SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
ing licence must contain information and docu- ments regarding the location and premises of the manufacturing site, equipment, personnel, medicines to be produced, relevant procedures, as well as other information required by the law. The Ministry issues a licence for a particular manufacturing site and certain forms of pharma- ceutical manufactured at that site. The licence may include an entire manufacturing process or only a part of the process. The licence is valid for an indefinite period. Manufacturing of Medical Devices Manufacturers of medical devices may be both legal entities and individuals. A manufacturing licence is necessary only for class I medical devices (other than Is and Im class), other in vit- ro diagnostic medical devices, medical devices for which no conformity assessment has been performed, those not covered by the sign of conformity, custom-made devices for a particu- lar 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 medi- cal 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 reg- istered seat in Serbia, who must obtain a manu- facturing licence for medical devices from their production programme, and (iii) entities perform- ing only import or export activities on behalf of and for the account of a medicines wholesale licence-holder. Applicants for a wholesale licence must pro- vide information and documents regarding the legal entity, location and premises, supply ter- ritory, products for which the wholesale licence is sought, personnel, equipment, a plan for an urgent withdrawal of products 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 Product Classification: Pharmaceu - ticals or Medical Devices relating to different categories of pharmaceuticals. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The import and export of pharmaceutical and medical 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 regulated in the rule books governing the wholesale of medicines and medical devices.
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