SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
marketing authorisations. A medicinal product may be granted a marketing authorisation after undergo- ing pharmaceutical (pharmaceutical, chemical, and biological), pharmaco-toxicological and clinical trials and provided that it has the required quality, safety and efficacy. The ALIMS conducts a formal review of an application for marketing authorisation within 30 days. The substantive review must be completed within 210 days. If the ALIMS requests additional documents from the applicant, the deadline is paused until submission of those documents. There is also an accelerated procedure for obtaining a marketing authorisation, for a medicinal product which obtained a marketing authorisation in accordance with the EU centralised procedure, and for medicines for human use of utmost importance for public healthcare. The accelerated procedure may last no longer than 150 days from receipt of a complete application. Medical Devices Medical devices are not subject to marketing authori- sation and may be placed on the market or in use if they comply with essential requirements set out in the Medical Devices Act regarding conformity assess- ment, labelling and supporting documents, if they are properly procured, installed and maintained, and used in accordance with their purpose. A manufacturer or its representative must submit the application for reg- istration of a medical device to the ALIMS before plac- ing it on the market or putting it to use. The Medicines Act contains a limited list of medical devices which do not need to be registered in order to be placed on the market or put to use (ie, medical devices for approved clinical trials or research and development, custom-made devices, devices for the personal use of a patient previously treated abroad, devices import- ed on a temporary basis for medical fairs, and those manufactured in medical institutions for in-house use). Variations A request for a variation is submitted to the ALIMS. Marketing authorisation-holders are obliged to: • report IA-type variations within 12 months from the moment of application (“do and tell” procedure); • report IAIN variations without delay following their application for the purpose of continuous monitor- ing of the medicinal product;
• request the ALIMS’s approval for IB-type and type- II variations before their application (“tell, wait and do” procedure); and • submit a new request for marketing authorisa- tion for variations related to changes of the active ingredient or changes in strength, pharmaceutical form, or manner of application of the medicine, and for variations of veterinary medicines for animals used in human alimentation. The ALIMS conducts a formal assessment of the application within 15 days from the day of the appli- cation and the substantive review within 90 days from the day when the application is deemed complete. The pharmaceutical product must be marketed in accordance with the approved variation at the latest within 12 months from the delivery of the ALIMS’s act on approval of the variation. 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 prospective new holder meets the requirements prescribed by the law. The ALIMS con- ducts a formal assessment of the application within 15 days from the day of the application and the sub- stantive 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 emergency situations; or • when the safe provision of healthcare is impeded, meaning when there are insufficient quantities
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