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<subordleg title="Medicines and Poisons (Monitored Medicines Database Testing) Regulation 2020" year.published="2020" year.citation="2020" no="59" pco.reg.ref="S20_0004" publication.date="2020-05-01" enabling.title="Medicines and Poisons Act 2019" enabling.acts="act-2019-026" sub.leg.type="reg" amending="none" print.type="published" published.how="website" stage.repeal="1" initial.admin.dept="Queensland Health" id="sl-2020-0059" version.desc.id="63057aef-1ad3-4964-a8cc-901ceccbbe15" version.series.id="d572476e-cc6e-44b6-a7c9-9a2fa7c489ee" in.force="partuncommenced"><wrapper><body numbering.style="manual"><part id="pt.1" guid="_a268abf6-e430-4b10-a90c-e43a1da01a98" affected.by.uncommenced="0"><no>Part 1</no><heading id="pt.1-he" guid="_0de06a78-897a-4f4f-9daa-0f9847e946c5">Preliminary</heading><clause id="sec.1" guid="_74046c49-f47c-4d1a-ada7-9e247c8ec989" affected.by.uncommenced="0" spent.amends="0" provision.type="shorttitle"><no>1</no><heading id="sec.1-he" guid="_62cc8300-9b8c-41e2-a3f2-1e7b3dcf4db0">Short title</heading><block><txt break.before="1">This regulation may be cited as the <legref jurisd="QLD" type="subordleg" check="invalid"><name emphasis="yes">Medicines and Poisons (Monitored Medicines Database Testing) Regulation 2020</name></legref>.</txt></block></clause><clause id="sec.2" guid="_a67ea8ee-e43f-4c28-a11f-5ad4d7f6440b" affected.by.uncommenced="0" spent.amends="0" provision.type="commence"><no>2</no><heading id="sec.2-he" guid="_f41e7369-bbcd-4c73-991e-943a4bd40af9">Commencement</heading><block><txt break.before="1">This regulation commences on 1 May 2020.</txt></block></clause><clause id="sec.3" guid="_209f18ec-5437-4bd9-83d6-267f48d300bf" affected.by.uncommenced="0" spent.amends="0" provision.type="other"><no>3</no><heading id="sec.3-he" guid="_bb64f63c-7a17-4316-b3ac-832312442179">Purpose</heading><block><txt break.before="1">The purpose of this regulation is to facilitate the establishment and testing of the monitored medicines database using information given and recorded under the <legref jurisd="QLD" type="act" target.doc.id="act-1937-031" target.version.series="84d40372-066e-4e32-8906-4de46972dadb" check="valid"><name emphasis="yes">Health Act 1937</name></legref>.</txt></block></clause><clause id="sec.4" guid="_8f19ca67-c740-4938-945f-12a67f054f91" affected.by.uncommenced="0" spent.amends="0" provision.type="other"><no>4</no><heading id="sec.4-he" guid="_d8093045-78b9-47ce-87f4-31f11451ab3d">Definitions</heading><block><txt break.before="1">In this regulation—</txt><deflist><definition id="sec.4-def.authority_" guid="_eaf782d2-d0bd-46a2-9836-cea9acef54ee" affected.by.uncommenced="0"><txt break.before="1"><defterm id="sec.4-def.authority" guid="_44bb3ede-dc9a-4822-89d8-28579864f594" type="definition">authority</defterm> see the <legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" check="valid"><name emphasis="yes">Health (Drugs and Poisons) Regulation 1996</name></legref>, appendix 9.</txt></definition><definition id="sec.4-def.controlleddrug_" guid="_04aa7245-4f65-420d-9756-b0532356ed1e" affected.by.uncommenced="0"><txt break.before="1"><defterm id="sec.4-def.controlleddrug" guid="_a6c38770-026e-4a02-be95-d310f2b206c6" type="definition">controlled drug</defterm> see the <legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" check="valid"><name emphasis="yes">Health (Drugs and Poisons) Regulation 1996</name></legref>, appendix 9.</txt></definition><definition id="sec.4-def.dispenser_" guid="_f0facf44-fc22-4021-aadd-a57deb9ad47e" affected.by.uncommenced="0"><txt break.before="1"><defterm id="sec.4-def.dispenser" guid="_e81bb3e3-ac70-4270-8a5c-9b7b44e7d522" type="definition">dispenser</defterm> see the <legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" check="valid"><name emphasis="yes">Health (Drugs and Poisons) Regulation 1996</name></legref>, appendix 9.