<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03-1" citation="COMAR 10.34.22.03-1" title_num="10" subtitle_num="34" chapter_num="22" heading="Minimum Application Requirements for Virtual Manufacturers.">
  <text>The information and qualification requirements for obtaining a permit under Regulation .03 of this chapter, beyond that required by federal law, do not apply to a virtual manufacturer that meets the following requirements:</text>
  <paragraph num="A.">
    <text>Provides a list of drug or device products it distributes;</text>
  </paragraph>
  <paragraph num="B.">
    <text>Provides a list of the NDA or ANDA numbers associated with each drug it distributes;</text>
  </paragraph>
  <paragraph num="C.">
    <text>Provides a list of the UDI numbers, as available, associated with each device it distributes;</text>
  </paragraph>
  <paragraph num="D.">
    <text>Provides the name and facility address of the contract manufacturer for each drug or device product it distributes;</text>
  </paragraph>
  <paragraph num="E.">
    <text>Provides verification of current FDA registration for each contract manufacturing facility listed;</text>
  </paragraph>
  <paragraph num="F.">
    <text>If the contract manufacturer distributes into this State, provides the wholesale distributor permit number for the contract manufacturer;</text>
  </paragraph>
  <paragraph num="G.">
    <text>If the contract manufacturer does not distribute into this State, provides name and Maryland’s wholesale distributor permit number for the entity that physically distributes the product into this State;</text>
  </paragraph>
  <paragraph num="H.">
    <text>Provides a statement affirming that the virtual manufacturer does not contract the manufacture or distribution for drugs or devices other than those for which it owns the NDA, ANDA, or UDI numbers;</text>
  </paragraph>
  <paragraph num="I.">
    <text>Provides an attestation by the owner of the virtual manufacturer that it does not hold product;</text>
  </paragraph>
  <paragraph num="J.">
    <text>Provides a copy of existing licensure from the state in which it is located, if applicable; and</text>
  </paragraph>
  <paragraph num="K.">
    <text>Has valid federal licensure or registration, as verified by the Board.</text>
  </paragraph>
</regulation>