Month: November 2023

What is Blanket No Changes Certification?

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

http://www.fdahelp.us

What is SPL?

SPL stands for Structured Product Labeling. SPL is an XML-based document markup standard that provides a consistent way to format and organize information about a drug or cosmetic product, including its ingredients, labels and other details.

Drug & Cosmetic companies are required to submit product information to the FDA in SPL format. SPL is used for various FDA submissions related to FDA regulated products. It is designed to improve the accuracy and consistency of product information and make it easier for healthcare professionals, regulators, and the public to access and understand this information. Some of the key FDA submissions that utilize SPL include:

  1. Drug Establishment Registration – Manufacturers of drug products must register their facilities with the FDA, and SPL is used for this purpose.
  2. Drug Listing – Manufacturers and distributors of drug products are required to list their products with the FDA. SPL is used to provide comprehensive product information for the FDA’s NDC Directory.
  3. Drug Renewals & Listing updates – Annual Drug renewals & any changes to a drug product’s label or listing info, must be submitted to the FDA using SPL.
  4. Cosmetic Facility Registration – Manufacturers & processors of cosmetic products must register their facilities with the FDA, and SPL is used for this purpose.
  5. Cosmetic Product Listing – A responsible person must list the cosmetic products with FDA by way of SPL submissions.
  6. Cosmetic Renewals & Listing updates – Annual Cosmetic renewals & any changes to a cosmetic product’s label or listing info, must be submitted to the FDA using SPL.

Liberty Management Group Ltd can help with SPL preparation & submissions to FDA.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us