EXPORT REQUIRMENT

1
EXPORT REQUIRMENT

• THE FOLLOWING MINIMUM DOCUMENTS ARE REQUIRED OF
  FOR OBTAINING ADC NOC FOR EXPORT DRUGS AND
  COSMETICS
• Shipping bill along with Custom marking for ADC
  NOC.
• Original Copy of invoice, packing list in
  duplicate duly signed by the authorized person.
• Certificate of analysis.
• Certified copy of Manufacturing License along
  with product permission and/or Certified copy of
  COPP or Free Sale certificate issued by the
  State/National Drug Control Authority.

2
EXPORT REQUIRMENT

• Representative samples of Drugs/Cosmetics from
  the Shipment/consignment sealed by the
  customs/excise officer.
• Uncontrolled copy of labels ( in case of Bulk
  Drugs ) carrying the seal and signature of the
  head of QA/QC department to be produced.
• Only custom/excise sealed samples are accepted
  for the clearance of Shipments/consignment
  through CSF/Foreign Post 0ffice/ICD/CWC. etc.

3
EXPORT REQUIRMENT

• Permission/Approval from DCG(I) in case of Export
  of New Drug.
• In case of Drugs Exported against a Quantity
  Based Permission, Original Copy of the same
  issued by the O/o DCG(I) to be produced.

4
EXPORT REQUIRMENT

• Narcotic Drugs Psychotropic Substances
• Export Authorization in original issued by
  Commissioner Narcotics Bureau Gwalior and Import
  Authorization from Govt. of the importing country
  in the case of exports of Narcotic and
  Psychotropic substances/precursors.

5
EXPORT REQUIRMENT

• NIGERIA Requirement
• QCS Certificate/ ARIL inspection report to be
  produced in the case of export to Nigeria.

6
EXPORT REQUIRMENT

• Biological Products (Vaccine Sera)
• Batch release certificate from CRI Kasauli/NCL
  Certificate for export of Vaccines and other
  Biological.

7
EXPORT REQUIRMENT

• Neutral Labels
• In the case of Neutral Label, Neutral code
  allotment letter from the State Drugs
  Controller/FDA.
• KTK/DRUGS/ MFG.LICENSE NO.

8
EXPORT REQUIRMENT

• Merchant Exporter
• In the case of merchant exporters the following
  are the documents to be produced
• Whole/Retail sale License.
• DCG(I) permission in the case of export of a new
  drug.
• Purchase bills

9
EXPORT REQUIRMENT

• Drugs intermediates Chemicals
• Flow chart.
• Reference of Standard Books for its end use
  justification.
• CAS no of intermediates and Chemicals
• Certificate of analysis.

10
EXPORT REQUIRMENT

• Advance license
• Copy of the advance license to observe the
  compliance conditions of Advance license like
  Rule/circular 9 and other special condition
• Custom/Excise sealed samples to establish at
  least the identity of exported material.

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EXPORT REQUIRMENT

• Export of Imported material
• Copy of the import License-form 10
• COA
• Details of bill of entry, invoice and COA

12
EXPORT REQUIRMENT

• Thanks