tag:www.gov.uk,2005:/government/organisations/medicines-and-healthcare-products-regulatory-agency HM Government 2025-05-16T15:58:34Z /government/news/mhra-approves-guselkumab-for-crohns-disease-and-ulcerative-colitis#2025-05-16T15:58:34Z 2025-05-16T15:58:34Z

As with all products, we will keep its safety under close review

/government/publications/rules-for-the-sale-supply-and-administration-of-medicines#2025-05-16T15:40:38Z 2025-05-16T15:40:38Z

Exception to the general rule for which healthcare professionals can sell, supply, and/ or administer medicines to patients also known as exemptions.

/guidance/medicines-reclassify-your-product#2025-05-16T11:17:18Z 2025-05-16T11:17:18Z

Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.

/government/publications/more-implementation#2025-05-16T11:08:55Z 2025-05-16T11:08:55Z

Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

/guidance/manufacturers-online-reporting-environment-more#2025-05-16T11:08:54Z 2025-05-16T11:08:54Z

A a digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.

/government/news/mhra-approves-vaccine-to-protect-against-pneumococcal-infections-such-as-pneumonia-and-meningitis#2025-05-15T16:11:51Z 2025-05-15T16:11:51Z

As with all products, the MHRA will keep its safety under close review.

/drug-safety-update/thiopurines-and-intrahepatic-cholestasis-of-pregnancy#2025-05-15T10:30:20Z 2025-05-15T10:30:20Z

Intrahepatic cholestasis of pregnancy (ICP) has been rarely reported in patients treated with azathioprine products and is believed to be a risk applicable to all drugs in the thiopurine class (azathioprine, mercaptopurine and tioguanine). Cholestasis of pregnancy associated with thiopurines tends to occur earlier in pregnancy than non drug-induced cholestasis of pregnancy, and elevated bile acid levels may not reduce with ursodeoxycholic acid.

/guidance/register-a-homeopathic-medicine-or-remedy#2025-05-14T16:09:31Z 2025-05-14T16:09:31Z

Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme

/government/publications/advertising-investigations-april-2025#2025-05-14T13:53:59Z 2025-05-14T13:53:59Z

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic#2025-05-14T07:55:23Z 2025-05-14T07:55:23Z

List of manufacturers and their medical devices granted an exemption by MHRA. 皇冠体育app list also includes manufacturers whose exemption expired or was cancelled.

/drug-device-alerts/field-safety-notices-5-to-8-may-2025#2025-05-14T07:47:13Z 2025-05-14T07:47:13Z

List of Field Safety Notices from 5 to 9 May 2025.

/government/publications/orphan-registered-medicinal-products#2025-05-13T11:26:11Z 2025-05-13T11:26:11Z

A list of authorised orphan medicinal products registered by the UK licensing authority.

/drug-device-alerts/class-4-medicines-notification-chemidex-pharma-ltd-various-products-el-25-a-slash-21#2025-05-13T10:00:04Z 2025-05-13T10:00:04Z

Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances.

/government/publications/parallel-import-licences-granted-in-2025#2025-05-13T08:50:33Z 2025-05-13T08:50:33Z

Parallel import licences granted in 2025.

/government/publications/international-recognition-procedure#2025-05-13T08:37:02Z 2025-05-13T08:37:02Z

How to use the procedure for medicines licensing applications.

/government/publications/marketing-authorisations-granted-in-2025#2025-05-13T08:36:22Z 2025-05-13T08:36:22Z

Marketing authorisations granted in 2025.

/government/news/meet-the-women-helping-ensure-that-digital-mental-health-technologies-are-safe-effective-and-developed-considering-the-needs-of-the-people-who-use-th#2025-05-12T23:00:00Z 2025-05-12T23:00:00Z

Mental health apps are everywhere, offering everything from mood tracking to therapy. But with so many options, how can people tell what these tools actually do?

/government/news/mhra-approves-first-uk-treatment-for-congenital-thrombotic-thrombocytopenic-purpura-cttp#2025-05-12T16:41:15Z 2025-05-12T16:41:15Z

As with all products, the MHRA will keep its safety under close review.

/guidance/medicines-apply-for-a-parallel-import-licence#2025-05-12T15:22:24Z 2025-05-12T15:22:24Z

How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.

/government/consultations/consultation-on-the-international-council-for-harmonisation-ich-e6-r3-guideline-for-good-clinical-practice-annex-2#2025-05-12T13:25:48Z 2025-05-12T13:25:48Z

皇冠体育app ICH Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) GCP guideline. 皇冠体育app MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG.