The pharmacovigilance system is actively developing.
The competent authority responsible for monitoring adverse events is the Analytical Expertise Center (AEC) of the Ministry of Health of the Republic of Azerbaijan.
To date, the Applicant is not required by law to appoint a local person responsible for pharmacovigilance in Azerbaijan. However, certain requirements for safety monitoring and submission of information about adverse reactions to medicinal products are being put forward.
National legislation establishes the following cases of reporting:
- all adverse reactions to new medicinal products (medicinal products are considered as new within 5 years after their registration);
- all unexpected adverse reactions;
- all serious adverse reactions;
- undesirable effects of drug interactions;
- unexpected therapeutic effects (previously unknown);
- results of observations in which there is clear evidence that the medicinal product causes adverse reactions (for example, the similar reaction to the repeated administration of the medicinal product);
- laboratory abnormalities, the consequences of an overdose (accidental or intentional).
National legislation provides for different deadlines for reporting depending on the nature and characteristics of the adverse event. For example, information about all serious and unexpected adverse effects of the medicinal product should be sent to the ACE as soon as possible, but not later than 3 days.
Cratia provides professional services on the establishment and maintenance of pharmacovigilance in Azerbaijan. We have an excellent knowledge of national legislation, necessary experience and resources.
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.