Registration Dossier definition

Registration Dossier means a technical dossier of a Substance which includes the Core Data;

Registration Dossier means a written regulatory submission or document describing Product Specifications and manufacturing methods as submitted by Company and approved by the applicable regulatory agency and Distributor.

Registration Dossier means the registration files, as compiled and owned by Supplier, containing all information, processes, techniques and documentation according to the current requirements of applicable laws and regulations in the Territory, as far as is necessary or beneficial for obtaining and maintaining a Marketing Authorization for the Product in the Territory.

Examples of Registration Dossier in a sentence

• No warranty for acceptance by the Agency of the Joint Registration Dossier or any data it contains is given.

• Whereas the Non-Lead Member has the intention to register the Substance and he is willing to appoint the Lead Registrant as lead registrant in order to have him to submit the Joint Registration Dossier.

• This Agreement does not grant any ownership rights or change existing ownership rights to any of the Information provided under this Agreement to the Non-Lead Member, on whatever form and whenever, by the Lead Registrant, including without limitation, the Joint Registration Dossier.

• The participation in the Joint Registration Dossier may deviate per requesting Non-Lead Member according to its tonnage band or possible opt-outs for certain endpoints.

• Each Party having submitted a study which has been used in the Joint Registration Dossier represents to the others (i) that it is the rightful owner of the study(ies) and free to grant rights therein, (ii) that, to the knowledge of this Party, these studies do not infringe on the rights, in particular, but without limitation, intellectual property rights, of any third party and (iii) that this Party has not received a claim or notice of any alleged infringement.

More Definitions of Registration Dossier

Registration Dossier means all written pertinent and necessary information in such detail as currently requested by the FDA in order to grant authorization for sale and marketing of the Licensed Product and including all technical and scientific information in written form, acquired and/or developed by Rosemont relating to active ingredients of the Licensed Product;

Registration Dossier means, with respect to the Product, the package of technical and clinical information and data concerning such Product (and relevant manufacturing site) that is prepared by Allergan or its Affiliates for use in seeking any relevant Regulatory Approval.

Registration Dossier means the registration dossier designed to support Marketing Approval by the FDA and Marketing Approval in the EU (excluding any country-specific approvals for pricing or reimbursement).

Registration Dossier means any pre-clinical, clinical, medical, scientific an technical information relating to the Product and contained in the registration dossier prepared or to be prepared by ANESIVA in order to file an application to obtain a Registration under the decentralized procedure in accordance with: ii) EU standards; and any and all EU regulations and directives currently in force;

Registration Dossier means the registration dossier of technical data and information compiled by or on behalf of DS with respect to a Licensed Product submitted to a Regulatory Authority to obtaining Regulatory Approval of a Licensed Product in the Field in the DS Territory.

Registration Dossier means all data and information (including, but not limited to, composition, method of manufacture, analytical procedures, cell lines and other genetic material, and field trial reports) required for an application for a Product Licence by the applicable Regulatory Authority;

Registration Dossier means the registration document that was submitted to the BIE General Assembly and approved at the 167th session;