Marketing Medicinal Products

In the activities regarding the marketing of a medicinal product, issuing a marketing authorization and authorization renewal and variations, the Agency cooperates with manufacturers of medicinal products and their agencies, expert committees and experts cooperators of the Agency.

In accordance with Law, marketing authorizations are granted based on the supervision of the complete CTD or the European dossier within the time limits and in the manner prescribed in line with the EU directives. Experts employed in the Agency, as well as the expert cooperators of the Agency participate in the evaluation of pharmaceutical and pharmacological-toxicological and clinical documentation on quality, safety and efficiency of a medicinal product.

Particular expert interviews about the quality of a medicinal product, its components, efficiency, range of indiciations, adverse reactions, pharamcoeconomic parametars, etc., are carried out with the applicants for marketing authorizations, especially when there are innovative medicinal products, or products which have not been marketed in Serbia before.

The procedure of granting a marketing authorization of a medicinal product have been harmonized with the EU directives and guidelines for Good Regulatory Practice. Documentation, regarding the security of data, is particularly kept in the manner set forth by the EU. National marketing authorizations for medicinal products are issued in Serbia.

Since Serbia is not a member of the EU, in this phase of the development of pharmaceutical regulatory system for granting centralized authorization or marketing authorization based on mutual reckognition is not yet possible. Although Serbia is not yet a member of the EU, when marketing medicinal products, there is a possibility of reckognizing and accepting expert oppinions and performed clinical trials, in line with the Declaration of Helsinki, as well as the study on bioequivalence and bioavailability, with the applications processed in accordance with the internationally reckognized standards, and with medicinal products that have already been marketed.

When granting the marketing authorization for a medicinal product, the Medicines and Medical Devices Agency of Serbia keeps in sight the provisions of international agreements on the obligation of marketing good quality, safe and efficient medicinal products, the increase of marketed false medicinal products in the world and the need for cessation thereof, as well as the illegal marketing of the unregistered medicial products. In order to ensure the best possible conditions for prevention, diagnosing, treatment and rehabilitation to Serbian citizens and medical workers during the provision of medical services, it is neccessary that the widest possible asortment of good quality, safe and efficient medicinal products is present on the Serbian market.

The Agency issues the approval for marketing authorizations for unregistered medicinal products when it is medically indicated and legally permitted.

The Agency publishes LISTS OF MEDICINAL PRODUCTS for which marketing authorizations were granted and decisions on the termination of their marketing authorizations was passed, in “The Official Gazette of the Republic of Serbia”.