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New FDA Blanket No-Change Certification Requirements

Registrar Corp can renew your FDA registration and certify or update your drug product listings using the required SPL format on your behalf. Complete the form below for assistance:

Read below for more information on this new requirement

Drug establishments registered with the U.S. Food and Drug Administration (FDA) are required to renew their registrations with every year between October 1 and December 31. For the 2017 renewal period, registered establishments must submit a “blanket no change certification” for all drug product listings that required no updates within the year.

Product listings that are neither updated within the year nor certified during the renewal period may be removed from FDA’s database.  Marketing unlisted drugs in the United States is a prohibited act.

How can I obtain “blanket no change certification” for my drug product listings?

The notification must be submitted in structured product labeling (SPL) format.  Structuring data in SPL format requires SPL authoring software.  The SPL files can be submitted to FDA via the Agency’s Electronic Submission Gateway (ESG).  Users may also use CDERDirect to submit for human drug listings.  According to FDA, all SPL listing submissions will undergo a rigorous set of validation rules.