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primarily consisting of the clinical data at this stage, there is no policy from the EMEA on full electronic submissions, although this can be expected with time. It should still be possible, of course, to file CAPLAs to Reference Member States in the decentralized procedure if they wish to accept it. At present, it is also possible to submit Part 1A, 1B, and 1C of the dossier only in an electronic form to many Member States. At present, the priority of the EMEA is towards building a network for exchange of pharmacovigilance and administrative information between Member States and the Agency. |
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VII. Impact of New Procedures on Regulatory Strategies |
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Although there has been the possibility of filing applications through a European System for many years few companies have taken up this opportunity and most applications, including those for new active substances, have been filed nationally. Indeed, even for those applications that have used the new procedures, because of the structure of the existing legislation and the fact that the decisions are national, a harmonized outcome (especially SmPC) has often not been achieved. In terms of regulatory strategy for a company, this has tended to perpetuate individual country applications and strategies. |
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Some of the major changes that will influence strategies brought about by the new legislation are |
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1. Binding decisions on the Member Statesresulting in no national deviations to the SmPC. This occurs through the issue of one European Marketing Authorization from the centralized procedure for all of the European Union; mutual recognition in the decentralized procedure implies acceptance of the SmPC as authorized in the originating Member State. If arbitration takes place changing that SmPC then the newly agreed one will be binding on all Member States including the originating country. |
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2. It will be necessary to file exactly the same dossier in all countries. In the decentralized procedure the applicant is required to certify that the dossier is the same. |
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3. After 1998, separate national assessments and decisions are, in effect, no longer possible for products where applications are being made in more than one country. |
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4. Approval will be obtained for all of Europe at once (except for the first country in the decentralized procedure) with implications for launch strategies. Pricing and reimbursement decisions will still be conducted on an individual national basis. |
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5. If the time frames for the procedures are respected, approvals could be obtained relatively quickly for all of Europe in contrast to the previous |
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