New Medicine Registration Rules in Azerbaijan: Resolution No. 345
Azerbaijan Cabinet of Ministers Resolution No. 345 of 18 July 2024 renewed the medicine registration rules and repealed Resolution No. 108 of 2007.
Azerbaijan's Cabinet of Ministers approved new rules on the state registration of medications, medicinal substances and medical appliances through Resolution No. 345 of 18 July 2024. It entered into force on 20 July 2024, repealing the previous rules under Resolution No. 108 of 2007.
Registration is handled by the Center for Analytical Expertise under the Ministry of Health. Key provisions: state registration is valid for 5 years; a certificate is issued within 7 business days of a positive expert report; applicants get 10 business days to correct deficiencies; re-registration must be filed at least 90 days before expiry.
The scope covers medications (including generics and APIs), medicinal substances and risk-classified medical appliances. As CSC-AZ, we support document preparation and follow-up for the registration and import of Turkish-origin products in Azerbaijan.
Source: Azerbaijan Cabinet of Ministers Resolution No. 345 (18 July 2024, effective 20.07.2024); Ministry of Health Center for Analytical Expertise (pharma.az).