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C.__"Regulated advertisement" means the presentation to the | | general public of a commercial message regarding a | | prescription drug or biological product by a manufacturer of | | prescription drugs that is: |
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| | | (1)__Broadcast on television or radio from a station | | that is physically located in the State; |
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| | | (2)__Broadcast over the Internet from a location in the | | State;__or |
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| | | (3) Printed in magazines or newspapers that are | | printed, distributed or sold in the State. |
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| | | 2. Regulated advertisement requirement.__Beginning October 15, | | 2005, a manufacturer may not present or cause to be presented in | | the State a regulated advertisement, unless that advertisement | | meets the requirements concerning misbranded drugs and devices | | and prescription drug advertising of federal law and regulations | | under 21 United States Code, Sections 331 and 352(n) and 21 Code | | of Federal Regulations, Part 202 and state rules. |
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| | | 3.__Disclosure of clinical trials of prescription drugs.__ | | Beginning October 15, 2005, a manufacturer or labeler of | | prescription drugs that is required to report marketing costs for | | prescription drugs pursuant to section 2698-A shall post, with | | regard to those prescription drugs, on the publicly accessible | | Internet website of the federal__National Institutes of Health or | | its successor agency or another publicly accessible website the | | following information concerning any clinical trial that the | | manufacturer conducted or sponsored on or after October 15, 2002: |
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| | | A. The name of the entity that conducted or is conducting | | the clinical trial; |
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| | | B. A summary of the purpose of the clinical trial; |
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| | | C. The dates during which the trial has taken place; and |
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| | | D. Information concerning the results of the clinical trial, | | including potential or actual adverse effects of the drug. |
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| | | In order to satisfy the requirements of this subsection, the | | publicly accessible website and manner of posting must be | | acceptable to the department. |
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| | | 4.__Fees.__ Beginning April 1, 2006, each manufacturer of | | prescription drugs that are provided to Maine residents through | | the MaineCare program under section 3174-G or the elderly |
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