Sayings of wise doctors about medicine

Pharmacovigilance is crucial for monitoring the safety of drugs and medical products in the market, detecting and eliminating side effects, and minimizing risks for patients.

In the territory of the Republic of Azerbaijan, the license holder must appoint a person responsible for pharmacovigilance with the qualifications outlined in subsection 2.1.5 of the Regulation. The license holder is required to inform the Agency of the name and contact information of the person responsible for pharmacovigilance.​​​​​​​

When applying for state registration of a medicinal product, the permit holder shall submit a brief summary of the pharmacovigilance system. A summary of the pharmacovigilance system consists of:

- A document on the appointment of the license holder as a person responsible for pharmacovigilance.

- Contact information of the person responsible for pharmacovigilance (address, telephone, fax, e-mail, etc.).

- Certificate certified by signature and seal, attesting that the license holder possesses the necessary equipment to fulfill their duties and obligations related to pharmacovigilance.

- Certificate, certified by signature and seal, confirming the existence of the main dossier of the pharmacocontrol system of the medicinal product.

Pharmacovigilance in the postmarketing phase supports drug development by identifying safety issues and guiding corrections in use.

According to the legislation of the Republic of Azerbaijan, the state registration expertise of the medicinal product consists of two stages: initial and specialized expertise.

Yes, it is. In accordance with the "Rule of Conducting the Expertise of Medicines" approved by the Resolution of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019, No. 502, each medicine manufactured outside the country must be submitted to the relevant authority, and a registration certificate document allowing its import into the country must be provided.

Yes, any information regarding the quality, effectiveness, and safety of the medicinal product should be reflected in the instructions for the use of the medicinal product for consumers.

No, this case is considered as an initial registration. In accordance with the relevant legislation, resubmission for registration should be applied to the relevant authority at least 210 (two hundred and ten) calendar days before the expiration of the validity period of the state registration.