SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
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 phar- maceutical 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 obligation 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 Use of Online Tools to Support Clinical Trials There are no restrictions for using online tools to sup- port clinical trials, either for recruiting or monitoring purposes. Sponsors must, however, undertake all adequate measures to provide information to, and secure the consent of, the subjects and to protect their personal data. 2.5 Use of Data From Clinical Trials In accordance with the Data Protection Act (2018), data resulting from clinical trials is personal data, spe- cifically special category data (health data), as long as a particular individual is identifiable from that data. As it follows from an opinion of the Data Protection Commissioner, expressed in its ninth publication Pro- tection of Personal Data: Opinions and Stances of the
Commissioner (2024), the Commissioner considers clinical trial data identifiable (and therefore, personal) as long as any party, whether the controller or a third party, can identify the data subject. Data processing of the resulting data, including shar- ing the data with third parties or affiliates, may be per- mitted, however, the supervisory authority and courts have not given any clarification as to which legal bases and conditions for the processing are applica- ble. In particular, the Commissioner has not opined on whether consent from clinical trial participants can be freely given and thus serve as a legal basis for the processing of their personal data. Clinical trial data may be transferred abroad to coun- tries that are members of the Council of Europe Con- vention for the Protection of Individuals with Regard to Automatic Processing of Personal Data, and to countries determined by the European Union to pro- vide an adequate level of protection. Transfer to other countries is allowed if the data exporter applies one of the prescribed safeguards, such as the conclusion of controller-to-processor standard contractual clauses, adopted by the Commissioner, with the data import- er. Controller-to-controller clauses are not available in Serbia because the Data Protection Act does not authorise the Commissioner to adopt them. Alterna- tively, data transfer may occur in specific situations outlined in the Data Protection Act, such as transfer based on explicit and informed consent. 2.6 Personal or Sensitive Data Creation of a database with the resulting data from the clinical trials would require carrying out a data protec- tion impact assessment, in line with the Decision of the Serbian Data Protection Commissioner on the list of categories of data processing activities for which a data protection impact assessment must be carried out.
3. Marketing Authorisations 3.1 Product Classification
An assessment of whether a product should be clas- sified as a pharmaceutical or as a medical device is carried out by the ALIMS in the process of issuing of a
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