4.18

Provision for Pharmaceutical Products

Regional Authority may issue Advance Authorisation for pharmaceutical products manufactured through Non-Infringing (NI) process. A manufacturer exporter can avail the benefit of this provision whether the SION or the adhoc norms (under self declared basis in terms of paragraph 4.07 of the Hand Book of Procedures) for the said product is available or not. "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.