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News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.
How veterinary medicines can be advertised.
Information and documents on Public Health England’s review of the evidence for dependence on, and withdrawal from, prescribed medicines.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Information on clinical trials for medicines, how to apply for authorisation in the UK, how to manage your authorisation, reporting safety issues and details about the MHRA phase I accreditation scheme.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
The actions to take for sourcing medicines in different circumstances.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Apply for an authorisation to manufacture authorised veterinary medicines and medicines marketed under the Exemptions for Small Pet Animals.
Information on herbal medicines, how to apply for a traditional herbal registration (THR), banned or restricted herbal ingredients, homeopathic medicines and fees.
You must get permission to export certain drugs and medicines.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
Links to EU guidance, as it stood immediately before end of transition period.
Information on carrying medicine containing controlled drugs for individual travellers entering or leaving the UK.
The medicines regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the continued need for COVID-19 medicines that are safe, effective and of high quality
Guidance for prescribing vets on the use of the cascade.
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