Health Registration Dossier definition

Health Registration Dossier means all documentation which is now or shall hereafter be on file with the FDA or other applicable governmental agency, which comprises the information and data submitted to such agency in support of an application made by ILEX, MGI, or a sublicensee of MGI or ILEX, to such agency for Marketing Authorization for a Product to treat any Indication.
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Health Registration Dossier means all documentation which is now or shall hereafter be on file with the FDA, or any Competent Authority, which comprises the information and data submitted to such agency in support of an application made by either Party, or a Sublicensee of either Party, to such agency for Marketing Authorization for any Licensed Product for treatment of any Indication.
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Health Registration Dossier means a regulatory dossier prepared for a Product for filing with the Committee for Proprietary Medicinal Products, the United States Food and Drug Administration, the Canadian Health Protection Board, or any other country mutually acceptable to LICENSOR and LICENSEE.
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Examples of Health Registration Dossier in a sentence

  • MGI shall provide to Kissei, if it has not already done so during the term of the Option Agreement, a copy in English of any documentation contained in or prepared for MGI's Health Registration Dossier for the Xerostomia Indication, within thirty (30) days after the Effective Date.

  • Within sixty (60) days after such submission (except if an earlier time frame is provided in Section 3.6(b)), Kissei shall provide MGI with a copy in English of (i) a summary of such Health Registration Dossier and (ii) a list of sections of the Health Registration Dossier which are contained within the Health Registration Dossier.

  • MGI shall also provide a copy in English of any new documentation which is added to the Health Registration Dossier after the Effective Date within thirty (30) days after the date on which MGI submits such documentation to the FDA or other Competent Authority, subject to the provisions of Section 3.6(b).

  • MGI shall determine the priority of translation into English of the various sections of such Health Registration Dossier, or amendment or supplement thereto.

  • MGI warrants that the manufacture of Bulk Drug Substance supplied hereunder shall be in strict conformity with Good Manufacturing Practices, and in accordance with the manufacturing information contained in the Health Registration Dossier for the Product for which such Bulk Drug Substance is to be used, as filed with a Competent Authority in the Territory under the terms of the Development, Marketing and Cooperation Agreement.

  • Kissei shall thereafter have the Health Registration Dossier, or amendment or supplement thereto, translated into English according to the priority established by MGI and shall provide MGI with a copy of such English translation as soon as practicable.

  • If MGI determines at any time that a particular section of such Health Registration Dossier, or amendment or supplement thereto, is needed on an accelerated basis, the Parties shall work together to revise the translation schedule to accommodate MGI's needs as the Parties shall mutually agree.

  • CIBA Vision shall provide to MGI complete and accurate copies of all documentation contained in CIBA Vision's or its Sublicensee's Health Registration Dossier, within reasonable time, but no more than sixty (60) days.

  • Kissei shall provide MGI with a complete copy of the Health Registration Dossier for any Indication, or any amendment or supplement thereto, immediately upon filing of the Health Registration Dossier with the PAB or other Competent Authority in the Territory, in the language it is written in for filing.


More Definitions of Health Registration Dossier

Health Registration Dossier means all documentation which is now or shall hereafter be on file with the FDA, the PAB or any other Competent Authority in any country other than Japan in the Territory, which comprises the information and data submitted to such agency in support of an application made by either Party, or a permitted sublicensee of either Party, to such Competent Authority for Marketing Authorization for a Licensed Product to treat any Indication.
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Related to Health Registration Dossier

  • Product Registrations means the Regulatory Approvals necessary to permit the development, manufacture, marketing, import, distribution, or sale of the Products.

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Business registration means a business registration certificate issued by the Department of the Treasury or such other form or verification that a contractor or subcontractor is registered with the Department of Treasury;

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory 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).

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • Company IP Registrations means all Company Intellectual Property that is subject to any issuance registration, application or other filing by, to or with any Governmental Authority or authorized private registrar in any jurisdiction, including registered trademarks, domain names and copyrights, issued and reissued patents and pending applications for any of the foregoing.

  • international registration means the registration of a mark effected under the Agreement or the Protocol or both, as the case may be;

  • Registration Data means certain personal and financial information that you are required to provide in order to download and use the Trading Platform and become our Client including Account Credentials, such information can include without limitation a copy of your passport, driving license and/or Photo identity card.

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • International registration plan means a reciprocal agreement of member jurisdictions that is endorsed by the American association of motor vehicle administrators, and that promotes and encourages the fullest possible use of the highway system by authorizing apportioned registration of fleets of vehicles and recognizing registration of vehicles apportioned in member jurisdictions.

  • Registration Form means a book voter registration form and a by-mail voter

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • certificate of registration means registration with the CPSBC that allows the Participant to practice medicine in British Columbia, other than the certificate of registration which allowed the Participant to enrol in Postgraduate Medical Education;

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Regulatory Authorities means the Commissions and the Exchange;