Legal Document
Medicines and Related Substances Control Act 13 of 2003 Regulations
| Attachment | Category | Type |
|---|---|---|
| General | Regulation |
Measures in the Legal Document
1. Records in respect of Schedule 4 substances and specified Schedule 3 substances for use by manufacturer, wholesaler, importer or exporter
| Type | Class | Valid From | Valid To |
|---|---|---|---|
| General | Goods | 25/07/2008 | |
Every holder of a permit or license for the manufacturing, packing, selling, importing, or exporting of Schedule 3 or Schedule 4 substances is required to maintain a detailed record for each substance. This record must include information about every import, export, manufacture, packing, and sale of these substances. Specifically, for imports and exports, the record must include the permit or license number associated with the relevant import or export activities. |
|||
2. Import permits for Schedule 4 substances or specified Schedule 3 substances
| Type | Class | Valid From | Valid To |
|---|---|---|---|
| General | Goods | 25/07/2008 | |
Any person wishing to apply for import permits for specific Schedule 3 or Schedule 4 substances must submit their application to the Permanent Secretary using the specified form. The Permanent Secretary may deny the permit if they believe the applicant cannot adequately store the substances, if the annual import quota has been met or exceeded, or if a suitable quality of the substance is already available in Namibia. Permits for importing these substances can only be granted after consulting with the Council and must adhere to specific conditions outlined in the regulations, ensuring that no deviations occur from the permit details during importation. |
|||
3. Export permits for Schedule 4 substances or specified Schedule 3 substances
| Type | Class | Valid From | Valid To |
|---|---|---|---|
| General | Goods | 25/07/2008 | |
A person who intends to apply for a permit referred to in section 29(15)(b) of the Act for the exportation of a specified Schedule 3 substance; or section 29(23)(b) of the Act for the exportation of a Schedule 4 substance. |
|||
4. Returns to be submitted in respect of Schedule 4 substances and specified Schedule 3 substances
| Type | Class | Valid From | Valid To |
|---|---|---|---|
| General | Goods | 25/07/2008 | |
Every individual or entity that imports, exports, produces, or manufactures medicines containing Schedule 4 or specified Schedule 3 substances must submit an annual return to the Registrar by February 28. This return must include: (a) the quantity of the substance held in stock as of December 31 of the previous year; (b) the quantity acquired during the previous year through importation, production, or manufacture of raw materials or preparations; and (c) the quantity disposed of during that year. |
|||
5. Import and export of medicines or scheduled substances
| Type | Class | Valid From | Valid To |
|---|---|---|---|
| General | Goods | 25/07/2008 | |
6. Who may import or export a scheduled substance
| Type | Class | Valid From | Valid To |
|---|---|---|---|
| General | Goods | 25/07/2008 | |
