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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 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.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
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 renew marketing authorisations for products granted through different routes and at different times.
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
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.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Guidelines to help mitigate and manage medicine shortages.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Guidance on how to complete your Electronic Application Form (eAF) and Cover Letter
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
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