Appendix -4I - Advance authorisation for pharmaceutical product manufactured through Non Infringing (NI) process - Foreign Trade Procedure 2015-2020 (From 5-12-2017 to 31-3-2023) Revised

APPENDIX - 4 I (Please see Para 4.18 to 4.21 of HBP) Register for accounting of consumption and stocks of duty free imported or domestically procured raw materials, components etc. allowed under advance authorisation for pharmaceutical product manufactured through Non Infringing (NI) process. inputs allowed in the authorisation Product (s) exported under the authorisation Balance inputs, if any In case of balance inputs as in column 9 remarks Sl.No. Authorisation No(s) with date Name of the Inputs Quantity Name of the Product Quantity Inputs Actually consumed for the exported product ** (4 - 8) Additional exports effected in proportion to excess inputs Input quantity reduced proportionately in the authorisation* Customs duty paid alongwith interest Inputs Quantity (Including actual wastage incurred) 1 2 3 4 5 6 7 8 9 10 11 12 13 *Applicable only in case either partial import or NIL import has been effected. ** In case of post export replenishment, details of inputs used (whether duty paid or not) in the exported product has to be furnished. We declare that the aforesaid particulars are correct. Place: Signature of the authorisation holder__________ Date: Name in block letters:____________ Full official address:___________ Official Seal/stamp Full Residential address :_________ Telephone No.: __________ Email : ___________ Note: 1. Please mention N.A. wherever the information required in the table is not applicable. 2. For columns 10 12 of the table, please furnish the copy of the documentary evidence. FORMAT OF CENTRAL EXCISE CERTIFICATE I hereby confirm that I have examined the production details and the records of M/s __________(Name of the authorisation holder) and verified the details furnished in Appendix 4-I format. I hereby certify the following details of consumption of inputs for the pharmaceutical product, manufactured through Non Infringing (NI) process, against their advance authorization No. -------------- dated --------.---. 1. Name of the Advance Authorisation holder: 2. Address of the manufacturing unit: 3. Name of the exported product: 4. Type of exports: Physical / Deemed / Both (pl strike out whichever is not applicable). 5. Period for which production details verified: 6. Quantity exported against the authorization: 7. Details of inputs consumed in per unit of exported product: Sl. No. Name of the Input(s) used Quantity consumed 1 2 Date: Name of the Central Excise official: Place: Designation: Office seal/Stamp: Telephone No. (O): E-mail address (if any): Postal Address: Note: 1. This certificate shall be required only when the product manufactured and exported is a pharmaceutical product manufactured through Non-Infringing (NI) process. This certificate is to be signed by an official not below the rank of Superintendent of Central Excise, under whose jurisdiction the manufacturing unit of the Advance Authorisation holder is located). 2. As per the policy provision, solvent(s) shall be allowed maximum upto 25% of the requirement of solvents indicated in the ANDA / DMF. However, in cases where recovery is not possible and the solvent gets poisoned, full quantity of solvent as per ANDA / DMF shall be allowed. Central Excise Authority shall verify and certify the actual requirement of solvents accordingly for the purpose of Sl. No. 7 above.