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Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Fees payable to the MHRA from 2025.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Guidance on using non-investigational medicinal products in a clinical trial.
How to write clear and effective field safety notices (FSNs) for medical devices.
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.
Detailed guidance on advertising and promoting medicines.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
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.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
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.
Don’t include personal or financial information like your National Insurance number or credit card details.
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