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.