The FDA Myanmar declares today that only electronic payment will be allowed for medicine registration renewals next year.
According to the Notification No. 161/2023 of the Ministry of Health, medicine registration renewals and annual subscription fees payment using e-Submission system will commence on 1 January 2024.
For medicine registration renewals , FDA Myanmar notified the companies to enter e-Submission system and submit the application 180 days before the expiry of the registration.
When submitting an application, the applicant has to pay K 300,000 of initial verification fees via digital payment in e-Submission system as well as laboratory charges, if still unpaid.
Failing to renew the registration during the specified period will make a registration holder to pay a fine of K 50000 a month,starting from the expiry date.
The firms are required to resubmit necessary data via online within one month, and if they fail, their registration will be removed from the online list, according to the announcement.
Annual fees for registered medicines also have to be paid via digital payment in e-Submission system while the rate is K 300000 per one medicine, according to the Notification No. 3(A) of the ministry.
A company which fails to make payments for two consecutive years will be disallowed to renew the registration, FDA Myanmar said.
MT/ZN
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