decision
on the appeal shall be final
All licensed shall be numbered by the State consecutively in respect of each
type and of year in which it was issued and commencing each year with the
number one.
A Register recording all the particular of each lic. and records any event on
cancellation or amendment have to be kept for all licence issued by the
Licensing Officer of every State. This register shall be accepted in any court
case as a prima facie evidence (s. 27).
The Director General of Health shall publish the name of all licence holder in
a Gazette annually in about the month of February each year. This
Government Gazette shall also be prima facie evidence in any court
proceeding (s. 28).

Enforcement of the Act


Section 2 define "Drug Enforcement Officer as, any
registered Pharmacist in the Public service, duly
authorised in writting by the Licensing Officer, (where
the Director General of Health is the Licensing Officer).
In order to enforce an Act, there shall be authorised
person who are given power appropriate to the needs of
the Act. Under the Poison Act the Drug Enforcement
Officer (DEO) are given the following powers;

Power to investigate
A DEO is given the power to investigate under
section 31(2). Power in oral examination of any
body acquinted with the fact and circumstances
of the case is also given (s. 31(3)) where it
means that they are given the power to record
statement of witnesses and the acused. Section
31(4), (5), and (6) laid the the caution involve in
taking the statement.

Power to enter primises


Section 31(8) give power of entry to the DEO
and any body accompanying him and who work
under his instruction. This section goes on
allowing the DEO to break open any doors or
remove any obstruction in gaining his entry. His
entry have to be at reasonable time and with
reasonable cause to believe that an offence
under this Act has been or is being committed in
the premises.

Power to inspect, detain, remove


any item reasonably related to the
case.
A DEO may search, inspect,
detain and remove any
substance reasonably believed to be a poison, book,
document, equipment, instrument, material or any other
article found in any premises in his opinion may furnish
evidence (s. 31(8)). Under this section the DEO is also
given the power to detain any person foun in such
premises untill the DEO finishes his search. Section
31(10) provide that it is an offence for any person to
obstruct or impedes a DOE in the performance of his
duties under this Act

Power of the police and custom


officer under this Act.
Section 31(9) give power the a police officer not
lower than the rank of an inspector and a senior
custom officer to exercise the same power as
given to the DEO under section 31(8) along with
an extra power to arrest any person if that
person is believed to conceal or deposit any
poison or any related articles.

Penalties and Court Proceeding


Penalties under the Act can be specific under any
offence sections in the Act or for general offences or
where those offences without the statement of penalty,
section 32 will invoke and section 32 in general can be
divided into two categories as follows:
i) A penalty punishable by fine not exceeding five thousand ringgit
or by imprisonment for a term not exceeding two years or both for
offences pertaining to keeping of record or false entery of records;
ii) A penalty punishable by a fine not exceeding three thousand
ringgit or by imprisonment for a term not exceeding one year or
both for offences which no penalty spesified under the Act or its
regulations.

Section 32 goes further into specifiying the liability of body corporate,


its officers and directors to be charge jointly under this Act and the
officer or directors are deem to be guilty the same untill they can prove
to the court that they have no knowledge what so ever or they have
taken precaution to stop the offence from being commited (s. 32(3)
(4)).
Section 32(5) any poison related to the case in which an offence under
this Act has been committed shall be forfieted and delivered to the
Director General of Health for disposal.
Section 33 provide that the Sessions Court or a First Class Mejistrate
Court in West Malaysia or a Sessions Court in the East Malaysia Shall
have full jurisdiction over offences against this Act. Prosecution
instituted under this Act or its regulations shall need to be sanction by
the Public Prosecutor and the prosecutor can be a registered
Pharmacist in the public service authorised in writting by the Public
Prosecutor (s. 34).

Regulations
Section 35 gives power to the Minister to make
regulations to carry out the purpose of this Act and these
regulations may be in respect or for the purpose related to
poisons such as importation, manufacturing, sale,
storage, transport, labelling, containers, compounding,
dispensing, record, qualification of poison guardian,
providing exemption, prescribing form of licences and
register, the act of dealing in specific poison such as lead
tetraethyl, presccribing penalties for offence againts the
regulations and regulate the control of Psychotropics
substance.

The Control Psychotropic Substances


In 1989 Malaysia become a signatory to the
International Psychotropic Convention 1971. After
signing this Convention there is a need to include
special control on Psychotropic Substances in the
Poison Act and there also seem to be aneed to regulate
more standardised control tuned toward this
Convention.
To cater for these needs the Poison Act was amended
to include section 30 in the Act which control Import,
export, manufacture, sale and other dealing in
Psychotropic Substances.

Third Schedule
This Act define Psychotropic Substances as those listed in
Third Schedule of the Act (s. 30(1).
The third Schedule listed out all the Psichotropic
Substances under the control of this Act.
not all psychotropic drugs as classified by way of their
Pharmacological action are listed under this Schedule.
Those listed are those Psychotropic which have abuse
tendencies.
The Minister from time to time can vary the Third Schedule
by way of Gazzett.
Section 30(3) provide that all dealing in Psy. Subst. have to
be in accordence with the regulations made under this Act.

