Frequently Ask Questions


PHARMACY LEGISLATIONS WHICH ARE ENFORCED BY
THE PHARMACY DIVISION OF THE SARAWAK HEALTH DEPARTMENT

Please contact the following for up to date information in respect of the Acts and Regulations as follows :

  1. Bahagian Perkhidmatan Farmasi,
    Kementerian Kesihatan Malaysia,
    Beg Berkunci No.924,
    Pejabat Pos Jalan Sultan,
    46790 Petaling Jaya,Selangor.

    Telephone: 03- 79682200
    Fax:03-79682222
    http:// www.pharmacy.gov.my

  2. Unit Penguatkuasa Farmasi,
    Pejabat Pengarah Kesihatan Negeri Sarawak,
    Jalan Tun Abang Haji Openg,
    93590 Kuching,Sarawak.

    Telephone: 082- 256566 ext: 570, 571 dan 572,
    Fax: 082-257552

DISCLAIMER:

The staff of the Sarawak Health Department shall not be responsible for the continued currency of the information and disclaim any and all liability to any person whosoever for any consequence arising from the use of the information in this publication.

Act 366 : POISONS ACT 1952 (REVISED 1989)

REGULATIONS:
  1. Poisons Regulations 1952,
  2. Poisons (Sodium Hydroxide) Regulations 1952,
  3. Poison (Exemption) (Sabah & Sarawak ) Regulations 1978,
  4. Poison (Exemption) Regulations 1980,
  5. Poison (Fees) Regulations 1983,
  6. Poison (Psychotropic Substances) Regulations 1989

OBJECTIVE:
An Act to regulate the importation, possession, manufacture, compounding, storage, transport, sale and use of poisons.

Poison as defined under Section 2 of the Poisons Act (Revised 1989) means any substance specified by name in first column of the Poisons List and includes any preparation, solution, compound, mixture or natural substance containing such substance, other than an exempted preparation or article or preparation included for the time being in the Second Schedule.

Under the Poisons Act (Revised 2000) and its Regulations,

  1. no person other than a person licensed or given permit under this Act in that behalf shall import any poison from outside Malaysia unless exempted under Section 8(2) of the Act.
  2. no person shall dispense, compound or mix any poison with any other substance, whether a poison or not, for the purpose of its being used for medical treatment otherwise than in accordance with sections or regulations made under this Act
  3. no person whether licensed under this Act or not, shall knowingly sell, supply, keep or have in his possession or under his control or store any poison otherwise than in accordance with regulations made under this Act

Any person who contravenes the provisions of the Poisons Act 1952 (revised 1989) commits an offence and upon conviction shall be liable to a fine not exceeding three thousand ringgit (RM3000.00) or imprisonment for a term not exceeding one year or both.

Act 234 : DANGEROUS DRUG ACT 1952 (REVISED 1980)

REGULATIONS:
  1. Dangerous Drug Regulations 1952,
  2. Dangerous Drugs [Hospitals, Etc.][General Exemption] order 1952.
OBJECTIVE:
An Act to make further and better provision for the regulating of the importation, exportation ,manufacture, sale and use of opium and certain other dangerous drugs and substances, for matter relating to the treatment and rehabilitation of drug dependants, to make special provision relating to the jurisdiction of courts in respect of offences there under and their trial, and for purposes connected therewith.

Dangerous Drug is defined as any drug or substance, which is for the time being comprised in the First Schedule of this Act.

Under the Dangerous Drug Act 1952 and its Regulations,

  1. No person shall except under the authorization of the Minister import into or export from Malaysia any dangerous drug.
  2. No person shall have in his possession, custody or control any dangerous drug unless he is authorized to be in possession, custody or control of such drug.
  3. Sec 16 of the act provides control and prohibiting the manufacture, sale, possession and distribution of any such dangerous drugs except by persons licensed or otherwise authorized under the regulations and subject to any conditions specified in the licence or authority

Any person who contravenes any of the provisions under the Act shall be liable on conviction to the relevant penalties stipulated under the Act.

