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UK MHRA to recognize foreign regulatory approvals for medicines and medical...

Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK.  It identified life sciences and digital technologies as “high growth sectors,” which the UK Government...

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EU Talking Life Sciences Audiocast: Episode 3 – Social Media Challenges for...

Tune into the third episode of Covington’s Life Sciences Audiocast, where Grant Castle, Stefanie Doebler, and Raj Gathani discuss social media challenges for pharma companies in Europe and the U.S.

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EU Pharma Legislation Review Series: Pharmacy and Hospital Exemptions

The existing EU pharmaceutical legislation provides for a number of specific exemptions from the marketing authorisation requirement, including products supplied on a named patient or compassionate...

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EU Pharma Legislation Review Series: Supply Security and Shortages Control

As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“the Proposal”), the European Commission (“Commission”) has introduced a series of measures aimed...

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EU Pharma Legislation Review Series: Decentralized Manufacturing

The EU’s General Pharmaceutical Legislation amendment proposal, which was published on 26 April 2023 (“the Proposal”), is introducing new measures to regulate decentralized manufacturing, which is...

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Fast-Tracking Access to New Medicines – UK Announces New International...

On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products.  This shows...

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Germany to enact new law with significant changes to drug pricing and...

In an earlier blog, we noted that the German drug pricing and reimbursement laws are among the most complicated legal areas in the entire field of life sciences law. Now, these laws and the respective...

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Germany plans significant hospital reform with broad impact on life sciences...

Germany’s hospital system is reported to be of high quality but is also very expensive by international standards. Hospitals and healthcare payers such as health insurances are exposed to increasing...

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UK Government Announces Launch of Pilot Scheme to Accelerate Access to...

On 19 September 2023, the UK  Government announced the launch of the Innovative Devices Access Pathway (“IDAP”) pilot scheme. The UK already has in place an Innovative Licensing and Access Pathway...

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VPAG – New 5-Year Pricing Agreement Agreed between UK Government and the UK...

On 20 November 2023, the UK Government and the Association of the British Pharmaceutical Industry (“ABPI”) ‒ the industry body representing the innovative pharmaceutical industry in the UK ‒ announced...

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