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PERUNDANGAN FARMASI

PHARMACY LIGISLATIONS The are 5 types of Malaysian Pharmacy

Legislations.

It consist of 5 Main Acts and several regulationmade 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.

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ORDINANCE,

ACT,

REGULATION &

GUIDELINE

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ORDINANCE

Laws before Merdeka Day

For Federal they are calledORDINANCE

For State they are known as

ENACTMENT

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ACT (AKTA)

Laws after Merdeka Day

Written Laws***Federal Constitution

***Constitution of State

***Act of Parliament

Common Laws

Customary Laws

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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

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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 underRegulations 20(1), 22.

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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.

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ADA

SOALAN

TAK?

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AKTA UBAT

(IKLAN DAN PENJUALAN) 1956

MEDICINE(ADVETISMENT & SALE)

ACT 1956

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PREAMBLE OR THE SPIRIT

OF THE ACT It is an Act to prohibit

certain advertismentsrelating to medicalmatters and to regulatethe sale of substancesrecommended as amedicine.

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INTERPRETATION &

DEFINITION OF CERTAINIMPORTANT WORDS AND

PHRASES

SECTION 2

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Advertisment Definition;

*advertisment includes any notice,circular, report, comentary, pemphlet,label, wrapper or other document or

any announcement made orally or byany means of producing ortransmitting 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..............

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OTHER IMPORTANT

SECTIONS Sec. 3

Sec. 4

Sec. 4A

Sec. 4B

Sec. 5

Sec. 6PRODUCT

TREATMENTSKILL & SERVICES

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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 sexualperformance of human

Paragraph 3(1)(d) prohibition of advertisment

relating to diagnosis of disease as specified in

schedule

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

amend the schedule

Subsection 3(2) give examption for such prohibitedadvertisment 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

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SECTION 4

Prohibition of advertisment relating toabortion

this section relates to advertisment for article

used for procuring the miscarriage of woman

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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 iscapable 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.

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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 listedunder 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

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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 articleas 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 servicefor treatment , prevention or diagnosis (S.4A)

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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

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SECTIONS 6

Disclosure of composition ofmedicines

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 itsregulations), ..........

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SEC. 6A: Powers of authorised officers

The Minister may

authorised in writting any

Pharmacist in the public

service to execise the

power of authorisedofficers

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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 ofinvestigation

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SECTION 6C

Examination of witness Recording statement of

who ever is acquainted with

the fact and circumstancesof the case

Proviso for caution and the

right of the personinvestigated upon

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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.

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SECTION 6E

Penalty for

obstructing or

impeding an

authorised

officer

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SECTION 6F

Sanction by the Public

Prosecutor before a

case under this Act canbe taken to court

Authorised Officer to

conduct prosecution

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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 thedicision of MAB

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MEDICINE ADVERTISMENTBOARD REGULATION 1976

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ANY

QUESTION?

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POISON ACT 1952

AKTA RACUN 1952

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PREAMBLE An act to regulate the

importation, possession,

manufacture, compounding,

storage, transport, sale anduse of poisons.

This Act apply throught

Malaysia

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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

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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.

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A veterinary Doctor is allow to use the

same substances for animal treatment.

There are several Regulations being madeunder this Act to supervise matters

pertaining to Poison.

l i

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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 thecourse of his work use Part II Poisons in substantial

quantity.An authorization may be granted subject to

restrictions and conditions as may be specified.

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The Poisons (Psychotropic Substances)

Regulation 1989 is an outcome of the signing of

the Single Convention on PsychotropicSubstances 1971. After becoming a signatory to

the said convention there seem to be a need to

regulate a more standardise control tunedtowards 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.

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SECTION 2INTERPRETATION,

DEFINITION

Some important definition

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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 orpreparation included for the time being in

the second schedule of the Act

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

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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 alicensed pharmacist on the premises specified in

his licence;

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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 forsale.

Sell or Sale, include barter, offering or attempting

to sell in the traditional meaning as sell or sale. definition ofsupply 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.

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Wholesale, the meaning of wholesale in this

Act is, a sale to a person who intent to sell

again and any sale by a wholesalerauthorised under this Act.

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Immediate Personal Supervision Subsection 2(2) of this Act give the presumption for

the term immediate personal supervision, where it isdeem 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 theperson doing such thing.

Provided that, where for compounding, mixing and

dispensing, it shall not be deem to have been so doneunless such person has himself checked such

compounding, mixing and dispensing.

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The Poison Board Section 3 laid out the establishment of the poisons

Board, appointment of member of the Board, who to beappointed 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

i f h B d

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constituent of the Board

outlined in Section 3 of the Act. It consist of 13

members, where 12 member are appointed bythe Minister.

