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The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
New Cosmetic Breast Augmentation Risk Awareness Tool for patients to use when considering cosmetic breast implant surgery.
A poster explaining the different symbols used on medical devices.
Overview of the different types of MHRA safety communications about medicines, medical devices and other healthcare products, including what they are and who they are aimed at, and information on decision-making around safet…
How to make sure your clinical investigation will meet the MHRA's requirements for medical devices.
Further explanatory guidance for Diagnostic Radiopharmaceutical (RP) Investigation Medicinal Products (IMPs) and Good Manufacturing Practice (GMP) requirements.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
How manufacturers can comply with the regulations when providing instructions for using medical devices in an electronic form.
How manufacturers in Northern Ireland should undertake a clinical investigation for medical devices to ensure they comply with EU medical device regulations.
Report on the service providing sterile, controlled environments for the preparation of injectable medicines into ready-to-administer formats for patients.
Guidance on how Pharmacy First will help pharmacies support their communities, with information on the new clinical pathways and fee structure.
The Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Information relating to the disapplication of falsified medicines under UK Law.
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
Guidance for local partnerships on how to review adult drug and alcohol related deaths and near-fatal overdoses to prevent future deaths.
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
How to carry out the biological safety evaluation, which is required before undertaking a clinical investigation for a medical device.
This report reviews data on patient doses and equipment trends in dental X-ray imaging procedures between 2014 and 2017.
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