When medicinal products are imported into the EU, they must undergo batch testing within the European Economic Area (EEA). Once the United Kingdom leave the EU due to Brexit, it has the following effects on the Pharmaceutical industry. Pharmaceutical manufacturers who have previously carried out batch testing in the UK must relocate their batch testing operations to the EU to import their products.
A letter has been sent to the Head of Medicines Agency of the remaining EU Member States (EU27) and to the Executive Director of the European Medicines Agency (EMA) by the European Commission’s Directorate-General for Health and Food Safety. The letter explained the possibility of an exemption for pharmaceutical companies currently carrying out batch testing within the UK.
The Commission acknowledges that some companies may not be able to carry out batch testing within the EU by the time Brexit takes place. The Commission wrote – “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.”
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