SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes The Medicines Act provides for a fast-track procedure for obtaining a marketing authorisa- tion for (i) medicines for human use of utmost importance for public healthcare, particularly with respect to therapeutic innovations, and (ii) for a medicinal product which obtained a mar- keting authorisation in accordance with the EU centralised procedure. The Rulebook on the content of application and documentation and the method of obtaining a marketing authorisation for placing the medi- cine on the market lays down the conditions for issuing the marketing authorisation through fast-track procedure. For medicinal products for human use of utmost importance for public healthcare, particularly with respect to therapeu- tic innovations, the applicant must first obtain an opinion on priority determination from a spe- cial commission formed by ALIMS, determining whether a medicinal product is of the highest public health interest in order to apply through the accelerated marketing authorisation proce- dure. A request on this basis may be submitted for: • the first generic application of a medicinal product or the next generic application if a generic medicinal product with the same INN has marketing authorisation in Serbia but is not on the market, with a limit of three generic applications based on the order of priority requests or marketing authorisation applica- tions; • applications related to the transfer of medici- nal product manufacturing in Serbia;
• applications for products manufactured in Serbia that are intended exclusively for export; • applications for medicinal products whose unavailability in Serbia poses a public health risk, particularly vaccines for mandatory immunisation; • applications for medicinal products included in the Positive List of medicines reimbursed from the national health insurance fund, but without a marketing authorisation in Serbia (D List) at the time of the priority determination request; • applications for medicinal products devel- oped, manufactured or marketed with state funding; and • applications for medicinal products of strate- gic importance as determined by official acts of Serbia and programmes implemented by the Ministry of Health, where applicable. With respect to conditions and documentation for fast-tracking of medicines approved through the EU centralised procedure, please see the answer to 4.2 Regulatory Reliance . The Agency is required to issue a decision on granting the marketing authorisation through the fast-track procedure, or a decision on rejecting the application, no later than 150 days from the date of receipt of a complete application, based on the evaluation of the documentation regard- ing the quality, safety and efficacy of the medici- nal product. If the application for a marketing authorisation under the fast-track procedure is incomplete, the Agency notifies the applicant in writing, requesting the submission of the miss- ing information within 30 days from the date of receipt of the written notification. The request for outstanding information stops the clock until the applicant completes the application.
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