Download export requirment

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.
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.
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.
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.
EXPORT REQUIRMENT
NIGERIA Requirement
QCS Certificate/ ARIL inspection report to
be produced in the case of export to
Nigeria.
EXPORT REQUIRMENT
Biological Products (Vaccine & Sera)
Batch release certificate from CRI
Kasauli/NCL Certificate for export of
Vaccines and other Biological.
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.
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
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.
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.
EXPORT REQUIRMENT
Export of Imported material
• Copy of the import License-form 10
• COA
• Details of bill of entry, invoice and COA
EXPORT REQUIRMENT
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