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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.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
This guidance demonstrates stakeholders, including the government, working together to address supply issues.
As a vet or pharmacist, you must follow legal requirements when working with controlled drugs in veterinary medicine.
Keep up to date with the latest information from the UK GLP monitoring authority.
How to use a micro-randomised trial to evaluate your digital health product.
Legal requirements and good practice guidance for Veterinary Practice Premises Inspections.
How an innovative funding mechanism is saving lives by speeding up the availability of vaccines and making them affordable.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Provides guidance on making effective use of land, including planning for higher density development.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer which has one or...
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Don’t include personal or financial information like your National Insurance number or credit card details.
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