</txt></definition><definition id="sec.4-def.monitoredmedicinetreatmentactivity_" guid="_47229e77-6e73-47b9-b1f4-643dc25fe661" affected.by.uncommenced="0"><txt break.before="1"><defterm id="sec.4-def.monitoredmedicinetreatmentactivity" guid="_510edf0a-d3ff-487b-b927-895f80eab53e" type="definition">monitored medicine treatment activity</defterm> means an activity—</txt><list number.type="manual" unnumbered.indent="0"><li id="sec.4-def.monitoredmedicinetreatmentactivity-para1.a" guid="_da6a58c4-5828-444a-a6ab-4e0dcfa26d6a" provision.type="other"><no>(a)</no><block><txt break.before="0">performed by the holder of an authority or a relevant approval; and</txt></block></li><li id="sec.4-def.monitoredmedicinetreatmentactivity-para1.b" guid="_8a38e7b9-2868-4181-8cb1-3596fd007dcf" provision.type="other"><no>(b)</no><block><txt break.before="0">equivalent to prescribing or supplying a monitored medicine for the treatment of a person.</txt></block></li></list></definition><definition id="sec.4-def.opioidtreatmentprogram_" guid="_622b6b2e-e431-44c2-8260-10a524e00e04" affected.by.uncommenced="0"><txt break.before="1"><defterm id="sec.4-def.opioidtreatmentprogram" guid="_f3714404-7473-4908-80ef-b558e28a9551" type="definition">opioid treatment program</defterm> means a program carried out in Queensland under the <legref jurisd="CTH" type="act" target.doc.id="act-1953-095" target.version.series="C1953A00095" check="valid"><name emphasis="yes">National Health Act 1953</name> (Cwlth)</legref>, <legref jurisd="CTH" type="act" target.doc.id="act-1953-095" target.version.series="C1953A00095" refid="sec.100" check="invalid">section&#160;100</legref> for the treatment of persons who are dependent on opioids, including a program that was in effect before the commencement.</txt></definition><definition id="sec.4-def.prescriber_" guid="_97f98724-1756-4139-b3c2-09a8032c2088" affected.by.uncommenced="0"><txt break.before="1"><defterm id="sec.4-def.prescriber" guid="_9b5fb04b-d8af-40e5-a47a-2a79721e406f" type="definition">prescriber</defterm> see the <legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" check="valid"><name emphasis="yes">Health (Drugs and Poisons) Regulation 1996</name></legref>, appendix 9.</txt></definition><definition id="sec.4-def.relevantapproval_" guid="_f3cdca79-d0ad-4769-83a3-5e7dea314614" affected.by.uncommenced="0"><txt break.before="1"><defterm id="sec.4-def.relevantapproval" guid="_8ea03f2d-d229-4124-9f4d-b17ddd927a29" type="definition">relevant approval</defterm> means—</txt><list number.type="manual" unnumbered.indent="0"><li id="sec.4-def.relevantapproval-para1.a" guid="_d90e63e8-6c33-497e-940d-88a0158dfdb3" provision.type="other"><no>(a)</no><block><txt break.before="0">an approval mentioned in the <legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" check="valid"><name emphasis="yes">Health (Drugs and Poisons) Regulation 1996</name></legref>, <legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" refid="sec.78" check="valid" target.guid="_f35e6ae8-54f3-4d0e-9079-0a78c79492f6">section&#160;78</legref><legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" refid="sec.78-ssec.1" check="valid" target.guid="_c9bef806-fc83-476c-91c5-bc09ca71020f">(1)</legref><legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" refid="sec.78-ssec.1-para1.a" check="valid" target.guid="_2476277d-5cff-49fd-8220-31c816e78528">(a)</legref>, if the approval is given for the treatment of a particular person; or</txt></block></li><li