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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
Processes for marketing authorisations granted before 31 December 2020, or submitted or ongoing from 1 January 2021.
Collecting and acting on information on any adverse effects of electronic cigarette devices and refill containers on human health.
summary
Information for manufacturers and users of medical devices containing plastic with DEHP phthalates.
Information relating to the disapplication of falsified medicines under UK Law.
Information and advice on submitting a dermatological product to the Advisory Committee for Borderline Substances (ACBS).
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Instructions for integrating with the new production MORE platform API.
Our Patient Involvement Strategy sets out how we will engage and involve the public and patients at every step of the regulatory journey.
Protocol, questionnaire and quarterly return form for the enhanced surveillance of post-herpetic neuralgia (PHN), a complication of shingles.
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Update on MHRA UK risk-based GxP inspection programme.
Submission of notifications for Northern Ireland under article 20 of directive 2014/40/EU.
Due diligence for suppliers of e-cigarettes and e-liquids.
Information for patients who have been prescribed Paxlovid (nirmatrelvir 150mg and ritonavir 100mg) film-coated tablets COVID-19 antiviral medication.
For manufacturers reporting adverse incidents with intraocular lenses under the vigilance system.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing and access in 2022.
The process to convert Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs)
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