therapeutic goods included in the part of the Register for goods known as registered goods; or

therapeutic goods included in the part of the Register for goods known as provisionally registered goods.

a reference in this Act to therapeutic goods that are registered includes a reference to a medicine that is provisionally registered; and

a reference in this Act to the registration of therapeutic goods includes a reference to the provisional registration of a medicine.

in the part of the Register for goods known as provisionally registered goods; or

a part for goods to be known as provisionally registered goods; and

a medicine is included in the part of the Register for goods known as provisionally registered goods; and

it appears to the Secretary that the quality, safety or efficacy of the medicine is unacceptable in relation to a class of persons;

to reduce the class of persons for whom the medicine is suitable or to change the directions for use; or

to add a warning, or precaution, that does not include any comparison of the medicine with any other medicine by reference to quality, safety or efficacy.

a medicine is included in the part of the Register for goods known as provisionally registered goods; and

the Secretary makes a decision under subsection 29(9) to extend the provisional registration period for the medicine;

give the person in relation to whom the medicine is registered written notice of the proposed variation and of the reasons for the proposed variation; and

give the person a reasonable opportunity to make a submission to the Secretary in relation to the proposed variation; and

if the person makes a submission in accordance with paragraph (b)—take the submission into account before making a decision whether or not to make the variation.

be made in accordance with a form approved, in writing, by the Secretary; and

be accompanied by the prescribed application fee; and

contain the information that the form requires, and any further information, statement or document the Secretary requires, whether in the form or otherwise; and

satisfy any other requirement prescribed by the regulations for the purposes of this paragraph.

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

the person to whom the determination relates; and

the medicine to which the determination relates; and

the indication of the medicine to which the determination relates; and

each active ingredient of the medicine to which the determination relates.

give the person written notice of the decision; and

if the Secretary refuses to make the determination—set out the reasons for the refusal in the notice.

comes into force on the day on which the Secretary gives the person notice under subsection 22D(4); and

subject to this section and section 22F, remains in force for the initial period.

be in a form approved, in writing, by the Secretary; and

be made at least 28 days before the determination would otherwise cease to be in force; and

be accompanied by the prescribed application fee.

is still satisfied that the criteria prescribed by the regulations for the purposes of subsection 22D(2) are met in relation to the medicine; and

is satisfied that, if the Secretary were to make the extension, the person would make an application under section 23 for provisional registration of the medicine before the end of the extended period.

give the person written notice of the decision; and

if the Secretary refuses to extend the initial period—set out the reasons for the refusal in the notice.

the person withdraws the application; or

the application lapses in accordance with subsection 24(2); or

the person gives the Secretary written notice under subsection 24E(2) that the person wishes to treat the application as having been refused; or

the application is finally determined.

give the person written notice of the revocation; and

for a revocation under subsection (1)—set out the reasons for the revocation in the notice.

a person makes an application under section 23 for the registration of a medicine; and

a provisional determination under section 22D relating to the person, the medicine and the indication to which the application relates is in force when the application is made;

unless the application is one referred to in paragraph (d)—whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established; and

for an application for provisional registration of a medicine:

whether, based on preliminary clinical data, the safety and efficacy of the medicine for the purposes for which it is to be used have been satisfactorily established; and

whether the quality of the medicine for the purposes for which it is to be used has been satisfactorily established; and

whether, if the Secretary were to register the medicine, the Secretary is satisfied with the applicant’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence; and

the provisional registration of medicine; and

a person makes an application for provisional registration of a medicine; and

in relation to that application, the Secretary decides under subsection 25(3) to register the medicine; and

the medicine is included in the Register in relation to the person;

the medicine is provisionally registered; and

the medicine remains included in the Register for the provisional registration period, unless the medicine’s registration is cancelled under this Part earlier.

be in a form approved, in writing, by the Secretary; and

contain the information that the form requires, and any further information, statement or document the Secretary requires, whether in the form or otherwise; and

be made at least 6 months before the provisional registration of the medicine is due to end; and

be accompanied by the prescribed application fee.

