PMDA Approval definition

PMDA Approval means Approval by the PMDA of a MAA filed with the PMDA for the applicable Licensed Product in Japan.
Sample 1Sample 2Sample 3
PMDA Approval means a Ninsho approval or Xxxxxx approval, as applicable, by the Japanese PMDA, signifying clearance to sell a particular Product within Japan.
Sample 1

Examples of PMDA Approval in a sentence

  • This Agreement shall continue in force until the fifth (5th) anniversary of the Products PMDA Approval Date, unless terminated earlier under the provisions of this Section 8.

Related to PMDA Approval

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • MAA Approval means the Approval of an MAA by the EMA for a Product in any country in the EU.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).