MHRA Newsletter Published – March 2024 The MHRA has published the latest edition of its industry newsletter. MHRA Newsletter Published – March 2024
Windsor Framework Q&A Publications The MHRA has published a new Q&A document to support the UK-wide licensing for human medicines guidance. Additionally, the Q&A document related to the labelling and packaging of medicinal products for human use following agreement of the Windsor Framework has been updated. Windsor Framework Q&A Publications
Nitrosamines – Updated Q&A Appendix 3 The European Medicines Agency (EMA) has published the Appendix 3 to Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. Nitrosamines – Updated Q&A Appendix 3
MHRA Guidance – Clinical trials for Medicines: Manage your Authorisation, Report Safety Issues MHRA has updated the guidance on clinical trials for medicines: manage your authorisation, report safety issues to include new Development Safety Update Reports (DSUR) guidance. MHRA Guidance – Clinical trials for Medicines: Manage your Authorisation, Report Safety Issues
PAGB OTC Medicines Pack Design Workshop The next PAGB OTC Medicines Pack Design Workshop is taking place in-person on 11 April. The workshop features a special guest from MHRA’s Product Information Quality Unit and will help you to find out what you need to know about pack design and labelling for OTC medicines. PAGB OTC Medicines Pack Design Workshop
MHRA Marketing Authorisations Granted 1 to 14 March 2024 MHRA granted five OTC licenses during 1 - 14 March 2024. MHRA Marketing Authorisations Granted 1 to 14 March 2024
RegulatoryConnect Portal Guidance MHRA’s new RegulatoryConnect portal and its first services are now available for customers to log in and use. RegulatoryConnect Portal Guidance
EU MDR/IVDR – Table Listing Language Requirements – First Revision The European Commission has published the first revision of its previously published overview tables for the EU MDR and IVDR listing the language requirements at national level for manufacturers concerning information and instructions accompanying the device. EU MDR/IVDR – Table Listing Language Requirements – First Revision
EMA Guideline on Environmental Risk Assessment for Medicinal Products EMA has published a guideline on the environmental risk assessment of medicinal products for human use. EMA Guideline on Environmental Risk Assessment for Medicinal Products
RegulatoryConnect Portal The MHRA’s new RegulatoryConnect portal and its first services will be available to customers from Monday 25 March 2024. RegulatoryConnect Portal
EMA Management Board – March 2024 Meeting Highlights The European Medicines Agency (EMA) has published the highlights of the EMA Management Board meeting that took place on 21 March 2024. EMA Management Board – March 2024 Meeting Highlights
UK ePI Task Force March 2024 Bulletin The UK ePI Task Force has provided an update on recent Task Force activity. UK ePI Task Force March 2024 Bulletin
