Controlled Drugs Act Article 16

The import, export, manufacture, selling or purchasing of controlled drugs shall follow the following procedures and guidelines:1. The pharmaceutical plant listed in Article 4 Paragraph 1 may handle the export, import, manufacture and sales of Schedule 1 and 2 controlled drugs.2. The commissioned pharmaceutical firms listed in Article 4 Paragraph 1 may manufacture the Schedule 1 and 2 controlled drugs.3. Human medicine manufactures or veterinary medicine manufactures may handle the buying and export of the raw materials of controlled drugs, and the export, manufacture or sales of Schedule 3 and 4 controlled drugs.4. Human medicine companies or veterinary medicine companies may handle the import, export or transfer of Schedule 3 and 4 controlled drugs.5. Medical institutions, drug stores, veterinarian institutions, pasturage veterinarian institutions and research laboratories may purchase controlled drugs.The institutions and companies mentioned in the preceding Paragraph shall apply to the FDA for registration and obtain controlled drugs registration license.Upon a change of circumstances regarding the registration mentioned in the preceding Paragraph, the registrants shall notify the FDA regarding the changes within 15 days.Controlled drugs registration licenses shall not be lent to other people nor shall the ownership be transferred.Regulations governing the issuance, alteration of registration, re-issuance, replacement, revocation, annulment and management of the controlled drugs registration license shall be prescribed by the central competent health authority.