<?xml version="1.0"?><Regulation lims:pit-date="2025-03-12" hasPreviousVersion="true" lims:lastAmendedDate="2025-03-12" lims:current-date="2025-03-17" lims:inforce-start-date="2018-10-17" lims:fid="834139" lims:id="834139" gazette-part="II" regulation-type="SOR" xml:lang="en" in-force="yes" xmlns:lims="http://justice.gc.ca/lims"><Identification lims:inforce-start-date="2018-10-17" lims:fid="834140" lims:id="834140"><InstrumentNumber>SOR/2016-231</InstrumentNumber><RegistrationDate><Date><YYYY>2016</YYYY><MM>8</MM><DD>5</DD></Date></RegistrationDate><ConsolidationDate lims:inforce-start-date="2018-10-17"><Date><YYYY>2025</YYYY><MM>3</MM><DD>18</DD></Date></ConsolidationDate><EnablingAuthority lims:inforce-start-date="2018-10-17" lims:fid="834142" lims:id="834142"><XRefExternal reference-type="act" link="F-27">FOOD AND DRUGS ACT</XRefExternal></EnablingAuthority><LongTitle lims:inforce-start-date="2018-10-17" lims:fid="834143" lims:id="834143">Cannabis Exemption (Food and Drugs Act) Regulations</LongTitle><RegulationMakerOrder><RegulationMaker>P.C.</RegulationMaker><OrderNumber>2016-744</OrderNumber><Date><YYYY>2016</YYYY><MM>8</MM><DD>5</DD></Date></RegulationMakerOrder></Identification><Order lims:inforce-start-date="2018-10-17" lims:fid="834144" lims:id="834144"><Provision lims:inforce-start-date="2018-10-17" lims:fid="834145" lims:id="834145" format-ref="indent-0-0" language-align="yes" list-item="no"><Text>His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to paragraph 30(1)(j) of the <XRefExternal reference-type="act" link="F-27">Food and Drugs Act</XRefExternal><FootnoteRef idref="fn_a">a</FootnoteRef>, makes the annexed <XRefExternal reference-type="regulation" link="SOR-2016-231">Cannabis Exemption (Food and Drugs Act) Regulations</XRefExternal>.</Text><Footnote id="fn_a" placement="page" status="official"><Label>a</Label><Text>R.S., c. F-27</Text></Footnote></Provision></Order><Body lims:inforce-start-date="2018-10-17" lims:fid="834146" lims:id="834146"><Heading lims:inforce-start-date="2018-10-17" lims:fid="834147" lims:id="834147" level="1"><TitleText>Definitions</TitleText></Heading><Section lims:inforce-start-date="2018-10-17" lims:lastAmendedDate="2025-03-12" lims:fid="834148" lims:id="834148"><MarginalNote lims:inforce-start-date="2018-10-17" lims:fid="834149" lims:id="834149">Exemption</MarginalNote><Label>1</Label><Text><DefinitionRef>Cannabis</DefinitionRef>, as defined in subsection 2(1) of the <XRefExternal reference-type="act" link="C-24.5">Cannabis Act</XRefExternal> and in relation to which an activity is conducted in accordance with the <XRefExternal reference-type="act" link="C-24.5">Cannabis Act</XRefExternal>, is exempt from the application of the <XRefExternal reference-type="act" link="F-27">Food and Drugs Act</XRefExternal>, unless the cannabis</Text><Paragraph lims:inforce-start-date="2018-10-17" lims:fid="834150" lims:id="834150"><Label>(a)</Label><Text>is manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, or in restoring or correcting organic functions, in human beings or animals;</Text></Paragraph><Paragraph lims:inforce-start-date="2018-10-17" lims:fid="834151" lims:id="834151"><Label>(b)</Label><Text>is represented for use in modifying organic functions in human beings or animals;</Text></Paragraph><Paragraph lims:inforce-start-date="2018-10-17" lims:fid="834152" lims:id="834152"><Label>(c)</Label><Text>is manufactured, sold or represented for use in disinfection in premises in which food is manufactured, prepared or kept;</Text></Paragraph><Paragraph lims:inforce-start-date="2025-03-12" lims:enacted-date="2025-02-26" lims:fid="834153" lims:id="1523355"><Label>(d)</Label><Text>is an <DefinitionRef>active pharmaceutical ingredient</DefinitionRef> as defined in subsection C.01A.001(1) of the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal>; or</Text></Paragraph><Paragraph lims:inforce-start-date="2025-03-12" lims:enacted-date="2025-02-26" lims:fid="834154" lims:id="1523356"><Label>(e)</Label><Text><Repealed>[Repealed, SOR/2025-43, s. 75]</Repealed></Text></Paragraph><Paragraph lims:inforce-start-date="2018-10-17" lims:fid="834155" lims:id="834155"><Label>(f)</Label><Text>is sold to be used for the purpose of a <DefinitionRef>clinical trial</DefinitionRef>, as defined in section C.05.001 of the <XRefExternal reference-type="regulation" link="C.R.C.,_c._870">Food and Drug Regulations</XRefExternal>, or an <DefinitionRef>experimental study</DefinitionRef>, as defined in section C.08.013 of those Regulations.