Poisons (Psychotropic
Substances) Regulations 1989
This Regulations regulate the possession,
import, export, sale, supply, purchase,use,
administration, dispensing, compounding,
mixing, manufacturing, storage, disposal
and labelling of Psychotropic Substances.

Possession of Psychotropic
Substance

Regulation 3 of the Poisons (Psychotropic Substances)


Regulation 1989 prohibit any person from possessing
Psychotropic Substances unsless such possession is
authorised and such Psychotropic Substances is for
alawful purpose and is obtained in accordance with this
Regulation and Reg. 4(2) listed the person or class of
person who shall be authorised to possess
Psychotropic Substances and the are as follows;
(a) a licensed Pharmacist
(b) a registered Medical Practitioner

(c) a registered Dentist Division 1


(d) a veterinary surgeon
(e) a permit holder issued under reg. 15 of this regulation, to
purchase and use Psy. Subst. such person can be a game
warden or any tradesman who use Psy. Subst. in his trade.
(f) a person incharge of any ward, operating theatre or section to
posseess Psychtropic Substance for the use of such places.
(g) a person who is concern with scintific reaseach or chemical
analysis in Uni. or any inst., own by Govt or approve by the
Director General of Health
(h) a pharmacist in the public service

(i) Custom, police or postal officer in the course of their


duty
(j) a Drug Enforcement Officer
(k) a perso engaged in the delivery of Psychotropic
Substances
(l) a person whose Psy. Sub. is lawfully supplied by
person in (b),(c), or (d)
(m) a person acting on behalf of any class of
authorised person who lawfully possess
(n) a peson possessing psychotropic substsnces to be
administered to a patient as directed by person in (b),
(c), or (d).

Import and export of Psychotropic


Substances
This Regulation supervise import and export of Psy. Subst.
and it follow closely the format suggested by the Convention.
every importation to be authorised by the importing country
and the exporting country need ti authorised the eportation.
All transection pertaining to import and export will be reported
to the International Narcotic Control Board INCB in Vienna
Austria which is the body who ensure that the agreement in
the Convention is followed by the member country.
This requirement on import and export authorization is laid out
in regulation 4(1).

Exemption on import for


personal use
regulation 4(2) exempt any person arriving or
leaving Malaysia with one month supplies for
himself or any member of the family a prepared
packed medicine containing Pschotropic
substances which is genuinely priscribed by a
qualified medical practitioner or any ship, aircraft
or any form of international transport leaving or
coming into Malaysia with alimited quantities of
psychotropic substances for emergency use on
their voyage.

application of import and export


Reg. 5 and 6 further laid out the procedure on application
of import and export authorization and indicates that it is
the prerogative of the Licensing Officer to issue these
authorization.
For each authorisation if approved, will be issued out in
triplicate where two copies will be given to the applicant
where the applicant will then send one copy to the
supplier in the other country and the Licensing Officer will
sent one copy to the Competent authority of the other
country.

These regulation priscribed the format for import authorization as


Form B in the regulations and export authorization as Form C.
The fee for import and export Authorization is ahundred ringgit
(r.7)
Due to the agreement in the Convention, certain pychotropic
substances such as the amphetamine, methaqualone, secobarbital
and etc. is compulsory to be to followed with an export
authorization if they are imported or in transit so reg. 9 was
promulgated so that this requirement is followed and a list of such
psychotropic substance is listed in Second Schedule of these
regulations.
All psychotropic substances in transit shall not be tempered with
and the packing shall not be change without a written consent of
the Licensing Officer.

Sale and Supply of Psy.Substance


Regulation 11 regulates that all psy. Subst. have to
prescribed only by reg. medical practioner, reg. division 1
dentist or a veterinary surgeon and this catogories of
professionals can do the supply themself or their priscribtion
can be dispensed by a registered pharmacist or any
pharmacist who is employed by the government treatment
institution or any institution approved by the Director
General of Health.
Asupply can also be made to any person who is authorised
to administered such pschotropic upon a priscribtion.
This regulation further priscribed the format for psy.
prescription and how this prescriptions are dealt with.

Prescription for Psy. Substances


Regulation 11(2) - every Psychotropic priscribtion should;
a) be writtern, sign and dated by the prisciber;
b) identify the priscriber by having in the priscibtion, his
name, address and telephone number;
c) indicate the age, full name and address of the patient
and for veterinary purpose should indicate the same
particulars of the person to which the items is to be dilivered;
d) indicate the total amount and the dose to be supplied;
e) spacify the number of time can the priscribtion be
dispensed and at what interval (this paragraph allows the
priscribtion to be dispensed for the maximum of three times)

all pschotripic's priscribtion can only be valid for 90 days.


Any Pharmacist dispensing this priscribtion have to endose
upon the face of the priscibtion above the prisciber signiture,
his full name and address and the date of dispensing.
For urgent cases or an emegency upon the request of a
medical practitioner, a Dvision 1 dentist or a veterinary
surgeon the pharmacist can dispense a one day supply of
psychotropic substance to a patient after he have made a
record in the psychotropic register and a priscribtion have to
follow up immediately the next day.
All priscibtion pertaining to psychotropic substances have to
be kept for a period of not less than two years.

