The Commission on Human Medicines (CHM) has endorsed changes to isotretinoin prescribing guidance. In addition, CHM is seeking further information from dermatology services who prescribe isotretinoin to inform any future changes to current risk minimisation measures.
Similar Posts
Class 3 Medicines Recall: Norgine Limited, MOVICOL Ease Citrus Powder for oral solution 13.7 g, EL(26)A/08
Norgine Limited is recalling one batch of product as a precautionary measure due to some units containing low amounts of active ingredients.
Guidance: International Recognition Procedure
How to use the procedure for medicines licensing applications.
Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution, Glenmark Pharmaceuticals Europe Ltd, EL(25)A/30
Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles.
Statutory guidance: MHRA fees
Fees payable to the MHRA from 2025.
Electronic Common Technical Document (eCTD) submissions update
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.
From Brussels sprouts to mobility scooters: five tips from the MHRA for staying safe and well over the festive period
The MHRA has five top tips to help you stay well through the festive season and beyond
