Dossier definition

Dossier means a copy of the complete registration file, as prepared for filing in the EU by Alvotech (or on behalf of Alvotech), including but not limited to any and all documentation, data, information, reports, case reports, clinical and non-clinical reports, sheets, correspondence with the Health Authorities, and approval documents, for the Product(s) for All Indications in accordance with the requirements, valid at the date of submission, of the CHMP regulatory guidelines in the EU and prepared in electronic Common Technical Document (e-CTD) format and English language for obtaining and maintaining MA’s in the EU.

Dossier means the document that is filed with and approved by a government or health authority for purposes of Registration, for example, a Marketing Authorization Application.

Dossier means the dossier of information and data filed, or to be filed with BfArM in relation with the application for Marketing Authorisation in Germany and other countries in the European Union or with a comparable Regulatory Authority, including any amendments thereto;

Examples of Dossier in a sentence

• The Tender Dossier issued to the Tenderer, including any amendments instructed in an Addendum to Tender Dossier, shall be used without further changes.

• 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.

• A substantially responsive tender is a tender compliant with all the terms, conditions, and specifications of the Tender Dossier without material deviation or reservation.

• Requests for clarification and responses shall be sent to all prospective Tenderers who received the Tender Dossier, but shall not constitute amendments to the Tender Dossier.

More Definitions of Dossier

Dossier means the information and data for the Product in a country in CTD Format (or otherwise) and as registered with a Regulatory Authority for the Regulatory Approval containing the administrative, safety, efficacy, quality, non-clinical and clinical data, chemistry and manufacturing control data and communications with the Regulatory Authority for the Product as it may change from time to time.

Dossier means performance appraisal dossier;

Dossier means (i) the dossier for a Product, including all contents, related data and CTD format and in all applicable forms that will be filed with any relevant Regulatory Authorities by Licensor following successful completion of the Phase III clinical trials for the Product, including all supporting documentation and (ii) the dossier for a Product as approved by a relevant Regulatory Authority from time to time.

Dossier means the complete dossier of data, information and Know-How relating to the applicable Product, as will become available from Alvotech following conduct of the Development Plan in e-CTD format according to the European Union requirements;

Dossier in support of their reappointment or promotion.

Dossier means the tenure dossier as provided for in the Regulations Relating to the Employment of Tenure Track and Tenured Academic Staff and the Regulations Relating to the Employment of Librarian Staff.

Dossier means the A Product and/or B Product and/or C Product registration file, as the case may be, which shall contain all necessary information and data, including without limitation pharmacokinetic and stability studies, expert reports, the open part of the Drug Master File, to be submitted to the Regulatory Authorities in order to obtain the Marketing Authorisation for such Product in the Territory.