European Commission means the authority within the European Union that has the legal authority to grant Regulatory Approvals in the European Union based on input received from the EMA or other competent Regulatory Authorities.
European Community means the territory comprised by the Member States of the European Community as constituted from time to time;
CPUC Decisions means CPUC Decisions 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000, 00-00-000 and any other existing or subsequent decisions, resolutions or rulings related to resource adequacy, as may be amended from time to time by the CPUC.
Nuclear Regulatory Commission (NRC) means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.
European Communities means the European Economic Community, the European Coal and Steel Community and the European Atomic Energy Community.
Major European Country means any of France, Germany, Italy, Spain or the United Kingdom.
Final Decision means a final action of the commission determining the legal rights, duties, or privileges of any person. “Final decision” does not include preliminary, procedural, or intermediate actions by the commission, actions regulating the internal administration of the commission, or actions of the commission to enter into or refrain from entering into contracts or agreements with vendors to provide goods or services to the commission.
Informed decision means a decision by a qualified patient, to request and obtain a prescription for medication that the qualified patient may self-administer to end his or her life in a humane and dignified manner, that is based on an appreciation of the relevant facts and after being fully informed by the attending physician of:
Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.
CFIUS means the Committee on Foreign Investment in the United States.
EU means the European Union.
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.
Major Decision means:
Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.
Major European Countries means France, Germany, Italy, Spain and the United Kingdom.
Regulatory Rules means all corporate and securities laws, regulations, rules, policies, notices, instruments and other orders of any kind whatsoever which may, from time to time, apply to the implementation, operation or amendment of this Plan or the Options granted from time to time hereunder including, without limitation, those of the applicable Regulatory Authorities.
Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.
European Monetary System means the European Monetary System established by the Resolution of December 5, 1978 of the Council of the European Communities.
Relevant Governmental Body means the Board of Governors of the Federal Reserve System or the Federal Reserve Bank of New York, or a committee officially endorsed or convened by the Board of Governors of the Federal Reserve System or the Federal Reserve Bank of New York, or any successor thereto.
key decision * means an executive decision which is likely to:
DOJ means the United States Department of Justice.
Appeal Tribunal means the all-citizen Tribunal duly appointed by Council to conduct hearings under this By-law; (200-08)
Proposed decision means the presiding officer’s recommended findings of fact, conclusions of law, decision, and order in a contested case in which the administrator did not preside.
IESO Market Rules means the rules made under section 32 of the Electricity Act, 1998 (Ontario), together with all market manuals, policies and guidelines issued by the IESO.
Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
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.