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The review of the safety of isotretinoin has concluded.
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
Common user charge rates and how the charge applies to imports entering Great Britain through the Port of Dover and Eurotunnel.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Check the tariff classification for peptide nisin standardised with sodium chloride
The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
The MHRA will introduce a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
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
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Urgent safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
Details of the VMD Corporate Priorities for 2023 – 2024.
This amended guidance was issued under s 182 of the Licensing Act 2003.
Resources to support Antibiotic Guardian, the UK-wide campaign to improve and reduce antibiotic prescribing and use.
Apply for an authorisation to manufacture authorised veterinary medicines and medicines marketed under the Exemptions for Small Pet Animals.
Check the tariff classification for agarose beads chemically modified with 10% by weight of protein A.
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