EU streamlines rules on variations to marketing authorisations
This article was originally published in SRA
A new regulatory framework for making changes to drug marketing authorisations in the European Union has been published. The framework, outlined in a European Commission regulation published on 12 December 2008, includes a new notification procedure for most minor changes, and will also allow multiple changes to be submitted together in certain cases. The regulation, which applies to both human use and veterinary medicinal products, comes into force on 1 January 2009. Its provisions will apply from 1 January 20101.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.