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BIA Head Attacks Rapporteur Reallocation, But Welcomes Further Clarity On Transition Period

April 23, 2018, The Pink Sheet

Grant Castle is quoted by The Pink Sheet in an article regarding comments from head of the UK BioIndustry Association stating that authorities are jumping the gun by reallocating all UK centralized rapporteurships to other EU member states before it is clear whether there will be some form of continued regulatory relationship between the UK agency, the MHRA, and the European Medicines Agency after Brexit. Castle says that during a transition period there would be no need, for example, for UK companies that wanted to market products in the EU after Brexit to set up a qualified person for batch release in an EU country. Article 37 of the draft withdrawal agreement says that any product lawfully placed on the EU or UK market before the end of the transition period "may be made further available on the UK or Union market, so there won't be a need for additional import and QP release as it crosses the EU-UK border." Castle notes, "This is without prejudice to customs procedures and tariffs and taxes and things - but from a purely drug regulatory perspective it is correct." Until the end of the transitional period there would be no need to import and re-release products across the border, he adds. "Obviously, subject to what is negotiated for the post-transition phase, there is a possibility and perhaps a likelihood" that products imported to the EU from the UK would need to be QP released after the end of the transition period, Castle says. "There is a possibility that they might have a mutual recognition agreement whereby batch release would be recognized, but we don't know that yet."

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