Regulatory information - Updated variations application form for human and veterinary medicines
From 4 August 2013, marketing-authorisation holders should use the updated application forms when submitting their variation applications for human and veterinary medicines to the European Medicines Agency. The European Commission has published these new forms, as well as guidelines on variations, on its website.
The Agency will publish the corresponding electronic variation application forms (eAFs) on its eSubmission website by 29 July 2013.
To allow marketing-authorisation holders and relevant stakeholders to prepare for the use of the eAFs and, where applicable, organise their information-technology-system interface upgrades, the data exchange standard has been available on the eSubmission website since 15 July 2013.
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- Application forms for variation to a marketing authorisation for medicinal products (human and veterinary), July 2013
- Guidelines of 16 May 2013 on the details of the various categories of variations, on the operation of the procedures laid down in chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures
- eSubmission – European Union electronic application forms