Registration of Medicines (Drugs) in Azerbaijan

Regulatory Bodies

Ministry of Health (MoH) (formulates state policy in the field and ensures its implementation)

Ministry of Economy (issues licences, permits, certificates and other documents for various entrepreneurial activities)

Tariff (Price) Council (in compliance with relevant legislation regulates prices of pharmaceuticals)

Overview of regulatory processes in MoH

• Duration of the new registration process-12 months; cost-1000 EUR;
• Renewal-6 months; cost-500 EUR;
• AZ can use EU dossier (ICH structure), Required Documents – module 3, clinical and non clinical overview,
• No local clinical trials required;
• New registration: samples and RS quantity for 3 full analyses are required;
• for renewal: samples and RS quantity for 1 full analysis are required;
• for variations: samples not required;
• all Samples and RS should be submitted with dossier;
• remaining shelf life should be: for new registration at least 1 year; for renewal- 6 months;
• CoA and proforma invoices should be submitted with samples;