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<title>Forms - Canada's Access to Medicines Regime</title>
<meta name="dc.title" content="Forms - Canada's Access to Medicines Regime">
<meta name="dc.creator" content="Government of Canada, Health Canada, Health Products and Food Branch, Therapeutic Products Directorate">
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<meta name="dc.date.created" content="2004-07-26">
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<meta name="meta_date" content="2006-07-18">
<meta name="dc.description" content="Lists forms required in a pharmaceutical company's application package to Canada's Access to Medicines Regime">
<meta name="description" content="Lists forms required in a pharmaceutical company's application package to Canada's Access to Medicines Regime">
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      <h1>Forms</h1>
      <p>Copies of the forms required for the application package are provided in portable document format (PDF) and in Microsoft Word (DOC) format on this website. The Word files have fields for the required information and can be completed in electronic form. For the most up-to-date versions of the forms, consult the <img src="/images/common/newwindow.gif" alt="Next link will take you to another website">&nbsp;<a href="http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/wr00116.html" title="Canadian Intellectual Property Office Web site (external link)">Canadian Intellectual Property Office</a> website for the Regime.</p>
      <ul>
        <li>"Application for Authorization Under Section&nbsp;21.04 of the <em>Patent Act</em>"<br>
(<a href="/doc/form/form01-eng.pdf"><img src="/images/common/pdf.gif" alt="Patent Act (PDF version will open in a new window)" title="Patent Act (PDF version will open in a new window)" width="41" height="11"></a> 45&nbsp;kB; <a href="/doc/form/form01-eng.doc"><img src="/images/common/doc.gif" alt="Patent Act (Microsoft Word (DOC) version will open in a new window)" width="41" height="11"></a> 54&nbsp;kB): Application for a compulsory licence to manufacture and export a generic version of a patented pharmaceutical product or medical device.</li>
        <li>"Solemn or Statutory Declaration Under Paragraph&nbsp;21.04(3)(<em>c</em>) of the <em>Patent Act</em>"<br>
(<a href="/doc/form/form02-eng.pdf"><img src="/images/common/pdf.gif" alt="Patent Act (PDF version will open in a new window)" title="Patent Act (PDF version will open in a new window)" width="41" height="11"></a> 70&nbsp;kB; <a href="/doc/form/form02-eng.doc"><img src="/images/common/doc.gif" alt="Patent Act (Microsoft Word (DOC) version will open in a new window)" width="41" height="11"></a> 43&nbsp;kB): Declaration that the applicant sought a voluntary licence from the patent holder or holders.</li>
        <li>"Solemn or Statutory Declaration Under Paragraph&nbsp;21.04(3)(<em>d</em>)(i)(A) of the <em>Patent Act</em>"<br>
(<a href="/doc/form/form03-eng.pdf"><img src="/images/common/pdf.gif" alt="Patent Act (PDF version will open in a new window)" title="Patent Act (PDF version will open in a new window)" width="41" height="11"></a> 45&nbsp;kB; <a href="/doc/form/form03-eng.doc"><img src="/images/common/doc.gif" alt="Patent Act (Microsoft Word (DOC) version will open in a new window)" width="41" height="11"></a> 42&nbsp;kB): Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule&nbsp;2, WTO member, product not patented).</li>
        <li>"Solemn or Statutory Declaration Under Paragraph&nbsp;21.04(3)(<em>d</em>)(i)(B) of the <em>Patent Act</em>"<br>
          (<a href="/doc/form/form04-eng.pdf"><img src="/images/common/pdf.gif" alt="Patent Act (PDF version will open in a new window)" title="Patent Act (PDF version will open in a new window)" width="41" height="11"></a> 41&nbsp;kB; <a href="/doc/form/form04-eng.doc"><img src="/images/common/doc.gif" alt="Patent Act (Microsoft Word (DOC) version will open in a new window)" width="41" height="11"></a> 39&nbsp;kB): Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule&nbsp;2, WTO member, product is patented).</li>
        <li>"Solemn or Statutory Declaration Under Paragraph&nbsp;21.04(3)(<em>d</em>)(ii)(A) of the <em>Patent Act</em>"<br>
          (<a href="/doc/form/form05-eng.pdf"><img src="/images/common/pdf.gif" alt="Patent Act (PDF version will open in a new window)" title="Patent Act (PDF version will open in a new window)" width="41" height="11"></a> 45&nbsp;kB; <a href="/doc/form/form05-eng.doc"><img src="/images/common/doc.gif" alt="Patent Act (Microsoft Word (DOC) version will open in a new window)" width="41" height="11"></a> 42&nbsp;kB): Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule&nbsp;2, not WTO member, product not patented).</li>
        <li>"Solemn or Statutory Declaration Under Paragraph&nbsp;21.04(3)(<em>d</em>)(ii)(B) of the <em>Patent Act</em>"<br>
          (<a href="/doc/form/form06-eng.pdf"><img src="/images/common/pdf.gif" alt="Patent Act (PDF version will open in a new window)" title="Patent Act (PDF version will open in a new window)" width="41" height="11"></a> 41&nbsp;kB; <a href="/doc/form/form06-eng.doc"><img src="/images/common/doc.gif" alt="Patent Act (Microsoft Word (DOC) version will open in a new window)" width="41" height="11"></a> 40&nbsp;kB): Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule&nbsp;2, not WTO member, product is patented).</li>
        <li>"Solemn or Statutory Declaration Under Paragraph&nbsp;21.04(3)(<em>d</em>)(iii)(A), (iv)(A) or (v)(A) of the <em>Patent Act</em>"<br>
          (<a href="/doc/form/form07-eng.pdf"><img src="/images/common/pdf.gif" alt="Patent Act (PDF version will open in a new window)" title="Patent Act (PDF version will open in a new window)" width="41" height="11"></a> 41&nbsp;kB; <a href="/doc/form/form07-eng.doc"><img src="/images/common/doc.gif" alt="Patent Act (Microsoft Word (DOC) version will open in a new window)" width="41" height="11"></a> 41&nbsp;kB): Declaration regarding the identity and patent status of the pharmaceutical product or medical device (Schedule&nbsp; 3 or&nbsp;4, product not patented).</li>
<li>"Solemn or Statutory Declaration Under Paragraph&nbsp;21.16(1)(<em>b</em>) of the <em>Patent Act</em>"<br>
(<a href="/doc/form/form08-eng.pdf"><img src="/images/common/pdf.gif" alt="Patent Act (PDF version will open in a new window)" title="Patent Act (PDF version will open in a new window)" width="41" height="11"></a> 45&nbsp;kB; <a href="/doc/form/form08-eng.doc"><img src="/images/common/doc.gif" alt="Patent Act (Microsoft Word (DOC) version will open in a new window)" width="41" height="11"></a> 43&nbsp;kB): Declaration regarding the monetary value of the pharmaceutical product or medical device and the number of units to be manufactured and sold.</li>
<li>"Application for Renewal of Authorization Under Section&nbsp;21.12 of the <em>Patent Act</em>"<br>
  (<a href="/doc/form/form10-eng.pdf"><img src="/images/common/pdf.gif" alt="Patent Act (PDF version will open in a new window)" title="Patent Act (PDF version will open in a new window)" width="41" height="11"></a> 44&nbsp;kB; <a href="/doc/form/form10-eng.doc"><img src="/images/common/doc.gif" alt="Patent Act (Microsoft Word (DOC) version will open in a new window)" width="41" height="11"></a> 54&nbsp;kB): Application for renewal of authorization for compulsory licence.<br>
</li>
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