The Director General shall be the an ex-officio

member and section 4 laid that he shall be thechairman of the Board and preside at all meeting

that he attends.

In his absent one member shall be elected topreside. 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

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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.

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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 alsoappoint 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 membersincluding the Chairman or member presiding shall form a

quorum.

Section 5(2) provides the procedure of the Board cannotbe 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

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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 notin 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.

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The Minister may from time to time amend

by adding, removing, reinstating,

transferring or including in any column ofthe Poisons List.

The Minister have to consult the Poison

Board Before amending this List and all theamendment have to be gazetted by

notification in an Order.

Amendment also include the exemption ofany preparation or amendment of any

definition of any poison in the Poisons List.

(Sec.6)

The Second Schedule

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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 byOrder notified in

the Gazette add to or remove from the second schedule any

article or preparation after consultation with the Poison Board.

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General control on all Poison

Since this Act divided Poison in various

grouping and each of these group havespecific control, it is important to discuss

the control of all poison in general before

going into each specific group.

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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;

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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 usefor 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)).

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Packaging , Labelling &

Storing of Poison. Section 9 prohibit the sale, supply, keeping orhaving 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 topackaging, 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

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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 toalso 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

Transportation of Poison

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Transportation of Poison Poisons have to be transported in accordance with

regulation made under this Act (s. 10). ThePoison 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))

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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

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Supply of Poison for the purposeof treatment by professional man.

In general all poison listed under the PLO are allowed tobe 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.

S l f i b Wh l l

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Sale of poison by Wholesale

Poison can only be wholesale by person who are having

a wholesale licence issued under this Act and such salehave 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 beexported 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

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(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 notfor 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

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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, dateof 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 theseller 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.

2 6 1 .

Sale of Poison By Retail

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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 thelicense 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 canalso 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".

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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" oran 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 orany 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)) .

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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 hismedical treatment.

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Control of Part I Poisons

We have discuss the general control on

Poison these control applies also in generalfor 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

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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 othertrade 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 in1992. (Adrenaline and other substance structurally

derived from Phenethylamine .....(item 13 in the Poison

List order)).

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Section 20 of the Act stated that Group A

Poisons shall be sold or supply by wholesale orretail 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 prescribedGroup A Poison for the purpose of treatment.

Control of Group B Poisons

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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 toa person who will then sell or supply again to another

person.

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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 whois 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 thesale 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

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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 inregulation 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

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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 Pharmacistto 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 inthe 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.

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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 signorder 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 signorder in respect of such sale to be obtain by the saler

within seven days after the date of the delivery (s.

23(3))

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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 ELicensed which is more specific for importation, storing and use

Sodium Hydroxide.

Control of Acetylating Substances

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Control of Acetylating Substances Acetylating substances such as Acetly-bromide or

Acetic-anhydride are control in a special mannerbecause these substances can be use in the acetylation

process on opiates.

Mere possession of acethylating agent withoutauthorisation 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

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Acethylating Substances are also listed under the

custom prohibition list and their importation need to

be authorised by the Ministry of Health through theissuence of Authorisation Permit (AP).

The penalty for infringing the control of acethylating

substances under this Act is very severe. Anoffender 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

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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 conditionof the license)).

Regulation 18 goes further in prohibiting the import,

sale or possession of ethyl petrol containing more than1/750 in proportion of lead tetraethyl

Regulation 19 restrict the import, sale or have in possession ofethyl petrol containing more than 1/150 in proportion of lead

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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 Directorof 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 haveto 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 specificfor 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

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Control of Colouring of Poison Regulation 15 of the Poison Regulation 1952 stated

that a distinctive dye have to be added to poisons foruse 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 export.

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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;

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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 thepharmacist to the licensing officer.

Type B Licence

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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, orissued to a responsible officer of a company incorperated

under the Companies Act 1965.

This type B licence allows a person to import, store and sellby 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 sellin oods b retail.

Type C Licence

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The Licensing Officer is issued to listed seller a Type C

Licence when there is no pharmacist in within a localauthority 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

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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 termof storage and safety)

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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 consideredby the Licensing Officer.

General: on license

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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 forauthorising 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 thelic. Any change of add. have to be made by application to the Licensing

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y g y pp g

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. Anybodyaggrieved 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 thenumber 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 courtcase 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

roceedin s. 28 .

Enforcement of the Act

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Section 2 define "Drug Enforcement Officer as, any

registered Pharmacist in the Public service, dulyauthorised 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 authorisedperson 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;

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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 circumstancesof 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.

