European Dossier definition

European Dossier means the necessary documentation for a medical device manufacturer to obtain a CE marking for its product according to the European Medical Device Directory.
Sample 1
European Dossier means a European drug marketing authorization application or the European equivalent to a PMA or ISO 9001/9002, submitted to the EMEA, an alternate body accepting such an application, or any European Union Member.
Sample 1

Examples of European Dossier in a sentence

  • PARI shall use commercially reasonable efforts to pursue regulatory approval of the European Dossier.

  • Falk and Altus will work to begin the writing and submission planninx xx the European Dossier.

  • Falk shall also provide the necessary regulatory, medical, clinical, xxxient and logistical support for the advancement of the program into Phase III study leading to a successful European Dossier.

  • Altus will ensure that the clinical studies and data conform to the International Committee on Harmonization (ICH) Guidelines to enable the data to be transferable to a European Dossier submission.

  • Post - Phase III -- Mutual Responsibilities - Falk will work with Altus to complete the writing and submission of xxx European Dossier.

  • Altus will also be responsible for all non-clinical product development aspects required by the US Food and Drug Administration (FDA) and to ensure that these aspects will be applicable to the European Dossier.

  • At SALUS’ request and expense, PARI will cooperate with SALUS by providing SALUS with the Inhaler Data as reasonably necessary for the NDA or European Dossier or otherwise reasonably desirable by SALUS for its preparation of the NDA or European Dossier.

  • PARI shall notify ABARIS in writing promptly after PARI receives an approval or other response to the European Dossier.

  • In accordance with a schedule reasonably agreed upon by the Parties, PARI shall prepare and make submissions as are necessary to complete and file a European Dossier which meets the requirements for validation under the EMEA’s validation process for the general use of the Test Inhaler, and specifically for the delivery of liquids containing drug molecules.

  • In such an event, PARI shall file such European Dossier which meets the requirements for validation under the EMEA’s validation process.

Related to European Dossier

  • Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.

  • Major European Countries means France, Germany, Italy, Spain and the United Kingdom.

  • European Community means the territory comprised by the Member States of the European Community as constituted from time to time;

  • European Commission means the European Commission or any successor entity that is responsible for granting Marketing Approvals authorizing the sale of pharmaceuticals in the European Union.

  • European Communities means the European Economic Community, the European Coal and Steel Community and the European Atomic Energy Community.

  • European Monetary System means the European Monetary System established by the Resolution of December 5, 1978 of the Council of the European Communities.

  • European Union means the member nations of the European Union established by the Treaty of European Union, signed at Maastricht on February 2, 1992, which amended the Treaty of Rome establishing the European Community.

  • EU means the European Union.

  • Treaty on European Union means the Treaty of Rome of March 25, 1957, as amended by the Single Xxxxxxxx Xxx 0000 and the Maastricht Treaty (which was signed at Maastricht on February 1, 1992 and came into force on November 1, 1993), as amended from time to time.

  • Major EU Country means France, Germany, Italy, Spain or the United Kingdom.

  • European Clearing Systems means, collectively, Clearstream, Luxembourg and Euroclear.

  • European Data Protection Laws means the EU General Data Protection Regulation 2016/679 (“GDPR”) and data protection laws of the European Economic Area (“EEA”) and their member states and the FADP.

  • Central Bank Rules means the UCITS Regulations, Central Bank Regulations and any regulations, guidance and conditions issued by the Central Bank from time to time pursuant to the UCITS Regulations, the Central Bank Regulations and/or the Central Bank Act regarding the regulation of undertakings for collective investment in transferable securities, as such may be amended, supplemented or replaced from time to time;

  • Customs territory of the United States means the 50 States, the District of Columbia, and Puerto Rico.

  • EU GDPR means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

  • Central Bank means the Central Bank of Ireland;

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Canadian Securities Regulatory Authorities means the securities commissions and similar regulatory authorities of each of the provinces or territories of Canada;