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Regulatory information – New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines

07.12.2016

Guidance reflects European Commission’s notice on the application of the Orphan Regulation

The European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of marketing authorisations and type II variations to include further details on the information companies need to provide when submitting a type II variation or a marketing authorisation extension for an orphan-designated medicine.