Psy. for other than human &animal


purpose

Regulation 12 provides that a licensed pharmacist or a pharmacist


in public services can sell or supply psychotropic substance other
than to medical practitioner, dentist or veterinary surgeon for the
purpose of treatment. Such sale and supply can be to;
another licensed pharmacist or pharmacist in public service;
a person concern with scientific reasearch
a person holding a permit under regulation 15, where reading together
regulation 14 and 15 we will understant that a permit for purchase and
use of pys.subs.may be issued by the Licensing Officer to a
profesional person or tradesman for their profession or trade only (for
example
) or to an authorised game warden for the use on
animals only.
to be legally exported to a puchaser outside Malaysia following the
procedure in regulation 4.

Giving of Commercial sample are not allowed under


regulation 12(2)(a) where there are only allowence for
clinical trial sample and the issuence of this clinical trial
sample have to be authorised by an import license under
The Control Drug and Cosmetic Regulation 1984
Any authorised person under the poison Act or this
regulation to purchase psychotropic substances,
purchasing an unusually large amount acting in his
ordinary course of duty shall be required to give an
attestation to the seller before the sale and supply can be
made (12(2)(b)).

Administration, Dispensing,
Compounding, Mixing and Mnufacturing
of
Psy.
Substance

Regulation 16 provide that only registered medical


practitioner, Division 1 dentist or veterinary surgeon or any
person directed by them.
Regulation 17 stated that only licensed pharmacist or a
pharmacist in the public service are allowed to dispense,
compound and mix.
Reg. 18 provides that only licensed pharmacist and
pharmacist in the public service are allowed to manufacture
psy. Subst. or any preparation containing psy. Subst. and this
manufacturing can be assisted by any other person who are
immediately supervise by them.

Register of Psychotropic
The recording of psychotropic provided in regulations 19,
20, 21, 22 and 23 and can be simplified as follows;
i) Records of sale and supply for the purpose of
treatment (r.19);
a) to keep a register containing
- name strength and quantity sold or supplied
- name and address of patient, name and address of reciepient for
veterinary

b) a separate register with respect to every types (can be in


separate part of the same register or in a separate book) of
psy. Subst., for the purpose ofrecording quantity recieved,
date, total current stock, name and address of supplier,

ii) Recs of sale & supp other than for the purpose of treat. (r.20);
a) to keep a supply register for Psychotropic, containing

name and address of purchaser


date of sale or supply
name, strength and quantity of Psychotropic substance
intended use of the psychotropic substances by the purchaser.

b) to keep the same Separate Register as in i).b) .

iii) Records of manufacturing of Psy. Subst. (r.21);


a) to keep a Production Register for Psychotropic, containing;
date and amount issued for manufacturing
Pharmacuetical dosage form of Psychotropic and quantity of psychotropic
substances in each dosage unit
theoritical yeild and batch number
actual yield
total taken as sample for Quality Control
total tranfered for sale.

b) to keep the same Separate Register as in i).b)

More on register
Any register of Psychotropic Substances should only be
corrected with a marginal note or footnote specifying the
date and the correction (r.22(c)).
All entery have to be made in cronological order (r.22(d))
register have to be in a bound book (r.23) or any other
form approved by the Licensing Officer
registers to be preserved for not less than 2 years from
the date of last entry.

Storage and Disposal of


Psychotropic Substances
The person authorised to possess Psychotropic
Substances for the purpose of manufacturing, dispensing,
compounding, mixing, sale, supply, education, research or
chemical analysis shall store them under lock and key
and the key have to be kept by the authorised person
himself (r. 24(1)(2)). In this case the storage have to be
proven secure to prevent theft and diversion.
All disposal of psy. Subst.have to be inaccordence to a
DEO's instruction and all disposal have to be witnessed
by a DEO (r.25). All disposal have to be recorded in the
register.

Power of Minister to make


Prohibitary Order.
The Minister can make prohibitary Order in the form of
gazzett on any registered medical practitioner,
Pharmacist, Division 1 dentist or veterinary surgeon from
dealing in Psy.Subst. by virtue of regulation 29. This
prohibitary order shall be made in the event when;
there have been a conviction relating to psychotropic
substances
the Minister has reasonable ground to believe that the
psychotropic substances has been dealt with in an
irresponsible manner.

Reg. 30 laid out the procedure for making the prohibitory


order, where;
The Minister shall serve on the person;
a) the term of the proposed order
b) the ground on which the order is to be made
c) the person right to make a representation in writting within30days

The Minister shall refer any representation made before the


aforesaid period to anadvisory committee established under
reg.31, where the Fourth Shedule under regulation 31 listed out
all the possible member of the advisory committe depending on
the profession of the person whom the prohibitory order is to be
made. Eg. in the case of a registered Pharmacist the advisory
committe shall consist of the Director General of Health, the
Director of Pharmaceutical Services, and two registered
pharmacist in the public services appointed by the Minister.

Other General provision under the Regs.


