EnforcementOne of the 3 main
activities of the Pharmaceutical Services Division is enforcement and licensing. The
objective of the activity is to ensure the import, manufacture, sale, supply, management,
and use of pharmaceuticals, cosmetics and health-care products are conducted in accordance
to existing national legislation.
The main activities of enforcement and licensing are as
follows:
The enforcement of pharmacy legislation as follows:
(i) Poisons Act 1952 (Revised 1989) and its regulations
(ii) Dangerous Drugs Act 1952 (Revised 1980) and its
regulations
(iii) Sale of Drugs Act 1952 (Revised 1989) and its
regulations
(iv) Registration of Pharmacists Act 1951 (Revised 1989)
and its regulations
(v) Medicines (Advertisement and Sale) Act 1956 (Revised
1983) and its regulations
To implement the provisions of the following international
conventions as Malaysia is a signatory to these conventions :
- Single Convention on Narcotics 1961
- Convention on Psychotropic Substances 1971
- UN Convention Against Illicit Traffic in Narcotic Drugs and
Psychotropic Substances 1988
Licensing under existing legislation is to ensure the
import, storage, sale and supply are carried out by qualified or fit persons complying
with the provisions of the laws.
- Control of Narcotics, Psychotropics & Chemicals
The requirements of narcotics, psychotropics and precursor
chemicals for legitimate use are controlled through the issues of special authorizations
in accordance to the quantities assessed and approved by the proper authorities.
- Medicines Advertisements Control
Issuing of approvals for medicine advertisements is to
curtail misleading advertisements and to ensure safe self-medication practiced by members
of the public.
Inspection at major entry points to ensure drugs, cosmetics
and chemicals are imported by legitimate importers.
- Inspections at Authorized or Licensed Premises
Inspections at premises of license holders and
professionals including medical practitioners, dental surgeons and veterinarians aims at
proper compliance with the laws.
Inspections and raids are being carried out at unlicensed
premises to ensure scheduled drugs are not sold or supplied by untrained and unqualified
persons.
Regular inspections are also carried out at all premises
dealing with medicines to ensure unregistered medicines are not sold at these premises.
Special inspections are also carried out at professional
outlets to ensure drugs with abuse potential are not misused by the professionals.
Licenses/permits/authorizations issued
- Under the Poisons Act 1952 as follows
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-for registered pharmacists to
deal generally with all poisons
Fee -free |
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-for any person whom the
licensing officer may consider fit and proper person to hold such licence, or issued to a
responsible officer of a company incorporated under the Companies Act 1965 to import ,
store and sell by wholesale such poisons (not being a group A Poison) as may be specified
in such licence.
Fee -RM100 |
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-for any person whom the
licensing officer may consider fit and proper person to hold such licence, to store and
sell by retail such Part II Poisons as may be specified in such licence.
Fee -RM20 |
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-for any person who in the course
of his business uses Sodium Hydroxide in such substantial quantity that the licensing
officer deems it appropriate to issue to him a licence, to import, store and use Sodium
Hydroxide.
