4.7A.2

Application & Processing

(a) An application for grant of an advance authorisation under this provision shall be made in ANF 4J along with the documents prescribed therein, to RA concerned. Each and every application for Advance Authorisation in ANF 4J shall be accompanied with the required documents stated therein.

(b) Input combination permitted under NI process for manufacturing the product shall be certified by the Chartered Engineer (Chemical) in the format given in Appendix 32C, after due verification of the details of each input and its quantity as given in Abbreviated New Drug Application (ANDA) / Drug Master File (DMF) of the applicant. RA shall cross verify the requirement of inputs as per the Chartered Engineer Certificate submitted along with the application to that shown in the application and issue the authorisation accordingly. RA shall not forward such application to NC and the inputs and export product so allowed by RA, shall be treated as input combinations permitted under NI Process.