<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".12" citation="COMAR 14.17.13.12" title_num="14" subtitle_num="17" chapter_num="13" heading="Novel Product Requests.">
  <paragraph num="A.">
    <text>In this regulation, “novel product” means a cannabis product that is:</text>
    <paragraph num="(1)">
      <text>Not presently authorized in Maryland; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Lawfully produced in another jurisdiction.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>A licensed processor may submit a request to the Administration in a manner prescribed by the Administration to approve a novel product.</text>
  </paragraph>
  <paragraph num="C.">
    <text>A valid novel product request shall include:</text>
    <paragraph num="(1)">
      <text>A detailed product description;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>An explanation of how the product deviates from current regulations;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Evidence that the same product type is permitted in at least one other state’s regulated cannabis market; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Health and safety information, including but not limited to:</text>
      <paragraph num="(a)">
        <text>Available information or studies regarding any beneficial or adverse effects from the use of the product; and</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Packaging and labeling strategies to minimize risk to patients, consumers, and children.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The Administration may:</text>
    <paragraph num="(1)">
      <text>Make its own determination to approve or deny the request; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Defer the request to the Public Health Advisory Council.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The Administration reserves the right to make a final determination on the request</text>
  </paragraph>
</regulation>