Market Authorization Approval definition

Market Authorization Approval means applications to market a new drug. Such applications document safety and efficacy of the investigational drug and contain all the information collected during the drug development process. At the conclusion of successful preclinical and clinical testing, this series of documents is submitted to the FDA in the U.S. or EMA in Europe or to the applicable regulatory authorities in other countries. The application must present substantial evidence that the drug will have the effect it is represented to have when people use it or under the conditions for which it is prescribed, recommended or suggested in the labeling.
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Market Authorization Approval means the approval by all relevant Governmental Authorities of a Marketing Authorization Application in a given country or regulatory jurisdiction (but which will not include any Pricing and Reimbursement Approvals).
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Examples of Market Authorization Approval in a sentence

  • JULPHAR shall correct any deficiencies of such audit observations identified by any Governmental Authority in a prompt and efficient manner so as to prevent any delay in DANCE obtaining Market Authorization Approval for the Product or in the shipment of any Product ordered by DANCE.

  • JULPHAR shall provide the appropriate authorizations to each applicable Governmental Authority allowing DANCE the right to reference all Drug Master Files to apply for, obtain and maintain any Market Authorization Approval or other regulatory approvals for the Product.

  • Pfizer shall not be obliged to commence its detailing and promotional efforts in a country of the Pfizer Commercialization Territory until after the Product has received a Market Authorization Approval (as opposed to an Emergency Use Authorization) and recommendations from the applicable Vaccine Technical Committee in such country.

  • DONGBAO shall provide the appropriate authorizations to each applicable Governmental Authority allowing DANCE the right to reference all Drug Master Files to apply for obtain and maintain any Market Authorization Approval or other regulatory approvals for the Product.

  • BioNTech shall not be obliged to commence its detailing and promotional efforts in a country of the BioNTech Commercialization Territory until after the Product has received a Market Authorization Approval (as opposed to Emergency Use Authorization) and recommendations from the applicable Vaccine Technical Committee, if any, in or for such country.

  • Interquim shall provide the appropriate authorizations to each applicable Governmental Authority allowing Company the right to reference all Drug Master Files to apply for, obtain and maintain any Market Authorization Approval or other regulatory approvals for the Product.

  • Company shall submit the appropriate regulatory filings to include a Second Facility Site to manufacture the API of the Final Drug Product into the corresponding NDA, Market Authorization Approval or other regulatory approvals without unreasonable delay not later than six (6) months after Interquim’s notification date of submission to the FDA of all the information related for the validation of the process to include a Second Facility Site in order to amend the current DMF.

  • DONGBAO shall correct any deficiencies of such audit observations identified by any Governmental Authority in a prompt and efficient manner so as to prevent any delay in DANCE obtaining Market Authorization Approval for the Product or in the shipment of any Product ordered by DANCE.

  • AERO PUMP shall provide the appropriate authorizations to each applicable Regulatory Authority allowing DANCE the right to reference all Drug Master Files to apply for, obtain and maintain any Market Authorization Approval or other regulatory approvals for the Product developed, manufactured and/or commercialized by DANCE.