Serbia Drug Product Registration

MOH

Ministry of Health

MOH Website 

https://www.zdravlje.gov.rs/ 

Regulatory Authority 

Medicine and Medical Device Agency of Serbia (ALIMS)

Regulatory Website 

https://www.alims.gov.rs/ 

Local Authorized Representative Required

Yes 

The Medicine and Medical Device Agency works with drug makers and their representative offices, expert commissions, and expert collaborators on activities such as putting medicines on the market, issuing license renewals, and varying licenses for putting medicines on the market. 

Permits to place medicines on the market are issued in line with the legislation after an inspection of the entire CTD or European dossier, within the time frame and method specified by EU directives. Experts hired by the Agency, as well as those working with the Agency, evaluate pharmaceutical, pharmacological-toxicological, and clinical documentation on the drug’s quality, safety, and efficacy.

The Agency collaborates with drug manufacturers and their representative offices, expert commissions, and expert collaborators on activities such as putting medicines on the market, renewing licenses, and changing licenses to put medicines on the market. 

Permits to place medicines on the market are issued in accordance with the legislation following an inspection of the whole CTD or European dossier, within the time range and method provided in EU regulations. The Agency hires and works with experts who analyze pharmaceutical, pharmacological-toxicological, and clinical documentation on the drug’s quality, safety, and efficacy.

National Procedure

In Serbia, a national license is required to place pharmaceuticals on the market. Because Serbia is not a member of the EU at this point in the development of the pharmaceutical regulatory system, issuing a centralized license or a license to place a medicine on the market based on the mutual recognition method is not currently feasible. 

Although Serbia is not yet a member of the EU, when placing medicines on the market, the possibility of recognizing and accepting expert opinions and performed clinical trials, and in accordance with the Helsinki Declaration, as well as bioequivalence and bioavailability studies, for applications processed in accordance with internationally recognized standards, and in the case of drugs already placed on the Market.

When approving the marketing of medicines, the Agency for Medicines of Serbia considers the provisions of international agreements on the obligation to market high-quality, safe, and effective medicines, the global increase in the circulation of counterfeit medicines and the need to prevent their circulation, as well as the illegal circulation of unregistered medicines. 

To provide the Serbian population and healthcare workers with the best possible conditions for prevention, diagnosis, treatment, and rehabilitation when providing healthcare services, there must be a wide range of quality, safe, and effective medicines available on the Serbian market.

The Agency grants permission to market unlicensed medications where they are medically indicated and permitted by law.

The Agency publishes listings of medications for which a marketing license has been issued and decisions to terminate the marketing license in the RS Official Gazette.