id="sec.4-def.relevantapproval-para1.b" guid="_2a357033-e71d-477a-b9cd-862d9a8701ae" provision.type="other"><no>(b)</no><block><txt break.before="0">an approval given under the <legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" check="valid"><name emphasis="yes">Health (Drugs and Poisons) Regulation 1996</name></legref>, <legref jurisd="QLD" type="subordleg" target.doc.id="sl-1996-0414" target.version.series="cc089199-e0ed-4bf4-96ed-9441a954adde" refid="sec.122" check="valid" target.guid="_c5c4affc-eab8-499e-b1b1-a638ea9f1785">section&#160;122</legref>, if the approval is given for the treatment of a class of persons.</txt></block></li></list></definition></deflist></block></clause></part><part id="pt.2" guid="_a3f65815-0d4f-46e7-b56c-85aef02c6eda" affected.by.uncommenced="0"><no>Part 2</no><heading id="pt.2-he" guid="_66b3aeed-a1ee-4509-afc0-ea6fb8378926">Monitored medicines database</heading><clause id="sec.5" guid="_52621672-928c-4e35-9e65-86cdd17d9718" affected.by.uncommenced="0" spent.amends="0" provision.type="other"><no>5</no><heading id="sec.5-he" guid="_234b2b39-63e2-4e4a-8a29-c4acd78da742">Monitored medicines—<legref target.doc.id="act-2019-026" target.version.series="f8e0808d-437e-4842-9076-fd1e9c60b7b7" jurisd="QLD" type="act" check="valid">Act</legref>, <legref target.doc.id="act-2019-026" target.version.series="" jurisd="QLD" type="act" refid="sch.1" check="invalid">sch&#160;1</legref></heading><block><txt break.before="1">For <legref target.doc.id="act-2019-026" refid="sch.1" jurisd="QLD" type="act" check="invalid">schedule&#160;1</legref> of the <legref target.doc.id="act-2019-026" target.version.series="f8e0808d-437e-4842-9076-fd1e9c60b7b7" jurisd="QLD" type="act" check="valid">Act</legref>, definition <defterm guid="_cc6e7542-c0fb-4d30-8e8c-037c20dd448b" type="mention">monitored medicine</defterm>, a controlled drug is prescribed to be a monitored medicine.</txt></block></clause><clause id="sec.6" guid="_e7b64ebd-d592-42a0-aab7-97ff962714a4" affected.by.uncommenced="0" spent.amends="0" provision.type="other"><no>6</no><heading id="sec.6-he" guid="_931e7355-d8b0-4da3-9eeb-57acab3aa1b9">Departmental information for database—<legref target.doc.id="act-2019-026" target.version.series="f8e0808d-437e-4842-9076-fd1e9c60b7b7" jurisd="QLD" type="act" check="valid">Act</legref>, <legref target.doc.id="act-2019-026" target.version.series="" jurisd="QLD" type="act" refid="sec.225" check="invalid">s&#160;225</legref></heading><subclause id="sec.6-ssec.1" guid="_b9a3467d-9979-4238-9cb2-13105ac59d11" affected.by.uncommenced="0" provision.type="other"><no>(1)</no><block><txt break.before="0">For <legref target.doc.id="act-2019-026" refid="sec.225" jurisd="QLD" type="act" check="invalid">section&#160;225</legref><legref target.doc.id="act-2019-026" refid="sec.225-ssec.1" jurisd="QLD" type="act" check="invalid">(1)</legref> of the <legref target.doc.id="act-2019-026" target.version.series="f8e0808d-437e-4842-9076-fd1e9c60b7b7" jurisd="QLD" type="act" check="valid">Act</legref>, the following information is prescribed—</txt><list number.type="manual" unnumbered.indent="0"><li id="sec.6-ssec.1-para1.a" guid="_67f5370b-c732-4df3-abeb-4dc03aba3aad" provision.type="other"><no>(a)</no><block><txt break.before="0">relevant health information that—</txt><list number.type="manual" unnumbered.indent="0"><li id="sec.6-ssec.1-para1.a-para2.i" guid="_9a030f75-806c-4ee4-87a3-1994ee51c967" provision.type="other"><no>(i)</no><block><txt break.before="0">is given to, or recorded by or on behalf of, the chief executive under the <legref jurisd="QLD" type="act" target.doc.id="act-1937-031" target.version.series="84d40372-066e-4e32-8906-4de46972dadb" check="valid"><name