Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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Hepatitis B

All function of NCLB are now under DRAP Act, 2012 (Act No. XXI of 2012) and all previous actions and SROs are protected.

Lot Release is now under Schedule I, and NCLB is part of DRAP under Section 3 of this Act.

For detailed description of various aspects of DRAP Act, 2012 visit this link

Http://www.drap.org.pk

DRAP Act, 2012 pdf file. 

 

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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: 17-Mar-2015