DRUG REGISTRATION SERVICES

Shelf Life Extension/Reduction

There can be Changes in Shelf life of a product once an approval is received by an applicant. Shelf life of products can either be extended or reduced.

In both cases, an application for seeking permission to change Shelf Life of a product post approval has to be submitted to the Import & Registration Division of CDSCO.

The application for the same has to be submitted to the Import & Registration Division of CDSCO.

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Checklist of Documents
  1. Covering letter explaining the Extension or Reduction
  2. Stability data for the proposed Shelf life
  3. Shelf-life approval of the products from National Regulatory Authority
  4. Original Labels of the product

As per GSR No. 1193(E), the Government Fees in application seeking Permission for Change in Registration Certificate post approval (in this case change of shelf life) is USD 1800. The requisite government fee and prescribed documents needs to be submitted to CDSCO for processing of such an application.

Only when the approval is granted, can an applicant claim the new shelf life on the product label.

Why NKG for Drug Regulatory Services

NKG experts assist clients in filing and approval of applications for Shelf Life Extension  to ensure that there is neither any regulatory gap nor there is any disruption in supply chain of its clients.

    get compliant now!

    Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or brand owner, one is already engrossed in various business aspects prior to launch of a brand in India. If a mistake is made, it can lead to complete delay in business plan, overheads, financial planning issues  as well as supply chain disruption. 

    CONTACT US FOR YOUR REGULATORY NEEDS.




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