EMA – Questions & Answers on Article 117 – Fifth Revision Published EMA has updated its guidance on the implementation of EU regulations on medical devices and in vitro diagnostic medical devices to address situations when a declaration of conformity is not available for class I integral medical devices. EMA – Questions & Answers on Article 117 – Fifth Revision Published
AESGP Webinar – Interruption or Discontinuation of Supply Under Article 10a MDR: Practical Guidance On 27 February, AESGP is hosting a webinar on the interruption or discontinuation of supply under Article 10a MDR. AESGP Webinar – Interruption or Discontinuation of Supply Under Article 10a MDR: Practical Guidance
UK-wide Licensing for Human Medicines: Supplementary Guidance Published MHRA has published supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework. UK-wide Licensing for Human Medicines: Supplementary Guidance Published
HPRA – Guide to Labels and Leaflets of Human Medicines The Health Products Regulatory Authority (HPRA) has published an updated guide to labels and leaflets of human medicines. HPRA – Guide to Labels and Leaflets of Human Medicines
European Shortages Monitoring Platform Fully Live The European Shortages Monitoring Platform (ESMP) has now gone fully live. MAHs can now log in and begin using the platform. European Shortages Monitoring Platform Fully Live
EMA Publishes Final Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs) EMA has released the final guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs). EMA Publishes Final Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs)
MHRA Engagement on Facilitating the Use of Digital Packing Notes to Accompany Medicinal Products MHRA is seeking views from stakeholders to understand potential impacts and benefits of a proposal to facilitate the use of digital packing notes to accompany medicinal products. MHRA Engagement on Facilitating the Use of Digital Packing Notes to Accompany Medicinal Products
PackUK Launched: the Scheme Administrator for Packaging Extended Producer Responsibility PackUK will implement the UK’s new Extended Producer Responsibility for packaging (pEPR) programme. The EPR SI came into force on 1 January. PackUK Launched: the Scheme Administrator for Packaging Extended Producer Responsibility
Publication of PPWR in Official Journal of the EU The Packaging and Packaging Waste Regulation (PPWR) has been published in the Official Journal of the EU. The regulation will enter into force on 11 February 2025 and will apply from 12 August 2026, with Article 67(5) becoming applicable from 12 February 2029. The PPWR is a step toward harmonised packaging standards across the EU. Publication of PPWR in Official Journal of the EU
MHRA – Scientific Advice Update MHRA has announced from 21 January 2025, they will review all new requests for scientific advice meetings against whether the requirements can be addressed with existing guidance, written advice or a scientific advice meeting. This means for a temporary period, companies can expect an increased number of requests will be progressed as written-only advice. MHRA – Scientific Advice Update
PAGB Briefing Paper: The Ban of Titanium Dioxide in Foods and Its Implications for Medicines A PAGB briefing paper on titanium dioxide has been uploaded to our website. PAGB Briefing Paper: The Ban of Titanium Dioxide in Foods and Its Implications for Medicines
MHRA – RWE Scientific Dialogue Programme MHRA is launching a pilot Real-World Evidence (RWE) Scientific Dialogue Programme during 2025, designed to help innovators refine their evidence generation strategies while providing clear guidance on regulatory expectations. MHRA – RWE Scientific Dialogue Programme
