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Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Detailed guidance on advertising and promoting medicines.
How to make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
Guidance on the process for ending a clinical trial.
Guidance on the deadlines for initial and response submissions.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Guidance on transitional arrangements for the Clinical Trials Regulations.
A national programme to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
How to join the phase I accreditation scheme.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Fees payable to the MHRA from 2025.
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
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