Product Registration means, with respect to a Licensed Product, a NDA approved by the FDA in the United States or any other government approval required by a government or Regulatory Authority of a country in the Territory necessary to permit the marketing, import, use and sale of a Licensed Product in such country. Product Registration shall include governmental approval of pricing and/or reimbursement in jurisdictions where such approval is required (either legally or commercially) for commercial sale of a Licensed Product.
Product Registration means, with respect to a Product in a particular country or territory, the registration or regulatory approval granted by the applicable governmental authority in such country or territory allowing for such Product to be marketed, distributed, sold or imported there.
Product Registration means any permit, approval, authorization, clearance, qualification, designation, licensure, registration, or marketing or other authorization or notarization by the U.S. Food & Drug Administration (FDA) or comparable Governmental Entity, in each case as necessary to market, promote, or sell any Product.
Examples of Product Registration in a sentence
Unless otherwise revoked, this EUA shall be valid only within the duration of the declared public health emergency due to COVID-19, or upon issuance of a marketing authorization/Certificate of Product Registration.
Take container, label or product name and Pest Control Product Registration Number with you when seeking medical attention.
Dealer must attach the Warranty Start Form to the Product Registration screen in OWL.
Valid Product Registration certificate issued by the DRAP where applicable.ii.
Product Registration is required for all packaged food products in Guatemala.
More Definitions of Product Registration
Product Registration means such approval as may be granted by a relevant regulatory authority to use, sell, supply, advertise or store a certain plant protection product or fertilizer in a particular jurisdiction;
Product Registration means the approvals, permits, applications, licenses or registrations (including but not limited to the NDA) for the Product which have been received in order to market or sell same in the Territory.
Product Registration means permission from any governmental authority allowing a device or a software to be lawfully distributed for commercial use in a country, including establishment registration and device or software listing with the Federal Communications Commission.
Product Registration means a list of all governmental authorizations granted to Seller by, or applications therefor pending with, any Governmental or Regulatory Authority in the Territory to manufacture, market, import, distribute and/or sell any of the Products in the Territory, except for those Governmental or Regulatory Authority authorizations that the failure to possess would not be material to the operation of the business related to the Products taken as a whole.
Product Registration means a recognition granted to regulated product in accordance with set requirements;
Product Registration means with respect to any country, the registrations, permits, licenses, consents, authorizations and other approvals and pending applications and requests therefor, required by applicable Governmental Authorities relating to the marketing, sale, distribution, pricing and reimbursement of the Product in such country, including, without limitation, INDs and NDAs, marketing authorizations, and any supplements or amendments to any of the foregoing, and any other equivalent of the foregoing, in each case whether now existing or owned or hereafter arising or acquired for the Product, including, without limitation, those listed on Schedule IV of the Security Agreement, and including all filings and files with respect thereto, including, without limitation, all documents referred to in the complete regulatory chronology for each Product registration.
Product Registration in relation to the Product means a New Drug Application submitted to the United States Food and Drug Administration and/or its equivalent in other countries of the Territory submitted to a Regulatory Authority, including any amendments or supplements.