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Drug Regulatory Authority of Pakistan

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Hepatitis B

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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Manufactured by AVP Islamabad WHO TRS
AVP imports the concentrate and fill it locally in single dose ampoules under GMP compliant conditions and test it according to WHO requirements. Amendment 1997,
WHO TRS No 889, Annex 4

  Hepatitis B vaccines, DNA recombinant
Title: Requirements for Hepatitis B vaccines made by Recombinant DNA Techniques;
Adopted 1988,
WHO TRS No 786, Annex 2

  Supplementary for guidance:
Title: Biological products prepared by recombinant DNA technology; Adopted 1990,
WHO TRS No 814, Annex 3

 

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Last modified: 01-Sep-2018