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Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Fees payable to the MHRA for 2023 to 2024
The Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring…
Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.
In light of the most recent evidence, the previous advice on the concomitant use of clopidogrel with proton pump inhibitors has now been modified. Use of either omeprazole or esomeprazole with clopidogrel should be discourag…
Further measures to be introduced to ensure patients who are prescribed montelukast for the treatment of asthma are informed of the risk of neuropsychiatric reactions
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
Globally, there has been a very small number of reports of new-onset or aggravation of pre-existing myasthenia gravis with atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin and pitavastatin (singl…
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 microgram auto-injectors (also referred to as pens) from patients due to an error in one com…
Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …
Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are a…
Progestogen-only contraceptive pills will be available for the first time from pharmacies without prescription, increasing choice for women in the ways in which they can access contraception.
How to prepare for implementation and compliance of the Safety Features Regulation.
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study befor…
Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta XL 18mg and 36mg prolonged release tablets mentioned in th…
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
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