RD 84/2015 definition

RD 84/2015 means Royal Decree 84/2015, of 13 February, implementing Law 10/2014 (Real Decreto 84/2015, de 13 de febrero, por el que se desarrolla la Ley 10/2014, de 26 de junio, de ordenación, supervisión y solvencia de entidades de crédito), as amended fron time to time.
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Examples of RD 84/2015 in a sentence

  • RD 84/2015 means Royal Decree 84/2015, of 13 February, implementing Law 10/2014 (Real Decreto 84/2015, de 13 de febrero, por el que se desarrolla la Ley 10/2014, de 26 de junio, de ordenación, supervisión y solvencia de entidades de crédito), as amended or replaced from time to time.

  • RD 84/2015 means Royal Decree 84/2015, of 13 February, implementing Law 10/2014, as amended.

  • RD 84/2015 means Royal Decree 84/2015, of 13 February, implementing Law 10/2014, as amended or replaced.

  • The Compensation Policy has been prepared by reference to Law 10/2014, RD 84/2015 and the guidelines issued by the EBA.

Related to RD 84/2015

  • NI 51-101 means National Instrument 51-101 Standards of Disclosure for Oil and Gas Activities;

  • NI 54-101 means National Instrument 54-101 – Communication with Beneficial Owners of Securities of a Reporting Issuer;

  • NI 51-102 means National Instrument 51-102 – Continuous Disclosure Obligations;

  • NI 52-107 means National Instrument 52-107 Acceptable Accounting Principles, Auditing Standards and Reporting Currency;

  • NI 81-107 means National Instrument 81-107 Independent Review Committee for Investment Funds;

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • MI 61-101 means Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions;

  • NI 81-106 means National Instrument 81-106 Investment Fund Continuous Disclosure;

  • NI 44-101 means National Instrument 44-101 – Short Form Prospectus Distributions;

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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.

  • Technology Transfer Plan has the meaning set forth in Section 4.1.5.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • NI 31-103 means National Instrument 31-103 Registration Requirements, Exemptions and Ongoing Registrant Obligations;

  • NI 62-104 means National Instrument 62-104 – Take-Over Bids and Issuer Bids;

  • NI 45-106 means National Instrument 45-106 – Prospectus and Registration Exemptions;

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • NI 58-101 means National Instrument 58-101 Disclosure of Corporate Governance Practices;

  • NI 81-102 means National Instrument 81-102 – Investment Funds.

  • NP 11-202 means National Policy 11-202 – Process for Prospectus Reviews in Multiple Jurisdictions;

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • NI 41-101 means National Instrument 41-101 – General Prospectus Requirements;

  • PM10 means particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers as measured by an EPA reference or equivalent method.