| Name | License by the National Drug Administration |
|---|---|
| Description | All (drug) importers are required to: be licensed by the National Drug Administration and to “fulfill standard requirements of the Ministry of Health in providing and maintaining suitable premises and quality procedures including appropriate storage conditions for medicines to preserve their quality and efficacy (Good Distribution Practices) and that qualified personnel are available to ensure good pharmacy practices.” |
| Comments | The National Drugs and Medicines Policy requires all parties involved in the procurement, import and distribution of medicines to follow the WHO Certification scheme, and the WHO based guidelines on good distribution and storage practices and good pharmacy practice procedures. The importer submits a detailed list of pharmaceuticals for every import, prior to importation. These data are reported to the UN Drugs Agency. Each pharmaceutical must be produced under Good Manufacturing Practice (GMP), contain a Certificate of Pharmaceutical Products (COPP) and a Drug Certificate of Analysis (containing the description, definition, and expiry date). |
| Validity From | 2004-05-26 |
| Validity To | 9999-09-09 |
| Reference | |
| Technical Code | |
| Measure Type | Licensing Requirement |
| Agency | Ministry of Health |
| Legal Document | - Pharmaceutical Activities |
| Is Standard | No |
| UN Code | (not set) |
| Measure Class | Good |
| Created Datetime | 2023-03-21 19:22:47 |
| Updated Datetime | 2024-03-11 13:07:19 |
Procedures
| # | Procedure Name | Description | Category | View Detail |
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Forms
| # | Title | Description | Issued By | File |
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Commodity/s
| # | HS Code | Description |
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Step-by-Step Guide
| # | Process name | Process short name | Activity |
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