</Text></Paragraph><HistoricalNote><HistoricalNoteSubItem lims:inforce-start-date="2018-10-17" lims:fid="834157" lims:id="834157">SOR/2018-144, s. 373</HistoricalNoteSubItem><HistoricalNoteSubItem lims:inforce-start-date="2025-03-12" lims:enacted-date="2025-02-26" lims:fid="1523357" lims:id="1523357" lims:enactId="1515030">SOR/2025-43, s. 75</HistoricalNoteSubItem></HistoricalNote></Section><Section lims:inforce-start-date="2018-10-17" lims:lastAmendedDate="2018-10-17" lims:fid="834158" lims:id="834158"><MarginalNote lims:inforce-start-date="2018-10-17" lims:fid="834159" lims:id="834159">Cannabis for medical purposes</MarginalNote><Label>2</Label><Text>Despite paragraph 1(a), cannabis that is manufactured or sold in accordance with the <XRefExternal reference-type="regulation" link="SOR-2018-144">Cannabis Regulations</XRefExternal> is exempt from the application of the <XRefExternal reference-type="act" link="F-27">Food and Drugs Act</XRefExternal> from the time it is manufactured or sold by any of the following persons, unless it is represented for a use referred to in that paragraph:</Text><Paragraph lims:inforce-start-date="2018-10-17" lims:fid="834160" lims:id="834160"><Label>(a)</Label><Text>a person to which a licence, other than a cannabis drug licence, was issued under subsection 62(1) of the <XRefExternal reference-type="act" link="C-24.5">Cannabis Act</XRefExternal>; and</Text></Paragraph><Paragraph lims:inforce-start-date="2018-10-17" lims:fid="834161" lims:id="834161"><Label>(b)</Label><Text>a <DefinitionRef>designated person</DefinitionRef> as defined in Part 14 of the <XRefExternal reference-type="regulation" link="SOR-2018-144">Cannabis Regulations</XRefExternal>.</Text></Paragraph><HistoricalNote><HistoricalNoteSubItem lims:inforce-start-date="2018-10-17" lims:fid="834163" lims:id="834163">SOR/2018-144, s. 373</HistoricalNoteSubItem></HistoricalNote></Section><Section lims:inforce-start-date="2022-12-02" lims:enacted-date="2022-12-02" lims:lastAmendedDate="2022-12-02" lims:fid="834164" lims:id="1382517"><MarginalNote lims:inforce-start-date="2022-12-02" lims:enacted-date="2022-12-02" lims:fid="1382518" lims:id="1382518">Non-therapeutic research on cannabis</MarginalNote><Label>3</Label><Text>Despite paragraph 1(f), cannabis is exempt from the application of the <XRefExternal reference-type="act" link="F-27">Food and Drugs Act</XRefExternal> if it is sold to be used for the purpose of <DefinitionRef>non-therapeutic research on cannabis</DefinitionRef>, as defined in subsection 1(2) of the <XRefExternal reference-type="regulation" link="SOR-2018-144">Cannabis Regulations</XRefExternal>, that is conducted in accordance with those Regulations.</Text><HistoricalNote><HistoricalNoteSubItem lims:inforce-start-date="2022-12-02" lims:enacted-date="2022-12-02" lims:fid="1382520" lims:id="1382520" lims:enactId="1381812">SOR/2022-251, s. 25</HistoricalNoteSubItem></HistoricalNote></Section><Heading lims:inforce-start-date="2018-10-17" lims:fid="834165" lims:id="834165" level="1"><TitleText>Repeal</TitleText></Heading><Section lims:inforce-start-date="2016-08-24" lims:lastAmendedDate="2016-08-24" lims:fid="834166" lims:id="834166"><Label>4</Label><Text>[Repeal]</Text></Section><Heading lims:inforce-start-date="2018-10-17" lims:fid="834167" lims:id="834167" level="1"><TitleText>Coming into Force</TitleText></Heading><Section lims:inforce-start-date="2016-08-05" lims:lastAmendedDate="2016-08-05" lims:fid="834168" lims:id="834168" type="transitional"><MarginalNote lims:inforce-start-date="2016-08-05" lims:fid="834169" lims:id="834169">August 24, 2016</MarginalNote><Label>5</Label><Text>These Regulations come into force on August 24, 2016.</Text></Section></Body><RecentAmendments><Amendment><AmendmentCitation>SOR/2025-43</AmendmentCitation><AmendmentDate>2025-03-12</AmendmentDate></Amendment><Amendment><AmendmentCitation>SOR/2022-251</AmendmentCitation><AmendmentDate>2022-12-02</AmendmentDate></Amendment></RecentAmendments></Regulation>