emphasis="yes">Health Act 1937</name></legref> on or after the commencement; and</txt></block></li><li id="sec.6-ssec.1-para1.a-para2.ii" guid="_6c50252a-6881-4e1d-bc12-385435fb92ed" provision.type="other"><no>(ii)</no><block><txt break.before="0">is kept electronically by the chief executive;</txt></block></li></list></block></li><li id="sec.6-ssec.1-para1.b" guid="_f1122efd-b3e7-43a3-abee-a2954eb845fa" provision.type="other"><no>(b)</no><block><txt break.before="0">relevant registration information for a monitored medicine treatment activity performed under an opioid treatment program that—</txt><list number.type="manual" unnumbered.indent="0"><li id="sec.6-ssec.1-para1.b-para2.i" guid="_e1ff21ad-8d6a-4bff-ab8b-731dd37647e3" provision.type="other"><no>(i)</no><block><txt break.before="0">was given to, or recorded by or on behalf of, the chief executive under the <legref jurisd="QLD" type="act" target.doc.id="act-1937-031" target.version.series="84d40372-066e-4e32-8906-4de46972dadb" check="valid"><name emphasis="yes">Health Act 1937</name></legref> at any time before the commencement; and</txt></block></li><li id="sec.6-ssec.1-para1.b-para2.ii" guid="_f840415b-461f-4a1e-bb71-4f9211c7d4b5" provision.type="other"><no>(ii)</no><block><txt break.before="0">is kept electronically by the chief executive.</txt></block></li></list></block></li></list></block></subclause><subclause id="sec.6-ssec.2" guid="_5b5683ba-5ebe-4084-8c5c-c86a9739b65c" affected.by.uncommenced="0" provision.type="other"><no>(2)</no><block><txt break.before="0">In this section—</txt><deflist><definition id="sec.6-ssec.2-def.relevanthealthinformation_" guid="_929854d5-87f4-4af6-b056-b22cbc3f2f07" affected.by.uncommenced="0"><txt break.before="1"><defterm id="sec.6-ssec.2-def.relevanthealthinformation" guid="_08da2c0a-8cfc-4424-b8e9-126a8f32c595" type="definition">relevant health information</defterm> means the following information—</txt><list number.type="manual" unnumbered.indent="0"><li id="sec.6-ssec.2-def.relevanthealthinformation-para1.a" guid="_9be603bd-4339-4a95-bd5d-f02f7fe21eac" provision.type="other"><no>(a)</no><block><txt break.before="0">information in relation to a monitored medicine treatment activity;</txt></block></li><li id="sec.6-ssec.2-def.relevanthealthinformation-para1.b" guid="_c1a45256-e616-4fbd-837f-247c89360d91" provision.type="other"><no>(b)</no><block><txt break.before="0">information in relation to a relevant approval;</txt></block></li><li id="sec.6-ssec.2-def.relevanthealthinformation-para1.c" guid="_4a99e1b6-761f-4ded-8bc0-ad2dac699dc0" provision.type="other"><no>(c)</no><block><txt break.before="0">information kept, from time to time, on a register under the Health Practitioner Regulation National Law for a prescriber or dispenser who holds an authority or a relevant approval;</txt></block></li><li id="sec.6-ssec.2-def.relevanthealthinformation-para1.d" guid="_4ee26c9b-cd77-41ae-9383-a65aa7e4923b" provision.type="other"><no>(d)</no><block><txt break.before="0">personal information to identify a prescriber or dispenser for accessing or using the monitored medicines database;</txt></block></li><li id="sec.6-ssec.2-def.relevanthealthinformation-para1.e" guid="_e2aa4be7-e545-4fd4-ba46-a81f1d346a4a" provision.type="other"><no>(e)</no><block><txt break.before="0">information recorded in relation to a prescriber’s or dispenser’s access to, or use of, the monitored medicines database.