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Guidance on the deadlines for initial and response submissions.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
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.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Guidance on clinical trials that are categorised as ‘notifiable’.
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.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How to write clear and effective field safety notices (FSNs) for medical devices.
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
This register contains all websites that are authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) to sell medicines online, in Northern Ireland.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
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