SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
secrets – ie, when the following cumulative conditions are met: • the data is confidential – ie, not generally known or easily available to persons usually dealing with that kind of information; • the data has commercial value due to its confiden- tiality, during the period of confidentiality; and • an applicant for a marketing authorisation, vari- ation, and/or renewal, under the circumstances, takes reasonable measures to keep that data confidential. Information from the documentation submitted during the procedure of obtaining a marketing authorisation, as well as in other procedures handled by the Agency and/or relevant Ministries, may only be disclosed to third parties with the consent of the applicant, or if the data is already available to the general or profes- sional public for the purpose of providing information necessary for use or handling of a pharmaceutical or a medical device, or required for the protection of health in humans and animals. 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 authorisation for (i) medi- cines for human use of utmost importance for public healthcare, particularly with respect to therapeutic innovations, and (ii) for a medicinal product which obtained a marketing authorisation in accordance with the EU centralised procedure. The Rulebook on the content of application and docu- mentation and the method of obtaining a marketing authorisation for placing the medicine on the mar- ket lays down the conditions for issuing the market- ing authorisation through fast-track procedure. For medicinal products for human use of utmost impor- tance for public healthcare, particularly with respect to therapeutic innovations, the applicant must first obtain an opinion on priority determination from a special commission formed by ALIMS, determining whether a medicinal product is of the highest public
health interest in order to apply through the acceler- ated marketing authorisation procedure. 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 medici- nal 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 authori- sation applications; • applications related to the transfer of medicinal product manufacturing in Serbia; • applications for products manufactured in Serbia that are intended exclusively for export; • applications for medicinal products whose unavail- ability in Serbia poses a public health risk, particu- larly 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 mar- keting authorisation in Serbia (D List) at the time of the priority determination request; • applications for medicinal products developed, manufactured or marketed with state funding; and • applications for medicinal products of strategic 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 grant- ing 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 regarding the quality, safety and effi- cacy of the medicinal product. If the application for a marketing authorisation under the fast-track proce- dure is incomplete, the Agency notifies the applicant in writing, requesting the submission of the missing information within 30 days from the date of receipt of the written notification. The request for outstanding
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