What Brexit means for the pharmaceutical industry

It's just a few months until the interim period ends and Brexit becomes a reality. Here, Diapharm regularly publishes news of what is known so far, so that the pharmaceutical industry can prepare for the ensuing new trade and regulatory relationship between United Kingdom and European Union.

Use the intervening period and contact us to learn more!

Sandner, Thilo
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.com

The right Brexit strategy: preparing medicinal products and medical devices for the EU27

Let’s be optimistic and say that a “No deal” Brexit is a threat nobody wants to carry out. Pharmaceutical companies from the United Kingdom then have another two years to prepare their medicinal products and medical devices for continued marketability on the other side of the English Channel. The implementation period will end in 2020. That’s sufficent to develop a long-term access to the EU27 market following Brexit. We reveal which aspects companies need to consider now – and where the pitfalls are lurking.  more >>
Bolte
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.com

Pharma and Brexit: an update

The British MHRA recently published some “Guidance” relating to the impact that a transitional agreement would have on the healthcare sector if it became part of the final Withdrawal Agreement. Ultimately, the many “what ifs” mean that everything could stay the way it is. However, barely seven months before Brexit is supposed to take place, a lot is still unclear. Just last year, we reported on the relationship between the pharmaceutical industry and Brexit with the headline, “the clock is ticking”. This headline is now more relevant than ever before.  more >>
Bolte
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.com

The pharmaceutical industry and Brexit: the pseudo transition period

The DIA EuroMeeting in Basel, which just concluded, once again made it clear that the Brexit transition period for pharmaceutical companies means practically no extension. Several key provisions are set to expire in less than a year on 29 March 2019. During the meeting, Hugo Hurts, Head of the Brexit Task Force of the Heads of Medicines Agencies (HMA), even encouraged pharmaceutical companies to assume that the United Kingdom will receive “third-country” status in future.  more >>
Bolte
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.com

Pharma and Brexit: "Nothing is agreed until everything is agreed"

The future relationship between the United Kingdom and the European Union remains completely unclear, even after the “breakthrough” in the first phase of the Brexit negotiations announced on 8 December 2017. The joint statement by the parties involved in the negotiation makes this perfectly apparent in a single sentence: “Nothing is agreed until everything is agreed.” At the same time, Brexit is increasingly becoming a reality following the announcement of the EMA’s move to Amsterdam. On Friday, 29 March 2019, the United Kingdom will leave the European Union, leaving pharmaceutical companies with a little over 16 months to adapt to the new situation. The EMA is already preparing for the worst-case scenario – a hard Brexit.  more >>
Leyers
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.com

Pharma and Brexit – the clock is ticking

Brexit is approaching rapidly. From 23 March 2019, the United Kingdom will no longer be a member of the European Union. Overnight, medicinal products and medical devices that do not comply with this new reality will suddenly no longer be marketable (without restrictions). Many details still remain unclear, especially the regulatory steps manufacturers will have to take with their medicinal products to avoid losing markets and revenue. Marketing authorisation holders therefore have no other option but to prepare for the worst-case scenario.  more >>
Pressemitteilung|Press release
| Diapharm GmbH & Co. KG | Logo Diapharm GmbH & Co. KG | https://diapharm.com

Brexit for the Chinese: Diapharm explains volatility in the EU pharmaceutical industry at CPhI China

General Manager of Diapharm Ralf Sibbing discussed the impact of the upcoming Brexit at CPhI China, which took place in Shanghai from 20 to 22 June 2017. His presentation focused on the preparations of Chinese pharmaceutical companies aimed at launching products on the European market. “The volatility caused by the United Kingdom’s upcoming exit from the EU is already having an impact on the decision-making processes of providers from third countries,” Ralf Sibbing remarked in Shanghai.  more >>
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