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An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Placing a veterinary medicine on the market, including non-medicinal products, medicinal words and phrases, how to obtain advice, report non-compliance.
Guidance for prescribing vets on the use of the cascade.
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.
Information on carrying medicine containing controlled drugs for individual travellers entering or leaving the UK.
How to comply with the exemption from the Veterinary Medicines Regulations that allow certain animal medicines to be sold without a marketing authorisation.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
From brussels sprouts to dodgy diet products, these tips from the MHRA will help you stay safe during the festive season and beyond
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 2023.
Guidance on naming human medicines, including Braille requirements for the name on the product label.
medac GmbH (t/a medac Pharma LLP) is recalling the product for the batch specified in this notification due to particles detected during long-term stability tests.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
Legal requirements and good practice guidance for SQP retailers’ premises inspections.
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
Guidance for industry on flexible approaches we are taking on good distribution practices.
Information on granted EAMS scientific opinions, including the public assessment report and treatment protocols.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
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