New MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes
On 29 September 2023, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published further guidance (“MHRA Guidance”) on changes to labelling and packaging for medicinal products intended for the UK market (including Northern Ireland) under the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here).
The MHRA Guidance follows the Agency’s announcement of new labelling and packaging measures in June 2023, which will take effect from 1 January 2025. The new measures require, amongst other things: (i) medicinal products intended for the UK market to be authorized by the MHRA; (ii) a single UK-wide pack that bears a “UK only” label; and (iii) disapplication of the EU Falsified Medicines Directive 2011/62/EU (“EU FMD”) to UK packs (please see our blog post on this announcement here).
The latest MHRA Guidance provides further detail on the above measures.Continue Reading New MHRA Guidance on the Windsor Framework: Detail on Labelling and Packaging Changes
Fast-Tracking Approval of Medicines – UK Publishes Detailed Guidance on its New International Recognition Procedure
On 30 August 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) published detailed guidance on its recently announced new International Reliance Procedure (“IRP”) (see our prior blog and audiocast). The IRP will apply from 1 January 2024 and will replace and significantly expand on existing EU reliance
Continue Reading Fast-Tracking Approval of Medicines – UK Publishes Detailed Guidance on its New International Recognition ProcedureGerman court strengthens market exclusivity right of orphan drugs and the legal position of their marketing authorization holders
Orphan drugs have a special position under EU pharma laws. Among other things, the EU orphan drug laws grant the marketing authorization holder (MAH) of an orphan drug a 10 year period of so-called “market exclusivity”. According to Article 8(1) of the Regulation (EC) No. 141/2000 on orphan medicinal products,
Continue Reading German court strengthens market exclusivity right of orphan drugs and the legal position of their marketing authorization holders
EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle
Hot on the heels of recent announcements from the U.S. Food and Drug Administration (see our prior blogs here), the European Medicines Agency (“EMA”) has joined the conversation on the use of Artificial Intelligence (“AI”) and Machine Learning (“ML”) technologies in the medicinal product lifecycle.
AI and ML have
Continue Reading EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle
Fast-Tracking Access to New Medicines – UK Announces New International Reliance Route
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 the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations. The MHRA
Continue Reading Fast-Tracking Access to New Medicines – UK Announces New International Reliance Route
EU Pharma Legislation Review Series: Marketing Authorisations
The European Commission’s proposal to amend the EU’s general pharmaceutical legislation includes a new draft directive replacing Directive 2001/83/EC (the draft Directive) and a new draft regulation replacing Regulation (EC) No 726/2004, which will also incorporate the EU’s amended paediatric and orphan medicine rules (the draft Regulation
Continue Reading EU Pharma Legislation Review Series: Marketing Authorisations