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Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Information for patients, healthcare professionals and developers of new medicines
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
Information and recommendations for manufacturers on the preparation and presentation of a post-market surveillance report (PMSR).
How to use PharmaQC to access pharmaceutical suppliers, Quality Control (QC) pharmacists and Commercial Medicines Unit (CMU) buyers.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Links to EU guidance, as it stood immediately before end of transition period.
Points to consider when using real-world data in clinical studies
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
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.
This publication clarifies which regulatory guidelines should be followed, and which apply, in the development of phage therapeutic products.
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