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erinary medicinal products. These products are also covered in the Regulation 2309/93. There will be no further discussion of veterinary products in this chapter although broadly the same procedures apply. National authorization procedures will continue although their use will become more limited as will be explained below. |
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The decision to place the Agency in London was taken in November 1993. Both the new centralized and decentralized procedures were effective from January 1, 1995. During the period 19951998, a transition period will operate. The most significant aspect of the transition period is the possibility for Member State Regulatory Authorities to suspend assessment of a dossier if they note another Member State has the dossier under active examination. The strategic significance of this procedure will be discussed later. |
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From January 1, 1998, the decentralized procedure will be fully in operation. This means that if the product is authorized in one Member State, other Member States must either take the assessment report of the original country into account and mutually recognize the decision or they can raise serious objectives for referral to the EMEA. From 1998 applications under national legislation will be focused on assessment of products for one-country marketing only and maintenance of products approved nationally before the new procedures. Pharmacovigilance and inspections (Good Manufacturing Practice [GMP], Good Laboratory Practice [GLP], Good Clinical Practice [GCP]) will also continue to be the responsibility of Member States although coordination may take place through the EMEA. |
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The national Regulatory Authorities will of course also be fully involved in the new procedures as first-country approvals for the decentralized procedure will have been the result of a national examination. In addition, the national Regulatory Authorities will be supporting the new procedures and the EMEA by providing experts to assess the products. |
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III. European Medicines Evaluation Agency Structure and Tasks |
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The overall structure of the European Medicines Evaluation Agency (EMEA) is laid out in Figure 1. The main tasks of the EMEA are: |
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1. Coordination of the scientific evaluation of the quality, safety, and efficacy of medicinal products; |
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2. Transmission of assessment reports, Summaries of Product Characteristics (SmPC), labels, and package leaflets or inserts for these medicinal products; |
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