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Employment Appeal Tribunal Judgment of Mrs Justice Eady on 3 May 2024.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Information on designs hearings including costs and how to appeal against an outcome.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance to support the command and control in the future project.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Protocols and procedures for testing the value for cultivation or use (VCU) of agricultural crops.
Information about opinions requests we have received this year
The Coronation Roll is the official record of the Monarch’s accession and crowning.
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 and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
To protect your patent outside of the UK, you usually need to apply in each country you want protection in.
Field inspection reports for the Genetic Modification Inspectorate deliberate release inspection programme in England.
The process for the simultaneous review of veterinary medicine submissions by Switzerland’s Swissmedic and the UK's Veterinary Medicines Directorate.
Apply for a licence for a bovine semen collection centre and get approval to use bovine animals and boars for artificial breeding and semen trade.
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
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.
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