| Name | Exporter/ Importer License by Regulating Commission of Pharmaceutical Activities |
|---|---|
| Description | Decree-Law No. 12/2004 on Pharmaceutical Activities set down the requirements for licensing the import of and export of medicines for human use. To import or export medicines the business is required to be registered as a licensed business (Licensing of Commercial Activities 24/2011) and licensed by the Regulating Commission of Pharmaceutical Activities. The detailed information required by the Regulating Commission is listed under Article 3. A technical manager must be designated as the responsible person for complying with all the technical norms, and must be a pharmacist, pharmacy technician or pharmacy assistant. The Ministry of Health is required to verify through inspection the technical adequacy of the premises and the means of transport for importing or exporting the pharmaceuticals. |
| Comments | Decree-Law No. 12/2004 on Pharmaceutical Activities set down the requirements for licensing the import of and export of medicines for human use. To import or export medicines the business is required to be registered as a licensed business (Licensing of Commercial Activities 24/2011) and licensed by the Regulating Commission of Pharmaceutical Activities. The detailed information required by the Regulating Commission is listed under Article 3. A technical manager must be designated as the responsible person for complying with all the technical norms, and must be a pharmacist, pharmacy technician or pharmacy assistant. The Ministry of Health is required to verify through inspection the technical adequacy of the premises and the means of transport for importing or exporting the pharmaceuticals. |
| 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 19:16:15 |
| Updated Datetime | 2024-03-21 03:57:38 |
Procedures
| # | Procedure Name | Description | Category | View Detail |
|---|---|---|---|---|
| 1 | Exporter/ Importer License by Regulating Commission of Pharmaceutical Activities | Activities of import, storage, sales in bulk, sales in retail, and export of medicines for human use may only be exercised by entities duly registered in accordance with the applicable law for the registration of businesses and duly licensed by the Regulating Commission of Pharmaceutical Activities. | Import/Export |
Forms
| # | Title | Description | Issued By | File |
|---|
Commodity/s
| # | HS Code | Description |
|---|
Step-by-Step Guide
| # | Process name | Process short name | Activity |
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