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5. Initiation by a Member State |
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Although the procedure described above, initiated by the applicant, will be the most used for full or abridged applications, there are other cases where referrals may be made to the CPMP using the same procedure. These are briefly described below. |
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As mentioned earlier, from January 1, 1995, when a Member State notes that an application for authorization is under active examination in another Member State, it may decide to suspend examination of the dossier and to wait for the assessment report of the first Member State. If the Member State decides not to recognize the decision of the other Member State, the matter of disagreement will be referred to the CPMP as described above. This facility will continue even after January 1, 1998. From January 1, 1998, Member States must take into account the assessment report from another Member State on that medicinal product and either recognize the decision or refer the objections to the CPMPi.e., the decentralized procedure is fully in operation. |
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Article 11 of Directive 75/319/EEC as amended states that where divergent decisions have been made on a product that has been the subject of several applications for marketing authorization in the Member States, the matter may be referred to the CPMP. The referral may be made by either one or more Member States, the Commission, or the company. The objective of Article 11 is to provide a mechanism for resolution of divergent national decisions that will hinder free movement of medicinal products in the Community. Although these divergent decisions will gradually disappear through the new procedures, there could still be divergence during the transition until 1998. The scope and procedure for Article 11 referrals are covered in detail in the Notice to Applicants. |
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Article 12 of Directive 93/39/EEC covers the cases where the interests of the Community are involved and the Member States, the Commission, or the company may refer the matter to the CPMP for an opinion before decisions are taken on granting an authorization or suspending, withdrawing, or varying one. This Article has already been used for several pharmacovigilance matters. Referrals are made on a case-by-case basis and must be in the interests of the Community; apart from pharmacovigilance cases the Article is likely to be used for products that are of high importance to protection of public health but that are not eligible for the centralized procedure. Again the objective, scope, and procedure are covered in detail in the Notice to Applicants. |
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The CPMP must also be consulted in cases of proposed variations (i.e., changes to the details in the marketing authorization application dossier). A Regulation |
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