Reminder: Establishment Registration Renewals are Due by EOY

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The U.S. Food and Drug Administration (FDA) Establishment Registration renewals for 2019 must be submitted between October 1 and December 31. With certain exemptions, any establishment engaged in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution is required to register with FDA annually. Registration is required within five days of introducing a product into commercial distribution.

Establishment Registration Renewals

Annual renewal of registration must occur between October 1 and December 31 of each year.

No Changes

If there are no changes to your existing establishment or contact information, create a No Changes Notification SPL document. Fill in the SetID with the SetID from your previous or most recent submissions. Enter the appropriate effective date and version number (generally, one number higher than the previous submission) and submit to FDA.

Changes

If there are changes/updates to the existing establishment data:

  • Create a copy/new version of the most recent submission;
  • Do not change the SetID. Retain the original SetID from the previous version;
  • Generate a new DocumentID/RootID;
  • Enter an appropriate effective date and version number (generally, one number higher than the previous submission);
  • Modify all establishment and contact information as appropriate; and
  • Submit to FDA.

Need assistance or have additional questions? Contact Synchrogenix or visit our website.

Author: Synchrogenix

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