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TMI BlogIncorporation of a new provision as paragraph 4.7A in the HBP. v1 to allow access to duty free inputs based on actuals, for pharmaceutical products manufactured through Non-Infringing process- regarding.X X X X Extracts X X X X X X X X Extracts X X X X ..... uch products (which are still under Process Patent, but product patent of which has expired) cannot be availed by manufacturer, other than the Patent holder. Such manufacturer, who wish to manufacture and export the product through a Non-infringing (NI) Process may require inputs and input quantities, other than that prescribed as per existing norms (SION or adhoc norms). Hence it has been decided to: a) Incorporate a new provision as paragraph 4.7A (as stated below) within the scope of advance authorisation scheme to allow this facility to pharmaceutical sector subject to fulfillment of certain specified conditions. b) Prescribe a new Advance Authorisation Application Form as ANF 4 J for such products. c) Specify a format of Chartered Engineer (Chemical) Certificate in Appendix 32 C. This certificate shall be based on verification and authentication of the input combination required for pharmaceutical products manufactured through NI process. d) Incorporate a new format for the Consumption Details of the inputs used, to be verified and certified by the Jurisdictional Central Excise Official in Appendix 23A for these pharma products in lieu of Appendix 23 for other products. e ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ails of Appendix-23A, duly verified and certified by the jurisdictional Excise Authority, with that of the inputs made/allowed in the authorisation, before allowing redemption or Bond-waiver against individual advance authorization issued for pharmaceutical product(s) manufactured through NI process. In this verification process, in case, it is found that the Authorisation holder has consumed lesser quantity of inputs than imported, Authorisation holder shall be liable to pay customs duty on unutilized imported material, alongwith interest thereon as notified, or effect additional export within the EO period. However, for the customs duty component, the authorisation holder has also the option to furnish valid duty credit scrips issued under Chapter 3 of FTP and DEPB. Maintenance of Proper Accounts : Every advance authorisation holder shall maintain a true and proper account of consumption and utilization of duty free imported / domestically procured inputs against each authorisation as prescribed in Appendix 23A. This record in Appendix 23A format, duly verified and certified by the jurisdictional Excise Authority, shall be submitted to the concerned RA at the time of filing appl ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ntral Excise Authority) i. Excise Registration Number ii. Issuing Authority 6. Status House Details: i. EH / SEH / TH / STH / PTH ii. Certificate Number iii. Date of Issue iv. Issuing Authority v. Valid Upto 7. Application Fee Details i Amount (Rs) ii Demand Draft / Bank Receipt / Electronic Fund Transfer No Iii Date of Issue iv Name of the Bank on which drawn v Bank Branch on which drawn 8. Total CIF value of Imports applied for i. In Rupees ii. In currency of imports iii. In US $ 9. Total FOB / FOR value of Exports to be made, excluding commission i. In Rupees ii. In currency of exports iii. In US $ 10. Value Addition (in %): 11. Port of Registration as per paragraph 4.19 of HBP v1 (for the purpose of imports):________. 12. Country of Import (Destination Country): 13 . Whether approval of the Food & Drug Administration / Concerned regulatory authority of the country of import received for the product: Yes / No. 14. Details of items to be exported / supplied under the Authorisation: S No Item Description Item Technical Characteristics / Quality etc. ITC (HS) Code Quantity Unit of Measurement FOB / FOR Value (in Rs) FOB / FOR value (in f ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... declare that the particulars and the statements made in this application are true and correct to the best of my / our knowledge and belief and nothing has been concealed or held there from. If found incorrect or false, it will render me / us liable for any penal action or other consequences as may be prescribed in law or otherwise warranted. 2. I / We undertake to abide by the provisions of FT(D&R) Act, the Rules and Orders framed there under, the FTP, HBP v1, HBP v2 and the ITC(HS) Classification of Export & Import Items. 