tag:www.gov.uk,2005:/search/guidance-and-regulation Guidance and regulation 2025-06-10T13:57:21+01:00 HM 바카라 사이트 tag:www.gov.uk,2005:/guidance/decentralised-manufacture-marketing-authorisation-application 2025-06-10T13:57:21+01:00 Decentralised Manufacture: Marketing Authorisation application Guidance 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-ireland 2025-06-09T11:21:39+01:00 Supplying authorised medicines to Northern Ireland What you need to do to supply authorised medicines from Great Britain to Northern Ireland. tag:www.gov.uk,2005:/government/publications/borderlines-with-medical-devices 2025-06-09T09:35:08+01:00 Borderline products: medical devices and other products How 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-initiative 2025-06-06T15:16:25+01:00 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:/government/publications/disapplication-of-falsified-medicines-directive-safety-features-requirements-for-parallel-imports 2025-06-03T14:54:12+01:00 Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel Imports Information relating to the disapplication of falsified medicines under UK Law. tag:www.gov.uk,2005:/government/publications/medical-devices-uk-approved-bodies 2025-05-23T19:10:20+01:00 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/medicines-reclassify-your-product 2025-05-16T12:17:18+01:00 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-apply-for-a-parallel-import-licence 2025-05-12T16:22:24+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. tag:www.gov.uk,2005:/government/publications/the-northern-ireland-mhra-authorised-route-nimar 2025-05-09T11:14:01+01:00 The 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-medicines 2025-04-11T16:18:36+01:00 Advertise your medicines How 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-overview 2025-04-08T08:53:46+01:00 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 therapeut바카라 사이트¦ tag:www.gov.uk,2005:/guidance/guidance-on-the-handling-of-applications-for-centrally-authorised-products-caps 2025-04-01T09:14:02+01:00 Guidance 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-products 2025-04-01T09:13:38+01:00 Periodic Safety Update Reports (PSURs) for medicinal products How 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-eams 2025-04-01T09:13:24+01:00 Early Access to Medicines Scheme - Information for Applicants Guidance 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-medicines 2025-03-28T13:18:23+00:00 Blue Guide: advertising and promoting medicines Detailed guidance on advertising and promoting medicines. tag:www.gov.uk,2005:/government/publications/category-lists-following-implementation-of-the-windsor-framework 2025-03-25T09:36:01+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:/government/publications/uk-wide-licensing-for-human-medicines 2025-03-12T14:49:14+00:00 UK-wide licensing for human medicines Information 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-rmps 2025-03-11T11:59:25+00:00 Reference 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-advice 2025-03-11T11:46:34+00:00 Conditional marketing authorisations, exceptional circumstances MAs, scientific advice Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice. tag:www.gov.uk,2005:/guidance/rolling-review-for-marketing-authorisation-applications 2025-03-11T11:01:36+00:00 Rolling review for marketing authorisation applications Use 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.