</txt></block></li></list></definition><definition id="sec.6-ssec.2-def.relevantregistrationinformation_" guid="_60ebe140-4876-481b-9c0a-00486bf4b07c" affected.by.uncommenced="0"><txt break.before="1"><defterm id="sec.6-ssec.2-def.relevantregistrationinformation" guid="_e7c7eaba-0a28-49b3-beef-2dda58c9bffa" type="definition">relevant registration information</defterm>, for a monitored medicine treatment activity performed under an opioid treatment program, means information about the registration of particular persons in the program.</txt></definition></deflist></block></subclause></clause><clause id="sec.7" guid="_a2d806f0-dfbb-4335-a2e4-74d897c0311d" affected.by.uncommenced="0" spent.amends="0" provision.type="other"><no>7</no><heading id="sec.7-he" guid="_ceec440c-82f7-41a2-856a-2dccf015396d">Users of database—<legref target.doc.id="act-2019-026" target.version.series="f8e0808d-437e-4842-9076-fd1e9c60b7b7" jurisd="QLD" type="act" check="valid">Act</legref>, <legref target.doc.id="act-2019-026" target.version.series="" jurisd="QLD" type="act" refid="sec.227" check="invalid">s&#160;227</legref></heading><block><txt break.before="0">For <legref target.doc.id="act-2019-026" refid="sec.227" jurisd="QLD" type="act" check="invalid">section&#160;227</legref><legref target.doc.id="act-2019-026" refid="sec.227-ssec.4" jurisd="QLD" type="act" check="invalid">(4)</legref> of the <legref target.doc.id="act-2019-026" target.version.series="f8e0808d-437e-4842-9076-fd1e9c60b7b7" jurisd="QLD" type="act" check="valid">Act</legref>, definition <defterm guid="_345186f4-ef61-42c5-836c-84c64cece170" type="mention">user</defterm>, each of the following entities is prescribed to be a user—</txt><list number.type="manual" unnumbered.indent="0"><li id="sec.7-para1.a" guid="_ca8e0d93-16ec-420b-8e36-6a0890158277" provision.type="other"><no>(a)</no><block><txt break.before="0">a prescriber;</txt></block></li><li id="sec.7-para1.b" guid="_8bcf9186-e171-4349-980c-80cd4932d708" provision.type="other"><no>(b)</no><block><txt break.before="0">a dispenser;</txt></block></li><li id="sec.7-para1.c" guid="_df4e4e8d-89ca-42ae-9a65-f821d5954fe7" provision.type="other"><no>(c)</no><block><txt break.before="0">a person employed by the chief executive.</txt></block></li></list></block></clause><clause id="sec.8" guid="_78d19e00-afe1-4f69-a8db-6f09fdfeef4f" affected.by.uncommenced="0" spent.amends="0" provision.type="other"><no>8</no><heading id="sec.8-he" guid="_9e2b96a8-ee0c-41f4-9e58-23312e34183a">Purposes for disclosure—<legref target.doc.id="act-2019-026" target.version.series="f8e0808d-437e-4842-9076-fd1e9c60b7b7" jurisd="QLD" type="act" check="valid">Act</legref>, <legref target.doc.id="act-2019-026" target.version.series="" jurisd="QLD" type="act" refid="sec.227" check="invalid">s&#160;227</legref></heading><block><txt break.before="0">For <legref target.doc.id="act-2019-026" refid="sec.227" jurisd="QLD" type="act" check="invalid">section&#160;227</legref><legref target.doc.id="act-2019-026" refid="sec.227-ssec.2" jurisd="QLD" type="act" check="invalid">(2)</legref> of the <legref target.doc.id="act-2019-026" target.version.series="f8e0808d-437e-4842-9076-fd1e9c60b7b7" jurisd="QLD" type="act" check="valid">Act</legref>, each of the following purposes is prescribed—</txt><list number.type="manual" unnumbered.indent="0"><li id="sec.8-para1.a" guid="_1a31cc2f-999d-4b8a-9424-685b5a0cca9a" provision.type="other"><no>(a)</no><block><txt break.before="0">for a user who is a prescriber or dispenser—testing the monitored medicines database;</txt></block></li><li id="sec.8-para1.b" guid="_495f10d4-9120-4c88-8f58-503e446210be" provision.type="other"><no>(b)</no><block><txt break.before="0">for a user who is a person employed by the chief executive—establishing or testing the monitored medicines database, including training about using the database.</txt></block></li></list></block></clause></part></body></wrapper></subordleg>