tag:www.gov.uk,2005:/search/guidance-and-regulation Guidance and regulation 2025-06-17T11:59:37+01:00 HM Government tag:www.gov.uk,2005:/guidance/medicines-get-scientific-advice-from-mhra 2025-06-17T11:59:37+01:00 Medicines: get scientific advice from MHRA A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved. tag:www.gov.uk,2005:/government/publications/vietnam-mental-health-support-abroad 2025-06-17T04:47:50+01:00 Vietnam: mental health support abroad Information for British nationals with mental health issues in Vietnam, including how the British embassy can help. tag:www.gov.uk,2005:/guidance/electronic-common-technical-document-ectd-submissions-update 2025-06-17T00:00:00+01:00 Electronic Common Technical Document (eCTD) submissions update Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched … tag:www.gov.uk,2005:/government/publications/changes-to-the-childhood-vaccination-programme-why-are-they-happening 2025-06-16T12:30:04+01:00 Changes to the childhood vaccination programme: why are they happening This flyer explains the changes to the childhood vaccination programmes from 1 July 2025 to parents of eligible children. tag:www.gov.uk,2005:/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices 2025-06-16T10:00:01+01:00 Field safety notices: guidance for manufacturers How to write clear and effective field safety notices (FSNs) for medical devices. tag:www.gov.uk,2005:/guidance/device-specific-vigilance-guidance-cardiac-implantable-electronic-devices-cieds 2025-06-16T10:00:01+01:00 Device specific vigilance guidance: Cardiac Implantable Electronic Devices (CIEDs) Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable. tag:www.gov.uk,2005:/guidance/device-specific-vigilance-guidance-artificial-heart-valves 2025-06-16T10:00:01+01:00 Device specific vigilance guidance: Artificial Heart Valves Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable. tag:www.gov.uk,2005:/government/publications/field-safety-notice-fsn-what-it-is-and-why-its-important 2025-06-16T10:00:01+01:00 Field safety notice (FSN): what it is and why it's important A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action. tag:www.gov.uk,2005:/guidance/device-specific-vigilance-guidance-inferior-vena-cava-ivc-filters 2025-06-16T10:00:01+01:00 Device specific vigilance guidance: Inferior vena cava (IVC) filters Guidance for manufacturers of IVC filters. It outlines specific scenarios that should be considered when determining if an incident is reportable. tag:www.gov.uk,2005:/government/publications/medical-devices-post-market-surveillance-requirements 2025-06-16T10:00:01+01:00 Medical devices: post-market surveillance requirements How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain. tag:www.gov.uk,2005:/government/publications/medical-devices-examples-of-reportable-incidents 2025-06-16T10:00:01+01:00 Medical devices: examples of reportable incidents Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK. tag:www.gov.uk,2005:/government/publications/custom-made-medical-devices 2025-06-16T10:00:01+01:00 Custom-made medical devices in Great Britain How to comply with the regulatory requirements for manufacturing custom-made medical devices. tag:www.gov.uk,2005:/government/publications/medical-devices-periodic-safety-update-report-psur 2025-06-16T10:00:01+01:00 Medical devices: periodic safety update report Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR). tag:www.gov.uk,2005:/guidance/device-specific-vigilance-guidance-coronary-stents-and-associated-delivery-systems 2025-06-16T10:00:01+01:00 Device specific vigilance guidance: Coronary Stents and associated delivery systems Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable. tag:www.gov.uk,2005:/government/publications/rotavirus-vaccine-rotarix-patient-group-direction-pgd-template 2025-06-16T09:36:45+01:00 Rotavirus vaccine (Rotarix®): patient group direction (PGD) template Patient group direction template to support the national rotavirus (Rotarix®) vaccination programme for infants. tag:www.gov.uk,2005:/government/publications/reciprocal-healthcare-privacy-notice 2025-06-16T08:57:34+01:00 Reciprocal healthcare privacy notice Sets out how DHSC and NHSBSA collect and use personal information as part of the process of providing reciprocal healthcare. tag:www.gov.uk,2005:/government/publications/medicines-eligible-for-northern-ireland-mhra-authorised-route 2025-06-13T16:26:39+01:00 Medicines eligible for Northern Ireland MHRA Authorised Route Sets out medicines that can be moved to Northern Ireland to meet patient need. tag:www.gov.uk,2005:/government/publications/hepatitis-b-antenatal-screening-and-selective-neonatal-immunisation-pathway 2025-06-13T12:02:13+01:00 Hepatitis B: antenatal screening and selective neonatal immunisation pathway Guidance on the delivery of antenatal screening and selective neonatal immunisation services for pregnant women living with hepatitis B and their babies. tag:www.gov.uk,2005:/government/publications/pneumococcal-the-green-book-chapter-25 2025-06-13T09:53:36+01:00 Pneumococcal: the green book, chapter 25 Pneumococcal immunisation information for public health professionals. tag:www.gov.uk,2005:/government/publications/introduction-of-new-routine-mpox-and-4cmenb-for-gonorrhoea-vaccination-programmes-letter 2025-06-13T09:30:10+01:00 Introduction of new routine mpox and 4CMenB for gonorrhoea vaccination programmes letter Information about the new routine mpox and 4CMenB for gonorrhoea vaccination programmes.