Regulation 23 give exemption to govnt. Pharmacy Assistant or
in his absent, the Medical Assistant for possession in reg. 3,
supply in reg. 11(1) and dispense as in reg. 17.
A master of any ship is authorised to purchase and possess a
limited amount of psychotropic subst. for the purpose of firstaid or emergency cases (r.33). In consistency of this
allowances a licensed pharmacist may sell or supply upon a
certificate issued by a Port Health Officer in place of the sign
order as required under regulation 20.
Regulation 34 exempt Government Officer from all fee
pertaining to this regulation.

information in relation to any inquiry


Reg. 35 provides that every person who is authorised to deal in
psy. subst. shall have the duty to give information in relation to any
inquiry by a DEO, the Licensing Officer, a Police Officer not below
the rank of an Inspector or a senior Custom Officer. It is an
offence under reg. 36 to give false particular pertaining to any;
inquiry by any authorised officer (as provided by regulation 35)
enteries to the Psychotropic Substances Register
document to obtain psyc. Subs., eg. a false prescription or sign order.
declation in order to obtain psychotropic substances, for example a
false attestation
in order to obtain an unreasonalbe large amount of psychotropic
substances fron the
supplier.

DANGEROUS DRUG ACT


1952
control both the legitimate dealing and the
illegal dealing of Dangerous Drug.
We will focus more on the the control of
dangerous drug mean for legitimate use as
Ministry of Health is made responsible for
the dealing of dangerous drug for the
purpose of medicinal use in treatment of
human and animal and for scientific
research.

Since the tendency of abuse for dangerous drug is


very high the dealing of such drug have to be control
stringently.
As stipulated in the preamble of this Act that it
regulate the control of importation , exportation,
manufacture, sale and use of dangerous drug, these
responsibility lies upon Ministry of Health and form
part of the duties, jurisdiction and ministerial power of
Minister of Health.
The Police and the Custom Department shall focus
more on the smuggling, illegal possession, illegal use
of dangerous drug in the illegal market.

Single Narcotic Convention 1961


Malaysia is the signatory to the Single Narcotic
Convention 1961,
where we are also bound with the term and
agreement in the convention on the movement
of dangerous drug globally
The secretariat to this Convention is the
International Narcotic Control Board (INCB)
whose office is in Vienna, Austria.

All importation, exportation and statistic of use on


dangerous drug have to be reported to INCB and INCB
will study the trend of usage and will sometimes request
the competent authority of the member country to
comment if they detected an unusual trend in the use
of any dangerous drug.
The Convention also issued out classification for
dangerous drug and how are they dealt with following
the agreement in the convention. The member
countries can adopt the basic classification in to their
regulation to facilitate global harmonised control

What you have to know?


On this topic we will study the relevant part
of the Act pertaining issues under the
jurisdiction of the Ministry of Health.
The Dangerous Drug Regulation 1952 will
be studied in totality as it form the
supervisory tool on the control of dangerous
Drug in the legitimate market.

What is Dangerous Drug


The Dangerous Drug Act 1952 interprets
dangerous Drug as, those comprised in the first
schedule of the Act.
This restricted definition cause the authority to be
very careful in consideration of pharmacologically
classification and the abuse possibilities in order
to list them in the schedule.
The extent of abuse also have effect on the
classification of the drug in the first schedule.

Power of minister to vary the


First Schedule
Under sections 45 and 45A of the Act it is clear that the
Minister of Health play a very important role in building up
of the first schedule.
Section 45 give power to the minister in collaboration of
the United Nation (INCB) to exempt certain dangerous
drug from the list if the drug do not give rise to abuse (eg,.
Greater power are given under Section 45A where the
Minister can vary the schedule even after agreement in
the Single Convention on Narcotic 1961.

The first schedule under the act


was further divided into five
parts.

Part I

Part I of the first schedule consist of raw opium,


coca leaves, poppy straw and cannabis.
It is very clear that Part I control the raw
unprocessed drugs which are not at all use in
therapeutic treatment.
Possibility of the Ministry of health having
jurisdiction for this part is their used in research
institution or in the primary pharmaceutical active
manufacturing , if not the possession is more of
criminal in nature and the police or custom are the
enforcement authority.

Part II
Part II consist of prepared Opium and
cannabis resin. These are processed drug
but are still in the raw extract state. The
control are still the same as those in Part I.

Part III
Part III are made up of the longest list of
dangerous drug in the form of chemical
active or in the form of content in any
dosage form. Most of the Pharmaceutical
dosage forms are control under this Part.

Part IV
Part IV listed out ethylmorphin,
propoxyphene and most of the morphine
derivatives in the codiene groups. The
dangerous drugs under this part are also
very common in the pharmaceutical
preparation or dosage form.

Part IV
Part IV is considered to be the lowest
control dangerous. The drug listed in this
Part are pharmaceutical preparations. The
Act regulates that the items in this part do
not need an export authorisation on
exportation (more explanation will be given
on import and export of dangerous drugs in
the coming chapter) .

