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  Licensing

Licensing under legislation is to ensure the import, storage, sale and supply of pharmaceuticals, traditional medicine and scheduled chemicals are carried out by qualified or fit and proper person complying with the provisions of the law.

  1. Licenses, permits and approvals issued by Pharmaceutical Services Division:
    1. Psychotropic substances import/export authorizations
    2. Dangerous drugs import/export authorizations, manufacturing and wholesale licenses
    3. Approve permits under Custom Prohibitory Orders
    4. Advertisement approvals
       
  2. Licenses and permits issued by the states:
    • Type A Poison License: to deal generally all poisons issued to registered pharmacist only
    • Type B Poison License: to import, store and deal by wholesale industrial poison as listed in the license
    • Type E Poison License: to import and use Sodium Hydroxide (NaOH)
    • Permit NaOH: to purchase and use NaOH

 


 

Diversion Control

The role of the Diversion Control Unit is to prevent diversion and the misuse of controlled medicines, particularly dangerous drugs, psychotropic substances and medicines that are being used for recreational purposes without prohibiting their therapeutic indications.

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Precursor

Precursor Control Unit

Precursors are substances or essential chemicals, which are controlled under Table I and II of the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances 1988. There are 23 precursors listed under this Convention that must be monitored at international and domestic trade level. The precursor control is further strengthened in Malaysia with Poison Act 1952 and Customs (Prohibition of Exports/Imports) Order 1967. Application of Import/Export Permit of precursors must be submitted online through http://epermit.dagangnet.com.my.

Precursors List:

Table I Table II
Ephedrine and its salts
Pseudoephedrine and its salts
Potassium permanganate
1-phenyl-2-propanone
N-acetylanthranilic acid
Safrole
Isosafrole
3,4-methylenedioxy-phenyl-2-propanone
Piperonal
Ergometrine
Ergotamine
Lysergic acid
Norephedrine
Acetic Anhydride/Acetyl Bromide/Acetyl Chloride
Anthranilic acid and its salts
Sulphuric acid
Hydrogen Chloride (Hydrochloric acid)
Diethyl ether (ethyl ether)
Phenylacetic acid and its salts
Piperidine and its salts
Butanone (methyl ethyl ketone)
Acetone

 



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