WebAnnex 2 Recommendations for the production and control of poliomyelitis vaccine (inactivated) 32 Annex 3 Guidelines for the production and control of Japanese encephalitis vaccine (live) for human use 66 Annex 4 Recommendations and guidelines for biological substances used in medicine and other documents 99 Annex 5 WebHome • The Global Health Network
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WebThe dossier is assessed in accordance with the WHO prequalification procedure for vaccines (WHO TRS 978, Annex 6), as well as verification of compliance of the … WebAfter primary vaccination (e.g. 6, 10, 14 weeks; 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) with . ... (WHO TRS 978, Annex 6). The approval of the DTaP-Hep B-IPV-Hib vaccine was based on the review of EMA reports related to the quality, safety and efficacy data including evaluation of the consistency of the vaccine, the satisfactory ...
WebAnnex 3 Recommendations for the production and control of group C meningococcal conjugate vaccines (Addendum 2003) 90 Annex 4 Guidelines on regulatory expectations related to the elimination, reduction or replacement of thiomersal in vaccines 95 Annex 5 Biological substances: international standards and reference reagents103 Annex 6 WebApr 7, 2024 · WHO TRS No. 978, Annex 3. 2010 Provide guidance to NRAs, national control laboratories (NCLs) and manufacturers on the evaluation of animal cell cultures used as substrates for the production of biological medicinal products, and for the characterization of cell banks. All biological products including vaccines produced via animal cell substrates.
WebUnited Nations agencies”, WHO Technical Report Series 978, Annex 6, 2013 7 2. WHO EUL document 8 3. “Guidelines on clinical evaluation of vaccines: regulatory expectations”, WHO ... TRS 978, Annex 316 10. 17WHO good manufacturing practices for biological products. TRS 999, Annex 2 Web• active immunization of infants, children, and adolescents from 6 weeks through 17 years of age against invasive disease, pneumonia and otitis media caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. • Active immunization of adults, aged 18 years and older, against pneumonia and invasive
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