Management of Dangerous Drug for


legitimate use in Malaysia
The parent Dangerous Drug Act and the regulation
made under this Act have to be read together inoder to
understand the legal management of the Dangerous
drug act for legitimate used which include for
therapeutic and research.
Part IV of the Dangerous Drug Act entitle Control of
certain Dangerous Drugs stipulated this management
in general and the Dangerous Drugs Regulations
1952 regulates the full managements.

Part IV of the Act


Part IV of the Act (do not confuse PartIV of the Act and
Part IV Dangerous Drug) only control Part III, IV and V
Dangerous Drugs (S. 11(1)).
Section 11 (2) and (3) further give power to the minister
to vary the Dangerous Drugs listed under Part III, IV, V.
Generally Part IV of the act are made up of various
restriction in dealing with Part III, IV and V Dangerous
Drugs
Part V of the Act laid out the guidance for external trade.
It is very clear that these are the control and guidance
for dealing in legitimate used Dangerous Drugs.

What are the Controls


The control and guidance stipulated in the
parent Act and Regulations include:
Control of import of Dangerous Drugs
Control of export of Dangerous Drugs
Possessions of Dangerous Drugs
Manufacturing of Dangerous Drugs
Sale and supply and distribution of
Dangerous Drugs

Control of import of Dangerous


Drugs
Section 12:
required all importation of Dangerous Drugs
to be authorised by the minister
laid out the guidance for importation of
Dangerous Drugs.

The following chart depicted below in


general explain the guidance and control on
importation of Dangerous Drugs

Control of export of Dangerous


Drugs
Section 12:
required all exportation of Dangerous Drugs
to be authorised by the minister
laid out the guidance for exportation of
Dangerous Drugs.

The following chart depicted below in


general explain the guidance and control on
exportation of Dangerous Drugs

Possessions of Dangerous Drugs

Who can possesses DD


Mere possession of Dangerous Drugs without a valid
authorization is an offence under the Act and can be
punished severely. Authorised possessions of
Dangerous Drugs is among those discussed in Sec. 16 of
the Act and followed by Reg. 5, 6, 7 and 8. Generally the
control focus on:
Possessions of Dangerous Drugs by a person who have
been priscribed by a registered medical practitioner
Possessions of Dangerous Drugs by a person authorised
to possess

Manufacturing of Dangerous
Drugs

Manufacturing of Dangerous Drugs


Manufacturing of Dangerous Drugs includes:
The manufacturing of active Dangerous Drugs as a form of
pharmaceutical actives raw material
Manufacturing of Dangerous Drugs in the form of dosage
entity ( eg. Manufacturing of Pethedine tablet)

Both types of manufacturing can only be done with


a valid manufacturing license issued by the minister
by virtue of Section 16 of the Dangerous Drugs Act
1952and regulation 4,
of the Dangerous Drugs
Regulations 1952.
Reg. 9 - manufacturing in the daily course of retail
business

The manufacturing of active Dangerous Drugs as a


form of pharmaceutical actives raw material is
further regulated by the INCB where Malaysia
being the signatory to the Single Narcotic
Convention need to send quarterly report to this
board on the amount of Dangerous Drug
manufactured.
Until today Malaysia do not manufacture its own
active Dangerous Drugs in the form of
pharmaceutical actives raw material.
All Malaysian Dangerous Drug raw material are
imported.

Sale, Supply and Distribution


of Dangerous Drugs

Sec. 16: Control of manufacturing, sale,


supply, distribution and Possession of
DD
Reg. 5, Supply and procument to be done
by authorised person - proviso where
administration od DD to a patient is not
considered a supply.
Reg. 7, Delivery of DD by authorised
person - 7(4), using registered or insured
post.
Reg. 8, classes of authorised persons

Reg. 13 - supply by authorised retailer to


authorised persons 13(1), conditions to be followed
13(2), In urgent case, SO have to delivered
within 24 hrs - an offence punishable ...

Storage, Records of DD
Reg. 9 (2),- dengerous drug to be under lock and key and the
authorised person as guardian.
Reg. 15(1) & (2)
15(1)(a) - DD Register, in chronological order for every DD for receive
and supply (day book)
15(1)(b) - Separate book for every DD - purpose of audit
15(1) c - entry on supply to be made on the same day
15(1)(d) - format for cancellation of record
15(1)(e) - call for information by the DG of Health or the authority

15(2)(a) & (b) - exemption of day book if there is already


in existance of prescription book under the Poison Act,
Reg. 16 - all records to be kept for 2 years

Form of DD prescription
Reg. 11(2) - set the format for prescription
Format for Psy. Subst. Is an improved
format from DD prescription.

