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Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Guidance for industry on flexible approaches we are taking on good distribution practices.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Guidance on how Pharmacy First will help pharmacies support their communities, with information on the new clinical pathways and fee structure.
VDEC responds strategically to AMR pathogens and new emerging threats (fungi, viruses, and bacteria), by determining the most appropriate research goals to combat these pathogens
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
The Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
Helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living.
Guidance for healthcare establishments that manufacture medical devices in-house.
Information for manufacturers of software as a medical device, detailing events that may cause indirect harm and are therefore reportable.
What 'single-use' means and what symbol is used by manufacturers to show this.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing, access and growth in 2025.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
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