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European Medicines Agency (EMA)
Article 10b

Article 10b

▼M8
1.
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).
▼M5
2.
When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation.
▼B