Extension of the validity period of registration certificates & import licenses for clearance of products with residual shelf life less than 75%

This is to convey that the National Medicines Regulatory Authority has taken following decisions after reassessing the prevailing situation in the country due to COVID 19.1. To extend the validity of certificates of registration and import licenses pertaining to Medicines, Medical devices, Borderline products and Cosmetics up to 30th June 2021. The extension is applicable for certificates and licenses expiring after 30th June2019. The decision was taken in order to minimize the movement of people. The decision would be reassessed again on or before 30th June 2021.2. To grant approval to import & clear the above-mentioned products, at least twelve(12) months of shelf life to be retained, with the product at the time of importing until 30th June 2021. For parenteral, at least twelve (12) months of shelf life to be retained, with the product at the time of importing. For vaccines prior approval to be required from the NMRA if the shelf life is below than the 66%.

As such there is no requirement for the NMRA to consider individual requests in this regard.

Please note the attached letter supersede sour previous communication letters on above subject matter.

(Date: 17 March 2021)