Get the free Alignment in post-approval changes (PAC ... - Europe PMC
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MDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITYPUBLIC ASSESSMENT REPORT FOR DAY ER 750 (METFORMIN HYDROCHLORIDE
750 MG) EXTENDEDRELEASE TABLETSVersion number 0.1,
March,
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How to fill out alignment in post-approval changes
How to fill out alignment in post-approval changes
01
Review the approved marketing authorization submissions to understand the approved labeling and determine the changes needed for alignment.
02
Develop a regulatory strategy that outlines the proposed changes and the rationale for alignment.
03
Update all relevant sections of the labeling, including the prescribing information, patient information leaflet, and packaging.
04
Submit the proposed changes to the regulatory authorities for approval.
05
Implement the approved changes in accordance with regulatory requirements.
Who needs alignment in post-approval changes?
01
Manufacturers of pharmaceutical products
02
Regulatory affairs professionals
03
Health authorities
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What is alignment in post-approval changes?
Alignment in post-approval changes refers to ensuring that all aspects of a change are consistent with the original approved submission.
Who is required to file alignment in post-approval changes?
The holder of the approved application is usually required to file alignment in post-approval changes.
How to fill out alignment in post-approval changes?
Alignment in post-approval changes should be filled out by providing detailed information about the proposed change, including rationale and impact.
What is the purpose of alignment in post-approval changes?
The purpose of alignment in post-approval changes is to ensure that any changes made to a approved application are in line with the original approval and do not compromise product quality, safety, or efficacy.
What information must be reported on alignment in post-approval changes?
Information such as the nature of the change, the reason for the change, the impact of the change on product quality, safety, and efficacy, and any supporting data should be reported on alignment in post-approval changes.
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