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European Commission Clarifies Position on Post-Authorisation Efficacy Studies

May 2014

Focus on Regulation - Hogan Lovells Blog

On 10 April 2014, the European Commission (“Commission”) adopted Commission Delegated Regulation (EU) No 357/2014 as regards situations in which post-authorisation efficacy studies may be required (“Delegated Regulation”). The Delegated Regulation will enter into force on 30 April 2014.

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