Commencing 1 January, online drug registration extension applications open

The Department of Food and Drug Administration (FDA Myanmar) has announced that the process for extending drug registration online will be allowed starting from 1 January 2024.
FDA Myanmar has notified that applicants should submit their extension applications through the e-submission system on the FDA Myanmar website at least 180 days before the registration expires.
Applicants must pay K300,000 for the preliminary document scrutiny process through digital payment on the e-submission system.
According to the FDA Myanmar announcement, companies must resubmit the necessary documents online within a month. Failure to do so within the stipulated time will result in the removal of their registrations from the online system.
The annual fee for each registered drug item is K300,000, and it must be paid digitally on the e-submission system. — ASH/TMT

 

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