SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
BDK Advokati Bulevar kralja Aleksandra 28 11000 Belgrade Serbia Tel: +381 11 3284 212 Email: office@bdkadvokati.com Web: www.bdkadvokati.com
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices Applicable Legislation Pharmaceutical products in Serbia are regu- lated in the Medicines and Medical Devices Act of 2010 (as amended) (Medicines Act). The sections of the Medicines Act regulating medi- cal devices have ceased to apply and medical devices are now regulated separately in the Medical Devices Act of 2017. A considerable number of by-laws regulate in more detail dif- ferent matters governed by the Medicines Act and Medical Devices Act. Competent Bodies Competences for implementation and enforce- ment of pharmaceutical and medical devices legislation are shared between three govern- mental bodies: • the Agency for Medicines and Medical Devic- es (ALIMS), the regulatory body tasked with enforcement of pharmaceutical and medical devices legislation for pharmaceuticals for human and veterinary use. The ALIMS is an independent regulatory body established by law;
• the Ministry of Health has certain compe- tences with respect to the area of pharma- ceuticals and medical devices for human use, particularly with respect to licensing and administrative oversight; and • the Ministry of Agriculture, Forestry and Water Management is competent for mat- ters concerning the pharmaceutical products intended solely for veterinary use. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Right to Appeal Decisions of the ALIMS can be challenged before the competent ministry – ie, the Ministry of Health with regard to medicines and medical devices for human use, and the Ministry of Agri- culture, Forestry and Water Management with regard to medicines for veterinary use. A party to the proceeding before the ALIMS, or any person whose rights, obligations or legal interest may be affected by the outcome of the proceedings, may submit an appeal. An appeal may also be submitted if the ALIMS fails to adopt a decision within the statutory deadline.
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