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For more information visit our privacy policy.First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.
Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.
Indication means any human disease or condition, or sign or symptom of a human disease or condition.
Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.
Medication means any drug, chemical, compound, suspension, or preparation in suitable form for use as a curative or remedial substance taken either internally or externally by any person.
Cannabis production establishment agent means a cannabis cultivation facility
Cannabis production establishment means a cannabis cultivation facility, a
Second Indication means [***].
Prescription medication means any medication that requires a physician prescription before it may be obtained from a pharmacist.
Antipsychotic medications means that class of drugs
Psychotropic medication means medication the prescribed intent of which is to affect or alter thought processes, mood, or behavior including but not limited to anti-psychotic, antidepressant, anxiolytic (anti-anxiety), and behavior medications. The classification of a medication depends upon its stated, intended effect when prescribed.
Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.
Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.
Additional Indication means any indication other than the Initial Indication.
Step therapy means a protocol or
Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:
Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.
Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.
Cannabis production establishment agent registration card means a registration card that the department issues that:
Initial Indication means the use of a Product for the treatment of opioid addiction.
Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.
Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.
Commercial cannabis activity means the production, cultivation,
Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.
Unassigned medication for respiratory distress means albuterol, levalbuterol, or another medication designated by the executive commission of the Health and Human Services Commission for treatment of respiratory distress, prescribed by an authorized health-care provider in the name of the district with a non-patient-specific standing delegation order for the administration of a medication for respiratory distress, and issued by an authorized health-care provider.
Nonprescription medication means a drug or medication authorized pursuant to federal or state law for general distribution and use without a prescription in the treatment of human disease, ailments, or injuries.