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How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How to change the ownership from one marketing authorisation (MA) holder to another.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
Information about how approved bodies help regulate medical devices and how to apply for approval.
How to renew marketing authorisations for products granted through different routes and at different times.
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�
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
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.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
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