SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
Transfer of a Marketing Authorisation A marketing authorisation may be transferred to a new marketing authorisation-holder at the request of the existing one submitted to the ALIMS. The ALIMS will assess whether the pro- spective new holder meets the requirements prescribed by the law. The ALIMS conducts a formal assessment of the application within 15 days from the day of the application and the substantive review within 60 days from the day when the application is deemed complete. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations General Conditions An importer may submit to the ALIMS a request for importation of a pharmaceutical for which a marketing authorisation was not issued in Serbia if: • there is no registered pharmaceutical of the same international non-proprietary name (INN), strength, pharmaceutical form and packaging size on the market in Serbia; • the pharmaceutical is intended for treatment of rare diseases in humans; • it is necessary to ensure sufficient quantities and types of a pharmaceutical in the case of epidemics, natural disasters, or other emer- gency situations; or • when the safe provision of healthcare is impeded, meaning when there are insufficient quantities and types of medicines on the mar- ket for which a marketing authorisation has been issued due to production or distribution problems, if in Serbia there are insufficient quantities of a medicine with the same INN, strength, pharmaceutical form, and packag- ing size as the medicine for which an import request has been submitted.
Compassionate Use Programme In addition to the import of unregistered phar- maceuticals under the general conditions previ- ously described, import is also permitted on the basis of a compassionate use programme. The purpose of such a programme is to treat specific patients or a group of patients who are afflicted by life-threatening diseases such as AIDS, can- cer and other malignant or auto-immune diseas- es. Import is organised as a donation or humani- tarian aid to a health institution, provided that such pharmaceuticals are not subject to clinical trial in Serbia at the moment of the submission of request for import, and provided that they: • are undergoing an advanced stage (Phase III) of clinical trial procedure in an EU coun- try or in a country with similar requirements to Serbia regarding issuance of a marketing authorisation; • have completed a clinical trial procedure in that country; • are currently subject to a centralised market- ing authorisation procedure in the EU; or • have received a marketing authorisation in the EU centralised procedure. Exceptionally, a patient or a group of patients who are not eligible to participate in the ongoing clinical trial for that medicinal product in Ser- bia may receive a donation or humanitarian aid in the form of unregistered pharmaceuticals or registered pharmaceuticals for an unregistered indication, which are at that time subject to clini- cal trial in Serbia. Import of Unregistered Medical Devices The ALIMS may also authorise the import of a medical device not registered in Serbia. This is permissible if that import is intended for a par- ticular patient or group of patients, or comes as a donation or humanitarian aid, or the subject-
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