EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020

Regulatory NewsRegulatory News | 30 July 2019 |  By 

The European Commission (EC) said recently that all marketing authorization holders (MAHs) need to ensure that all work at batch testing facilities in the UK is transferred to EU facilities and that all the necessary regulatory submissions are completed by 1 January 2020.

The reminder announcement follows a letter sent last February that said drugmakers under certain circumstances would be allowed to continue batch testing in the UK even after the UK departed from the EU, although that letter had anticipated Brexit occurring on 29 March. But with the extension of Brexit to 31 October, the EC has not extended the deadline for transferring batch testing facilities.

To qualify for the extension, the Commission said previously that drugmakers must have identified a new batch release site within the EU by the UK’s withdrawal from the EU and that existing UK sites be supervised by an EU-based qualified person. Drugmakers will also need to show that they have taken “all necessary steps” to prepare to move quality control testing operations to the EU.

That letter further noted that MAHs must confirm and set out their precise timetable for transfer of the quality control testing site from the UK to the EU, “(which should allow the process to be completed quickly and in principle by the end of 2019 at the latest).”

The need for such transfers comes as under article 51(1)(b) of Directive 2001/83/EC and article 55(1)(b) of Directive 2001/82/EC, drugs imported into the EU must undergo batch testing within the EU/European Economic Area. Once the UK leaves the EU, either on 31 October or later, drugmakers who previously conducted batch testing in the UK will need to move their batch testing operations to the EU in order to import their products.

“In these cases, Article 20(b) of Directive 2001/83/EC and 24(b) of Directive 2001/82/EC provide that competent authorities may allow importers of medicinal products coming from third countries to have in justifiable cases certain of the controls carried out by third parties,” the Commission writes.

Information on batch testing of medicinal products in the context of withdrawal of the United Kingdom from the Union


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Tags: batch, Brexit, EC, UK

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