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How to use PharmaQC to access pharmaceutical suppliers, Quality Control (QC) pharmacists and Commercial Medicines Unit (CMU) buyers.
How to notify the MHRA that you are going to undertake a clinical investigation of a medical device.
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Information and recommendations for manufacturers on the preparation and presentation of a post-market surveillance report (PMSR).
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Transitional arrangements and timelines for acceptance of CE marked medical device in Great Britain.
Guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates.
The review of the safety of isotretinoin has concluded.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
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 on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme.
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 therapeut…
A 5-year deal setting out how community pharmacy will support delivery of the NHS Long Term Plan.
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Information on how to request assistance from the NSDR.
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product licence submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched …
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
MHRA's Improving Patient Information project aims to modernise how medicines product information is delivered, making it more accessible, trusted, and future-ready.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
A list of herbal ingredients that are banned or restricted for unlicensed medicines.
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