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Data, Freedom of Information releases and corporate reports
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How to use PharmaQC to access pharmaceutical suppliers, Quality Control (QC) pharmacists and Commercial Medicines Unit (CMU) buyers.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Recommendations for prescribing methadone and buprenorphine to people in treatment for opioid dependence in England.
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.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Resources for World Antimicrobial Resistance Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) for healthcare professionals in England.
Information about suspected side effects of e-cigarettes and how to report side effects.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
Patient factsheet to provide information on vaccines and vaccine safety.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Guiding principles for the use of predetermined change control plans (PCCPs) for managing rapid product changes in medical devices.
The MHRA has published advice for patients and healthcare professionals
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
This publication supports local authority health and wellbeing boards to develop and update pharmaceutical needs assessments (PNAs).
Information for manufacturers of software as a medical device, detailing events that may cause indirect harm and are therefore reportable.
A poster explaining the different symbols used on medical devices.
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