WHO Prequalification definition
Examples of WHO Prequalification in a sentence
Licensee agrees that it will manufacture the Compound, Product and Licensed Product in a manner consistent with (a) WHO Prequalification standards; or (b) the standards of any SRA.
Licensee shall submit a complete file for WHO Prequalification or any SRA approval within thirty-six (36) months after the Effective Date for any existing formulation of the Licensed Products, or within a period to be agreed among Pfizer, MPP and Licensee for any new formulation of the Licensed Product.
Licensee will not sell any Licensed Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale.
Licensee acknowledges and agrees that it shall be permitted to use any such WHO Prequalification or SRA Approval solely to support any filings to an Agency for Key Approval to Commercialize Licensed Product in the Field in the Territory and shall in no event be permitted to use any such WHO Prequalification or SRA approval as the basis of, or for a reference to, support for any filings to an Agency for Key Approval to Commercialize Licensed Product outside the Field and/or outside the Territory.
Licensee will not sell any Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale.
Licensee acknowledges and agrees that it shall be permitted to use any such WHO Prequalification or SRA approval solely to support any filings to an Agency for Key Approval to Commercialize Licensed Product in the Field in the Territory and shall in no event be permitted to use any such WHO Prequalification or SRA approval as the basis of, or for a reference to, support for any filings to an Agency for Key Approval to Commercialize Licensed Product outside the Field and/or outside the Territory.
Licensee agrees that it will manufacture the Compound and Licensed Product in a manner consistent with (a) WHO Prequalification standards; or (b) the standards of any SRA.
Licensee agrees that it: (a) subject to Section 3.8, will not sell any Licensed Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA; and (b) will comply with applicable regulatory requirements in the country of manufacture and the country of sale.
Licensee shall submit a complete file for WHO Prequalification or any SRA approval within thirty- six (36) months after the Effective Date for any existing formulation of the Licensed Products, or within a period to be agreed among Shionogi, MPP and Licensee for any new formulation of the Licensed Product.
WHO / US FDA / CE certification / WHO Prequalification / Prequalification by Provincial or Federal Institutes.