Epidemic prevention materials manufacturers, FDA call you annual registration update!

Release time:

2020-11-20 14:09

Disinfection wipes, hand sanitizer, disinfection spray and other registered FDA OTC manufacturers please pay attention! This year, the FDA's annual registration renewal period is October 1, 2020 to December 31, 2020. In order to maintain your current registration status for 2021, you must submit a registration update or no change notice during this period.

FDA Section 510 of the Federal Food, Drug, and Cosmetic Act (FD & C Act) requires companies that manufacture, prepare, synthesize, or process pharmaceutical products in the United States or that are to be imported into the United States to register with FDA. These domestic and foreign companies must list at the time of registration all pharmaceutical products manufactured, prepared, compounded, or processed in the United States. In addition, foreign agencies must identify U.S. agents and importers at the time of registration.

Please follow the appropriate process to update or renew your registration:

If there is no change to the existing agency or contact, create a no change notification SPL document. Populates the SetID with the value you previously or recently submitted. Enter the appropriate effective date and version number (usually one number higher than the version number of the last commit) and commit.

If there are changes/updates to existing institution data: Create a copy/new version of the most recently submitted document; do not change SetID. Retain the original SetID of the previous version; generate a new DocumentID/RootID; enter the appropriate effective date and version number (usually one number higher than the version number of the previous commit);

Amend all agency and contact information as necessary; and submit.

If you wish to deregister an agency or notify the FDA of the closure of an agency, please create an agency deregistration or closure notice SPL document. Populates the SetID with the value of the last commit. Enter the appropriate effective date and version number (usually one number higher than the version number of the last commit) and commit.

New Anrun Consulting provides FDA annual update services for new and old customers.

EPA Continues to Adjust New Coronavirus Disinfectant Registration Requirements

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EPA Continues to Adjust New Coronavirus Disinfectant Registration Requirements

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