Since having joined the European Union the medicinal products having been authorised centrally have been automatically considered as valid marketing authorisations in Hungary as well. The marketing authorisation process of centralized procedure having been adopted since 1995 is well-defined by directives 2309/93/EEC and 93/41/EEC. It is obligatory to apply for centralized procedure in case of medicinal products manufactured biotechnologically, products used for cancer, AIDS, diabetes, and in neurogenerative diseases – these medicines should be considered as chemically new substances, accordingly they have not been authorised in the EU. In any other cases where the conditions are given for an assessment in a cetralized procedure however it is not oligatory to proceed the manufacturer of the medicinal product may choose which way to follow.
The application for a centralized marketing authorisation has to be submitted directly to the EMEA (European Medicines Agency), London. According to the submitted documentation a committee belonging to the EMEA, the CHMP (Committee for Medicinal Products for Human Use) – consisting of one delegate from each Member State - is to assess the clinical applicability by considering the risk/benefit rate of the medicinal product. The European Commission will make the decision on the fact of authorisation which is to be considered obligatory in all Member States. However the manufacturer decides whether putting the product on the market.
The application for marketing authorisation is always assessed by two CHMP-members - the rapporteur and the co-rapporteur - asigned by the CHMP-chair. The first assessment is to be done until the 70th day of the procedure. Then a list of questions is compiled according to the assessors' and the CHMP-members' opinions – this is to be forwarded to the applicant. The applicant has 30 days to respond these questions (however if there is a need for more time to collect data for answering the questions the clock may be stopped at the request of the applicant). To decide whether the applicant's responses are satisfactory 20 more days are available. Finally the rapporteur and the co-rapporteur prepare the Assessment Report (AR) and after approval by the CHMP send it to the applicant.
The following step of the procedure is the phase of decision making: the opinions and annexes (e.g. Product Information Leaflet, Summary of Product Characteristics) of all Member States on their own languages are sent by the EMEA to the European Commission where these documents are examined from the legal point of view and then framed to a legally binding decision valid in all Member States. The Commission has 30 days to prepare the draft decision which is sent for report to the Committe for Medicinal Products for Human Use (one delegate from each Member State). The Member States have 15 and 30 days for resending their opinions on linguistic, scientific or technical issues. Views of the different Member States are exchanged in written form, however if any Member State had a well-established objection the Commission in full force assemble for discussion. In so far as the marketing authorisation is given a favourable verdict a final decision is to be issued. Both the Marketing Authorisation Holder and the Member States are informed about this fact and the final decision is published in the offical paper of the European Commission, in the Official Journal of the European Communities.
The centralized marketing authorisation is valid for five years, the application for extension has to submitted to the EMEA 3 months before the expiry.
For details please see the website of the EMEA.
