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Submission and update of Drug Registration samples (Circular)

Thursday, 19th January 2017

                                          CIRCULAR NO. 012/DAR/2017

                  SUBMISSION AND UPDATE OF DRUG REGISTRATION SAMPLES                         

National Drug Authority is in the process of updating all registration samples whose shelf life has expired.

ALL REGISTERED SAMPLES

This is to request you to provide two (2) new samples for each pack size for all registered products.

Please note that these samples should be the same as those submitted for registration, Amendment/Variation (approval) and should have the same shelf life as the registered samples.

In case of any changes you will be required to apply for Variation/Amendment as per the guidelines.

NEW SUBMISSIONS

With effect from January 2017, clients should update their samples every two years.

NOTE:

It is the responsibility of the applicant to see to it that their samples are updated two months prior to expiry.

Thank you for your usual corporation.