Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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NCLB implements Lot release and Lab testing of Biological Drugs as per Schedule I of DRAP Act, 2012 (Act No. XXI of 2012)

and is part of DRAP Authority under Section 3 of this Act.

DRAP Act, 2012 scanned pdf file. 

Http://www.dra.gov.pk

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MINIMUM REQUIREMENTS FOR SUBMISSION OF LOT RELEASE APPLICATION

 

1)               One page Lot Release Request Form addressed to Federal Analyst

2)               Summary Protocol of the product manufacture and Quality Control

3)               Lot Release Certificate from NRA of exporting country OR 4) Lot Release Exemption Certificate from NRA    of exporting country.

5)               Batch Production Record (BPR) of the product that are locally manufactured.

6)               Original copy of bank challan paid in NBP/SBP for lot release fee.

7)               Copy of commercial invoice duly endorsed by the concerned ADC.

8)               Copy of Registration letter issued by the Ministry of Health, Islamabad.

9)               Any other document required to establish the safety and efficacy of the product as  determined by the Federal Analyst.

 

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Last modified: 01-Sep-2018