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Members of parliament in the UK want the government to take "all necessary steps" to keep the country in the EU medicines regulatory network after Brexit. It's not that easy, though.
Latest From Brexit
The UK is unmistakeably in the period of the calm before the storm, and an enforced Brexit lull is in place. But the thoughts of UK and EU decision-makers – and UK medtech companies – are not straying too far from the upcoming trade deal negotiations and the business of making the best of Brexit, however and whenever it manifests itself.
The UK and EU27 medtech industries are desperate for information about what to do to prepare for Brexit. The UK medtech regulator has issued documents that might give insight, but there are still no certainties on the horizon.
Guidance documents on the regulation of medicines in the UK during a Brexit transition period have been published by the government, covering areas like batch release, drug approvals, and the role of the UK MHRA in the EU regulatory system.
Pharmaceutical companies need to get their message over to MPs and MEPs about the risks of Brexit to medicines supply chains, and would do well to work more closely with patient groups to highlight the possible health risks of reduced access to medicines.
Stakeholders are focusing on timing as implementation deadlines for the EU's new medtech regulations look increasingly unmanageable. Brexit is yet another complication that continued to catch Medtech Insight readers' attention in July, based on a look at the top 10 EU regulatory stories from last month.
In an urgent notice to clients, notified body BSI warns that time is running out to recertify against the current EU directives, as pressures mount for all notified bodies.
The EMA is halting its cherished transparency initiative on study data as it reckons with the fact that many of its employees will not be relocating to its new headquarters in Amsterdam. International collaboration, guidelines development and revision, and the agency's involvement in stakeholder meetings will all be cut back.
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