tag:www.gov.uk,2005:/search/guidance-and-regulationGuidance and regulation2026-05-06T13:59:29+01:00HM Governmenttag:www.gov.uk,2005:/guidance/export-drugs-and-medicines-special-rules2026-05-06T13:59:29+01:00Export drugs and medicines: special rulesYou must get permission to export certain drugs and medicines.tag:www.gov.uk,2005:/government/publications/medicines-eligible-for-northern-ireland-mhra-authorised-route2026-04-27T11:43:11+01:00Medicines eligible for Northern Ireland MHRA Authorised RouteSets out medicines that can be moved to Northern Ireland to meet patient need.tag:www.gov.uk,2005:/guidance/medicine-supply-management2026-04-07T14:01:11+01:00Medicine supply managementAn overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.tag:www.gov.uk,2005:/government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk2026-03-25T17:56:30+00:00Medicines that you cannot export from the UK or hoardSets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.tag:www.gov.uk,2005:/guidance/medicines-reclassify-your-product2026-02-27T17:09:33+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:/government/publications/a-guide-to-defective-medicinal-products2026-02-16T10:00:04+00:00A guide to defective medicinal productsReporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).tag:www.gov.uk,2005:/government/publications/health-institution-exemption-for-general-medical-devices2026-01-20T13:10:32+00:00Health Institution Exemption for general medical devicesGuidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE). tag:www.gov.uk,2005:/government/publications/medical-devices-uk-approved-bodies2025-12-18T16:33:57+00:00Medical 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/apply-for-manufacturer-or-wholesaler-of-medicines-licences2025-09-12T13:03:53+01:00Apply for manufacturer or wholesaler of medicines licencesHow to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines. tag:www.gov.uk,2005:/government/publications/human-medicines-modular-manufacture-and-point-of-care-regulations-2025-overview2025-06-10T13:57:00+01:00Human medicines Modular Manufacture and Point of Care 2025Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 regulations.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/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/uk-parallel-import-licences-following-agreement-of-the-windsor-framework2025-06-03T14:52:44+01:00UK parallel import licences following agreement of the Windsor FrameworkInformation relating to parallel imports and the implementation of the Windsor Framework.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/medicines-register-to-manufacture-import-or-distributor-active-substances2025-04-01T09:13:28+01:00Medicines: register to manufacture, import or distribute active substancesHow to register as a manufacturer, importer or distributor of active substances.tag:www.gov.uk,2005:/guidance/medicines-register-as-a-broker2025-04-01T09:13:20+01:00Medicines: register as a brokerApply for and maintain registrations for the brokering of human medicines.tag:www.gov.uk,2005:/government/publications/wholesalers-manufacturers-guidance-following-agreement-of-the-windsor-framework2025-03-11T10:03:49+00:00Wholesalers & manufacturers guidance following agreement of the Windsor FrameworkActions QPs, RPis and RPs need to take following agreement of the Windsor Frameworktag:www.gov.uk,2005:/government/publications/importing-investigational-medicinal-products-into-great-britain-from-approved-countries2025-02-12T15:51:21+00:00Importing investigational medicinal products into Great Britain from approved countriesOutlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.tag:www.gov.uk,2005:/guidance/import-a-human-medicine2025-01-29T09:01:44+00:00Import a human medicineGuidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.tag:www.gov.uk,2005:/guidance/guidance-on-mah-and-qppv-location2025-01-08T16:31:09+00:00Guidance on MAH and QPPV locationThe locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)