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MAGYAR

Process of Marketing Authorisation

During the process of marketing authorisation quality, safety and efficacy of a new medicinal product are assessed by a professional authority. In case of suitability of the product it will be declared to be a medicine by a public administration decision.

There are four types of procedures to issue the marketing authorisation in Hungary – as it is common in the EEA (European Economic Area) as well:


centralized procedure: the documentation of the new product is assessed by the EMEA-CHMP, the authorisation is issued by the European Commission;

decentralized procedure (DCP): the new product has not been authorised in any European coutries in the time of the submission of the application; the National Institute of Pharmacy is entitled to assess the documentation and to issue the marketing authorisation;

mutual recognition procedure (MRP): the new product has been authorised at least in one European country in the time of submission of the application; the National Institute of Pharmacy is entitled to assess the documentation and to issue the marketing authorisation;

national procedure: assessment is carried out by the National Institute of Pharmacy; the marketing authorisation is valid only in Hungary.
 
Concerning the differencies regarding the marketing authorisation of herbal medicines and homeopathic medicinal products for details please see the relevant pages.
Last updated: 2008.08.18 20:07