3. I / We hereby certify that none of the Proprietor/ Partner(s) / Director(s) / Karta / Trustee of the firm / company, as the case may be, is / are a Proprietor / Partner(s) / Director(s) / Karta / Trustee in any other firm / Company which has come to the adverse notice of DGFT. 4. I / We hereby certify that the Proprietor / Partner(s)/Director(s) / Karta / Trustee, as the case may be, of the firm / company is/are not associated as Proprietor/Partner(s)/Director(s) / Karta / Trustee in any other firm / company which is in the caution list of RBI. 5. I / We hereby declare that I/we have perused the list of SCOMET items as contained in the Appendix 3 to the Sc ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nstallation of captive power plant based on the specified fuel unless the permission is specifically waived by the State Electricity Board; and b. Self-certified copy of the letter intimating the date of commissioning of the captive power plant from the concerned authority which issued the permission letter is to be submitted. Note: Import of only such fuel(s) shall be allowed which have / has been specified in the said permission. B . For ARO / Invalidation letter : Applicant may furnish information in respect of Sl. No. 1, 2 & 20 of the application only. C. Please state 'Not Applicable' wherever the information / data is not applicable to you. ***** Annexure II (Appended to Public Notice No. 29 dated 14.02. 2011) APPENDIX 32 C FORMAT OF CHARTERED ENGINEER (CHEMICAL) CERTIFICATE (For Pharmaceutical Product manufactured through Non-Infringing process) 1. I am a Chartered Engineer (Chemical) with Registration No. ______ dated ______. This Certificate is being furnished as per the requirement of paragraph 4.7A of Handbook of Procedure, Vol. 1. 2. I hereby certify that the approval communication dated ______ of the Food & Drug Administration / concerned regulatory auth ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 1992 (as amended), Rules and Orders framed there under and the provisions of any other Act, in force. Date: Signature of Chartered Engineer (Chemical) Place: Name: Seal of Chartered Engineer: E-mail : Tel. No. (O): Official Address: Residential Address: Registration Number: Name & Address of the Institution with which registered: Note : 1. Unless and otherwise provided for, solvent(s) shall be allowed maximum upto 25% of the requirement of solvents indicated in the ANDA / DMF for the purpose of advance authorisation. However, in cases where recovery is not possible and the solvent gets poisoned, full quantity of solvent as per ANDA / DMF shall be allowed. Chartered Engineer shall verify and certify the same accordingly for the details of solvents required as in Table 4(b) above. 2. In case of deemed exports, this certificate shall be based on details given in ANDA of the recipient unit and DMF of supplying unit (deemed exporter). ***** Annexure III (Appended to Public Notice No. 29 dated 14.02. 2011) APPENDIX 23 A Format for accounting of consumption and stocks of duty free imported or domestically procured raw materials, components etc. allowed under advance ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... eal/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. Annexure IV (Appended to Public Notice No. 29 dated 14.02.2011) GUIDELINES FOR APPLICANTS [Please see paragraphs 4.7 A, 4.25 & 4.26 of HBP v1] 1. Two copies of the application must be submitted unless otherwise mentioned. 2. Each individual page of the application has to be signed by the applicant. 3. FOB value of export for the pu ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... to a unit producing non excisable product(s), a project authority certificate (PAC) certifying quantity, value and date of supply would be acceptable in lieu of excise certification. However, in respect of supplies to EOU/EHTP/ STP/ BTP, a copy of CT-3/ARE-3 duly signed by the jurisdictional excise authorities certifying the item of supply, its quantity, value and date of such supply can be furnished in lieu of the excise attested invoice (s) or statement of invoices as given above. However in case of supply of the product by the Intermediate supplier to the port directly for export by the ultimate exporter (holder of Advance Authorisation or DFIA) in terms of paragraph 4.13 of HBP v1, copy of the shipping bill with the name of domestic supplier as Intermediate supplier endorsed on it along with the file No. / Authorisation No. of the ultimate exporter and the intermediate supplier shall be required to be furnished. II. Payment certificate from the project authority in the form given in Appendix-22C. In the case of Advance Authorisation for Intermediate Supplies/ deemed exports, supplies to the EOUs / EHTPs / STPs/ BTPs, documentary evidence from the bank substantiating the reali ..... X X X X Extracts X X X X X X X X Extracts X X X X
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