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paration done to be able to answer them. In addition, the project team needs to be kept together in order to have dedicated resource for answering the queries. This will be particularly important in the decentralized procedure to avoid the arbitration step if at all possible; the more prepared the applicant is to deal with Member State objections in the first 90-day period (see IV B.1) the better the chance of mutual recognition being achieved. |
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Oral explanations before the CPMP will be a feature of the new procedures and it will be important to have staff with the necessary skills of negotiation besides their scientific skills. As more than one language may be spoken in a CPMP meeting, it could also be useful to have staff with fluency in more than one European language. |
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The new marketing authorization system is having a considerable influence on the regulatory strategy for companies. Contrary to old practices there is a need to submit the same dossier to all countries, one assessment by the CPMP is carried out (at least in the centralized procedure), and both procedures result in a binding decision on all Member States. With the entry of Austria, Sweden, and Finland into the European Union in 1995, the size of the market covered by this regulatory system is considerable. Strategic decision making in the Regulatory Affairs Department and its full involvement in the development process will become a key factor in the success of the company's business. |
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I wish to acknowledge the considerable support of my secretaries, Aisling Blagg and Tracy Warman, and the internal Pfizer reviewers of this chapter. |
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1. Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high technology medicinal products particularly those derived from biotechnology. |
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2. Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law regulation or administrative action relating to proprietary medicinal products. |
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3. Council Directive 83/570/EEC of 26 October 1983 amending Directives 65/65/EEC, 75/318/EEC, and 75/319/EEC on the approximation of provisions laid down by law, regulation, or administrative action relating to proprietary medicinal products. |
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4. Council Directive EEC No. 2309/93 of 22 July 1993 laying down Community Procedures for the authorization and supervision of medicinal products for human |
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