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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 onallowing 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

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p , ,

any item reasonably related to the

case. A DEO may search, inspect, detain and remove anysubstance 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. Section31(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

Po er of the police and c stom

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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 seniorcustom 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 thatperson is believed to conceal or deposit any

poison or any related articles.

Penalties and Court Proceeding

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Penalties and Court Proceeding

Penalties under the Act can be specific under any

offence sections in the Act or for general offences orwhere 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 thousandringgit 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,

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g p y g y y p

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 theyhave 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 tothe 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

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g Section 35 gives power to the Minister to make

regulations to carry out the purpose of this Act and theseregulations 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

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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 regulatemore standardised control tuned toward this

Convention.

To cater for these needs the Poison Act was amendedto include section 30 in the Act which control Import,

export, manufacture, sale and other dealing in

Psychotropic Substances.

Third Schedule

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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 Scheduleby 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

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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

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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 foralawful 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 PsychotropicSubstances and the are as follows;

(a) a licensed Pharmacist

(b) a registered Medical Practitioner

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(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 toposseess 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 theDirector General of Health

(h) a pharmacist in the public service

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

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(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 beadministered to a patient as directed by person in (b),

(c), or (d).

Import and export of PsychotropicSubstances

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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 reportedto 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

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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 preparedpacked 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 vo a e

application of import and export

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pp p p

Reg. 5 and 6 further laid out the procedure on application

of import and export authorization and indicates that it isthe prerogative of the Licensing Officer to issue these

authorization.

For each authorisation if approved, will be issued out intriplicate 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 willsent one copy to the Competent authority of the other

country.

These regulation priscribed the format for import authorization as

F B i th l ti d t th i ti F C

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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 anexport 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

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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 treatmentinstitution or any institution approved by the Director

General of Health.

Asupply can also be made to any person who is authorisedto 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

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p y 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 patientand 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.

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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.

y. upurpose

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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 (forexample ) 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

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g p

regulation 12(2)(a) where there are only allowence for

clinical trial sample and the issuence of this clinical trialsample have to be authorised by an import license under

The Control Drug and Cosmetic Regulation 1984

Any authorised person under the poison Act or thisregulation 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)).

, ,Compounding, Mixing and Mnufacturing

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p g g g

of Psy. Substance Regulation 16 provide that only registered medicalpractitioner, 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 manufacturepsy. 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

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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

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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)

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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 ofPsychotropic Substances

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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 aDEO'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 makeProhibitary Order

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Prohibitary Order.

The Minister can make prohibitary Order in the form ofgazzett 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 thepsychotropic substances has been dealt with in an

irresponsible manner.

Reg. 30 laid out the procedure for making the prohibitoryorder, where;

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, ;

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 bemade. 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.

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p g 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 first-aid 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

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Reg. 35 provides that every person who is authorised to deal in

psy. subst. shall have the duty to give information in relation to anyinquiry 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

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DANGEROUS DRUG ACT

1952 control both the legitimate dealing and the

illegal dealing of Dangerous Drug.

We will focus more on the the control ofdangerous 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

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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, theseresponsibility 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.

Si l N i C i 1961

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Single Narcotic Convention 1961

Malaysia is the signatory to the Single Narcotic

Convention 1961,

where we are also bound with the term andagreement in the convention on the movement

of dangerous drug globally

The secretariat to this Convention is theInternational Narcotic Control Board (INCB)

whose office is in Vienna, Austria.

All importation, exportation and statistic of use on

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p , p

dangerous drug have to be reported to INCB and INCB

will study the trend of usage and will sometimes requestthe 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 membercountries can adopt the basic classification in to their

regulation to facilitate global harmonised control

Wh h k ?

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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

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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 theFirst Schedule

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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 inthe Single Convention on Narcotic 1961.

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The first schedule under the act

was further divided into fiveparts.

Part I Part I of the first schedule consist of raw opium

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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 ofcriminal in nature and the police or custom are the

enforcement authority.

P t II

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Part II

Part II consist of prepared Opium and

cannabis resin. These are processed drug

but are still in the raw extract state. Thecontrol are still the same as those in Part I.

P t III

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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 anydosage form. Most of the Pharmaceutical

dosage forms are control under this Part.

P t IV

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Part IV

Part IV listed out ethylmorphin,

propoxyphene and most of the morphine

derivatives in the codiene groups. Thedangerous drugs under this part are also

very common in the pharmaceutical

preparation or dosage form.

P t IV

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Part IV

Part IV is considered to be the lowest

control dangerous. The drug listed in this

Part are pharmaceutical preparations. TheAct 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

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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 fortherapeutic and research.

