Grant or Renewal of Test Licenses

Submitted by DCA on Wed, 11/22/2017 - 15:27

Grant or Renewal of Test Licenses

 

 

DOCUMENTS TO BE SUBMITTED TO THE LICENSING AUTHORITY WITH APPLICATION FOR GRANT OF TEST LICENCE IN FORM-29
 

1. Covering Letter   (Introduction of applicant with address of the Plant and Administration office and his requirement)

2. Application (Statutory) in Form - 30 (duly signed or counter signed by the  Director of the firm)

3. Challan in original remitting the fee of Rs.250/- per each product in the following Head of Account 

                                                                                 0210 – Medical and Public Health,
                                                                                     04 – Public Health,
                                                                                   104 – Fees, Fines etc                                                                                                                                                                                                                 

4.Memorandum and articles of association / Copy of registered partnership deed.

5. List of Manufacturing and analytical equipment.

6. Attested Photo copy of PAN Card and Bank Account Copy for address Proof of Managing Director / Partners/ Proprietor.

7. NOC from DCG (I) for the new drugs.

8. Reconciliation for the last licensing period incae of Renewal of test license

 

POINTS TO BE CONSIDERED WHILE APPLYING  FOR GRANT OF TEST LICENCE

  1. Test Licence shall be granted only for Chemical, Instrumental, Microbiological or Biological Analysis only.
  1. New drugs shall not be permitted under Test Licence unless the permission from DCG (I) is obtained.
  1. In an applied FDC, the individual drugs do not fall under New Drugs category the applied FDC may be permitted for chemical or instrumental analysis, Biological or Microbiological Analysis.