FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.
New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.
FDA means the United States Food and Drug Administration.
Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.
FD&C Act means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.
Prescription drug order means a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacist.
EU Data Protection Law means (i) prior to 25 May 2018, Directive 95/46/EC of the European Parliament and of the Council on the protection of individuals with regard to the processing of Personal Data and on the free movement of such data ("Directive") and on and after 25 May 2018, Regulation 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of Personal Data and on the free movement of such data (General Data Protection Regulation) ("GDPR"); and (ii) Directive 2002/58/EC concerning the processing of Personal Data and the protection of privacy in the electronic communications sector and applicable national implementations of it (as may be amended, superseded or replaced).
MHLW means the Ministry of Health, Labour and Welfare of Japan, or the successor thereto.
EMA means the European Medicines Agency or any successor agency thereto.
Drug addiction means a disease characterized by a
Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.
Federal Energy Regulatory Commission or "FERC" means the
Federal Aviation Act means the sections of Title 49 of the United States Code relating to aviation, as amended and in effect from time to time, or any similar legislation of the United States of America enacted in substitution or replacement thereof.
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.
Data Protection Law means the applicable legislation protecting the fundamental rights and freedoms of persons and their right to privacy with regard to the processing of Personal Data under the Agreement (and includes, as far as it concerns the relationship between the parties regarding the processing of Personal Data by SAP on behalf of Customer, the GDPR as a minimum standard, irrespective of whether the Personal Data is subject to GDPR or not).
FDA Act means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.
FMC Act means the Financial Markets Conduct Act 2013.
Federal Aviation Administration and "FAA" mean the United States Federal Aviation Administration and any agency or instrumentality of the United States government succeeding to their functions.
EU Data Protection Laws means EU Directive 95/46/EC, as transposed into domestic legislation of each Member State and as amended, replaced or superseded from time to time, including by the GDPR and laws implementing or supplementing the GDPR;
Compact commissioner means: the voting representative of each compacting state appointed pursuant to Article VIII of this compact.
Occupational Health and Safety Act means the Occupational Health and Safety Act, 1993 (Act No 85 of 1993);
Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.
Drug means (i) articles or substances recognized in the official United States Pharmacopoeia
FDCA shall have the meaning ascribed to such term in Section 3.1(hh).
Medication administration means the direct application of medications by injection, inhalation, ingestion, or any other means to an individual receiving services by (i) persons legally permitted to administer medications or (ii) the individual at the direction and in the presence of persons legally permitted to administer medications.