MHRA Consultation Response on Proposed Changes to Statutory Fees to Support Ongoing Cost Recovery The MHRA has published the government response to the consultation on proposed changes to statutory fees to support ongoing cost recovery. MHRA Consultation Response on Proposed Changes to Statutory Fees to Support Ongoing Cost Recovery
OTC Medicines Pack Design – Get It Right First Time! Join Us on 3 April The PAGB OTC Medicines Pack Design Workshop is taking place online on 3 April from 10am to 4pm. OTC Medicines Pack Design – Get It Right First Time! Join Us on 3 April
AESGP Webinar – Environmental Risk Assessment AESGP is hosting a webinar on 'Environmental Risk Assessment' on Monday 10 March from 11.30am to 1.00pm (GMT) The webinar will provide a general overview of the environmental risk assessment looking at its scope and main objectives. AESGP Webinar – Environmental Risk Assessment
Updated MHRA Guidance on Format and Content of Applications for Agreement or Modification of a Paediatric Investigation Plan MHRA has updated the guidance on format and content of applications for agreement or modification of a Paediatric Investigation Plan with respect to the Windsor Framework and to provide clarity on instructions. Updated MHRA Guidance on Format and Content of Applications for Agreement or Modification of a Paediatric Investigation Plan
MHRA Consultation Response on Future Medical Device Regulations The MHRA has published the first part of the Government’s response to the medical devices regulations consultation, focusing on the retention of four pieces of EU law. MHRA Consultation Response on Future Medical Device Regulations
Defra Guidance on Registering and Paying Fees for Extended Producer Responsibility (EPR) for Packaging Defra has published guidance on EPR registration and fees for organizations responsible under the Extended Producer Responsibility (EPR) for packaging. Defra Guidance on Registering and Paying Fees for Extended Producer Responsibility (EPR) for Packaging
UK Joint Policy Statement on Enhanced Producer Responsibility for Packaging A joint policy statement on Extended Producer Responsibility (EPR) for packaging has been published by Defra, the Scottish Government, the Welsh Government, and DAERA in Northern Ireland. UK Joint Policy Statement on Enhanced Producer Responsibility for Packaging
PAGB Food Supplements Regulatory Workshop The next PAGB Food Supplements Regulatory workshop will take place at the PAGB offices on Tuesday, 18 March, from 10:00 AM to 4:00 PM. PAGB Food Supplements Regulatory Workshop
Updated MHRA Guidance on Exceptions and Modifications to EU Good Pharmacovigilance Practices for UK MAHs and MHRA MHRA has detailed the changes made to the guidance which clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) on 1 January 2025. Updated MHRA Guidance on Exceptions and Modifications to EU Good Pharmacovigilance Practices for UK MAHs and MHRA
European Medicines Agencies Network Strategy to 2028 – Webinar The presentations and recording of the webinar on the European Medicines Agencies Network Strategy (EMANS) to 2028 have been published. European Medicines Agencies Network Strategy to 2028 – Webinar
AESGP Hearing with EMA HMPC September 2024 – Report The report of the AESGP hearing with the EMA Committee on Herbal Medicinal Products (HMPC) that took place on 25 September 2024 has been published. AESGP Hearing with EMA HMPC September 2024 – Report
Updated MHRA Guidance on Exceptions and Modifications to EU Good Pharmacovigilance Practices for UK MAHs and the MHRA The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the guidance that clarifies he expectations on the application of the EU guidance on good pharmacovigilance practices (GVP). Updated MHRA Guidance on Exceptions and Modifications to EU Good Pharmacovigilance Practices for UK MAHs and the MHRA