SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and
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, cus- tom-made devices, devices for the personal use of a patient previously treated abroad, devices imported 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 continu- ous monitoring 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 authori- sation for variations related to changes of the active ingredient or changes in strength, pharmaceutical form, or manner of applica- tion of the medicine, and for variations of vet- erinary medicines for animals used in human alimentation. The ALIMS conducts a formal assessment of the application within 15 days from the day of the application and the substantive review within 90 days from the day when the application is deemed complete. The pharmaceutical prod- uct 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.
Medical Devices Pharmaceuticals
The Medicines Act and a series of implement- ing by-laws govern the granting of a market- ing authorisation. The ALIMS is the competent authority for issuing marketing authorisations. A medicinal product may be granted a marketing authorisation after undergoing pharmaceuti- cal (pharmaceutical, chemical, and biological), pharmaco-toxicological and clinical trials and provided that it has the required quality, safe- ty and efficacy. The ALIMS conducts a formal review of an application for marketing authorisa- tion within 30 days. The substantive review must be completed within 210 days. If the ALIMS requests additional documents from the appli- cant, the deadline is paused until submission of those documents. There is also an accelerated procedure for obtaining a marketing authorisa- tion, 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 com- Medical devices are not subject to market- ing authorisation 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 assessment, 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 applica- tion for registration of a medical device to the ALIMS before placing it on the market or putting it to use. The Medicines Act contains a limited plete application. Medical Devices
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