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 a regulatory dossier prepared for a Product (in the case of the Product Ethyol, claiming protection against hematological toxicities associated with the use of alkylating agent(s), including cyclophosphamide) 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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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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Examples of Health Registration Dossier in a sentence

  • 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.

  • If the Parties determine that the development schedule cannot be accelerated and that the review period for the Health Registration Dossier by the PAB is not likely to be significantly shorter than the period set forth in this subsection, then the Parties will cooperate and use their Best Efforts to approach E.

  • In the event that the submission of such Health Registration Dossier in Japan is delayed more than twelve (12) months beyond such date or such extended date, the Parties shall confer and discuss in good faith the causes and potential solutions for such failure.

  • Notwithstanding Kissei's Best Efforts, if the submission of such Health Registration Dossier in Japan is delayed beyond such date, the Parties shall consult with one another on modification of such date.

  • In the event that the submission of such Health Registration Dossier in Japan is delayed more than twelve (12) months beyond such date, and for so long thereafter as such delay shall continue, MGI may elect to terminate this Agreement pursuant to Section 12.2, regardless of whether the delay is due to Kissei's fault or not.

  • 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.

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

  • 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.

  • 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.

  • 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).

Related to Health Registration Dossier

  • Product Registrations means the approvals, licenses, registrations, listings, franchises, permits, certificates, consents, clearances, or other authorizations (including, but not limited to, NDAs and NDSs) and comparable regulatory filings required by any Governmental Authority for the Products held in Sellers’ name as set forth in Schedule 1.1(d).

  • 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 of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • 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.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Registration decal means an adhesive sticker produced by the department and issued by the

  • 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.

  • Provisional registration means a building official, plan reviewer, or inspector who is registered subject to his or her completion of the amount of training, education, and experience required by the commission and the appropriate advisory board and described in section 1007(2).

  • 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, with respect to a country, region or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorisations of any Regulatory Authority necessary to commercially distribute, sell, or market Product in such country or other jurisdiction, including, where applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite manufacturing approval or authorisation related thereto), and (b) approval of Product labelling.

  • Registration Process means the online account opening procedure followed by the Client in order to open a trading account with the Company.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • 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;

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

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

  • certificate of registration means registration with the College that allows the Participant to practise 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.