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


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.