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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
How investigators and sponsors should manage clinical trials during COVID-19
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
How to use a before-and-after study to evaluate your digital health product.
The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months
Get help to classify cigarettes, cigars, raw tobacco, smoking tobacco, tobacco for heating and nicotine substitutes for import and export.
Get help to classify organic chemicals that contain certain permitted additives or can be dissolved in water, for import and export.
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.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (7 March 2024) approved the medicine ganaxolone (Ztalmy) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).
How schools should setup a Microsoft Windows laptop or tablet before lending the device to a child, family or young person.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Foreign, Commonwealth & Development Office (FCDO) advice for lesbian, gay, bisexual and transgender (LGBT+) people travelling abroad.
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