4.7A.1

Provision

RA may issue Advance Authorisation for pharmaceutical products manufactured through Non-Infringing (NI) process. A manufacturer exporter can avail the benefit of this provision even if the SION or the adhoc norm (under self declared basis in terms of paragraph 4.7 of the HBP v1) for the said product is available. “Input combination permitted under NI process, as approved by the concerned agency of the regulated markets”, shall be exporter specific and country specific and shall be available only when the exports are destined for the same country.