Act 368 : SALE OF DRUGS ACT 1952 (REVISED 1989)

REGULATIONS:
    Control of Drugs and Cosmetics Regulations 1984

OBJECTIVE:
    An Act relating to the sale of drugs

Under the Sale of Drugs Act (Revised 2000) and Control of Drugs and Cosmetics Regulations 1984 all prescription drugs, over-the-counter (OTC) medicines, traditional medicines in pharmaceutical dosage forms and cosmetics as defined under the Act or Regulations require to be registered with Drug Control Authority prior to being manufactured, imported, sold or supplied, unless the product is exempted under specific provisions of the Regulations.

Any person or corporate body who contravenes the provisions of the Control or Drugs and Cosmetics Regulations 1984 commits an offence and upon conviction shall be liable to a fine or imprisonment or both as in Section 12, Sale of Drugs Act 1952 (Revised 2000), as follows:

First OffenceSubsequent Offence
Individual RM25,000 fine or 3 years
Imprisonment or both
RM50,000 fine or 5 years
Imprisonment or both
Corporate Fine not exceeding RM50,000Fine not exceeding RM100,000

The objective of the registration of these products is to ensure the quality and safety i.e. no contamination of heavy metals (e.g. Lead, mercury, arsenic), do not contain adulterated items (e.g. corticosteroid, antibiotics etc.), no microbial contamination and contain only the specified ingredients in order to safeguard the consumers.

Example of registration number is as follows;

PBKD 881234A/X/T/K OR MAL19991234A/X/T/K
Where A is for schedule poisons, X for over the counter product,
T for traditional product and K for cosmetic.

All enquiries and information pertaining to the registration of these products can be directed to or obtained from the Drug Control Authority at:

National Pharmaceutical Control Bureau,
Ministry Of Health Malaysia,
Jalan Universiti, P.O.Box 319, 46730 Petaling Jaya.

(Telephone: 03-79573611, Fax: 03-79582960)
http:// www.bpfk.gov.my

Act 368 :MEDICINES (ADVERTISEMENT AND SALE ) ACT 1956 (REVISED 1983)

REGULATIONS:
    Medicines Advertisements Board Regulations 1976 Regulations 1984

OBJECTIVE:

An Act to prohibit certain advertisements relating to medicinal matters and to regulate the sale of substances recommended as medicine.

All advertisements on health products and services are subject to control under the Medicines (Advertisements and Sale) Act 1956 whereby approval from the Medicine Advertisements Board is required prior to publicizing in any media such as printed media (newspapers, magazines, pamphlets and others), radio broadcast, television, exhibitions, promotional talks and the like.

Under the Act, advertisement for the prevention or treatment of the following diseases is prohibited:-

  1. Diseases or defects of the kidney
  2. Diseases or defects of the heart
  3. Diabetes
  4. Epilepsy or fits
  5. Paralysis
  6. Tuberculosis
  7. Asthma
  8. Leprosy
  9. Cancer
  10. Deafness
  11. Drug addiction
  12. Hernia or rupture
  13. Diseases of the eye
  14. Hypertension
  15. Mental disorder
  16. Infertility
  17. Frigidity
  18. Impairment of the sexual function or impotency
  19. Venereal disease
  20. Nervous debility, or other complaint or infirmity, arising from or relating to sexual intercourse.
Advertisements without approval from the Medicine Advertisements Board contravene the provision of the Medicines (Advertisements and Sale) Act 1956 and upon conviction, a fine of RM3,000 or one year imprisonment or both in respect to the second and subsequent offence, will be imposed on any person who takes part in the publication of the advertisement. Besides that, the Drug Control Authority will deregister the product if the advertisement has claims in addition to the indications approved.

Any advertisement that has been approved will be issued the approval number (no. K.K.L.I.U) to be displayed on the advertisement. The approval number can be verified by the Medicine Advertisements Board at :-

Setiausaha Lembaga Iklan Ubat
Bahagian Perkhidmatan Farmasi,
Kementerian Kesihatan Malaysia,
Beg Berkunci No.924,
Pejabat Pos Jalan Sultan,
46790 Petaling Jaya,
Selangor.
(Telephone: 03- 79682200 Fax: 03-79682222)
http:// www.pharmacy.gov.my