Abstract
1. The Committee for Proprietary Medicinal Products (CPMP), set up by the EEC in 1975, plays an important role in the harmonization of drug regulations between Member States. 2. When objections are raised within the Multi-State procedure for applications for marketing authorization, the CPMP considers these and the manufacturer’s response, before drafting recommendations. 3. The introduction of the Multi-State procedure has improved co-operation between national delegations, an essential basis for a free market of medicinal products in Europe. 4. The CPMP has so far received six applications for biotechnology products under the High-tech concertation procedure, which came into effect on 1 July 1987. This procedure represents an important step towards a single assessment accepted throughout the community. 5. In addition to establishing various working parties to provide recommendations and guidelines, the CPMP has important pharmacovigilance responsibilities, concerning the side-effects of drugs. 6. The future role of the CPMP will largely depend on the system chosen for the free market of medicinal products in Europe in 1992.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
