1. Distribution – EU

The Court of Justice of the European Union has confirmed that wholesale distributors must obtain their supplies of medicines only from persons who themselves are in possession of a wholesale distribution licence or are exempt from obtaining such a license and that Article 80 does not provide for any exception for pharmacies. Similar restrictions are also envisaged in the EU Pharmaceutical Package.

Read the decision here

2. EU Pharmaceutical Package

EFPIA publishes its response to the draft EU pharmaceutical legislation, confirming the Industry’s view that the draft legislation in its current form would harm patient access to medicines and innovation in the EU

Read the EFPIA Response here

3. Clinical Trials – EU

The European Medicines Agency has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System. A key change is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial to protect personal data and commercially confidential information.

See the Revised CTIS Transparency Rules here


New ’streamlined and risk-proportionate’ notification scheme for lowest risk clinical trials announced, allowing for a 14-day processing for the lowest risk Phase 3 and 4 trials.

See MHRA announcement here

4. Packaging and Labelling – UK

The MHRA has published further Guidance on the implementation of labelling and packaging requirements for medicinal products for human use intended for the UK market, following agreement of the Windsor Framework. The Guidance is effective on 1 January 2025 and provides for a single UK-wide pack that bears a ‘UK only’ label, as well as disapplication of the EU Falsified Medicines Directive to UK packs.

The Guidance is available here

5. EU Pharmaceutical Draft Legislation Package

EU – EFPIA research assesses the impact of the EC draft pharmaceutical legislation on Europe’s competitiveness.

See EFPIA Press Release here and its Report here

6. Product Information

EU – The Heads of Medicines Agencies, The European Commission and the EMA have published electronic product information (ePI) for selected human medicines harmonised across the EU for the first time.

See the Press Release here

7. Health Technology Assessments

UK – NICE launches its refreshed support service, NICE Advice, for the life science industry, providing a single service to provide advice, insight and education.

See Press Release here

8. Data Protection

EU/UK – The UK ICO and the European Data Protection Supervisor have signed a Memorandum of Understanding, reinforcing their common mission to uphold individuals’ data protection and privacy rights and cooperate internationally to achieve this goal.

See the ICO Press Release here and Memorandum of Understanding here

9. Competition Law

UK – Competition and Markets Authority (CMA) Statement on the pricing of combination therapies in the UK published, which clarifies the circumstances when the CMA will not prioritise enforcement action against drug companies when they implement a specific ‘negotiation framework’ to make combination therapies available to the NHS.

See Guidance here

For further information on these developments and how it could affect business, please contact us, we are always happy to provide our insights.

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