Dispensing of DD
Reg. 12(1) - validity of prescription
Reg. 12(1)(a) - prescription should comply to format
Reg. 12(1)(b) - to ascertain that the prescription is
genuine

Reg. 12(2) - Offence section for dispensing of


faulty prescription
Reg. 12(3) - interval of lapse for supplies
Reg. 12(4) - date of dispensing to be noted and
completed dispensed prescription to be retained
Reg. 12(5) - offence section

Labelling & Packaging


Reg. 14(1) - Marking of Packages and Bottles
Reg. 14(1)(a) - amount of drug to be marked on the container
Reg. 14(1)(b) - for a preparation - amt. Per unit and total
amount

Reg. 14(2) - exemption on DD as dispensed


medicine

DD Licenses
Reg. 18 - Wholesale license
Reg. 4 - Manufacturing License

Appointment of Drug
Enforcement Officer

Appointment of Drug
Enforcement Officer

.Other than the traditional authorised officers in


enforcing this Act such as the police and
custom, section 3 of this Act give power to the
Yang di-Pertuan Agong to appoint such person
as he may think fit to be the Drug Enforcement
Officer. All Pharmacist in the public service
are Drug Enforcement Officers appointed under
this section.

How do this regulation apply on


Codeine Cough Mixture or
Dyphenoxylate Tablet?

25

AKTA JUALAN DADAH 1952


SALE OF DRUGS ACT 1952

Mohamed Ibrahim bin Noordin


BIRO PENGAWALAN PHARMACEUTIKAL KEBANGSAAN

SEJARAH AKTA INI


Akta ini berasal dari Akta Jualan Makanan dan
Dadah 1952
Pada tahun 1985 Akta Makanan 1983 telah
dikuatkuasa dan dengan penguatkuasaan Akta ini
kebanyakan proviso di dalam Akta Jualan Makanan
dan Dadah 1952 telah dimansuhkan.
Pada tahun 1989 Akta Jualan Makanan dan Dadah
1952 telah disemak kepada Akta Jualan Dadah 1952
Pada tahun 1992 Akta Jualan Dadah telah
dipanjangkan ke Sabah dan serawak.

Akta ini tidak meliputi kawalan


terhadap ubat-ubatan Veterina
Definasi drugdan sale [ S. 2 ]
drug means any substance or mixture of substances
use by man as a medicines, whether internally or
externally, and includes anaesthetics

sale or sell includes barter and exchange


and include offering or attempting to sell or
allowing to be sold or exposing for sale or
recieving or sending or delivering for sale or
having in possession any drug knowingly that
the same is likely to be sold or offered or
exposed for sale, and refer only for sale for
human consumption or use.

KUASA PELANTIKAN DI
BAWAH SEK.3
Yang Dipertuan Agung melantik
Analyst[S. 3(1)]
Menteri besar melantik pegawai
berkuasa dan Inspector[S.3(2)]
Menteri Kesihatan diberi kuasa
mengadakan peraturan-peraturan
untuk tugas-tugas analyst, pegawai
berkuasa dan inspector. [S. 3(3)]

KUASA-KUASA PEGAWAI
BERKUASA DAN INSPECTOR DI
BAWAH SEK. 4
Memasuki dan memereksa [S. 4(1)(a)]
Menjalankan kerja-kerja mark, seal,
secure, weigh, count, measure
[S.
4(1)(b)]
merampas drug yang unwholesome atau
deleterious [S. 4(2)(a)]
memusnahkan drug[S. 4(2)(a)]

KAEDAH PENSEMPELAN,
SEKSYEN 5 dan 7
Sample diperolehi
(pembelian)[S.5(1)]
memberitahu pehak dimana sample diperolehi
yamg sample berkenaan adalah untuk dianalisa
[S. 7(1)]
sample dibahagikan kepada 3 bahagian
1 bahagian kepada kepada pehak disample
1 bahagian kepada analyst
1 bahagian disimpan oleh Pegawai atau Inspector
[S. 7(2) dan 7(3)]

SEKSYEN 10 :
OFFENCES AND PENALTIES

1. adultration [ S. 10(1)(a) ]
2. misleading statement [ S. 10(1)(b)]
3. containing prohibited substances [ S. 10(1)(c)]
4. containing greater propotion of certain substance
than is permitted [ S 10(1)(d) ]
5. containing methly alcohol,isopropyl alchohol or
denatured alcohol [S.10(1)(e)]
7. nature of substance not as demanded by purchaser [
S. 10(1)(f) ]

PERATURAN-PERATURAN KAWALAN
DADAH DAN KOSMETIK 1984
Digubal di bawah Akta Jualan Makanan dan
Dadah 1952
Bhg. I; Definasi dan Intepretasi
Bhg. II; Pelantikan Pihak Berkuasa (PBKD)
Bhg. III; Keperluan pendaftaran & lesen
Bhg. IV; Kritiria-kritiria GMP, QC dan QA
Bhg. V; Kuasa-kuasa pegawai, Keperluan rekod,
lapuran kesan adverse, hukuman dan kuasa
Menteri

DEFINASI PRODUCT
[r. 2]
product means a drug in a
pharmaceutical dosage
form, or a cosmetic, having
a singular identity,
composition, characteristics
and origin.

