SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
Record of Pharmaceuticals and Medical Devic- es . A legal entity that performs only the activities of import and export may perform these activities without a medicinal product wholesale licence if it conducts the import and customs clear- ance activities on behalf of and for the account of a wholesale licence-holder to the site of the goods’ free marketing, in accordance with the customs regulations. Generally, only medicinal products with a valid marketing authorisation and medical devices registered in the ALIMS’s registry of medical devices may be imported. Exceptionally, the ALIMS may approve import of medicinal prod- ucts without a marketing authorisation in Serbia or unregistered medical devices under conditions prescribed for compassionate-use programmes, donation or humanitarian aid, or the emergency situations described in 3.5 Access to Pharma- ceuticals and Medical Devices Without Mar- keting Authorisations . Persons entering or leaving Serbia may carry medicinal products in the amount not exceeding their six-month requirement within one calendar year, for their personal usage or for an animal travelling with them, depending on the type and length of the underlying illness. They have to provide to the Customs Authority the approval of a competent Serbian ministry for bringing in or carrying out medicinal products for personal use. The transfer of medicinal products across the border in the amount not exceeding the 15-day requirement of an individual is not subject to any approval.
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 tis- sue samples for clinical trials’ procedures of medicinal products, (ii) approvals for the import of medicines for clinical trials, and (iii) approvals for the import of medicines without a marketing 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 wholesale licence. Furthermore, a pharmaceutical or a medical device manufacturer may import products from its production programme, raw materials and substances for production, interim products, and semi-finished products, in accordance with the manufacturing licence, medicinal products marketing authorisation, or a subcontracting agreement. Manufacturers of medical devices with a regis- tered seat in Serbia who do not need a manufac- turing licence must obtain a wholesale licence for medical devices from their production pro- gramme. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices The import and export of pharmaceuticals and medical devices is subject to a prior issuance of a medicinal product wholesale licence, subject to exceptions described under 7.2 Importer of
270 CHAMBERS.COM
Powered by FlippingBook