FDA Drug establishment registration renewal 2020 calendar year will begin from 1st October, 2019. Drug establishments which are registered in the year 2019 must renew the registration between 1st October to 31st Decemebr 2019 in order to avoid expiration of drug establishment registration.
For establishments submitted their initial, updated or annual registration between 1st October to 31st Decemebr 2019 , it is considered registered until 31st Decemebr 2020.
What information is required for drug establishment registration renewal ?
Additional information is not required for registration renewal, you must notify if there are any changes to previously submitted registration. You must verify , the contact person name, email and address to make sure that all the information is up to date.
FDA does not charge fee for establishment registration or drug establishment registration renewal in the subsequent years.
If you fail to renew the registration before deadline published by the FDA, such establishments will be removed from FDA’s drug establishment registration database. Also, the drug listings in which such establishments are referred may get deactivated.
We offer assistance for Drug establishment renewal at lowest fee. It will take two working days to complete the renewal process. if you have any questions, contact us.