Applications for AMC eligibility

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Applications for AMC eligibility

On 15 January 2010, Pfizer Inc. submitted an application for AMC Eligibility to the AMC Secretariat for the pneumococcal vaccine Prevenar 13. In accordance with the AMC legal agreements, copies of this application were sent to the Independent Assessment Committee. An AMC Eligibility Determination Meeting will be scheduled within 30 business days when the candidate vaccine meets WHO prequalification to review such application. Pfizer's Prevenar 13 received WHO prequalification on 19 August 2010. An AMC Eligibility Determination Meeting was scheduled on 23 August 2010 to review the application and determine if the candidate product met the AMC Target Product Profile (TPP). See summary of meeting

On 9 March 2010, GlaxoSmithKline (GSK) Biologicals submitted an application for AMC Eligibility to the AMC Secretariat for the Synflorix 2 dose presentation vaccine. In accordance with the AMC legal agreements, copies of this application were sent to the Independent Assessment Committee. GSK's Synflorix 2 dose presentation vaccine received WHO prequalification on 19 March 2010. An AMC Eligibility Determination Meeting was scheduled on April 16 2010 to review such application and determine if the candidate product meets the AMC Target Product Profile (TPP). See summary of meeting

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