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SECURITIES AND EXCHANGE COMMISSIONER POS AMI Posteffective amendments to 40 Act only filingsFiling Date: 20220428SEC Accession No. 000119312522127267 (HTML Version on secdatabase.com)FILER Master
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What is pos ami form?
Pos AMI form stands for Post Approval Monitoring Information form. It is a form used to monitor and report post-approval information related to a specific approval.
Who is required to file pos ami form?
The marketing authorization holder (MAH) is required to file the pos ami form.
How to fill out pos ami form?
The pos ami form can typically be filled out electronically through a regulatory authority's online portal, following the instructions provided.
What is the purpose of pos ami form?
The purpose of pos ami form is to monitor and report any post-approval information related to a specific approval, such as safety updates, labeling changes, or efficacy changes.
What information must be reported on pos ami form?
The pos ami form typically requires information on any changes to the product's safety profile, labeling updates, changes in efficacy data, or any other relevant post-approval information.
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