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

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.

European Medicines Agency

Source: http://www.ema.europa.eu/ema

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