EU:European Commission Opens Review of Variations Guidance
| Posted: 15 June 2012
By Louise Zornoza, RegLink
The European Commission has opened a public consultation on proposed changes to the current guidance on making changes to the terms of approved marketing authorizations, otherwise known as the “Variations Regulation.”
The document takes into account scientific and technical progress since the entry into force of guidelines in January 2010 and addresses an update required by the implementation of the new Pharmacovigilance legislation, which will enter into force in July 2012.
EMA – Public Consultation on Proposed Variations Guidance Changes
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