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Guidance on using non-investigational medicinal products in a clinical trial.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
How manufacturers should undertake a clinical investigation for a medical device to ensure they comply with medical device regulations.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
How to notify the MHRA that you are going to undertake a clinical investigation of a medical device.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
Detailed guidance on advertising and promoting medicines.
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.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How to determine if you will need to undertake a clinical investigation of a medical device, or if it is exempt under the regulations.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
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