With the deadline for Brexit fast approaching, various scenarios for exiting the EU are still being discussed by politicians, but there is now a huge amount of information being thrown at the pharmaceutical industry on how it will be asked to work if we do leave without a deal in place.
Writing a blog post on the UK BioIndustry Association (BIA) website, CEO of the organisation Steve Bates noted that the European Commission has now provided some useful guidance for medicines batch testing, making it clear that this will be required in the EU and European Economic Area but there is a bit of flexibility with regards to this.
For example, this will be allowed where a batch release site is identified by the marketing authorisation holder by the withdrawal date, where the batch release site is supervised by a qualified person in the EU27 by the withdrawal data, and where the establishment selected by the party carrying out the testing may be verified by a competent authority of the EU27, including where spot checks are concerned.
When it comes to the production of pharmaceutical items, one of the most important parts of the process is making good use of pharmaceutical validation services to test products and document the evidence that this process is bringing out goods that reach the desired levels of quality and compliance.
Validation is broken down into three stages – process design, qualification and continued process qualification. The first step typically takes place in a lab and can be experimental, depending on the drug in question.
No-deal communications have also been published by NHS England for patients and healthcare providers, covering medicines, getting medication if there is a no-deal exit and more.
And the government has also written to marketing authorisation holders regarding shipping routes between the EU and the UK, as well as warehousing capacity for extra buffer stock.
If you want to keep up to date with all the latest Brexit information as it happens relative to the pharmaceuticals industry, the BIA has set up a Brexit Portal, which could help you find out what’s happening and when.
As noted on the site, the BIA is clear that it’s essential we have a deal in place with the EU when leaving this month as a no-deal Brexit will have a negative impact on patients, the life sciences sector and public health. A deal would significantly improve the chance of stability and heightened certainty for business.
The life sciences industry has already seen a huge amount of duplication, disruption and uncertainty and it’s likely that this will carry on being the case in the months to come.