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News about GMP/cGMP

2017-09-05

British MHRA busy with Brexit

The British Medicines and Healthcare products Regulatory Agency (MHRA) is dealing with the outcome of the EU referendum to move things into the right direction for the post-Brexit period.

On 21 August 2017, a position paper on the “Continuity in the availability of goods for the EU and the UK” was published by the MHRA that clearly states the desire for a smooth and orderly withdrawal from the EU, one that avoids any disruption for business and consumers. According to the British Regulator Authority, to move to the freest possible future economic relationship should be the goal.

 

A status quo oriented business as usual? As far as the MHRA is concerned, the answer is a definite “Yes”. Following is an extract from the position paper wherein the following four principles are proposed:

  • First,  to ensure the continued availability of products on EU and UK markets at the date of withdrawal, goods placed on the  Single Market before exit should continue to circulate freely in the UK and the EU, without additional requirements or restrictions.
  • Second, to avoid unnecessary duplication of activities and provide legal certainty, where businesses have undertaken compliance activities prior to exit, they should not be required to duplicate these activities in order to place goods on the UK and the EU market after exit. This includes recognising the validity of type approvals, certificates and registrations issued prior to exit.
  • Third, to ensure that goods in circulation continue to comply with product legislation, and market surveillance authorities can ensure the necessary action is taken with respect to non-compliant products, the agreement should facilitate the continued oversight of goods.
  • Fourth, where goods are supplied with services, there should be no restriction to the provision of these services that could undermine the agreement on goods.

The EMA, on the other hand, is preparing for Brexit by drawing a different picture. In its “Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use”, it is clearly said that the UK will become a “third country” from 30 March 2019 on with all consequences. This is what the Q&A Paper published by the European Commission and the EMA confirms: As of the date of the withdrawal of the UK from the Union, medicinal products and APIs manufactured in the UK will be considered imported medicinal products (Question 6, 7). Also the site of batch release has to be transferred to a location established in the Union (Question 8).

So far, the approaches are quite different. Which direction will it go and what lies ahead? And what does industry has to say in all this?

According to a 75-pages industry report  “Life Sciences Industrial Strategy – A report to the Government from the life sciences sector” a rather detailed picture of UK`s future outside the European Union is already sketched by industry leaders. The idea of separating completely from the European Medicines Agency (EMA) is not supported at all. John Bell, the Oxford professor who authored the report, writes “Relatively speaking, the UK market is too small even with the fastest and most innovative regulatory system in the world, to stand alone from a larger decision-making bloc”. A focus on maintaining a degree of harmonisation with the EU and to further strengthen the exchange of information seems much more preferable for the industry leaders.

It remains to be seen how this changing situation within Europe will be managed on both sides. If you are interested in more information take  a look at the the news story "MHRA and making a success of Brexit" published on the agency's website. Therein the agency emphasises outright that playing a full, active role in European regulatory procedures for medicines in a close working partnership with the EU is its top priority.

Source:

MHRA: Position Paper

EMA: Q&A to UK's withdrawal

Life Sciences Industrial Strategy – A Report

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