Companies that manufacture drug products are required to list their products with FDA and renew such listings annually. A Drug listing is a submission to FDA containing detailed information about a drug product, such as its proprietary name, active ingredients, dosage form, route of administration, and NDC number. It also includes details about the manufacturing facilities and labeling information.
A Blanket No Changes Certification of drug Listing is a declaration made by manufacturers and labelers to the US FDA certifying that there are no changes to their drug products listed with the FDA. This certification is submitted to the FDA annually.
A blanket no change certification is submitted to FDA electronically as per the regulatory requirements in an SPL format. SPL stands for Structured Product Labeling. SPL provides transparency and assurance to the agency that the products remain consistent with their previous submissions.
The purpose of this certification is to keep the FDA informed about the status of regulated products, and it helps FDA to ensure that the products on the market continue to be in compliance with their approved or cleared specifications.
Failure to submit or update these listings as required can lead to regulatory action, which includes misbranding and warning letters.
Liberty Management Group Ltd, provides assistance with drug establishment registration, NDC labeler code request, Drug listings, blanket no change certification and US agent service.
Namrata
Regulatory Consultant
support@libertymanagement.us