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SOP for review of orphan designation at the time of granting/varying a marketing authorisation

This SOP describes the procedure for reviewing the orphan designation at the time of the initial authorisation of an orphan medicinal product, or an extension of indication (type II variation) for a designated orphan product with a new orphan condition. The procedure runs in parallel with the adoption of the opinion by the CHMP and the granting of or variation to a marketing authorisation by the European Commission.

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