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Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
An independent tribunal responsible for handling appeals against decisions made by the Secretary of State for Health and Social Care from pharmaceutical companies.
Guidance on Animal Test Certificates (ATCs) required to carry out the field trial of a veterinary medicine in animals (clinical trial) in the UK.
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.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
Find out about coronavirus (COVID-19) treatments available outside of hospital, including information on free prescriptions and lateral flow tests.
How to use a quasi-experimental study to evaluate your digital health product.
Check the tariff classification for a defined daily dose of active substances.
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)’
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
The way you apply to licence biological products has changed
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Development of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale
The characteristics, diagnosis, treatment, and epidemiology of group B streptococci.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
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