tag:www.gov.uk,2005:/search/guidance-and-regulation Guidance and regulation 2026-05-13T11:43:35+01:00 HM Government tag:www.gov.uk,2005:/guidance/medicines-pipeline-data 2026-05-13T11:43:35+01:00 Medicines Pipeline data Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA. tag:www.gov.uk,2005:/guidance/medicines-get-integrated-scientific-advice-from-the-mhra-and-nice 2026-04-14T11:07:42+01:00 Medicines: Get integrated scientific advice from the MHRA and NICE Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE). tag:www.gov.uk,2005:/government/publications/get-medicines-to-nhs-patients-earlier-via-the-mhra-nice-aligned-pathway 2026-04-09T14:54:19+01:00 Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner. tag:www.gov.uk,2005:/guidance/medicine-supply-management 2026-04-07T14:01:11+01:00 Medicine supply management An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages. tag:www.gov.uk,2005:/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk 2026-04-01T14:45:10+01:00 Apply for a licence to market a medicine in the UK An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees. tag:www.gov.uk,2005:/government/publications/get-more-help-to-apply-for-medicines-integrated-scientific-advice-isa 2026-03-16T16:00:29+00:00 Get more help to apply for medicines Integrated Scientific Advice (ISA) Extra information for the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) Integrated Scientific Advice (ISA) service. tag:www.gov.uk,2005:/guidance/medicines-get-scientific-advice-from-mhra 2026-03-04T17:00:53+00:00 Medicines: get scientific advice from the MHRA A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved. tag:www.gov.uk,2005:/government/publications/early-access-to-medicines-scheme-overview 2026-03-02T17:08:35+00:00 Early Access to Medicines Scheme: Overview The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut… tag:www.gov.uk,2005:/government/publications/category-lists-following-implementation-of-the-windsor-framework 2026-03-02T13:40:47+00:00 Category lists following implementation of the Windsor Framework A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework. tag:www.gov.uk,2005:/guidance/mhra-portal-register-to-submit-forms 2026-03-02T10:19:54+00:00 MHRA Portal: register to submit forms How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications. tag:www.gov.uk,2005:/guidance/medicines-reclassify-your-product 2026-02-27T17:09:33+00:00 Medicines: reclassify your product Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification. tag:www.gov.uk,2005:/guidance/medicines-marketing-authorisation-holders-submission-of-nitrosamine-risk-evaluation 2026-02-25T14:31:29+00:00 Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present. tag:www.gov.uk,2005:/government/publications/updates-to-cir-5202012-information-for-uk-marketing-authorisation-holders 2026-02-09T17:06:00+00:00 Updates to CIR 520/2012 – Information for UK Marketing Authorisation Holders This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products. tag:www.gov.uk,2005:/guidance/orphan-medicinal-products-in-great-britain 2026-02-06T15:45:36+00:00 Orphan medicinal products The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application. tag:www.gov.uk,2005:/guidance/access-new-active-substance-nas-work-sharing-initiative 2026-01-30T16:28:07+00:00 Access, new active substance and biosimilar work sharing initiatives Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products. tag:www.gov.uk,2005:/guidance/medicines-apply-for-a-variation-to-your-marketing-authorisation 2026-01-26T16:49:20+00:00 Medicines: apply for a variation to your marketing authorisation Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions. tag:www.gov.uk,2005:/government/publications/medical-devices-uk-approved-bodies 2025-12-18T16:33:57+00:00 Medical devices: list of UK approved bodies Details of the organisations that are currently approved to undertake conformity assessments on medical devices. tag:www.gov.uk,2005:/guidance/variations-to-marketing-authorisations-mas 2025-10-16T17:11:34+01:00 Variations to marketing authorisations (MAs) How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland. tag:www.gov.uk,2005:/guidance/medicines-marketing-authorisation-transfer-ownership 2025-10-02T16:28:26+01:00 Medicines marketing authorisation: change of ownership How to change the ownership from one marketing authorisation (MA) holder to another. tag:www.gov.uk,2005:/guidance/medicines-apply-for-a-parallel-import-licence 2025-09-02T15:19:07+01:00 Medicines: apply for a parallel import licence How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.