tag:www.gov.uk,2005:/search/guidance-and-regulationGuidance and regulation2025-06-09T11:21:39+01:00HM 바카라 사이트tag: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:/guidance/access-new-active-substance-nas-work-sharing-initiative2025-06-06T15:16:25+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/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:/government/publications/medical-devices-uk-approved-bodies2025-05-23T19:10:20+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-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 therapeut바카라 사이트¦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.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.