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Consultations and strategy
Data, Freedom of Information releases and corporate reports
Guidance for healthcare and social services organisations on managing medical devices in practice.
Information for patients, healthcare professionals and developers of new medicines
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance to help applicants and licence holders get and maintain a manufacturer licence - MHRA guidance note 5.
Information for clinicians and patients.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Relevant safety information for users of magnetic resonance imaging (MRI) equipment in clinical use.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
Comply with good pharmacovigilance practice and prepare for an inspection.
How to renew marketing authorisations for products granted through different routes and at different times.
How to apply for marketing authorisation via this new procedure.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
Links to EU guidance, as it stood immediately before end of transition period.
The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
Information relating to parallel imports and the implementation of the Windsor Framework.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Information for patients, public and health care professionals.
The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK.
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