Regulatory Dossier definition

Regulatory Dossier means the technical, medical and scientific registrations, authorizations and approvals (including approvals of NDAs, supplements and amendments, pre- and post- approvals, pricing and Third Party reimbursement approvals, and labeling approvals) of any Regulatory Authority necessary for the Development (including the conduct of clinical studies), Manufacture, distribution, marketing, promotion, offer for sale, use, import, reimbursement, export or sale of a product in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each NDA, including all Regulatory Materials and drug master file(s) (if any).

Regulatory Dossier has the meaning set forth in Section 6.3.1.

Regulatory Dossier means in relation to the Product and/or Optional Product, the technical registration dossier produced in relation to that Product and/or Optional Product (including any and all information, processes, techniques, data and Intellectual Property Rights) in an electronic format which allows for compilation into the relevant country format according to the regulatory requirements necessary to obtain and maintain Marketing Authorizations for the relevant Product in any country in the Territory and outside of the Territory.

Examples of Regulatory Dossier in a sentence

• Each Party (and where appropriate its Sublicensees) shall be entitled, without the approval or consent of the other Party, to have full access to the Regulatory Dossier submitted to the FDA and the EMA by Entasis, to use it with any Drug Regulatory Authority in its Territory and to exercise its licensing rights (including sublicensing rights in accordance with this Agreement.

• The composition of Products to be said in the EU / U.S. will be as stated in the applicable Product DMF / ANDA / NDA and European Regulatory Dossier, as applicable.

• DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.

• The Company hereby continues to employ Employee and Employee hereby accepts the continued employment with the Company for the Term (as defined below), in the position and with the duties and responsibilities set forth in Section 3 below, and upon the other terms and subject to the conditions hereinafter stated.

• Each Party will, on the reasonable request from the other Party, remove from any proposed manuscript or presentation any Confidential Information of the other Party provided that neither Party will be prevented from publishing Confidential Information of the other Party (and in particular clinical data) to the extent that publication of such Confidential Information is required for any Regulatory Dossier or in order to obtain a Marketing Authorisation.

More Definitions of Regulatory Dossier

Regulatory Dossier means a dossier which contains all the relevant information relating to a drug which is required by the EMEA or by the FDA, as the case may be; such dossier will normally contain information about the chemistry, formulation, manufacture, toxicology, pharmacology, pharmacokinetics and clinical studies related to a drug;

Regulatory Dossier means all files regarding the Regulatory Approvals, including but not limited to correspondence, records, applications (including without limitation ANDAs), supplements, annual reports, adverse event reports, clinical studies and pre-clinical studies to the extent related to the Product.

Regulatory Dossier means the technical, medical and scientific registrations, authorizations and approvals (including, without limitation, approvals of NDAs or foreign equivalents, supplements and amendments, pre- and post- approvals, pricing and third party reimbursement approvals, and labeling approvals) of any Regulatory Authority necessary for the development (including the conduct of clinical trials), manufacture, distribution, marketing, promotion, offer for sale, use, import, reimbursement, export or sale of a Subject Product in the Field in a regulatory jurisdiction in the Territory, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each NDA or foreign equivalent, including the IND, NDA and supplemental new drug applications (sNDAs), or foreign equivalents in the Territory.

Regulatory Dossier means the technical, medical and scientific registrations, authorizations and approvals (including approvals of NDAs, supplements and amendments, pre- and post- approvals, pricing and Third Party reimbursement approvals, and labeling approvals) of any Regulatory Authority necessary for the Development (including the conduct of clinical trials), Manufacture, Commercialization (including distribution, marketing, promotion, offer for sale, use, import, reimbursement, export or sale) of a product in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each NDA, including all Regulatory Materials and drug master file(s) (if any).

Regulatory Dossier means all regulatory documents and filings registered with a Drug Regulatory Authority for a Marketing Authorisation containing the administrative, safety, efficacy, quality, non-clinical and clinical data and CMC data for the Drug Product as it may change from time to time;

Regulatory Dossier means that portion of the Pozen Know-How consisting of data Controlled by Pozen which may be relevant to a Marketing Authorization Application for the Product in the Territory in the Field.

Regulatory Dossier means: (a) all MAs filed with a Regulatory Authority and all corresponding or related pre-MA and post-MA filings with, and approvals and authorizations issued by, any Regulatory Authority pertaining to the Licensed Formulation; (b) all corresponding technical and regulatory registrations necessary for the conduct of clinical trials of the Licensed Formulation, and the manufacture, labeling, distribution, marketing, sale, use, import, reimbursement, or export of the Licensed Formulation in the jurisdiction of a Regulatory Authority; and (c) all MA Approvals of any Regulatory Authority.