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MHRA invites current and former suppliers to join Risk Ledger and complete a security profile to strengthen supply chain cyber security.
Guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs).
A practical guide to using medical devices in a range of healthcare settings.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
How to carry out the biological safety evaluation, which is required before undertaking a clinical investigation for a medical device.
Further explanatory guidance for Diagnostic Radiopharmaceutical (RP) Investigation Medicinal Products (IMPs) and Good Manufacturing Practice (GMP) requirements.
On this page the Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
Industry must notify the MHRA if they will not be using these flexibilities
The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
Video series explaining the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Sets out the process for pharmaceutical companies to appeal against decisions made by the Secretary of State for Health and Social Care.
Advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Guiding principles for the use of predetermined change control plans (PCCPs) for managing rapid product changes in medical devices.
Information for pharmaceutical wholesalers explaining the main changes the Windsor Framework introduces to the packaging for all medicines licensed in the UK, effective from 1 January 2025.
Guidance and advice for community pharmacies in England providing services to people who use drugs and alcohol.
summary
Resources for pharmacies to achieve Healthy Living Pharmacy (HLP) Level 1 status.
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