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Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Find out how to prove the originating status of your goods and check if you can claim preferential tariff treatment.
How to self-upload evidence when making an application to come to or stay in the UK.
How to make an origin declaration if you're using it as proof of origin for products using the Developing Countries Trading Scheme.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Submission dates and how the submissions using the EC decision reliance procedure work.
Explains your rights over your data and how the regulator processes and protects your personal information in line with data protection legislation.
A suite of template legal documents to support the development of mutuals.
Supplier declarations are where your UK supplier provides you with information needed to prove the origin of your goods for preferential rates of duty between the UK and other countries.
How to change the ownership from one marketing authorisation (MA) holder to another.
Learn how to publish accessible documents to meet the needs of all users under the accessibility regulations.
The Planning Inspectorate appeals casework portal - Troubleshooting
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How UK nationals who plan to live in Spain for more than 3 months must register as a resident and on the padrón at their town hall.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Pharmacovigilance system requirements
Find out how to import your personal belongings, pets and private motor vehicles when moving or returning to the UK.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Don’t include personal or financial information like your National Insurance number or credit card details.
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