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You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
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 comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Submission dates and how the submissions using the EC decision reliance procedure work.
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.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Guidelines to help mitigate and manage medicine shortages.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
How to apply for marketing authorisation via this new procedure.
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.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
Don’t include personal or financial information like your National Insurance number or credit card details.
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