Regulatory information - Updated variations application form for human and veterinary medicines

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19/07/2013

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.