KESALAHAN-KESALAHAN DI BAWAH
PERATURAN-PERATURAN
Ubat-ubat tidak berdaftar [r. 7(1)(a)]
Pengilang, pengimport dan pemborong yang tidak
berlesen [r. 7(1)(b)]
Memberi maklumat palsu kepada PBKD
[r.
8(9)]
Pengilangan tidak mengikut apa yang di gariskan
oleh peraturan ini
Tidak melapurkan kesan adverse ubat [r. 28]
Pemborong tidak merekod transaksi ubat [r.27]
Tidak mengikut arahan Pihak Berkuasa [r. 29]

SELAIN DARI PENGUATKUASAAN


KE ATAS UBAT-UBAT TIDAK
BERDAFTAR DAN PELESENAN
PERATURAN-PERATURAN
KAWALAN DADAH DAN KOSMETIK
BOLEH DIKUATKUASAKAN KE
ATAS KEHENDAK-KEHENDAK
GMP

GMP

QA

QA

GMP

REG. 19; PERSONEL


REG. 20; PREMISE
REG. 21; EQUIPMENT
REG. 22; MANUFACTURING
OPERATION
REG. 23; QUALITY CONTROL
REG. 24; SELF INSPECTIONS
REG. 25; RECORDS

DAFTAR YANG DISIMPAN


OLEH SETIAUSAHA PBKD
[r. 9]
Nama keluaran berdaftar
kandungan bahan aktif dan kuantiti
kandungan nya
nama dan alamat pengilang
nama dan lamat pemegang sijil pendaftaran
nombor sijil pendaftaran keluaran
tarikh sijil pendaftaran dikeluarakan dan
tarikh luput nya.

KETEMPANGANKETEMPANGAN AKTA JUALAN


DADAH 1952
Kuasa penyiasatan yang tidak sempurna,
dimana tiada kuasa merakam percakapan
Kuasa pegawai dan inspector hanya
meliputi negeri
Masih terdapat kriteria-kriteria pengawalan
makanan
Tiada pengawalan keatas ubat-ubatan
veterina

REGISTRATION
OF PHARMACIST
ACT 1951

PREAMBLE
An Act relating to the
establishment of a Pharmacy Board
and the registration of Pharmacist
It set up Pharmacy Board
Registration of Pharmacist as a
person
Registration of Bodies Corporate

DEFINITIONS

Board means the Pharmacy Board


established under sec. 3 of the Act;
person does not include abody
corporate
registered pharmacist means a
peson whose name appears for the
time being in the register kept under
this Act (Section 5)

therapeutic substance means


any substance which may be
prescribed by the Board for the
purpose of this Act, provided
that there is written law on
therapeutic substance, meaning
in such writtern law will be
taken;

SEC. 3: Estab. and constitution of


Pharmacy Board.
3(1) membership and
representative in the
establihment of the Board;
3(2) 3 years period of
appointment for ex-officio
members and elligiblity for
reappointment;

3(3) the Minister have power to


terminate or appoint a replacement for
member of the Board who is unable to
act or absent for 3 consecutive
meetings except ex-officio members
(proviso of replacent to follow 3(1)
3(4) safeguard the Action of by the
Board when there are defect in the
appointment or vacancy

SEC. 4:President & meeting of


the Board
DG of Health shall be the president
and shall chair all meeting attended
by him
If the DG is absent the member will
elect one among them to be the
chairman

Chairman shall have an original


vote and a casting vote
The Board shall meet at place
and time decided by the
President
5 member of the Board will form
a quorum

SEC.5: Register of Pharmacist


A Register have to be kept in
the form prescribed by the DG
The DG is reffered as the
Registra
The registra is responsible for
the maintainance and custody
and perform duties as as may
prescribed

SEC:6 Person eligible for


registration
6(1) person eligible shall be holder of degree
in Pharmacy USM and any person who was
previously registered with Pharmacist
Odinanace of the Straits Settlement

6(2) the Board may also register person


holding any other appropriate Pharm.
qualification approve by the Minister after
consulting the Board or any person practising
Pharmacist who applies before 31 Dec 1954
and have been practising for the past 5 years
6(3) no qualification will be entered into the
register untill the Registra is satisfied that
such qualification is entitled thereto
6(4) person to be registered nedd to attained
the age 21

SEC. 6A: Conditions precedent to


regidtration
any person who is eligible for registration
under Sec. 6(2)(a)(i) may be required by the
Board to comply with condition on
apprenticeship and training or to sit for
examination set by the Board

SEC.7: Restriction on the use


of certain titles

7(1) person not registered under this


Act shall no t use the titles
Phamaceutical Chemist,
Pharmaceutist, Chemist, Druggist,
Pharmacist or any thing to implies
that the outlet having somebody
registered under this Act.

7(2) noting should be use or affix


at a premise any title or
descibtion to suggest that he or
any one employed in the premise
possess any qualification on
selling, dispensing, or
compoundong of drugs or
poisons

7(4) contravention of this sec. is an


offence
7(3) the use of the words pharmacy
or dispensary shall deemed the
premise to have aperson registered
under this Act. The re is a proviso to
allow the use of such terms by a
registered medical practitioner or a
vet. surg.

SEC. 8:

Application for

registration
To be made in such a manner and
to be accopanied with such
documens, photograph and
particulars as may be prescribed
for the purpose of satisfactory
proof of identity

SEC.9:

Power to refuse
registration
If a person is being guilty of
infamous conduct after due
inquiry by the Board,
admission to the register may
be refused.

