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Information for health professionals on the epidemiology, transmission and prevention of Chlamydia abortus which can cause stillbirth or abortion in humans.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance for people with symptoms of a respiratory infection including COVID-19, or a positive test result for COVID-19.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
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