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MHRA: No change for pre-Brexit products after UK exits the EU

And UK plans to follow EU rules for an implementation period after March 2019

MHRAThere will be no need for pharmaceutical companies in the UK to modify or re-label products launched pre-Brexit once the country leaves the European Union.

That’s according to the Medicines and Healthcare products Regulatory Agency (MHRA), which moved this week to provide a measure of regulatory clarity before second phase of Brexit talks begin.

The MHRA also said the UK was looking to quickly secure an implementation period after March 2019 that would be based on “the existing structure of EU rules and regulations”, with a “deep and special future partnership” to follow that.

Its plans would prevent pharma from facing a cliff-edge situation as it assesses the ramifications from the UK’s exit from the EU and the EMA’s move to Amsterdam.

Agreeing with the proposals, the Association of the British Pharmaceutical Industry (ABPI) said: “We share the MHRA and the government’s ambition for patients in the UK And EU to have continued access to best and most innovative medicines through a close working relationship with Europe, underpinned by the strongest regulatory framework and the sharing of data.”

The group also agreed with the MHRA’s ‘pragmatic’ plan for no sudden changes to the UK regulatory framework. These include the UK regulator giving “adequate notice [to] ensure that companies had sufficient time to implement any changed requirements” in the event of a ‘no deal’ Brexit.

Late last year, global law firm Baker McKenzie and economic consultancy Oxford Economics warned the industry of a potentially heavy impact of a hard Brexit, predicting pharma and medical supply firms could face a potential 10% revenue drop along with staff shortages should no deal be struck.

19th January 2018

From: Regulatory



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