tag:www.gov.uk,2005:/search/guidance-and-regulationGuidance and regulation2025-04-25T09:50:10+01:00HM Governmenttag:www.gov.uk,2005:/government/publications/medical-devices-uk-approved-bodies2025-04-25T09:50:10+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/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:/guidance/supplying-authorised-medicines-to-northern-ireland2025-03-20T14:58:07+00:00Supplying 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/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.tag:www.gov.uk,2005:/guidance/reference-medicinal-products-rmps2025-03-11T11:59:25+00:00Reference medicinal products (RMPs)There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.tag:www.gov.uk,2005:/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-authorisations-and-national-scientific-advice2025-03-11T11:46:34+00:00Conditional marketing authorisations, exceptional circumstances MAs, scientific adviceGuidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.tag:www.gov.uk,2005:/guidance/rolling-review-for-marketing-authorisation-applications2025-03-11T11:01:36+00:00Rolling review for marketing authorisation applicationsUse the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.tag:www.gov.uk,2005:/guidance/how-marketing-authorisation-applications-referred-under-article-29-are-handled2025-03-11T10:53:49+00:00Marketing authorisation applications referred under Article 29How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.tag:www.gov.uk,2005:/guidance/orphan-medicinal-products-in-great-britain2025-03-11T10:47:10+00:00Orphan medicinal productsThe MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.tag:www.gov.uk,2005:/guidance/advanced-therapy-medicinal-products-regulation-and-licensing2025-03-06T16:25:39+00:00Advanced therapy medicinal products: regulation and licensing in UKHow to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.tag:www.gov.uk,2005:/government/publications/format-and-content-of-applications-for-agreement-or-modification-of-a-paediatric-investigation-plan2025-02-28T12:57:13+00:00Format and content of applications for agreement or modification of a Paediatric Investigation PlanAlso covering requests for waivers or deferrals and concerning the operation of the compliance check.tag:www.gov.uk,2005:/guidance/licensing-plasma-master-files-and-vaccine-antigen-master-files2025-02-27T17:34:23+00:00Licensing plasma master files and vaccine antigen master filesApplying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).tag:www.gov.uk,2005:/guidance/medicines-reclassify-your-product2025-02-20T15:52:03+00:00Medicines: 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/access-new-active-substance-nas-work-sharing-initiative2025-02-18T17:33:54+00:00Access, 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.