List of Field Safety Notice for 20 December 2024. The Medicines and Healthcare products Regulatory Agency (MHRA) has today (20 December 2024) granted a conditional marketing authorisation for the medicine givinostat (Duvyzat) to treat Duchenne muscular dystrophy (DMD). Marketing authorisations granted in 2024 Parallel import licences granted in 2024 Initial list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework. Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended. Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency. How to make a payment to MHRA by credit or debit card or a bank transfer. Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 20 September 2022 and 5 May 2023. Meeting minutes taken from meetings of the Vaccine Benefit Risk Expert Working Group (VBREWG) held between 13 April 2022 and 25 August 2022.GxP News
Field Safety Notices: 20 December 2024
Press release: Givinostat conditionally approved to treat patients with Duchenne muscular dystrophy (DMD)
Decision: Marketing authorisations granted in 2024
Decision: Parallel import licences granted in 2024
Standard: Category lists following implementation of the Windsor Framework
Decision: Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
Guidance: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines
Guidance: Make a payment to MHRA
Transparency data: Meeting minutes of the Vaccine Benefit Risk Expert Working Group from the Covid-19 Pandemic – 20 September 2022 to 5 May 2023
Transparency data: Meeting minutes of the Vaccine Benefit Risk Expert Working Group from the Covid-19 Pandemic – 13 April 2022 to 25 August 2022
