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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 to the Agency and if the company receives no queries within 30 days the variation can be implemented, i.e., this is a notification system. If there are queries the applicant has 30 days to amend the application; if this cannot be done, the application is rejected. |
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2. Major changes are termed Type II variations; they are not defined as such being all changes which are not a Type I or requiring a new application (for which there is a definition in Annex II of the Regulation). A Type II variation will be assessed in the Agency within 60 days. Within that time the applicant may be requested to provide more information; an extra 60 days are allowed for this. This can be extended both by the applicant or by the Agency. If the opinion is favorable the decision to approve is taken through the procedure described previously for a full application (IV A.4.). An unfavorable opinion can result in an appeal followed by the decision as described for the full procedure. |
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B. Decentralized or Mutual Recognition Procedure |
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The objective of this procedure is to facilitate access to a single market through the principle of mutual recognition of an authorization issued by one Member State (Reference Member State) by the other Member States. Only in the case of serious objections on the quality, safety, or efficacy of the product would the matter be referred to the EMEA for a single binding decision on the area of disagreement. The procedure results in a series of national harmonized authorizations as opposed to one authorization in the centralized. The procedure is not available for products of biotechnology (Table 1) but is open by choice to new active substances, products classed as high technology (Table 2), and all other products. |
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The procedure can be initiated either by the company or by a Member State. The full procedure is explained in the Notice to Applicants currently under revision and expected to be reissued by mid-1996 [11]. A diagrammatic representation of the procedure is given in Figure 3 with the main points of note discussed below. |
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1. Originating Application and Mutual Recognition |
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The application to the Reference Member State (RMS) should be evaluated within 210 days by national procedures and an assessment report produced plus the Summary of Product Characteristics (SmPC). These documents are |
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