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Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Information on trade sanctions, arms embargoes and trade restrictions, including trade controls, transit controls and restrictions on terrorist organisations.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
If you hold certain information, you should contact OFSI as soon as practicable.
Explains requirements of the Town and Country Planning (Environmental Impact Assessment) Regulations 2017.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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 Guide for Employers and Employees to the role of the Central Arbitration Committee (CAC) for these regulations
Read the Council Directive 2003/48/EC of 3 June 2003 on taxation of savings income in the form of interest payments.
The review of the safety of isotretinoin has concluded.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Find out what information accountable persons must provide to different individuals and organisations and when to transfer it.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Explains planning controls relating to the storage of hazardous substances in England and how to handle development proposals around hazardous establishments.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Using metadata to make it easier to catalogue, validate, reuse and share your data.
What operators need to do in terms of submitting plans for radioactive waste disposal following our exit from Euratom and requirements under Article 37.
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