This applies for local manufacturers only
For initial registration
Comparative Dissolution study data should be submitted according to the WHO guidelines for Comparative Dissolution or Biowaiver. The comparator for the dissolution study should be decided in consultation with the NMRA.
At the end of the Provisional Registration period, for conversion from provisional Registration to Full Registration.
Rolling Provisional Registration is granted for a maximum of four year within which a Bioequivalence study data should be submitted.