Procedure for assessing the acceptability, in principle, of vaccines ...

More documents

Recommendations

Info

70 WHO/BS/10.2155 Page 70 http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/index.html The prequalified status of a vaccine is valid until revoked by WHO. Assurance of continued acceptability After the prequalification of the product has been granted, follow-up activities to ensure continued acceptability of the vaccine for supply through United Nations agencies will be performed according to the general prequalification procedure, as follows: − reassessments; − evaluation of variations submitted by the applicant; − targeted testing of lots supplied to United Nations agencies; − monitoring of continued compliance with specifications; − follow-up of complaints and reports of adverse events following immunization (AEFI). The above list is indicative but not exhaustive. Failure of manufacturers to submit variations through the EMA may lead to withdrawal of the scientific opinion and the prequalification status. Note: These activities will be conducted, whenever applicable, in collaboration with the EMA within the context of Article 58 of Regulation (EC) No 726/2004.
Appendix 5 Confidentiality agreement 71 WHO/BS/10.2155 Page 71 Provisions for team members participating in WHO missions to assess/reassess the acceptability, in principle, of vaccines for purchase by United Nations agencies In the course of discharging your functions as an expert adviser under this Agreement, you will gain access to certain information which is proprietary to WHO or to the manufacturer(s) of the vaccine(s) which need(s) to be assessed for purchase by United Nations agencies. You undertake to treat such information (hereinafter referred to as “the Information”) as confidential and proprietary to WHO or the aforesaid manufacturer(s). In this connection, you agree to: 1) not use the Information for any other purpose than discharging your obligations under this agreement; and 2) not disclose or provide the Information to any person who is not bound by similar obligations of confidentiality and non-use as contained herein. However, you will not be bound by any obligations of confidentiality and non-use to the extent that you are clearly able to demonstrate that any part of the Information: 1) was known to you prior to any disclosure by WHO and/or the manufacturer(s); or 2) was in the public domain at the time of disclosure by WHO and/or the manufacturer(s); or 3) has become part of the public domain through no fault of your own; or 4) has become available to you from a third party not in breach of any legal obligations of confidentiality to WHO and/or the manufacturer(s). You also undertake not to communicate the deliberations and findings of the team(s) of experts in which you will participate, as well as any resulting recommendations and/or decisions of WHO, to any third party, except as explicitly agreed by WHO. You will discharge your responsibilities hereunder exclusively in your capacity as an expert adviser to WHO. By signing this Agreement, you furthermore confirm that you have no financial interest and/or other relationship with a party, which:
Page 1 and 2:
Procedure for assessing the accepta
Page 3 and 4:
Acronyms The following acronyms are
Page 5 and 6:
The prequalification procedure esta
Page 7 and 8:
• The candidate vaccine meets the
Page 9 and 10:
Such meetings are important for dis
Page 11 and 12:
immunization programmes and vaccine
Page 13 and 14:
As soon as the PSF is accepted and
Page 15 and 16:
manufacturer, to organize an abbrev
Page 17 and 18:
with both the WHO requirements and
Page 19 and 20: o review and approval of variations
Page 21 and 22: − confirmation that the vaccine m
Page 23 and 24: collaborative effort. Special atten
Page 25 and 26: for submission of PSFs do not apply
Page 27 and 28: In cases where the vaccine manufact
Page 29 and 30: WHO reserves the right to take appr
Page 31 and 32: C. The manufacturer should provide
Page 33 and 34: If, as a result of the reassessment
Page 35 and 36: In the event of situations as descr
Page 37 and 38: identifying the confidential inform
Page 39 and 40: Authors The proposals for the revis
Page 41 and 42: Geneva, Switzerland; Dr U Rosskopf,
Page 43 and 44: Acknowledgments Acknowledgements ar
Page 46 and 47: Appendix 1 The product summary file
Page 48 and 49: 3.3 Describe ventilation systems in
Page 50 and 51: For recombinant vaccines, a descrip
Page 52 and 53: 7.3 Provide information on stabilit
Page 54 and 55: particular attention to any data th
Page 56 and 57: 9.3 Summarize the arrangements and
Page 58 and 59: Appendix 2 Flowcharts of WHO prequa
Page 60 and 61: Request/supply of Additional Data Y
Page 62 and 63: Satisfactory Completion of PSF revi
Page 64 and 65: 4 5 oversight. Validation of the cr
Page 66 and 67: 9 10 the critical tests • Review
Page 68 and 69: 68 WHO/BS/10.2155 Page 68 1) An app
Page 72 and 73: 72 WHO/BS/10.2155 Page 72 1) may ha
Page 74 and 75: 74 WHO/BS/10.2155 Page 74 meeting o
Page 76 and 77: the meeting or work? 4a Patents, tr
Page 78: true and complete to the best of my
show all

Procedure for assessing the acceptability, in principle, of vaccines ...

Create successful ePaper yourself

Delete template?

Save as template?