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How to change the ownership from one marketing authorisation (MA) holder to another.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
How to renew marketing authorisations for products granted through different routes and at different times.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Guidelines to help mitigate and manage medicine shortages.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Information about how approved bodies help regulate medical devices and how to apply for approval.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut鈥�
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
How to apply for marketing authorisation via this new procedure.
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