SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The import and export of pharmaceutical and medi- cal devices in Serbia are governed by the Medicines Act and the Medical Devices Act, respectively. Import and export constitute the wholesale of medicines and medical devices and as such are additionally regu- lated in the rule books governing the wholesale of medicines and medical devices. Depending on whether the product is intended for human or veterinary use, the Ministry of Health or the Ministry of Agriculture issues a pharmaceutical wholesale licence. The ALIMS issues (i) opinions on the import of cell or tissue samples for clinical tri- als’ procedures of medicinal products, (ii) approvals for the import of medicines for clinical trials, and (iii) approvals for the import of medicines without a mar- keting authorisation. Customs officials check if all the conditions are met in each case. 7.2 Importer of Record of Pharmaceuticals and Medical Devices An importer of record for pharmaceuticals or medical devices may be a legal person with a relevant whole- sale licence. Furthermore, a pharmaceutical or a medical device manufacturer may import products from its produc- tion programme, raw materials and substances for production, interim products, and semi-finished prod- ucts, in accordance with the manufacturing licence, medicinal products marketing authorisation, or a sub- contracting agreement. Manufacturers of medical devices with a registered seat in Serbia who do not need a manufacturing licence must obtain a wholesale licence for medical devices from their production programme.
particular patient, and medical devices for clinical tri- als, as well as a system or a kit. The Ministry of Health issues a manufacturing licence for medical devices, which is valid for five years. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Wholesale of medicines and medical devices includes purchase, storage, distribution, imports and export. A wholesale licence is issued by the Ministry of Health for an indefinite period for pharmaceuticals, and for medical devices for a period of five years. The exception from obtaining a wholesale licence applies to (i) manufacturers of medicines for products from their production programme, (ii) manufacturers of medical devices with a registered seat in Serbia, who must obtain a manufacturing licence for medi- cal devices from their production programme, and (iii) entities performing only import or export activities on behalf of and for the account of a medicines wholesale licence-holder. Applicants for a wholesale licence must provide infor- mation and documents regarding the legal entity, location and premises, supply territory, products for which the wholesale licence is sought, personnel, equipment, a plan for an urgent withdrawal of prod- ucts from the market, as well as the other information of relevance for the issuance of the wholesale licence. 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Categories of Pharmaceuticals or Medical Devices relating to different categories of pharmaceu- ticals.
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