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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.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
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
How to change the ownership from one marketing authorisation (MA) holder to another.
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.
Submission dates and how the submissions using the EC decision reliance procedure work.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
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.
Information about how approved bodies help regulate medical devices and how to apply for approval.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
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.
How to renew marketing authorisations for products granted through different routes and at different times.
Guidelines to help mitigate and manage medicine shortages.
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