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Commission calls for study on authorization of drugs

The European Commission has recently published an open invitation to tender for a study to evaluate the operation of Community procedures as regards the authorization of medicinal products. The objectives of this evaluation are general and specific, as follows: - General obj...

The European Commission has recently published an open invitation to tender for a study to evaluate the operation of Community procedures as regards the authorization of medicinal products. The objectives of this evaluation are general and specific, as follows: - General objectives: It is advisable to check whether the main goals of the initial establishment of the new procedures were attained and to what extent additional efforts must be made; - Specific objectives: The Commission would like an in-depth functional evaluation of the following elements: - - A centralized procedure for authorization of medicinal products; - - A decentralized procedure for authorization of medicinal products; - - A European Agency for the Evaluation of Medicinal Products (EAEMP); - - Telematic systems for the transfer of data between competent national authorities, the EAEMP and the Commission. The contract is for 12 months, and there will be a possibility of a single 12-month renewal. The service provider must be free of any organizational or financial link with the pharmaceutical industry or national or Community administrations. For further information, please contact: European Commission Directorate-General III Industry Unit E/3- Pharmaceuticals and Cosmetics Mrs Rosa de Briones rue de la Loi 200 (AN-88 1/57) B-1049 Brussels Fax +32-2-2961520