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Mutual recognition had rarely happened during the old multistate procedure and although there appears to be a will to make it work now, it can be expected that in some cases significant objections will still be raised by some Member States. In order to allow time to resolve these between Member States and the applicant, the new procedures state that the Member States have agreed to notify these objections within 60 days so that there is a chance to still have all queries resolved with the applicant within the remaining 30 daysthis is an ambitious time frame and will depend on the applicant being able to respond quickly. |
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Allowing for some time between the first approval and starting up the second part of the procedure (90 days) the total time could be 390 days (210 + 90 + 90 days). This could be shorter if less than 90 days are required by the first Member State to update the assessment report. The amount of time the company takes to update the dossier and distribute it to the second wave of countries will of course also determine the total time taken. |
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In the event that there is still disagreement, the matter must be referred to the CPMP to undertake a scientific evaluation. This should take place within 90 days. The CPMP will appoint a rapporteur from one of its members to lead the evaluation of the disagreement. This rapporteur may be from the originating country or may be another member (perhaps from an objecting Member State?). Other experts may also be appointed to assist. At the beginning of this 90-day period, the clock can be stopped to allow the applicant to prepare comments in writing. Subsequent to submitting these it will be possible to have interaction with the rapporteur to know if any issues remain. An oral explanation by the applicant will be possible at the CPMP meeting. Useful guidance on the conduct of oral explanations is given in the Notice to Applicants. |
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After the issue of the opinion there is the possibility of appeal if the opinion was unfavorable. An unfavorable opinion not only covers the possibility of rejection but also it may request a Summary of Product Characteristics change or special conditions attached to the authorization. Appeals are therefore quite likely, given the frequency of SmPC changes made during the assessment processes now. During the appeal, a different rapporteur will generally be appointed to make the assessment and an oral explanation is available again to the applicant. |
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A legally binding decision on all Member States then has to take place. This is the same procedure as described under the centralized procedure, but with the issue of national authorizations. |
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