SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation Applicable Legislation Pharmaceutical products in Serbia are regulated in the Medicines and Medical Devices Act of 2010 (as amended) (the “Medicines Act”). The sections of the Medicines Act regulating medical devices have ceased to apply and medical devices are now regu- lated separately in the Medical Devices Act of 2017. A considerable number of by-laws regulate in more detail different matters governed by the Medicines Act and Medical Devices Act. Competent Bodies Competences for implementation and enforcement of pharmaceutical and medical devices legislation are shared between three governmental bodies: • the Agency for Medicines and Medical Devices (ALIMS), the regulatory body tasked with enforce- ment of pharmaceutical and medical devices legis- lation for pharmaceuticals for human and veterinary use. The ALIMS is an independent regulatory body established by law; • the Ministry of Health has certain competences with respect to the area of pharmaceuticals 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 matters concerning the pharmaceutical products intended solely for veterinary use. 1.2 Challenging Decisions of Regulatory Bodies 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 Agriculture, Forestry and Water Management with regard to medicines for vet- erinary 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 statu- tory deadline. Appeal Procedure A party may submit an appeal against the ALIMS’s decision to the competent ministry through the ALIMS. The deadline for submitting an appeal is 15 days from adoption of the first-instance decision or, in the case of failure to adopt a decision, within a year from the expiry of the statutory deadline. Decisions of the com- petent ministry upon appeal, as well as first-instance decisions of the ministries in the matters from their competence, are final and may be challenged only before the Administrative Court. 1.3 Categories of Pharmaceuticals and Medical Devices Classification of Pharmaceuticals Pharmaceuticals are classified into pharmaceuticals for human use and those for veterinary use. Further- more, pharmaceutical products are classified into (i) prescription-only, and (ii) over-the-counter (OTC) pharmaceuticals. The ALIMS carries out the classifi- cation in the process for issuing marketing authorisa- tions. Prescription-only and OTC pharmaceuticals are subject to different regimes with respect to pricing, Medical devices are classified into (i) general medical devices, (ii) in vitro diagnostic medical devices, and (iii) active implantable medical devices. General medical devices are classified according to the degree of risk for the users into: • Class I – medical devices with a low degree of risk for the user; • Class IIa – a low-to-medium degree of risk for the user; • Class IIb – a medium-to-high degree of risk for the user; and • Class III – medical devices with a high degree of risk for the user. A notified body carries out the classification of medi- cal devices. As an exception, the manufacturer clas- advertising, dispensing and sale. Classification of Medical Devices
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