SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
Clinical trials of pharmaceuticals are conduct- ed in accordance with the Ministry of Health’s guidelines on Good Manufacturing Practice (2017), Good Laboratory Practice (2008), and Good Clinical Practice (2017). Clinical Trials for Medical Devices The Medical Devices Act and the Rulebook on Clinical Trials for Medical Devices of 2018 (as amended) regulate clinical trials for medical devices. Clinical trials of medical devices are conducted in accordance with the guidelines of the Good Clinical Practice. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial Clinical Trials Subject to Approval Sponsors must request simultaneous authori- sations for conducting a clinical trial from the ALIMS and the Ethics Committee of Serbia, a government-appointed expert body that takes care of the provision and implementation of healthcare at the national level, in the case of: • clinical trials for medicines which do not have a marketing authorisation or for which a different use from the one prescribed in the approved summary of product characteristics is proposed, or medical devices for which a conformity assessment has not been carried out; and • an interventional post-marketing clinical trial, where the medicinal product is applied in accordance with the conditions prescribed in the marketing authorisation, but requires additional diagnostic procedures, as well as the monitoring procedures defined by the clinical trial protocol, or where a medi- cal device has been subject to conformity assessment, but the clinical trial is conducted
for a purpose that is absent from the con- formity assessment. Clinical Trials Subject to Notification Only Sponsors must only notify the commencement of a trial to the ALIMS if they wish to conduct a non-interventional post-marketing clinical trial of a pharmaceutical or a medical device in accordance with an approved summary of product characteristics of a pharmaceutical for which a marketing authorisation has already been issued, or a clinical trial of a medical device for which a conformity assessment has already been carried out. 2.3 Public Availability of the Conduct of a Clinical Trial Clinical Trials Database Basic information on all clinical trials conducted at a given moment in Serbia are publicly available within the database kept by the ALIMS on the e-government Portal. The information includes the date and number of the relevant decision on approval of the clinical trial, the protocol number, the names of the sponsor and the client, and the title of the trial, as well as its basic description. Publication of Clinical Trial Results Sponsors of clinical trials do not have an obliga- tion to make the results of clinical trials publicly available. They must submit to the ALIMS, within one year of completion of the clinical trial, the report containing detailed results, both positive and negative, obtained through the trial. 2.4 Restriction on Using Online Tools to Support Clinical Trials There are no restrictions for using online tools to support clinical trials, either for recruiting or monitoring purposes. Sponsors must, however, undertake all adequate measures to provide
260 CHAMBERS.COM
Powered by FlippingBook