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Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
The actions to take for sourcing medicines in different circumstances.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Importing investigational medicinal products for use in clinical trials
Information about ensuring blood and blood component safety.
How to join the phase I accreditation scheme.
Submission dates and how the submissions using the EC decision reliance procedure work.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
Register as a manufacturer, importer or distributor of active substances.
Order a certificate of free sale to export medical devices outside the UK.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
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