E-DRUG: WHO-Prequalification Rules and new manufacturers (2)
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Dear Dr Reddy
It is true that the current prequalification of vaccines requires a 3 years
domestict/export production however a revision of the procedures has taken
place last april in WHO geneva and has suggested to take into consideration
PQ for :
Fast track procedure: in case of outbreak/emergency response, in case of
acute vaccine shortage.this is not applicable for the introduction of novel
vaccines into routine programme.
If you may wish have further information you may also contact Dr Nora
Dellepiane, who is responsible of PQ of vaccines in WHO.
Sincerely
Lahouari Belgharbi
World Health Organization (WHO)
Immunization, Vaccines and Biologicals (IVB)
Access To Technologies (ATT)
Tel: +41227913925
Fax:+41227914384
Email: belgharbil@who.int