Market Authorization definition

Market Authorization means an official document issued by the Authority for the purpose of marketing or free distribution of the product in Ethiopia;
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Market Authorization means that specific Regulatory Approval issued by a Regulatory Authority in a jurisdiction to register the Product and required for Commercialization in such jurisdiction, but excluding any pricing or reimbursement approval.
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Market Authorization means approval by one or more Regulatory Authorities to market, sell and distribute the Drug Product in any part of the world.
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Examples of Market Authorization in a sentence

  • Supplier shall have the right to modify the Product packaging and labeling at any time, including, without limitation, to address modifications required or suggested by the relevant Government Authority issuing the Market Authorization.

  • Subject to the supervision of the Operations Committee, consistent with the license grants of Article 9 and except as otherwise provided herein, Crucell shall fund and be responsible for the preparation and submission of Regulatory Filings, including Market Authorization Application and Clinical Trial Applications, relating to Licensed Products in its own name with Regulatory Authorities in the Territory.

  • Labeling and packaging printing shall include any information required by local authorities under the Registration and Market Authorization.

  • It shall automatically expire when the Nominee transfer the Market Authorization to Cytovia or any of its Affiliate pursuant to clause 2.3.

  • In the event an Approved Local Distributor fails to comply with any terms of this Agreement, the Licensor shall have the right to withdraw its approval of such Approved Local Distributor with immediate effect by providing written notice to the Licensee, who will ensure that the Approved Local Distributor withdraws or otherwise doesn’t make use of the Market Authorization obtained in the name of the Approved Local Distributor.

  • JULPHAR agrees to provide to DANCE, as requested, with all information and data in JULPHAR’s possession or control for DANCE to obtain and maintain Market Authorization Approvals for the Product in any country, including information relating to the Production Site, or the methodology, raw materials used in the manufacture, processing or packaging of API, or any other matters, if proven by DANCE, that are required or requested to be provided to the EMA, FDA or any other Governmental Authority.

  • BNI shall use its best efforts to have the Amended FDA Market Authorization License (as defined herein) approved by the U.S. FD&A as soon as practicable.

  • The Lead Regulators will use their best efforts to complete this examination by July 1, 2007.

  • In all events such Amended FDA Market Authorization License approved by the U.S. FDA shall be approved prior to [date] (the “Amended Market Authorization Deadline”).

  • DISTRIBUTOR shall provide SUPPLIER with prior written notice of its contacts, liaisons, discussions, meetings, and correspondence with, and submissions to, any Government Authority to the extent relating to, or otherwise affecting, the Market Authorization of each Product (“Regulatory Correspondence”) and shall provide details of what will be, and what was, covered in such Regulatory Correspondence.


More Definitions of Market Authorization

Market Authorization means the valid documented approval by the Registration Authority in each of the Countries, or groups of Countries where applicable, within the Territories permitting Kuhnil to commence selling, marketing and distribution of the Products.
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Market Authorization means the valid documented approval by the Registration Authority in each Country within the Territory permitting SOI to market, sell and distribute the Product. April 16th, 2007 2
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Market Authorization means the valid documented approval by the Registration Authority in each Country within the Territory permitting OA to commence selling, marketing and distributing the Product
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Market Authorization means appropriate authorization for commercialization of the Products received from the relevant regulatory body.
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Market Authorization means any approved Marketing Application promulgated by Regulatory Authorities.
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Market Authorization means registration of a veterinary medicine by the Council and the issuance of a registration certificate under regulation 23;
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Related to Market Authorization

  • Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Standard Body necessary for the manufacture, development, distribution, use storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • Sell Authorization means that Partner needs to meet specific training and qualification requirements for the products included in an “On Premise” Product Family that Partner wants to resell as set out in detail in the PartnerEdge Program Guide and the applicable RSPI.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority.

  • 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).

  • Prior authorization means that we must approve the Services in advance in order for the Services to be covered.