Part IV of the Dangerous Drug Act entitle Control of

certain Dangerous Drugs stipulated this managementin 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

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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

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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 DrugsSale and supply and distribution of

Dangerous Drugs

Control of import of Dangerous

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p g

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

APPLICANT

(Importing

Company)

MINISTER

(Pharmacy

Division as

the Competent

Authority)

COMPETENT

AUTHORITY

OF THE

EXPORTING

COUNTRY

EXPORTING

COMPANY

ENFORCE-

MENT UNIT

(At the

Malaysian

entry point)

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Applica

-tion for

import

authori-zatio

Received

by

Pharmacy

Division

Import

Autho-

rization

Approval

of Import

Certificate

To be

used for

clearance

at entry

point

To

received 2

copies, 1

to be

forwarded

to the

exporting

company

To

prepare

for

export

authori-

zation

To

release

consign

-ment

upon

arrival&

declara

-tionTo

export

the Drug

only

after all

requirem

ent of

their

compe-

tent

authority

have

been

fullfilled

Control of export of Dangerous

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p g

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

APPLICANT(Exporting

Company)

MINISTER(Pharmacy

Division as

the Competent

Authority)

COMPETENTAUTHORITY

OF THE

IMPORTING

COUNTRY

FOREIGNIMPORTING

COMPANY

ENFORCE-MENT UNIT

(At the

Malaysian

entry point)

Applica- Issuance Receive a

f

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tion of

import

authori-

zation

of import

authoriza-

tion

or/and

approval

of import

authoriza-tion

copy of

importauthoriza-

tion or

approval of

importauthoriza-

tion fromimporting

country

competent

authority

Receive

import

authoriza-

tion or/and

approval ofimport

authoriza-

tion from

the related

CompetentAothority

Receive

import

authoriza-

tion or

approval

of importauthoriza-

tion from

the

importing

company

Issuence of

Export

Authoriza-tion in

triplicate

Applica-

tion for

Export

Authori-

zation

Receive 2

copiesExport

Authoriza

-tion

To

release

consign-ment forexport

upon

produc-

tion of

export

authori-

zation

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Possessions of Dangerous Drugs

Who can possesses DD

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Mere possession of Dangerous Drugs without a valid

authorization is an offence under the Act and can bepunished 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 thecontrol 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

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Manufacturing of Dangerous

Drugs

Manufacturing of Dangerous Drugs Manufacturing of Dangerous Drugs includes:

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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 witha 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

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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.

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Sale, Supply and Distribution

of Dangerous Drugs

Sec. 16: Control of manufacturing, sale,supply, distribution and Possession of

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pp y

DD Reg. 5, Supply and procument to be done

by authorised person - proviso where

administration od DD to a patient is notconsidered a supply.

Reg. 7, Delivery of DD by authorised

person - 7(4), using registered or insuredpost.

Reg. 8, classes of authorised persons

Reg. 13 - supply by authorised retailer to

authorised persons -

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authorised persons

13(1), conditions to be followed13(2), In urgent case, SO have to delivered

within 24 hrs - an offence punishable ...

Storage, Records of DD

R 9 (2) d d t b d l k d k d th

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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

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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

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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

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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

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DD Licenses

Reg. 18 - Wholesale license

Reg. 4 - Manufacturing License

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Appointment of Drug

Enforcement Officer

Appointment of Drug

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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 personas he may think fit to be the Drug Enforcement

Officer. All Pharmacist in the public service

are Drug Enforcement Officers appointed underthis section.

How do this regulation apply on

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How do this regulation apply on

Codeine Cough Mixture orDyphenoxylate Tablet?

25

AKTA JUALAN DADAH 1952

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AKTA JUALAN DADAH 1952

SALE OF DRUGS ACT 1952

Mohamed Ibrahim bin Noordin

BIRO PENGAWALAN PHARMACEUTIKAL KEBANGSAAN

SEJARAH AKTA INI

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Akta ini berasal dari Akta Jualan Makanan dan

Dadah 1952

Pada tahun 1985 Akta Makanan 1983 telah

dikuatkuasa dan dengan penguatkuasaan Akta inikebanyakan 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.

SEJARAH AKTA INI

Akta ini tidak meliputi kawalan

t h d b t b t V t i

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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

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and include offering or attempting to sell or

allowing to be sold or exposing for sale orrecieving 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 forhuman consumption or use.

KUASA PELANTIKAN DI

BAWAH SEK 3

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BAWAH SEK.3

Yang Dipertuan Agung melantikAnalyst[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

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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 d 7

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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

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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 KAWALANDADAH DAN KOSMETIK 1984

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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