Periodic safety update reports definition

Periodic safety update reports means the periodical reports containing the records referred to in regulation 68.
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Periodic safety update reports means the periodical reports containing the records referred to in Article 104 of Directive 2001/83/EC and in Article 24(3) of Regulation (EC) No 726/2004;
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Examples of Periodic safety update reports in a sentence

  • OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports (PSURs) The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

  • OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

  • Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market and once a year for the following two years.

  • OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports (PSURs)The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

  • OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION  Periodic safety update reports (PSURs) The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

  • Periodic safety update reports shall also be submitted imme- diately upon request or at least every six months during the first two years following the initial placing on the Community market and once a year for the following two years.

  • OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.

  • Periodic safety update reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the Community market and once a year for the following two years.

  • Periodic safety update reports (PSURs) should present cumulative and interval summaries of global safety data obtained from various sources worldwide.

  • OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic safety update reports (PSURs) The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

Related to Periodic safety update reports

  • SOS Reports means the official reports from the Secretaries of State of each Collateral State, the state where Borrower’s chief executive office is located, the state of Borrower’s formation and other applicable federal, state or local government offices identifying all current security interests filed in the Collateral and Liens of record as of the date of such report.

  • Acoustic Assessment Report means the report, prepared in accordance with Publication NPC-233 and Appendix A of the Basic Comprehensive User Guide,by HGC Engineering and dated August 22, 2008 submitted in support of the application, that documents all sources of noise emissions and Noise Control Measures present at the Facility and includes all up-dated Acoustic Assessment Reports as required by the Documentation Requirements conditions of this Certificate to demonstrate continued compliance with the Performance Limits following the implementation of any Modification.

  • Periodic Reports means the Company’s (i) Annual Reports on Form 10-K, (ii) any Quarterly Report to be filed on Form 10-Q and (iii) all other financial reports required to be filed by the Company with the Commission under applicable laws and regulations (including, without limitation, Regulation S-K) for so long as any amounts are outstanding under this Debenture or any Other Debenture; provided that all such Periodic Reports shall include, when filed, all information, financial statements, audit reports (when applicable) and other information required to be included in such Periodic Reports in compliance with all applicable laws and regulations.

  • Progress Reports The Progress Reports as required by the individual Task Work Orders issued pursuant to this Agreement. Responsible: Responsible or Responsibility means the financial ability, legal capacity, integrity and past performance of Contractor and as such terms have been interpreted relative to public procurements. See NYS Finance Law § 163(1)(c).

  • Technical Report means a report prepared and filed in accordance with this Instrument and Form 43-101F1 Technical Report that includes, in summary form, all material scientific and technical information in respect of the subject property as of the effective date of the technical report; and

  • Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • MI Reporting Template means the form of report set out in the Annex to Framework Schedule 8 (Management Information) setting out the information the Supplier is required to supply to the Authority;

  • Updates are changes that do not require a change to the established Centralized Contract terms and conditions. A request to add new products at the same or better price level is an example of an update. “Amendments” are any changes that are not specifically covered by the terms and conditions of the Centralized Contract, but inclusion is found to be in the best interest of the State. A request to change a contractual term and condition is an example of an amendment.

  • Company’s Reports means (i) the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC, including the audited financial statements contained therein and the information from the Company’s definitive proxy statement for its 2020 annual meeting of shareholders incorporated by reference into the Form 10-K; and (ii) the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the SEC, including the unaudited financial statements contained therein.

  • Transparency Reports means a report in accordance with Schedule 7 Part 1 (Transparency Reports) containing the contract information as set out in the table for that Part for publication by the Authority in the interests of transparency.

  • Monthly Reports shall have the meaning specified in Section 5.16(b) of the Indenture.

  • Inspection Report means the report delivered by the Master Servicer or the Special Servicer, as the case may be, substantially in the form of Exhibit L hereto.

  • Electronic Subcontracting Reporting System (eSRS) means the Governmentwide, electronic, web-based system for small business subcontracting program reporting. The eSRS is located at http://www.esrs.gov.

  • ESDM Report means the Emission Summary and Dispersion Modelling Report, dated June 12, 2009, prepared in accordance with the Procedure Document by Golder Associated Ltd. and submitted in support of the application, and includes any amendments to the ESDM Report listed in Schedule A and all up-dated ESDM Reports prepared as required by the Documentation Requirements conditions of this Certificate.

  • Annual Statement of Compliance As defined in Section 3.13.

  • Physical Conditions Report means, with respect to the Property, a report prepared by a company satisfactory to Lender regarding the physical condition of the Property, satisfactory in form and substance to Lender in its sole discretion, which report shall, among other things, (a) confirm that the Property and its use complies, in all material respects, with all applicable Legal Requirements (including, without limitation, zoning, subdivision and building laws) and (b) include a copy of a final certificate of occupancy with respect to all Improvements on the Property.

  • Geotechnical report or "geotechnical analysis" means a scientific study or evaluation conducted by a qualified expert that includes a description of the ground and surface hydrology and geology, the affected land form and its susceptibility to mass wasting, erosion, and other geologic hazards or processes, conclusions and recommendations regarding the effect of the proposed development on geologic conditions, the adequacy of the site to be developed, the impacts of the proposed development, alternative approaches to the proposed development, and measures to mitigate potential site-specific and cumulative geological and hydrological impacts of the proposed development, including the potential adverse impacts to adjacent and down-current properties. Geotechnical reports shall conform to accepted technical standards and must be prepared by qualified professional engineers or geologists who have professional expertise about the regional and local shoreline geology and processes.

  • Compliance Statement is that certain statement in the form attached hereto as Exhibit B.

  • Benchmarking Report means the report produced by the Supplier following the Benchmark Review and as further described in this Framework Schedule 7;