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SUBMISSION PORTAL OVERVIEW Is the Application a \"Test\" Submission? No, this is my official Submission.Part 1: ADMINISTRATIVE INFORMATION Application Window This application is being submitted in
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What is European Medicines Agency post-authorisation?
The European Medicines Agency post-authorisation refers to the processes and activities that are required after a medicine has been authorized for use in the European Union, ensuring ongoing safety monitoring and efficacy of the medication.
Who is required to file European Medicines Agency post-authorisation?
The marketing authorization holders (MAHs) of the medicinal products are required to file European Medicines Agency post-authorisation submissions, as they are responsible for ongoing safety and efficacy monitoring.
How to fill out European Medicines Agency post-authorisation?
Filling out European Medicines Agency post-authorisation documentation typically involves completing specific forms provided by the EMA, ensuring that all required data regarding the safety and efficacy of the medication is accurately reported.
What is the purpose of European Medicines Agency post-authorisation?
The purpose of European Medicines Agency post-authorisation is to monitor the safety and effectiveness of medicines once they are on the market, to detect any potential adverse effects, and to ensure that the benefits of the medication continue to outweigh the risks.
What information must be reported on European Medicines Agency post-authorisation?
Information that must be reported includes adverse drug reactions, changes in benefit-risk balance, updates to the Summary of Product Characteristics (SmPC), and any new data suggesting a modification of the original authorization.
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