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Fig. 3
Decentralized procedure. |
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essential for the procedure to progress to the mutual recognition phase with the second wave of countries so it will be important that they are available as soon as possible. The Member States are allowed 90 days to produce the upto-date assessment report. Only a few national regulatory authorities are able at present to evaluate a product within a 210-day period so this will be one of a series of important points in selection of this first country by the company (see Section VII). Once the assessment report and SmPC are obtained by the |
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