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How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
How to change the ownership from one marketing authorisation (MA) holder to another.
How to renew marketing authorisations for products granted through different routes and at different times.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
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.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Guidelines to help mitigate and manage medicine shortages.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
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.
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…
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
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