2 events today

There are 2 events today which may relate to Vitrogro. The first is the Pharmacovigilance Risk Assistance Committee "Output Adoption". This apparently includes the Risk Management Protocol Assessment and Advice. As Pistol pointed out Vitrogro does not appear in the PRAC agenda so it is possible it bypasssed the need for referral to PRAC.

Secondly, and this is much more relevant to our application, there is an "Early Peer Draft Review" today. This is a is a process by which other members of the CHMP review the (Co) Rapporteurs’ scientific evaluation, as well as the validity of the scientific/regulatory conclusions reached. It applies during the initial phase of the assessment of a new Marketing Authorisation Application (MAA).

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