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to maintain products registered before January 1, 1995 (variations, renewals, etc.); |
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to handle adverse drug reactions; |
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to authorize clinical trials (where legislation demands it); and |
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to inspect (GMP, GLP, and GCP). |
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This is by no means a complete list but illustrates that the Member States have an important and continuing role to play in the new procedures as well as still having many activities locally. This new emphasis has resulted in the recent reorganization of many regulatory bodies in the European Union to enable them to carry out their new functions. |
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A Council Regulation on Fees [14] was issued in February 1995. The Agency has discussed the intention to be self-financing, with fees as the main source of revenue, within 35 years. Figure 4 details the present fees. |
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VI. Computer Assisted Product Licence Applications (CAPLAs) |
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Although various national Regulatory Agencies have been accepting and experimenting with Computer Assisted Product Licence Applications (CAPLAs), |
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| | | Centralized Procedure | | | Additional strengths/forms | | | | | Generics | | | Additional strengths/forms | | | | | Extensions | | | Type I Variation | | | Type II | | | Renewal | | | Inspection | | | Transfer of MA holder | | | Arbitration | | | Fig. 4 Council Regulation Fees. |
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