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Information relating to parallel imports and the implementation of the Windsor Framework.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
Find out about coronavirus (COVID-19) treatments available outside of hospital, including information on free prescriptions and lateral flow tests.
How to apply for marketing authorisation via this new procedure.
How to renew marketing authorisations for products granted through different routes and at different times.
The actions to take for sourcing medicines in different circumstances.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
A 5-year deal setting out how community pharmacy will support delivery of the NHS Long Term Plan.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
How to join the phase I accreditation scheme.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Information for clinicians and patients.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
This publication supports local authority health and wellbeing boards to develop and update pharmaceutical needs assessments (PNAs).
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.
Guidance on what approved bodies are, what they do and how you can become one.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
Information for patients, healthcare professionals and developers of new medicines
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