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European Medicines Agency (EMA)
Article 10b

Article 10b

The Commission is empowered to adopt delegated acts in accordance with Article 87b, in order to supplement this Regulation by determining the situations in which post-authorisation efficacy studies may be required under point (cc) of Article 9(4) and point (b) of Article 10a(1).
When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation.