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Pre-authorization

To register medicinal products for new/initial registration, the applicant should choose the legal basis1 (full application; bibliographic; generic or mixed application; similar biological medicinal product; fixed-combination; informed consent application; homeopathic or herbal preparation) and the procedure of registration (decentralised procedure (DCP), mutual recognition procedure (MRP), national procedure or centralised procedure). Prepared application for the marketing authorisation through DCP, MRP or national procedure should be submitted to the State Agency of Medicines (SAM) for assessment.After the evaluation of the application, the product may be granted a marketing authorization by SAM where the medicines safety, quality and efficacy assessment and assessment of benefit/risk balance of the product is positive.

In order to obtain authorisation through the centralised procedure, a marketing authorisation application must be submitted to the European Medicines Agency (EMA).


1 In accordance with Directive 2001/83/EK, Part III, “Placing on the market”