BIA Head Attacks Rapporteur Reallocation, But Welcomes Further Clarity On Transition Period
Steve Bates, CEO of the BIA, is concerned that the EU authorities are overloading national regulatory agencies by reallocating UK rapporteurships to other member states before they are ready to take them on. However, he has welcomed clarification from the UK government over the movement of medicines during any Brexit transitional period.
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The EMA has completed the reallocation to the EU27 member states of more than 370 centrally authorized drugs for which the UK was rapporteur or co-rapporteur. The move has been necessitated by Brexit, which means the UK will no longer play an active role in new drug evaluations at the EMA.
Under EU rules, once a medicinal product has been placed on the market in a country of the EEA – the EU plus Iceland, Liechtenstein and Norway
The EU pharmaceutical strategy published on 25 November will be the first step in a “complete overhaul” of the medicines legislative framework to be proposed in about two years’ time, says the European Commission.