UK will accept EU-based batch testing of medicines

| By | EMA, Regulatory

European pharmaceutical companies will be able to supply their medicines in the UK on the basis of approved batch testing carried out in the EU for at least two years from the point the UK leaves the EU in the event of a ‘no deal’ Brexit, according to the UK government.

But UK companies will not be able to sell medicines to the EU based on UK testing unless the EU changes its position on pharmaceuticals regulation. The UK government confirmed the position in one of a series of technical notices published on the implications of a ‘no deal’ Brexit for businesses and consumers.

The move ensures that the existing practice of accepting EU-based batch testing of medicines will continue in the UK even if the UK fails to reach an agreement with the remaining 27 EU member states on the terms of its withdrawal from the trading bloc by the scheduled date of Brexit, 29 March 2019.

The British government’s technical notice on batch testing medicines said:

“The UK will continue to accept batch testing of human medicines carried out in countries named on a list set out by the MHRA (Medicines and Healthcare products Regulatory Agency). On exit day, this list would include EU countries, other EEA countries and those third countries with which the EU has an MRA (mutual recognition agreement).”

The same arrangements will apply to investigational medicinal products, which are substances being used in medical trials, where they are manufactured in EU and EEA states, the government said. The UK government said the arrangements around batch testing in a no deal scenario that it has outlined would not be altered without industry consultation.

However, its approach is different to the one outlined earlier this summer by the European Commission and European Medicines Agency (EMA) regarding post-Brexit recognition of UK regulatory processes in the pharmaceuticals sector. According to a ‘question and answer’ paper the Commission and EMA issued, UK-based pharmaceutical companies will be unable to rely on marketing authorisations (MAs) issued by UK regulator, The Medicines and Healthcare products Regulatory Agency (MHRA), to sell their products across the EU after Brexit in a no deal scenario.

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