The Product License Application (PLA) package an electronic product license applicatin (ePLA) (only for a class 1 or 2 NHP), and for a class 3 NHP, an electronic product license application, an evidence summary report (which includes safety and efficacy support information), and a finished product specification form. Classes of Natural Health Product License Applications are as follows:
Class 1 – Based on 1 NHP Monograph. NNHPD performance target is 10 days for an NPN
Class 2 – Based on 2 or more NHP Monographs. NNHPD performance target is 30 days for an NPN
Class 3 – At least 1 ingredient in the formula is either not monographed or outside the scope of an NHP Monograph. NNHPD performance target is 210 days for an NPN after acknowledgement letter has been received.
Applications are one of our core competencies. Quality Smart Solutions can prepare any category of Product License Application in an efficient, cost-effective manner.