4.19

Application & Processing

(i) An application for grant of an advance authorisation under paragraph 4.18 shall be filed online in ANF 4E to concerned Regional Authority along with the documents uploaded therein.

(ii) Input combination permitted under NI process for manufacturing the product shall be certified by the Chartered Engineer (Chemical) 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. The Chartered Engineer (Chemical) will certify the details as per Appendix 4L prescribed in Hand Book of Procedures. Regional Authority shall cross verify the requirement of inputs as per the details given in the application and with Chartered Engineer Certificate accompanying the application and issue the authorization. Regional Authority shall not forward such application to Norms Committee and the inputs and export product so allowed by Regional Authority, shall be treated as input combinations permitted under NI Process.