WHO Prequalification definition

WHO Prequalification means a service provided by WHO to assess the quality, safety, and efficacy of medical products for priority diseases, and which are intended for United Nations and international procurement to developing countries.
Sample 1Sample 2Sample 3
WHO Prequalification. Programme means the programme managed by WHO which prequalifies (a) Medicines that are considered to be acceptable for procurement by the United Nations and specialized agencies; and (b) Quality Control laboratories for Medicines.
Sample 1Sample 2Sample 3
WHO Prequalification means a service provided by WHO to assess the quality, safety and efficacy of medical products for priority diseases, and which are intended for United Nations and international procurement to developing countries.
Sample 1Sample 2Sample 3

Examples of WHO Prequalification in a sentence

  • Quoted product must have WHO Prequalification /JpMHLW/EMA/US FDA approval.

  • 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.

  • 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.

  • Manufacturing process The manufacturing site and process used for the pharmaceutical product must comply with current Good Manufacturing Practice (cGMP) requirements, as evidenced by GMP certificate and/or inspection report issued by the WHO Prequalification Team: Medicines (PQTm), an SRA, a Pharmaceutical Inspection Co-operation Scheme (PIC/S) member inspectorate, or a recognized NMRA or regional registration harmonization initiative.


More Definitions of WHO Prequalification

WHO Prequalification means listing of the Vaccine on the list of prequalified medicines maintained by the WHO.
Sample 1Sample 2
WHO Prequalification means the positive written advice provided by the WHO to United Nations agencies of the acceptability of Covid Vaccine for purchase by United Nations agencies and the inclusion of Covid Vaccine on the list of pre-qualified vaccines for such purchase.
Sample 1Sample 2

Related to WHO Prequalification

  • Prequalification means the process set out in the Rules for determining whether an applicant is eligible to bid in a capacity auction in respect of a CMU;

  • Qualification Date means the date as of which the Offering Statement was or will be qualified with the Commission pursuant to Regulation A, the Act and the Rules and Regulations; and

  • pre-qualification means the first stage of the Bidding Process involving the submission, opening and evaluation of the Qualification Documents submitted by the Prospective Bidders.

  • Qualification Period means the period of time in which the List of Approved Suppliers shall be valid in accordance with the Tender; in which the Company shall have the right, at any time to issue Purchase Order(s) for Goods and/or to approach any or all of the Approved Suppliers and invite them, by way of RFQ to supply Goods, all in accordance with the terms and conditions of the Contract.

  • Qualifications , in relation to an employee, means any degree, diploma or other academic, technical or professional qualification relevant to the position which he held.

  • Minimum Qualifications are qualifications mandated for the position and which must be possessed by an employee before he/she can be considered for employment in a specific class.

  • Qualification Requirements means the qualification requirements as set forth in Section-2, Clause 2.1 of RFQ;

  • Monthly Qualification Cycle means a period beginning one (1) day prior to the first day of the current Statement Cycle through one (1) day prior to the close of the current Statement Cycle.

  • Request For Qualifications (RFQ means the written solicitation, including all Addenda thereto, issued by the Department seeking SOQs in order to identify and Short-List the Proposers to receive the RFP for the Project.

  • Request for Qualifications means all materials and

  • Qualification means any degree, diploma or certificate conferred upon a person after having been examined in respect of that person’s proficiency in a particular field of study;

  • Qualification Deadline has the meaning set forth in Section 2(a)(ii).

  • Disqualification means the Athlete’s results in a particular Competition or Event are invalidated, with all resulting Consequences including forfeiture of any medals, points and prizes;

  • Impermissible Qualification means, relative to the opinion or certification of any independent public accountant as to any financial statement of any Obligor, any qualification or exception to such opinion or certification

  • Statement of Qualifications means a written statement submitted to a procurement unit in response to a request for statement of qualifications.

  • TLAC Disqualification Event means OSFI has advised the Bank in writing that the bail-inable notes issued under the applicable pricing supplement will no longer be recognized in full as TLAC under the TLAC Guideline as interpreted by the Superintendent, provided that a TLAC Disqualification Event will not occur where the exclusion of those bail-inable notes from the Bank’s TLAC requirements is due to the remaining maturity of those bail-inable notes being less than any period prescribed by any relevant eligibility criteria applicable as of the issue date of those bail-inable notes.

  • Nondisqualification Opinion An Opinion of Counsel, prepared at the Trust’s expense and payable from the Collection Account, that a contemplated action will not cause (i) either the Lower-Tier REMIC or the Upper-Tier REMIC to fail to qualify as a REMIC or (ii) a “prohibited transaction” or “prohibited contributions” tax to be imposed on either the Lower-Tier REMIC or the Upper-Tier REMIC at any time that any Certificates are outstanding.

  • Specific Nomination Factors means the nomination factors set out in clause 4.3.

  • Statewide special election means a special election called by the governor or the

  • MREL Disqualification Event means that, at any time, all or part of the outstanding nominal amount of Securities is or will be excluded fully or partially from the eligible liabilities available to meet the MREL Requirements provided that: (a) the exclusion of a Series of such Securities from the MREL Requirements due to the remaining maturity of such Securities being less than any period prescribed thereunder, does not constitute a MREL Disqualification Event; (b) the exclusion of all or some of a Series of Securities due to there being insufficient headroom for such Securities within a prescribed exception to the otherwise applicable general requirements for eligible liabilities does not constitute a MREL Disqualification Event; and (c) the exclusion of all or some of a Series of Securities as a result of such Securities being purchased by or on behalf of the Issuer or as a result of a purchase which is funded directly or indirectly by the Issuer, does not constitute a MREL Disqualification Event.

  • Qualification Defect With respect to a Mortgage Loan, (a) a defective document in the Mortgage File, (b) the absence of a document in the Mortgage File, or (c) the breach of any representation, warranty or covenant with respect to the Mortgage Loan made by the Company, but, in each case, only if the affected Mortgage Loan would cease to qualify as a “qualified mortgage” for purposes of the REMIC Provisions.

  • Licensure means the status of a licensee when OCCL issued a child care license when the applicant demonstrated compliance with these regulations and applicable codes, regulations, and laws.

  • Local special election means a special election called by the governing body of a

  • Disqualification Event has the meaning set forth in Section 4.2.4.

  • type-approval means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

  • Institutional Review Board or “IRB” means, in accordance with 45 C.F.R. Part 46, 21 C.F.R. part 56, and other applicable regulations, an independent body comprising medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of the Human Subjects involved in a study.