tag:www.gov.uk,2005:/government/organisations/medicines-and-healthcare-products-regulatory-agency HM Government 2025-04-02T13:01:02Z /drug-device-alerts/class-3-medicines-recall-urospir-50mg-slash-5ml-oral-solution-el-25-a-slash-14#2025-04-02T13:01:02Z 2025-04-02T13:01:02Z

Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being stated incorrectly in the SmPC and PIL.

/guidance/medical-devices-information-for-users-and-patients#2025-04-02T08:23:07Z 2025-04-02T08:23:07Z

Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.

/government/publications/human-medicines-register-of-electronic-export-certificates#2025-04-02T08:09:42Z 2025-04-02T08:09:42Z

Department of Health and Social Care and MHRA register of electronic export certificates (human).

/government/publications/suspended-licences-for-manufacturers-and-wholesalers-of-medicines#2025-04-01T10:14:53Z 2025-04-01T10:14:53Z

Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.

/drug-device-alerts/field-safety-notices-24-to-28-march-2025#2025-04-01T10:08:20Z 2025-04-01T10:08:20Z

List of Field Safety Notices from 24 to 28 March 2025.

/drug-device-alerts/class-2-medicines-recall-utrogestan-vaginal-200-mg-capsules-progesterone-el-25-a-slash-13#2025-04-01T09:58:54Z 2025-04-01T09:58:54Z

Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms� where it should actually state ‘milligrams�.

/government/news/mhra-showcases-next-phase-of-regulatory-science-to-bring-innovative-treatments-to-patients-sooner#2025-04-01T08:14:29Z 2025-04-01T08:14:29Z

Seven new CERSIs came together to showcase how partnerships will modernise regulation in AI, clinical trials, and advanced therapies, bringing innovations to patients sooner.

/guidance/register-for-the-distance-selling-logo#2025-04-01T08:14:15Z 2025-04-01T08:14:15Z

Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.

/guidance/established-medicines-marketing-authorisation-application-process-changes#2025-04-01T08:14:11Z 2025-04-01T08:14:11Z

Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.

/guidance/guidance-on-the-handling-of-applications-for-centrally-authorised-products-caps#2025-04-01T08:14:02Z 2025-04-01T08:14:02Z

This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.

/guidance/export-drugs-and-medicines-special-rules#2025-04-01T08:13:43Z 2025-04-01T08:13:43Z

You must get permission to export certain drugs and medicines.

/guidance/periodic-benefit-risk-evaluation-reports-for-medicinal-products#2025-04-01T08:13:38Z 2025-04-01T08:13:38Z

How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)

/government/publications/early-access-to-medicines-scheme-overview#2025-04-01T08:13:33Z 2025-04-01T08:13:33Z

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 therapeutics.

/guidance/medicines-register-to-manufacture-import-or-distributor-active-substances#2025-04-01T08:13:28Z 2025-04-01T08:13:28Z

How to register as a manufacturer, importer or distributor of active substances.

/guidance/apply-for-the-early-access-to-medicines-scheme-eams#2025-04-01T08:13:24Z 2025-04-01T08:13:24Z

Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.

/guidance/medicines-register-as-a-broker#2025-04-01T08:13:20Z 2025-04-01T08:13:20Z

Apply for and maintain registrations for the brokering of human medicines.

/government/publications/mhra-fees#2025-04-01T08:11:59Z 2025-04-01T08:11:59Z

Fees payable to the MHRA from 2025.

/government/news/lawrence-tallon-begins-role-as-new-mhra-ceo#2025-04-01T08:03:09Z 2025-04-01T08:03:09Z

Lawrence Tallon today (1 April 2025) begins his role as Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency (MHRA).

/guidance/exceptional-use-authorisation#2025-03-31T14:50:35Z 2025-03-31T14:50:35Z

How to apply for an exceptional use authorisation to place medical devices on the UK market.

/drug-device-alerts/class-4-medicines-defect-notification-sirdupla-25-microgram-slash-250-microgram-per-metered-dose-pressurised-inhalation-suspension-el-25-a-slash-12#2025-03-31T10:04:37Z 2025-03-31T10:04:37Z

Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, batch 77518.