DRAFT CHECK LIST OF DOCUMENTS TO BE SUBMITTED FOR THE GRANT OF FORM 10 LICENSES FOR THE IMPORT OF NON –CRITICAL DIAGNOSTIC KITS/REAGENTS

 

 

1.     Original Application in Form 8 as per the format prescribed in the Rules, duly signed and stamped by the authorized signatory of the importer/Indian agent. The list of proposed products to be submitted as an annexure to the Form 8 should also be signed and stamped by the authorized signatory of the importer/Indian agent on all pages.

2.     A copy of the authorization letter issued by the Director/Partner revealing the name & designation of the person authorized to sign Form 8.

3.     a) Original Form 9 undertaking along with the product list issued by the manufacturer which shall be notarized/Apostilled/attested by the Indian Embassy in the country of origin.

b) Original Form 9 undertaking shall indicate the name & designation of the authorized signatory along with the date of issue.

c) The list of proposed products to be submitted as an annexure to the Form 9 should be signed & stamped by the manufacturer.

     4. Receipt (Challan) of payment of fees in the form of a Treasury Challan (TR6). The fee should be deposited in the Bank of Baroda under the Account Head of 0210 Medical + Public Health, 04 Public Health & 104 Fees& Fines adjustable to PAO, DGHS, New Delhi.

     5. Duly notarized and valid copy of any one of the following issued by the national regulatory authority of the country of origin (e.g. - FDA): -

       a) Free Sale Certificate in respect of the proposed Diagnostic Kits/Reagents issued by the National Regulatory Authority of the country of origin.

       b) Exportability Certificate in respect of the proposed Diagnostic Kits/Reagents issued by the National Regulatory Authority of the country of origin clearly stating that the proposed kits/reagents are freely sold in the country of origin.

       c) If the proposed products are not sold freely in the country of origin, Free Sale Certificates/Import Licenses from other countries where the proposed products are being freely sold/ an affidavit listing the names of the countries where the proposed products are being freely sold needs to be submitted.

       d) If the proposed products are neither sold in the country of origin nor in any other country, Performance Evaluation Reports for 3 consecutive batches of the proposed products conducted by any NABL accredited Laboratory in India needs to be submitted in respect of the products.

     6. Duly notarized & valid copy of ISO 13485 Certificate/CE Certificate/GMP Certificate.

      7. Duly attested and valid copy of Drugs Sale License in Form 20B & 21B or renewal in 21C issued by the State Licensing Authority.

      8. Duly attested and valid copy of Manufacturing License issued by the State   Licensing Authority in case the Indian Manufacturer is the importer.

      9. Performance Evaluation Reports for 3 consecutive batches of the proposed products conducted by any NABL accredited Laboratory in India needs to be submitted in respect of Kits/Reagents meant for screening of TB, Dengue, Malaria, Chikunguniya, Typhoid, Syphilis Test Kits & Cancer Markers. [Applicants are also requested to furnish proof that the Laboratory conducting the aforesaid evaluation has been accredited by NABL.]

      10. Package Inserts, Literature (English version or authenticated

           translated copy) circulated in the country of origin for the Diagnostic  

           Kits/Reagents proposed to be imported.

      11. Certificate of Analysis issued by the manufacturer in respect of the

           proposed products.

      12. Labels in respect of the proposed products.

      13. A List of products listing the specific intended use in respect of each

            of the proposed products.

     14. It is advisable that the names of the proposed products should

           correlate in the Form 8, Form 9 & Free Sale Certificate etc. submitted  

           by the applicant.

     15. Applicants are advised to clearly mention the intent of their application in the covering letter and clearly list the documents that are being enclosed as part of the application.

16. In case of Re-issue of Import Licenses, applicants are advised to enclose a copy of their original Form 10 Licenses, in case they wish to continue using the old Import License Number. The same should also be clearly mentioned on the covering letter stating the details of the old Import License Number.

 

NOTE: - Applicants are requested to submit a softcopy of the list of proposed products in a CD along with their application for the grant of Import License in Form 10.