UPDATE on drugs with serious side effects – 2024-07-22 20:39:42 – 2024-07-22 20:39:42

The decision on the change in the “Rule of pharmacocontrol of medicinal products” was changed.

Publika.az reports that the decision in this regard was signed by Prime Minister Ali Asadov.

Medical and pharmaceutical workers will send notifications of serious side effects that do not correspond to the information contained in the instructions for use of the medicinal product obtained from other countries where the medicinal product is on sale to the Analytical Expertise Center of the Ministry of Health within 15 (fifteen) calendar days after receiving that information.

Thus, in relation to medicinal products whose active substance is not included in the list mentioned in this Regulation (based on the active substance), the periodically updated safety report shall be submitted within the first 2 months from the date of their registration or from the date of international registration of the medicinal product, if the first state registration of those medicinal products is in the Republic of Azerbaijan. It will be presented to the Institution every six months during (two) years, once a year during the following 2 (two) years, and every 3 (three) years during the following period. The periodically updated security report will be submitted to the Institution no later than 90 (ninety) calendar days from the data lock date.

It should be noted that before the change, if the notifications received from other countries where the medicinal product was on sale changed the benefit-risk ratio of the medicinal product, it sent that information to the Institution immediately after receiving it.