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

Such meetings are important for discussing programmatic suitability issues and can be
scheduled when requested by the manufacturer.
Additional meetings may be held during the evaluation process, as required.
3.3 Product summary file (PSF)
A manufacturer whose application letter is accepted will prepare and submit one hard
copy and five electronic copies (on CD), in either Microsoft Word or PDF format, of a
PSF which should be fully up to date and written entirely in English following the
WHO format provided below:
Chapter 1: General information
Chapter 2: Personnel
Chapter 3: Premises and equipment
Chapter 4: Vaccine composition
Chapter 5: Production
Chapter 6: Quality control
Chapter 7: Stability
Chapter 8: Clinical experience
Chapter 9: Production/distribution data
Chapter 10: Update of regulatory actions.
The WHO format is required; however, the common technical document (CTD)
format can be accepted so long as a detailed cross-referencing of contents and those
aspects required by WHO but not included in the CTD requirements are presented.
Where the PSF cross-references to the CTD format, the documentation may be in
electronic form only. Electronic documents should be in searchable text where
possible.
The information to be provided in the file is specified in Appendix 1 of this document.
WHO has established three deadlines per year for the submission of PSFs: 31 January,
31 May and 30 September.
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