tag:www.gov.uk,2005:/search/guidance-and-regulationGuidance and regulation2025-07-17T09:54:37+01:00HM Governmenttag:www.gov.uk,2005:/guidance/medicines-marketing-authorisation-holders-submission-of-nitrosamine-risk-evaluation2025-07-17T09:54:37+01:00Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testingMarketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.tag:www.gov.uk,2005:/guidance/access-new-active-substance-nas-work-sharing-initiative2025-07-15T17:43:02+01:00Access, new active substance and biosimilar work sharing initiativesInformation 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:/government/publications/medical-devices-uk-approved-bodies2025-07-04T12:37:11+01:00Medical devices: list of UK approved bodiesDetails of the organisations that are currently approved to undertake conformity assessments on medical devices.tag:www.gov.uk,2005:/guidance/medicines-get-scientific-advice-from-mhra2025-07-03T10:36:58+01:00Medicines: get scientific advice from MHRAA 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/introducing-new-medicines-in-the-nhs-in-the-uk2025-06-23T09:45:43+01:00Introducing new medicines in the NHS in the UKA pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.tag:www.gov.uk,2005:/guidance/decentralised-manufacture-marketing-authorisation-application2025-06-10T13:57:21+01:00Decentralised Manufacture: Marketing Authorisation applicationGuidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.tag:www.gov.uk,2005:/guidance/supplying-authorised-medicines-to-northern-ireland2025-06-09T11:21:39+01:00Supplying authorised medicines to Northern IrelandWhat you need to do to supply authorised medicines from Great Britain to Northern Ireland.tag:www.gov.uk,2005:/government/publications/borderlines-with-medical-devices2025-06-09T09:35:08+01:00Borderline products: medical devices and other productsHow the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.tag:www.gov.uk,2005:/government/publications/disapplication-of-falsified-medicines-directive-safety-features-requirements-for-parallel-imports2025-06-03T14:54:12+01:00Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel ImportsInformation relating to the disapplication of falsified medicines under UK Law.tag:www.gov.uk,2005:/guidance/medicines-reclassify-your-product2025-05-16T12:17:18+01:00Medicines: reclassify your productPharmacy (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-apply-for-a-parallel-import-licence2025-05-12T16:22:24+01:00Medicines: apply for a parallel import licenceHow to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application. tag:www.gov.uk,2005:/government/publications/the-northern-ireland-mhra-authorised-route-nimar2025-05-09T11:14:01+01:00The Northern Ireland MHRA Authorised Route (NIMAR)The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022. tag:www.gov.uk,2005:/guidance/advertise-your-medicines2025-04-11T16:18:36+01:00Advertise your medicinesHow to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
tag:www.gov.uk,2005:/government/publications/early-access-to-medicines-scheme-overview2025-04-08T08:53:46+01:00Early Access to Medicines Scheme: OverviewThe 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:/guidance/guidance-on-the-handling-of-applications-for-centrally-authorised-products-caps2025-04-01T09:14:02+01:00Guidance on the handling of applications for Centrally Authorised Products (CAPs)This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.tag:www.gov.uk,2005:/guidance/periodic-benefit-risk-evaluation-reports-for-medicinal-products2025-04-01T09:13:38+01:00Periodic Safety Update Reports (PSURs) for medicinal productsHow to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)tag:www.gov.uk,2005:/guidance/apply-for-the-early-access-to-medicines-scheme-eams2025-04-01T09:13:24+01:00Early Access to Medicines Scheme - Information for ApplicantsGuidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.tag:www.gov.uk,2005:/government/publications/blue-guide-advertising-and-promoting-medicines2025-03-28T13:18:23+00:00Blue Guide: advertising and promoting medicinesDetailed guidance on advertising and promoting medicines. tag:www.gov.uk,2005:/government/publications/category-lists-following-implementation-of-the-windsor-framework2025-03-25T09:36:01+00:00Category lists following implementation of the Windsor FrameworkA 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:/government/publications/uk-wide-licensing-for-human-medicines2025-03-12T14:49:14+00:00UK-wide licensing for human medicinesInformation on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.