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.  The 2017 renewal period marks the first time that registered establishments must submit a “blanket no change certification” for all drug product listings that required no updates within the year.

FDA requires drug establishments to report any changes to product listings in June and December each year.  Until recently, unchanged listings required no action.  This year, registrants must certify that all product listings which were not updated have had no changes occur to the data or labelling.  Product listings that are neither updated within the year nor certified during the renewal period may be considered expired by FDA and removed from the Agency’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?

Registered drug establishments should submit a “Blanket No Change Notification” for all products that have not been updated during the current year to certify there were no changes to the data or labelling as part of their annual registration renewal.  The notification must be submitted in structured product labelling (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 CDER Direct to submit for human drug listings.  According to FDA, all SPL listing submissions will undergo a rigorous set of validation rules.

Registrar Corp can renew your FDA registration and certify or update your drug product listings using the required SPL format on your behalf.  Our Regulatory Specialists are experienced in navigating FDA’s ESG and can complete your renewal quickly and properly.

EXPORT ACCESS is the Authorized Agent for UK & Ireland for REGISTRAR CORP, USA – the leading global provider of compliance services for goods entering the USA which are subject to regulation by the US Food & Drug Administration (FDA)