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How to change the ownership from one marketing authorisation (MA) holder to another.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
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 get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
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
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.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Guidelines to help mitigate and manage medicine shortages.
How to apply for marketing authorisation via this new procedure.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Guidance on what approved bodies are, what they do and how you can become one.
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