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Information relating to parallel imports and the implementation of the Windsor Framework.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
The Medicines and Healthcare products Regulatory Agency (MHRA), working with law enforcement partners, seized more than 15.5 million doses of illegally traded medicines with a street value of more than £30 million during 202…
Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place. Ensure all women and girls (and their parent, caregiver, or responsible person, if n…
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Information for patients, public and health care professionals.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced the UK’s biggest seizure of smart drugs, also known as cognitive enhancers or nootropics.
List of Field Safety Notices from 26 February to 1 March 2024
Specific batches of carbomer gel are being recalled as a precaution due to possible microbiological contamination.
Carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. An…
We want to remind healthcare professionals that use of systemic (oral and injectable) NSAIDs such as ibuprofen, naproxen, and diclofenac is contraindicated in the last trimester of pregnancy (after 28 weeks of pregnancy).
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
Amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. We remind healthcare professionals that patients should be supervised and reviewe…
Do not prescribe etoricoxib to patients whose blood pressure is persistently above 140/90 mmHg and inadequately controlled.
Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers.
In view of reports of serious bleeding events in patients taking miconazole and warfarin, we are considering further measures to minimise the risk of potentially serious interactions between miconazole and warfarin.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
St John’s wort interacts with hormonal contraceptives reducing the effectiveness and increasing the risk of unplanned pregnancy.
Statin use may be associated with a level of hyperglycaemia in some patients where formal diabetes care is appropriate.
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