Community Research and Development Information Service - CORDIS

Marketing authorisation for medicinal drugs

As part of an overall strategy for building a single market in the pharmaceuticals sector, the European Commission has adopted a communication on the implementation of Community marketing authorisation procedures for medicinal products. This is to ensure the continued successf...
As part of an overall strategy for building a single market in the pharmaceuticals sector, the European Commission has adopted a communication on the implementation of Community marketing authorisation procedures for medicinal products. This is to ensure the continued successful operation of the new authorisation systems and to clarify certain aspects relating to the implementation of the centralised and mutual recognition procedures.

The following aspects are covered in particular:

- The definition of the scope of Regulation (EEC) No. 2309/93 in order to set clear criteria to determine whether a medicinal product requires a Community marketing authorisation and where the centralised procedure is an option;
- The introduction of a biotechnology manufacturing step after the granting of an authorisation if an active substance from the same supplier is common to more than one marketing authorisation;
- The naming of medicinal products authorised by the Community;
- The conditions to be met whenever there is parallel distribution of these medicinal products;
- The conditions to be met when implementing the various provisions within the framework of the decentralised procedure.

Source: European Commission, DG III
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