Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Master File has the meaning set forth in the CAISO Tariff.
Death master file means the United States social security administration’s death master file or any other database or service that is at least as comprehensive as the United States social security administration’s death master file for determining that a person has died.
DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.
Seller Products means all products and services that are being manufactured or performed by Seller at any time, other than Logic Business Products that are being manufactured or performed by Seller as of the Closing Date.
Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;
Wholesale drug distributor means anyone engaged in the
Death master file match means a search of the death master file that results in a match of the social security number or the name and date of birth of an insured, an annuity owner or a retained asset account holder.[PL 2017, c. 129, §1 (NEW).]
WTO GPA country end product means an article that—
Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):
Servicer File means, collectively, all documents, records and copies pertaining to a Mortgage Loan which are required to be included in the related Servicer File pursuant to Section 3 thereof.
Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.
Central fill pharmacy means a pharmacy contracting with an originating pharmacy, or having the same owner as an originating phar- macy, that provides centralized prescription filling on behalf of the originating pharmacy pursuant to these rules.
NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.
Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.
API means the American Petroleum Institute.
Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”
Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.
Mail order pharmacy means a pharmacy licensed by this
Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.
NEC Electronics products means any product developed or manufactured by or for NEC Electronics (as defined above).
FDA means the United States Food and Drug Administration and any successor agency thereto.
Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.
Red Hat Products means Software, Services, Subscriptions and other Red Hat branded offerings made available by Red Hat.
Drug store means a place whose principal business is, the