centralised application

Streamline EU Approval with Strong Pharmacovigilance Documentation

The centralised procedure, which came into operation in 1995, allows applicants to pursue a marketing authorisation that is valid throughout the EU. The European Medicines Agency (EMA) can take up to 210 days to review these new product applications and the agency has an additional 15 days to submit its opinion to the Commission.

Manufacturers waiting for the EMA’s opinion may feel like time is standing still. Ensuring safety and regulatory documentation is properly prepared and consistent helps keep the review process moving.

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