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Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Information about ensuring blood and blood component safety.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
How to join the phase I accreditation scheme.
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
Guidance on infant and follow-on formula, the application form for infant and follow-on formula made from protein hydrolysates, and forms to notify the authority.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
Guidelines to help mitigate and manage medicine shortages.
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.
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.
Approved countries for batch testing and importation of medicines
How the MHRA treats traditional herbal medicines and homeopathic medicines.
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