Master Alliance Provisions Guide (MAPGuide)

Dominican Republic Ministry of Health – Pfizer/BioNTech, COVID-19 Vaccine Binding Term Sheet

  • Other | Regulatory strategy

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The Vaccine is a two (2) dose regimen in a non-preserved multi-dose vial configuration. Pfizer and BioNTech (a) have obtained conditional approval for the Vaccine granted by (i) The United States Food and Drug Administration (the federal agency of the United States Department of Health and Human Services) and (ii) the European Commission (subsection (i) and (ii) each a “Regulatory Approval”) and b) anticipate obtaining via an appropriate regulatory mechanism (Special Import Permit and the emergency use authorization by the Ministry of Public Health and Social Assistance of Dominican Republic (“MISPAS’s Regulatory Approval”) that allows the Vaccine to be placed on the market in the Dominican Republic (“Regulatory Approval” and “MISPAS’s Regulatory Approval” are collectively referred to as “Conditional Approval”).  For clarity, the MISPAS’s Regulatory Approval includes obtaining all the requirements and shall not be considered granted unless all of the following two have been issued:  Special Import Permit and the Emergency Use Authorisation.