Examples of WHO Prequalification in a sentence
Quoted product must have WHO Prequalification /JpMHLW/EMA/US FDA approval.
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 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 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.
Only those products listed on the WHO Prequalification Program website under the section: Manufacturers & Vendors whose Tuberculosis medicines have been found acceptable, in principle, for procurement by UN Agencies can be considered WHO Pre-qualified and claimed as such by the Contractor of the product which claim is attributed.
Certificate of conformance CE Mark (SRA), US FDA clearance (PMA/510K) or WHO Prequalification, or other when specified above in “Product Quality Standards by Product Category” The following product documentation is requested as part of the procurement process: • A certificate of analysis/conformance for each lot shall be provided as specified in product quality standards section • Additional product documentation may be requested.
Risk Based Classification of Diagnostics for WHO Prequalification.
Attachments in electronic format that are larger than 8MB should be submitted on CD/DVD, or else be printed and sent by courier or surface mail to the relevant PQ Group Lead, WHO Prequalification Team, World Health Organization, 20 avenue Appia, 1211 Geneva, Switzerland.
The assessment was done according to SOP 20 of the WHO Prequalification programme.