SEC.10:

Entry of higher
education into register
Every registered person have the
entitlement to insert, add or
substitute in the register a
higher qualification with prove
of achievement.

SEC.11:

Issue of certificate of
registration
After admission to the register the
Board may issue a certificate of
regitration with a photograph affixed.
If the is any condition as mention in
Sec 6(2)(c), such condition or
restriction will be specified in the
certificate.

SEC.12: Condition as to sale of drugs.


12(1) For bussiness related to keeping,
retailing, dispensing and compounding of
poisons, dangerous drugs or therapiutic
substances; the bussiness shall be bona fide
conducted by the registered Pharmacist and
his name and certificate shall be
conspicuously exhibited in his premises
12(2) offence section for non-compliance to
12(1)

SEC. 13: Registration of


bodies corporate
13(1) Body Coporate in Malaysia carring
the bussiness of keeping, retailing,
dispensing or compounding poisons,
dangerous drugs or therapeutic
substances have to be registered by the
Board

13(2) for this purpose the Board have to


be satisfied that the bussiness is under
the control and management of
asuperintendent who is a registered
Pharmacist and who does not act at that
time in the same capacity for another
company
13(3) a certificate of registration will be
issued upon registration

13(4) A body coporate registered under this


section carrying bussiness as mention in
S.13(1) shall; (a) have a superintendent who
is a registered pharmacist and who does not
act at the same time in a similar capacity for
another company to manage and control the
body corporate; (b) the business have to be
bona fide conducted by the body corporate
or by a manager who is also a registered
pharmacist under the directive of the
superintendent;

(c) his certificate have to be


conspicuously exhibited in those
premises; (d) the certificate of
registration for body coporate or copies
shall be conspicuously exhibited in each
set of premises.
13(5) a registered body corporate who
have complied with S.13(4) under this
Act may use the name or title as
mention in S.7

13(7) the Board may inquire into a


case and may refuse to register or
remove from the register a body
coporate if; (a) a body corporate is
convicted of an offence under this Act
or any written law relating to poisons,
dangerous drugs or therapiutic
substances; or

(b) any officer, director or any person


employed by such body corporate is
convicted the same or guilty of any
misconduct.
the body corporate have to satisfies the
Board that the act in question was not
instigated the body coporate
(superintendent, director or manager) and
the person guilty is no longer employed.

13(8) the Board can remove the name of


the body corporate from the register; (a)
when incorrect staetment was given to
obtain the registration or it was obtained
by fraudulent; (b) when the body
corporate cease to carry out the bussiness
of keeping, retailing, dispensing,and
compounding poisons, dangerous drugs
or therapiutic substances

13(9) offence section on


contravening this section.
13(10) power of the Board on
restoration of registration after its
action of removal.

SEC.14: Continuation of busines of a


deceased pharmacist or dispencer by his
representative
14(1) If a registered Pharmacist dies
while carrying a bussiness, any executor,
administrator or trustee shall carry on the
bussiness and shall entitle to use the tittle
in connection to the bussinesss, use by
the deceased

14(2) for 14(1) to be applicable, the


bussiness must be conducted by a
registered pharmacist and his certificate
be exhibited in the premises
14(3) If any of the representative have
conviction, the Board may inquire into
the case and may ceased him from using
te title used by the deceased pahrmacist

SEC.15:Publication of register&
presumptions
15(1) The register consist of name,
address, qualifications anddates of
qualification of pharmacist shall be
published annually in a Gazette and from
time to time if there are changes, the
changes shall also be published in a
Gazette

15(2),(3),(4) are presumption as


to prove of registration by the
Gazette and the cetificate with
the registra and these form
conclusive evidence

SEC.16: Annual Certificate


This section require the application aof
annual retension certificate before the
end of every year to mantain a person or
a body corporate in the register,

application have to befollowed by a fee


and acertificate will be issued which will
last untill the end of such year
late renewal of retention certificate will
be charge with an extra fee
non renewal of retention certificate will
cause the name to be removed from the
register

SEC. 17:Cancellation of annual certificate &


removal from the register

17(1) Board may cancel or remove any


registered pharmacist from the register if
proven that;
(a) there is a fraud in obtaining the registration;
(b)there is conviction which render him unfit;
(c)guilty of infamous or disgraceful conduct;
(d)is deceased;
(e)permanently left Malaysia;
(f)unsound mind, infirmity which render him unfit.

17(2) Board have jurisdiction in


restoring name in the register.
17(3) Board can remove name in
the register if there is a breach of
restriction or condition.

SEC.18:Alteration of the register can be done by


the Registra.(by directive of the Board)

SEC.19:Any person or body corporate aggrieved


by action of the Board may appeal to the Minister
whose dicision shall be final.

SEC.20: Penalty for Fraudulent registration


SEC.21: Appoint and powers of inspectors

SEC.22: Board have power to make


regulation with the approval of the
Minister
pupilage and training
examination to be eligible for registration
meeting procedure
matter required under this Act to be
priscribed

registration of body corporate


exaemption fron any operation of this Act
appointment and payment of legal
advisers
payment to members of the Board
any matter which will be expediet by
regulation