Fee -RM100 |
- Under the Poisons Regulations (Sodium Hydroxide)
1962 as follows
- Sodium Hydroxide Permit- to buy, store and use Sodium
Hydroxide Fee -RM20
- Under the Dangerous Drugs Regulations 1952,
the following;
- Dangerous Drugs Wholesale Licence
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- to sell by wholesale Dangerous
Drugs
Fee - RM100 |
- Dangerous Drugs Manufacturing Licence
|
- to manufacture Dangerous Drugs
Fee - RM100 |
- Dangerous Drugs Import authoriztion
|
- to import Dangerous Drugs (each
consignment)
Fee - RM100 |
- Dangerous Drugs Export authoriztion
|
- to export Dangerous Drugs (each
consignment)
Fee - RM100 |
- Dangerous Drugs removal licence
|
- to remove from a conveyance
(while in transit)
Fee - RM100 |
- Under the Poisons (Psychotropic Substances)
regulations 1989 the following;
- Psychotropic Substances Import authoriztion
|
- to import Psychotropic
Substances (each consignment)
Fee -RM100 |
- Psychotropic Substances Export authoriztion
|
- to export Psychotropic
Substances (each consignment)
Fee -RM100 |
- Under the Customs Order (Prohibition on Import)
Approved Permit to
import
|
| items |
| *Potassium
permanganate |
| *Phenylpropan-2-one
(1-phenyl-2-propanone) |
| *N-acetylanthranilic
acid |
| *Isosafrole |
| *3,4-methylenedioxyphenyl-2-propanone |
| *Piperonal |
| *Safrole |
| *Ergometrine
(INN) and its salts |
| *Ergotamine
(INN) and its salts |
| *Lysergic acid
and and its salts |
| *Ephedrine and
its salts |
| *Pseudephedrine
and its salts |
| *Norephedrine
and its salts |
| *saccharin and
its salts |
| *clenbuterol |
| *salbutamol |
| *salmeterol |
| *terbutaline |
| *formoterol |
|
| tariff
code number |
| 2841.61
000 |
| 2914.31
000 |
| 2924.29
000 |
| 2932.91
000 |
| 2932.92
000 |
| 2932.93
000 |
| 2932.94
000 |
| 2939.61
000 |
| 2939.62
000 |
| 2939.63
000 |
| 2939.41
000 |
| 2939.42
000 |
| 2939.49
000 |
| 2925.11
000 |
| 2922.19
000 |
| 2922.50
000 |
| 2922.50
000 |
| 2922.50
000 |
| 2924.29
000 |
|
|
|
| Item |
| *Hydrogen
Chloride (Hydrochloric acid) |
| *Sulphuric acid |
| *Potassium
permanganate |
| *Toluene |
| *Diethyl ether
(ethyl ether) |
| *Acetone |
| *Butanone
(methyl ethyl ketone) |
*Phenylacetone
(Phenylpropan-2-one)
(1-phenyl-2-propanone) |
| *Phenylacetic
acid and its salts |
| *Anthranilic
acid and its salts |
| *N-acetylanthranilic
acid |
| *Isosafrole |
*1-(1,3-Benzodioxol-5-yl)
propan-2-one
(3,4-methylenedioxy-phenyl-2-propanone) |
| *Piperonal |
| *Safrole |
| *Piperidine and
its salts |
| *Ergometrine
(INN) and its salts |
| *Ergotamine
(INN) and its salts |
| *Lysergic
acid and and its salts |
| *Ephedrine and
its salts |
| *Pseudephedrine
and its salts |
| *Norephedrine
and its salts |
|
|
tariff code
number |
| 2806.10
000 |
| 2807.00
000 |
|
2841.61 000 |
| 2902.30
000 |
| 2909.11
000 |
| 2914.11
000 |
| 2914.12
000 |
2914.31
000
|
| 2916.34
000 |
| 2922.43
000 |
| 2924.29
000 |
| 2932.91
000 |
2932.92
000
|
| 2932.93
000 |
| 2932.94
000 |
| 2933.32
000 |
| 2939.61
000 |
| 2939.62
000 |
| 2939.63
000 |
| 2939.41
000 |
| 2939.42
000 |
|
2939.49 000 |
|
- Under the Medicines (Advertisement and Sale) Act
1956 (Revised 1983):
- Approval for advertisement referring to skill or services
relating to the treatment, prevention or diagnosis of an ailment, disease, injury,
infirmity or condition affecting the human body by private clinic, private radiological
clinic or private medical laboratory
Fee- RM100
- Approval for advertisement referring to any article, or
articles of any description, in terms which are calculated to lead to the use of that
article, or articles of that description as a medicine, an appliance or a remedy for the
purpose of treatment or prevention of diseases or conditions of human beings
Fee- RM100
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