PERUNDANGAN FARMASIPHARMACY 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• Customary 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 SOALAN 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 medicine.

INTERPRETATION &DEFINITION OF CERTAIN IMPORTANT WORDS AND

PHRASESSECTION 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• Sec. 3• Sec. 4• Sec. 4A• Sec. 4B• Sec. 5• Sec. 6 PRODUCTPRODUCT TREATMENTTREATMENT

SKILL & SERVICESSKILL & SERVICES

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 2INTERPRETATION,

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 can’t 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 export.

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 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• 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 DrugsControl of export of Dangerous DrugsPossessions of Dangerous DrugsManufacturing of Dangerous DrugsSale 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

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)

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-tion

To export

the Drug only

after all requirem

ent of their

compe-tent

authority have been

fullfilled

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

APPLICANT (Exporting Company)

MINISTER (Pharmacy Division as

the Competent Authority)

COMPETENT AUTHORITY

OF THE IMPORTING COUNTRY

FOREIGN IMPORTING COMPANY

ENFORCE-MENT UNIT

(At the Malaysian

entry point)

Applica-tion of import

authori-zation

Issuance of import authoriza-

tion or/and

approval of import authoriza-

tion

Receive a copy of import

authoriza-tion or

approval of import

authoriza-tion from importing country

competent authority

Receive import

authoriza-tion or/and approval of

import authoriza-tion from the related Competent Aothority

Receive import

authoriza-tion or

approval of import authoriza-tion from

the importing company

Issuence of Export

Authoriza-tion in

triplicate

Applica-tion for Export

Authori-zation

Receive 2 copies Export

Authoriza-tion

To release

consign-ment for export upon

produc-tion of export

authori-zation

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 1952SALE OF DRUGS ACT 1952

Mohamed Ibrahim bin NoordinBIRO PENGAWALAN PHARMACEUTIKAL KEBANGSAAN

• 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.

SEJARAH AKTA INI

Akta ini tidak meliputi kawalan terhadap ubat-ubatan Veterina

• Definasi “drug”dan “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 diperolehiyamg sample berkenaan adalah untuk dianalisa

[S. 7(1)]

sample dibahagikan kepada 3 bahagian1 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 QA

GMP 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.

KETEMPANGAN-KETEMPANGAN 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 registrationIf 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 registerEvery 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 premises12(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