SERBIA

Information on submission procedure of clinical trials

The Serbian government has adopted the new law on clinical research and it is synchronised and consistent with EU Directives. Everything goes through the newly established Agency for Drugs, and the deadline for approval is 60 days. The Agency of Drugs meets every first Tuesday each month. The law on drugs and medical devices was published in the "Official Gazette of the Republic of Serbia No. 84/2004" on the 24th of 2004 and it came into effect on 2nd of August 2004. The application for approval of clinical trial is submitted for every preregistration clinical trial and for every postregistration clinical trial, in which the medicinal product is not used in compliance with the registration decision (i.e. phase I -III clinical trials and bioequivalence studies); the notification is submitted in case of clinical trial with registered medicinal products, when these products are used in compliance with the registration decision, e.g. according to the approved summary of product characteristics. Responsibilities: sponsor will notify that 1. The study initiated or earlier completed 2. All amendments to the official record influencing the conduction of the trial 3. The study is finished in 90 days after the termination 4. Summary of the final report 1 year after study finished Sponsor needs to report to National Center for Adverse Drug Reactions: Fax: +3615534, Phone: +381 11 361 5531 1. Unexpected SAE with maximum of 15 days of first knowledge by the sponsor 2. Fatal or life-threatening within 7 days and follow-up information in aditional 8 days 3. All AEs, after the study finished If requested - sponsor will present sample of tested product Submitted documentation - Serbian or English (1 copy of application form and other documents) Study protocol Approval by Ethics committee and the list of documents reviewed, included: · informed consent (Serbian) · patients information (Serbian) · chemical and pharmaceutical documentation, Investigators broshure Insurance certificate GMP certificate Case Report Form Authorisation of a person by the sponsor Summary of product characteristics Fee payment evidence Other Application forms could be obtained at Republika Srbija-Ministarstvo zdravlja Podkomisija za klinicka ispitivanja Nemanjina 22-26, Beograd Telefon/Phone: ( +381 11) 311 4949 ili 361 23 87 Email: sinisar@ncrc.ac.yu Serbia has no central EC yet, but all major institutions involved in clinical trials have their own EC. Their work is regulated by law, and they are very efficient. The ECs usually meet once a month. For multi-centric studies, only one EC approval is needed. Submissions to the Approval Committee in Agency for Drugs and to ECs in relevant institutions are to be submitted in parallel.