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Data, Freedom of Information releases and corporate reports
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.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
A suite of template legal documents to support the development of mutuals.
Submission dates and how the submissions using the EC decision reliance procedure work.
Guidance for those conducting research and development on genetic resources.
What to do if you think you've spotted a scam pretending to be from Companies House, and examples of scam emails, letters and telephone calls.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Investors and businesses may be legally required to tell the government about certain sensitive acquisitions under the National Security and Investment Act.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to make sure that your products are properly checked for conformity and your technical documents are managed correctly.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Documents, certificates, letters and notes available at British consulates in Turkey.
Follow this guidance to create forward-looking pipelines for the current versions of the commercial and digital and technology spend controls processes.
Use this form to complete a ‘statement of information’ to help the court decide whether the financial and property arrangements you’ve made are fair.
Pharmacovigilance system requirements
Guidance on certain consultation and publicity requirements of the Nationally Significant Infrastructure Project regime.
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