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.
download actChecklist of Documents
- Covering letter explaining the Extension or Reduction
- Stability data for the proposed Shelf life
- Shelf-life approval of the products from National Regulatory Authority
- 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.
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
