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is issued covering the variation procedure for products approved through the decentralized procedure [13]. |
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There will be two types of variation: |
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1. A minor variation (Type I)these are defined in Annex 1 to the Regulation and are generally small changes to chemistry and pharmacy and some administrative changes. A guideline details the supporting data needed for the variation. These Type I variations should be submitted simultaneously to all countries where the product has been authorized. The Type I procedure is a notification systemif the applicant has not received queries within 30 days then the variation is accepted and can be implemented. The Member State who examines the variation and could receive objections from the other Member States is termed the reference Member State and can be specified by the applicant. If the other Member States have objective grounds for nonacceptance of the variation they must inform the reference Member State within 20 days so the applicant can receive the objections within 30 days. The applicant then has 30 days to amend the application. If the applicant does not amend the application it is rejected. If the rejection resulted from divergent positions of the Member States, the applicant has the right to refer the matter to the EMEA. |
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2. A major variation (Type II) is not defined as such; it is all changes which are not a Type I or a new application (for which there is a definition in Annex II of the Regulation). Type II applications must go through a formal approval procedure within 90 days with the reference Member State leading the assessment. The possibility exists for the applicant or Member State to extend the time by up to 60 days for provision of more information. In the event of objections from one or more of the other Member States, a full arbitration procedure with the CPMP takes place as described earlier for a full application. |
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Although registering products for marketing in more than one country nationally will disappear after January 1998, the national regulatory bodies still have many functions. Correspondingly, national regulatory groups within companies will still have several functions. Listed below are some of the functions of the Member State regulatory bodies in the new systems: |
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to assess new medicinal products as Reference Member State for decentralized procedure; |
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to provide members of CPMP and other Committees (Standing Committee, Pharmaceutical Committee) in the European system; |
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to provide experts for the EMEA working groups and experts lists; |
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to authorize national applications; |
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