Pharmaceutical Activities

 

 

# Title Download
1 Pharmaceutical Activities PDF
Measures / Standards
# Name Type Agency Description Law Valid To Apply To
1 Exporter/ Importer License by Regulating Commission of Pharmaceutical Activities Licensing Requirement Ministry of Health 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. Pharmaceutical Activities 9999-09-09 ALL
2 Import Permit for Medicines Permit Requirement Ministry of Health The National Drugs and Medicines Policy provides further information on the requirements for importing pharmaceuticals. The Ministry of Health, Directorate of Pharmacy is responsible for monitoring, controlling and regulating the import and export of medicines. The Ministry of Trade and Development (specified in the National Drugs and Medicines Policy) is responsible for issuing a general trade license for a corporation prior to it submitting an application to the Drug Administration to operate as a medicine importer. The existing fees for obtaining a pharmacy license and an importer/wholesaler license are $500 and $1000 respectively. Both licenses are valid for three years and can be renewed. Pharmaceutical Activities 9999-09-09 ALL
3 Export Permit for Medicines Permit Requirement Ministry of Health The National Drugs and Medicines Policy provides further information on the requirements for importing pharmaceuticals. The Ministry of Health, Directorate of Pharmacy is responsible for monitoring, controlling and regulating the import and export of medicines. The Ministry of Trade and Development (specified in the National Drugs and Medicines Policy) is responsible for issuing a general trade license for a corporation prior to it submitting an application to the Drug Administration to operate as a medicine importer. The existing fees for obtaining a pharmacy license and an importer/wholesaler license are $500 and $1000 respectively. Both licenses are valid for three years and can be renewed. Pharmaceutical Activities 9999-09-09 ALL
4 License by the National Drug Administration Licensing Requirement Ministry of Health 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.” Pharmaceutical Activities 9999-09-09 ALL
5 Authorization to Import Commercialize Medicines Permit Requirement Ministry of Health No medicine may be imported, stored, sold, or exported without prior authorization of commercialization granted by the Ministry of Health Pharmaceutical Activities 0002-12-10 ALL
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