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A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Guidance on the deadlines for initial and response submissions.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Guidance on the process for ending a clinical trial.
How to change the ownership from one marketing authorisation (MA) holder to another.
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Comply with good pharmacovigilance practice and prepare for an inspection.
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Points to consider when using real-world data in clinical studies
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
How to make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
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