Incorporating latest amendment – P.U.(A) 52/2009
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General Information
The Poison Act 1952 (Revised in 1989) which is also cited as Poison Act 1952 was gazetted by the Malaysian Government via Ministry Of Health in order to regulate the importation, possession, manufacture, compounding, storage, transport, sale and use of poisons. In Malaysia, the Pharmacy Law is regulated and controlled by several related acts and regulations including the Poisons Act 1952 and its regulations. (1) This Act is applied throughout Malaysia. Appropriate regulations promulgated under the Act imposed more effective control of products produced or imported in order to conform to acceptable standards of quality, safety and efficacy before they are registered; and that all premises used and practices employed to manufacture, store and distribute these products are in compliance with the required standards, until they are delivered to the end users. Regulations specific for this purpose are as follows:
- Poison Regulations 1952
- Poison (Fees) Regulations 1983
- Control of Drugs and Cosmetics Regulations 1984 (incorporating latest amendment – P.U.(A) 477/2009)
- Poison (Psychotropic Substances) Regulations 1989
For the purpose of the Act, Poison means 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 an article or preparation included for the time being in the Second Schedule. Under the Act, Poison List means the Poison List set out in the First Schedule as may amended from time to time by the Minister, after consultation with the Poison Board in accordance with section 6 under this Act. (2) The Third Schedule [Section 30] listed the psychotropic substances (3).
Under the Poison Regulations, 1952, twenty eight (28) regulations are made by the Minister which came into force on the 1st September 1952. It covers introduction, import of poison by post in Regulation 4, storage of poison in Regulations 5 to 7, transport of poisons in Regulation 8, labeling of poisons in Regulations 9 to 14, colouring of poisons in Regulation 15, special provision relating to lead tetra ethyl in Regulations 16 to 22, supply of poison to out-patients for hospital and institutions in Regulations 23 to 23A, supply of poison for use in hospitals, etc in Regulation 24, storage of poisons in institutions in Regulation 25 as well as forms and fees in Regulations 26 to 28. The fees for Wholesaler’s Poisons Licence (Type B Licence), Retailer’s Licence For Part II Poisons (Type D Licence) and Type E Licence are RM100, RM20 and RM100 respectively. Form A for Poisons Wholesale Sales Book and Form B for Poisons Book in the First Schedule shall also be filled up and kept accordingly (4).
The Poison (Psychotropic Substances) Regulations 1989 has came into force since the 15th April 1989. Only authorised person shall possess any psychotropic substance for a lawful purpose and obtained according to the provisions of Regulations. Import or export of psychotropic substance are only allowed to a person providing a valid and subsisting authorisation and in accordance to the terms and conditions of import and export authorisation relating thereto and shall be authorised with fee of RM100.00. The application for authorisation shall be made to the Licencing Officer in Form A in the First Schedule and later Form B and Form C for convention on psychotropic substances shall be filled up. (5)
In regards to drugs and cosmetics products, no person shall manufacture, sell, supply or import any product unless the product is registered and the person provides the appropriate licence issued under the Regulations which fall under the Control of Drugs and Cosmetics Regulations 1984 (P.U.(A) 477/2009). Product can be defined as a drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medicinal purpose or a drug to be used as an ingredient of a preparation for a medicinal purpose. In addition, herbal remedy is not included as drug. Traditional medicine refers to any product used in the practice of indigenous medicine, in which the drug consists solely of one or more naturally occurring substance of plant, animal or mineral, of parts thereof, in the unextracted or crude extract form, and a homeopathic medicine. The processing fee for application of registration of product would be RM500.00 for traditional medicines, RM50.00 for each product variant and RM1000.00 for products other than traditional medicines. Every application for registration of product shall be supported with documents, items, samples, particulars or information as the Authority may require. The Director of Pharmaceutical Services shall also issue certification on any matter relating to any product which may be required by the product-importing country with a fee of RM50.00. (6)
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Contact Details
Pharmaceutical Services Division
Ministry of Health Malaysia
Lot 36, Jalan Universiti
46350 Petaling Jaya, Selangor, Malaysia
Tel: +603-7841 3200
Fax: +603-7968 2222
Website: http://www.pharmacy.gov.my
Reference:
- Pharmaceutical Services Ministry of Health. Pharmacy law. Malaysia: Ministry of Health; [updated 2012 Nov 1; cited 2012 Nov 12]. Available from: http://www.pharmacy.gov.my/index.cfm?&menuid=115&lang=EN
- Pharmaceutical Services Ministry of Health. Pharmacy law; laws of Malaysia, act 366 poisons act 1952 (revised – 1989) incorporating latest amendment –P.U.(A) 52/2009. Malaysia: Ministry of Health; [updated 2012 Nov 1; cited 2012 Nov 12]. Available from: http://cornerstone.my/pharmacy_portal/aeimages//File/Poisons_Act_1952_Act_366.pdf
- Pharmaceutical Services Ministry of Health. Pharmacy law; act 366 poisons act 1952 (revised – 1989) third schedule. Malaysia: Ministry of Health; [updated 2012 Nov 1; cited 2012 Nov 12]. Available from: http://cornerstone.my/pharmacy_portal/aeimages//File/THIRD_SCHEDULE(1).pdf
- Pharmaceutical Services Ministry of Health. Pharmacy law; poison regulations 1952. Malaysia: Ministry of Health; [updated 2012 Nov 1; cited 2012 Nov 12]. Available from: http://www.pharmacy.gov.my/aeimages//File/Penguatkuasaan/akta/Poison_Regulations_1952.pdf
- Pharmaceutical Services Ministry of Health. Pharmacy law; poison (psychotropic substances) regulations 1989. Malaysia: Ministry of Health; [updated 2012 Nov 1; cited 2012 Nov 12]. Available from: http://www.pharmacy.gov.my/aeimages//File/Penguatkuasaan/akta/Poisons_PsychotropicSubstances_Regulations_1989.pdf
- Pharmaceutical Services Ministry of Health. Pharmacy law; control of drugs and cosmetics regulations 1984. Malaysia: Ministry of Health; [updated 2012; cited 2012 Dec 3]. Available from: http://cornerstone.my/pharmacy_portal/aeimages//File/Control_of_Drugs_and_Cosmetics_Regulation_1984_1.1.09.pdf
