Registration file definition

Registration file means the set of documents that were submitted according to the regulatory standards of the Territory in order to obtain the Marketing Authorizations in the Territory and approved as the reference documentation. «Регистрационное досье» означает комплект документов, предоставляемых (в соответствии с нормативными требованиями, действующими на Территории) для получения Регистрационных удостоверений на Территории, а также документы, одобренные в качестве нормативной документации.

Registration file means the application for registration, supporting materials, annual reports, and amendments that constitute all information submitted and reviewed pertaining to a particular time-share program, time-share project, alternative purchase, exchange company, or time-share reseller registration. A document that has not been accepted for filing by the board is not part of the registration file.

Registration file means all the information, including regulatory, technical and clinical data, concerning the PRODUCT and that have been required to obtain the PRODUCT NDA.

Examples of Registration file in a sentence

• THESE MATERIALS ARE BEING MADE AVAILABLE TO EACH PROSPECTIVE INVESTOR IN CONNECTION WITH SUCH PROSPECTIVE INVESTOR’S FREE WRITING PROSPECTUS FILED PURSUANT TO RULE 433 REGISTRATION FILE NO.: 000-000000-00 IMPORTANT NOTICE REGARDING THE CERTIFICATES Investors are urged to read the final prospectus relating to these securities because it contains important information regarding the offering that is not included herein.

• FREE WRITING PROSPECTUS FILED PURSUANT TO RULE 433 REGISTRATION FILE NO.: 000-000000-00 COMM 2015-CCRE22 The depositor has filed a registration statement (including a prospectus) with the Securities and Exchange Commission (File No. 333-193376) for the offering to which this communication relates.

• FREE WRITING PROSPECTUS FILED PURSUANT TO RULE 433 REGISTRATION FILE NO.: 000-000000-00 IMPORTANT NOTICE REGARDING THE CONDITIONS FOR THIS OFFERING OF ASSET-BACKED SECURITIES The securities offered by these materials are being offered when, as and if issued.

• IX.1 IBSA shall supply the PRODUCT containing the substance in accordance with GMP manufacturing standards and within the technical specifications that is part of the REGISTRATION FILE.

• IV.1 The REGISTRATION FILE shall always remain property of IBSA or of any third party designated by IBSA (provided that such third party agrees to be bound by the provisions of this Agreement to the same extent as IBSA is bound).

More Definitions of Registration file

Registration file means the application for registration, supporting materials, annual reports, and amendments that constitute all information submitted and reviewed pertaining to a particular condominium registration. A document that has not been accepted for filing by the board is not part of the registration file.

Registration file means all the information, including regulatory, technical and clinical data, concerning the PRODUCT (including, but not limited to, all such information on which the FDA APPROVAL is based). EXCLUSIVE LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT BETWEEN IBSA INSTITUTE BIOCHIMIQUE SA AND BIOVENTUS LLC

Registration file means the application for registration, supporting materials, annual

Registration file means a file of an organizational/accounting type with permanently stored documents or computer files that are submitted to State Registrars in accordance with this Law;

Registration file means all written pertinent and necessary information regarding the Product (full approved consolidated dossier modules 2-5), which has been approved by the FDA (ANDA 211352), and that shall include, inter alia: ● Elite’s cGMP certificate; ● Elite’s manufacturing license; ● Elite’s QA audits of the API manufacturers; ● Any bio-studies and/or clinical studies available to Elite on the Effective Date hereof (each, a “BE Study”); ● A current, valid US Free Sale Certificate or US Certificate of Pharmaceutical Product (“CPP”) for the marketed Product; ● Certificate of compliance with good laboratory practice principles for the laboratories conducting the analytical tests for the BE Study. The certificate should be from a suitable authority in a recognized country (US, Canada etc.); ● Dissolution data of the reference product registered in Israel (Dexcel shall purchase and provide the samples of the reference product registered in Israel to Elite, at Dexcel’s cost; Elite shall perform the required studies, at Dexcel’s cost), (see Appendix 4).

Registration file means all records, documents, emails and things in the custody or control of the college that are relevant to the subject matter of a review, whether or not they have previously been collected and organized into a single “file” and whether or not they have been placed before the registration committee;

Registration file means an electronic file containing information relating to the registration of an individual passenger car;