Commodity

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.

If the Council believes it is not in the public's interest for a medicine or scheduled substance to be available, it can:

1. Issue a Notice:
   - Direct a person via written notice or through the Gazette to:
     - Return the medicine or substance in their possession to the manufacturer, supplier, or importer.
     - Deliver or send the medicine to another person designated by the Council.

2. Direct Manufacturers, Suppliers, or Importers:
   - Instruct them, via written notice, to manage any quantity of the specified medicine or substance, including those returned in response to previous directions.

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.

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.

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.

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.

The provision allows existing contracts related to the advertising of tobacco products and the organization, sponsorship, or promotion of activities by tobacco companies in Namibia to remain valid for up to six months after the enforcement of the Act. This applies to any agreements that were binding as of the Act's effective date. However, there are conditions outlined in subregulation (2) that may affect this continuation.

To combat illicit trade in tobacco products, the regulation stipulates that no person may sell or import tobacco products unless the packaging includes specific information. This information must state "Sales only allowed in Namibia" and "Manufactured in 'name of country'," displayed in Helvetica upper-case letters in black on a white background, covering at least 60% of either side panel of the package. The products must also comply with additional regulations. For tobacco products in transit through Namibia, the packaging must include details about the shipment route, destination, final selling point, point of departure, consignee, and a batch or serial number. Additionally, a consignment note or similar document containing this information must accompany the products.