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Detailed guidance, regulations and rules
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Data, Freedom of Information releases and corporate reports
How to prepare for implementation and compliance of the Safety Features Regulation.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
Details of certificates issued under the Special Import System for the top ten imported veterinary medicines 1 April - 30 June 2023.
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
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).
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.
You must get permission to export certain drugs and medicines.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm in size.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Covering thalidomide, lenalidomide, and pomalidomide: temporary guidance for pregnancy prevention arrangements for patients taking them during COVID-19
Industry must notify the MHRA if they will not be using these flexibilities
Check the tariff classification for peptide nisin standardised with sodium chloride
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
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