INVESTIGATIONAL MEDICINAL PRODUCTS Sample Clauses

INVESTIGATIONAL MEDICINAL PRODUCTS. The SPONSOR will supply the investigational medicinal products free-of-charge, including those for comparison and placebos, under the terms provided for in RD 1090/2015. The investigational medicinal product will be supplied via the HOSPITAL’s Pharmacy Service and dispensed on a controlled basis, in accordance with the guidelines in the PROTOCOL. The investigational medicinal product will not be made available to the HOSPITAL or the LEAD INVESTIGATOR until the favorable report from the CEIm and the mandatory authorization from the AEMPS are received.
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INVESTIGATIONAL MEDICINAL PRODUCTS. The performance of the study will not modify the doctor’s prescription habits or the dispensation of the pharmaceutical (in the event of drugs that do not require prescription).
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INVESTIGATIONAL MEDICINAL PRODUCTS. The SPONSOR will supply the investigational medicinal product, including comparison and placebo products, free of charge, in accordance with the terms of RD 1090/2015.
Sample 1
INVESTIGATIONAL MEDICINAL PRODUCTS. The SPONSOR will supply the investigational medicinal products free-of-charge, including those for comparison and placebos, under the terms provided for in RD1090/2015. The investigational medicinal product will be supplied via the HOSPITAL’s Pharmacy Service and dispensed on a controlled basis, in accordance with the guidelines in the PROTOCOL. The investigational medicinal product will not be made available to the HOSPITAL or the LEAD INVESTIGATOR until the favorable report from the CEIm and the mandatory authorization from the AEMPS are received. NINE. AMENDMENT, CANCELLATION OR SUSPENSION, AND TERMINATION OF THE CONTRACT.
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Related to INVESTIGATIONAL MEDICINAL PRODUCTS

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

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