PERUNDANGAN FARMASI PHARMACY LIGISLATIONS. The are 5 types of Malaysian Pharmacy Legislations. It consist of 5 Main Acts and several regulation made under each Act. Each Act stand by itself and are specific in its own way and control.
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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 • 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.
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 PRODUCT TREATMENT SKILL & 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
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.
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 byOrder notified in the Gazette add to or remove from the second schedule any article or preparation after consultation with the Poison Board.