EMA releases new forms for varying market approvals

Published: 2-Aug-2013
Regulatory

The new forms must be used from 4 August


A new updated application form will have to be submitted from 4 August for varying marketing authorisations to sell pharmaceuticals in the European Union (EU).

The European Medicines Agency (EMA) has released this document at ec.europa.eu/health/files/eudralex/vol-2/c/variation_form__201307_en.pdf

The agency has also published the corresponding electronic variation application forms on its eSubmission website. See esubmission.emea.europa.eu/eaf/index.html

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