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Ministry of International Relations & Trade

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Measure

Control of medicines and scheduled substances

Type Class Valid From Valid To
Restriction Goods 01/08/2008
Summary:

A person may not engage in the following activities concerning medicines or scheduled substances without the appropriate licenses and permits:

1. Manufacture or Pack and Sell:
   - Cannot manufacture or pack and sell medicines or scheduled substances unless holding the relevant license and complying with specified conditions.

2. Import or Export:
   - Cannot import or export these substances without the necessary license and compliance with Council-determined conditions.

3. Scheduled Substances (Schedule 3 or 4):
   - Additional permits are required for manufacturing, packing, selling, importing, or exporting these substances, alongside the necessary licenses.

4. Sale Restrictions:
   - Manufacturers, importers, or wholesale dealers cannot sell medicines or substances to unauthorized persons. However, authorized prescribers and pharmacists may sell them for consumption, subject to other provisions.

Description:

(3) Except as provided under the regulations made under section 44(1)(u) relating to own use, a person may not -

(a) in respect of medicines or scheduled substances -

(i) manufacture or pack and sell those medicines or scheduled substances, unless the person holds a licence contemplated in section 31(5)(a) or (b) for the manufacture or packing and selling and the person complies with the specified conditions;

(ii) import or export those medicines or scheduled substances, unless the person holds a licence contemplated in section 31(5)(c) for the import or export and the person complies with the conditions determined by the Council;

(b) in respect of a scheduled substance, which is a Schedule 3 substance or Schedule 4 substance -

(i) manufacture or pack and sell the substance, unless the person holds a licence contemplated in section 31(5)(a) or (b), and in addition, holds a permit referred to in subsection (15)(a) or (23)(a), as the case may be, for the manufacture or packing and selling of the Schedule 3 substance or Schedule 4 substance specified in the permit and the person complies with the prescribed conditions;

(ii) import or export the substance, unless the person holds a licence contemplated in section 31(5)(c), and addition, holds a permit referred to in subsection (15)(b) or (23)(b), as the case may be, for the import or export of the Schedule 3 substance or Schedule 4 substance specified in the permit and the person complies with the prescribed conditions;

(4) A manufacturer or an importer of, or a wholesale dealer in, pharmaceutical products, may not sell medicines or scheduled substances to a person, who himself or herself may not sell those medicines or scheduled substances: Provided that such manufacturer, importer or wholesale dealer, who is -

(a) an authorised prescriber, but not a pharmacist; or

(b) a pharmacist, irrespective of whether that pharmacist is an authorised prescriber or not,

may sell medicines or scheduled substances, subject to the other provisions of this section, for the purpose of consumption.

Commodities Affected by the Measure

# HS Code Description
1 30 Pharmaceutical products.
2 3001 Glands and other organs for organo-therapeutics uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, or elsewhere specified
3 3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines ,toxins, cultures of micro-orgarnisms (excluding yeasts) and similar products; cell cultures, whether or not modified.
4 3003 Medicaments (excluding goods of heading 3002,3005,3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sales
5 3004 Medicaments (excluding goods of heading 3002,3005,3006) consisting of mixed or unmixed products for therapeutic uses, put in measured doses(including those in the form of transdermal administration system) or in forms or packing for retails sales
6 3005 Wadding, gauze, bandages, and similar articles(example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental veterinary purposes

Procedures Implementing the Measure

1 Application Licence and Permit to Import, Export, Manufacture and sell Control of Medicines and Scheduled Substances
Activity Outcome Valid For Single Use
Export The council may issue a licence, on application by a person who may sell a medicine or a scheduled substance under this Act, authorising that person to import or export that medicine or scheduled substance subject to such conditions as the Council may determine. 12 Months No

Legal Documents Related to the Measure

Name Type Category
Medicines and Related Substances Control Act 13 of 2003 Act Import/Export