SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
Appeal Procedure A party may submit an appeal against the ALIMS’s decision to the competent ministry through the ALIMS. The deadline for submit- ting 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 mat- ters from their competence, are final and may be challenged only before the Administrative Court. 1.3 Different Categories of Pharmaceuticals and Medical Devices Classification of Pharmaceuticals Pharmaceuticals are classified into pharmaceu- ticals for human use and those for veterinary use. Furthermore, pharmaceutical products are classified into (i) prescription-only, and (ii) over- the-counter (OTC) pharmaceuticals. The ALIMS carries out the classification in the process for issuing marketing authorisations. Prescription- only and OTC pharmaceuticals are subject to different regimes with respect to pricing, adver- tising, dispensing and sale. Classification of Medical Devices Medical devices are classified into (i) general medical devices, (ii) in vitro diagnostic medi- cal devices, and (iii) active implantable medical devices. General medical devices are classified accord- ing 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 medical devices. As an exception, the manufac- turer classifies class I medical devices and oth- ers as in vitro medical devices.
2. Clinical Trials 2.1 Regulation of Clinical Trials Clinical Trials for Pharmaceuticals
The Medicines Act is the principal piece of leg- islation regulating clinical trials of pharmaceuti- cals. Additionally, the Healthcare Act of 2019 and the Rulebook on Clinical Trials for Medicines for Human Use (2022, as amended), set out detailed rules related to ethics committee approval and performance of clinical trials. In October 2023, the government introduced amendments to the Clinical Trials Rulebook to limit the phase I (I, Ia, and Ib) clinical trials in Serbia only to pub- lic healthcare institutions. However, in Decem- ber 2024, the government introduced further amendments to the Clinical Trials Rulebook. These changes eliminated the requirement for principal investigators to have prior clinical trial experience and removed the restriction that lim- ited private healthcare institutions to conducting only phases II and III clinical trials, allowing them to participate in all three phases. Additionally, import approval for medicines undergoing clini- cal trials will now be granted simultaneously with clinical trial approval. When reviewing clinical tri- al documentation, ALIMS will consider decisions from the EMA and other relevant international bodies, such as ICH, to enhance the efficiency of the approval process. To ensure transpar- ency, ALIMS will also publish information on all approved clinical trials on its website.
259 CHAMBERS.COM
Powered by FlippingBook