Procedure
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 |
| Description: On application by a person, who may manufacture, pack and sell, import or export scheduled substances under a licence contemplat The Council may issue a licence on application in the prescribed form by a person, who lawfully performs a health service, other than a person referred to in subsection (2) or (3), authorising that person to acquire, possess, prescribe, use in respect of, or sell to, his or her patients. Specified Schedule 1, Schedule 2 or Schedule 3 substances, subject to such conditions as the Council may determine, if the Council is satisfied that granting such a licence is in the public need and interest and that the person possesses the required competence to possess, prescribe, use, or supply those scheduled substances. The Council must issue a licence to a person, who is the holder of a permit issued by the Minister under subsection , to manufacture, pack and sell a medicine or a scheduled substance; may issue a licence, on application by a pharmacist, authorising him or her to manufacture, pack and sell a medicine or scheduled substance subject to such conditions as the Council may determine; 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. The Registrar must register, in the prescribed form, every person issued with a licence or permit under this section. If a medical practitioner, a dentist, a pharmacist, a veterinarian or other person granted a licence under this section ceases to carry out the functions authorised in that licence, he or she must notify the Registrar accordingly in writing and return the licence in question to the Registrar, and the Registrar must remove the name of that person from the relevant register. A licence referred to in this section must be issued on payment of the fee prescribed for the particular licence. A licence or permit issued under this section may be revoked, if a condition on which it was issued is not met. The permit referred to in subsection (15)(c) is valid for such period, not exceeding 12 months from the date of issue, as the Council may determine.
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Process Steps
| Name | Duration | Unit of Measure |
|---|---|---|
| Step process required for application for export permit for medicine and related substances | 12 | Months |
| Step process required for application for export permit for medicine and related substances | 12 | Months |
| The Council may issue a permit in the prescribed form and manner to a person to manufacture, pack and sell a specified Schedule 4 substance. | ||
| The Permanent Secretary may issue a permit in the prescribed form and manner to the person to import or export a specified Schedule 4 substance; | ||
| The Council may issue a permit in the prescribed form and manner to the person to cultivate or collect a plant, or a portion of a plant, from which a specified Schedule 3 substance can be extracted or manufactured. | ||
| The Permanent Secretary or the Council, as the case may be, may issue a permit referred to in subsection (15), if the Permanent Secretary or the Council is satisfied that the substance or plant in question is reasonably required for the treatment of a patient or in the public interest. | ||
| The Permanent Secretary or the Council, as the case may be, may cancel a permit issued in terms of subsection (15) at any time, if any condition on which the permit was issued is not met. | ||
| The permit referred to in subsection (15)(c) is valid for such period, not exceeding 12 months from the date of issue, as the Council may determine. | 12 | Months |
Required Documents
| Name | Description | Attachment |
|---|---|---|
| Application Forms to Export Medicine and Related Substances | Biowaiver Application Form: Biopharmaceutics Classification System (BCS) | NAM BW-BCS_Application Form_.doc |
| Bioequivalence Trial form | Bioequivalence Trial Information about the form. | NAM BTIF_application form.doc |
| Application form for Veterinary Medicines Registration Certificate | Application form for Veterinary Medicines Registration Certificate | Veterinary medicine registration Certificate_template.pdf |
| Application form for Veterinary Medicines Registration Certificate | Application form for Veterinary Medicines Registration Certificate | Veterinary medicine registration Certificate_template.pdf |
Applicable Fees
| Name | Fees Units | Amount |
|---|---|---|
| All Fees are uploaded/attached on the List Fees. |