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amended as well as more fundamental issues concerning quality, safety, and efficacyso it is likely that appeals will be very frequent. The CPMP has 60 days to consider the appeal and reissue an opinion. It is possible that additional experts may be involved at this stage. |
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The CPMP provides a scientific opinion and the conversion of this opinion to a decision takes place through the Commission using the Standing Committee on Medicinal Products. The Commission has the right to change the decision but must give detailed explanations of their reasons. This decision is sent to the Member States and the applicant. Member States are allowed 28 days to raise, in writing, important new questions of a scientific or technical nature that have not been addressed in the opinion delivered by the Agency. If this happens the procedure may be suspended and the matter referred back to the Agency for further consideration. |
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It is to be hoped that in most cases the Member States will not be objecting at this stage and the Standing Committee (which is composed of Member State representatives) will be able to deliver their opinion in writing. The opinion is delivered by a qualified majority, which means that each country has a weighted vote according to the population size of the country. |
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If the vote is unfavorable or if no opinion is delivered, the Commission has to submit a proposal to the Council of Ministers relating the measures to be taken. The Council also votes by a qualified majority and after 3 months the Council could vote in favor or against or take no decision in which case the Commission adopts their original opinion unless the Council has decided against the measures by a simple majority. Details of the decision procedure are published by the Commission. The final decision will be published in the Official Journal of the European Communities. |
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6. European Public Assessment Report (EPAR) |
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The EMEA makes available on the Internet the European Public Assessment Report for the product and the reasons for its opinion. This report will have any information of a commercially confidential nature deleted from it by the applicant. |
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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) to products approved through the centralized procedure. A Regulation has been issued covering the variation procedure for products approved through the centralized procedure [12]. |
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