whether the Secretary is satisfied with the applicant’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years starting on the day the provisional registration commenced; and

such other matters (if any) as the Secretary considers relevant.

give the applicant written notice of the decision; and

if the Secretary decides to extend the provisional registration period—specify in the notice the period of the extension (which must not exceed 2 years and may be less than the period sought by the applicant); and

if the Secretary refuses to extend the provisional registration period—set out the reasons for the refusal in the notice.

before the provisional registration period ends, the person in relation to whom the medicine is provisionally registered makes an application under section 23 for registration of the medicine; and

the application is for the medicine to be included in the part of the Register for goods known as registered goods;

the Secretary must have regard to any matters prescribed by the regulations for the purposes of this paragraph; and

the Secretary must ensure the provisional registration period continues while the Secretary is considering the application, unless the medicine’s registration is cancelled under this Part; and

the Secretary must not extend the provisional registration period so it would end more than 6 years after the provisional registration commenced, unless the extension is for the purposes of paragraph (b).

particular therapeutic goods were or were not included in the Register as provisionally registered goods; or

makes a decision under section 22D in relation to an application under section 22C; or

makes a decision under section 22E in relation to an application under subsection 22E(3); or

makes a decision under section 23B in relation to an application for provisional registration of a medicine; or

makes a decision under subsection 25(3) in relation to an application for provisional registration of a medicine;

makes a decision under subsection 29(6) in relation to an application under subsection 29(4); or

makes a decision under subsection 29(9) to end, or extend, the provisional registration period for a medicine;

if the medicine’s label contains one or more indications—each indication:

is covered by a determination under paragraph 26BF(1)(a); and

is proposed to be accepted in relation to the inclusion of the medicine in the Register; and

each indication proposed to be accepted in relation to the inclusion of the medicine in the Register is covered by a determination under paragraph 26BF(1)(a); and

if a determination under paragraph 26BF(1)(b) specifies requirements in relation to an indication proposed to be accepted in relation to the inclusion of the medicine in the Register—none of the requirements have been contravened; and

both:

the applicant holds information or evidence to support any claim (other than a claim that is an indication) proposed to be accepted in relation to the inclusion of the medicine in the Register; and

the information or evidence complies with any requirements specified in a determination under subsection (2B); and

both:

the applicant holds information or evidence to support each indication proposed to be accepted in relation to the inclusion of the medicine in the Register; and

the information or evidence complies with any requirements specified in a determination under subsection (2B); and

give the Secretary such further information in connection with the application as is specified in the notice; and

do so within such reasonable period as is specified in the notice.

the application contains information that is inaccurate or misleading in a material particular; or

information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular.

if further information is required to be given under subsection (2A) within a specified period—the information is given within that period;

notify the applicant in writing of his or her decision; and

state in the notice the reasons for the decision.

an application fee is prescribed for the purposes of paragraph (2)(d); and

regulations made for the purposes of paragraph 63(2)(daaa) prescribe a period within which recommendations under this section must be made; and

the Secretary makes a recommendation in relation to an application under subsection (1), but not within that period;

regulations made for the purposes of paragraph 63(2)(daaa) prescribe a period within which recommendations under this section must be made; and

at the end of that period, the Secretary has not made a recommendation in relation to an application under subsection (1);

the Secretary had decided not to make a recommendation under this section; and

the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and

the Minister’s decision had been made on the day on which notice was given to the Secretary under subsection (5C).

indications;

requirements in relation to indications.

maintaining health;

enhancing health;

preventing a dietary deficiency;

a disease, ailment, defect or injury, other than a serious form of the disease, ailment, defect or injury.

the use of particular indications in specified circumstances; or

the use of particular indications if certain specified conditions are met.

be made in accordance with a form approved, in writing, by the Secretary; and

set out the recommendation sought; and

be delivered to an office of the Department specified in the form; and

be accompanied by the prescribed application fee (if any).

an indication specified in a determination under section 26BG;

an indication that is or contains a restricted representation (within the meaning of Part 5-1);

unless subsection (4) applies—an indication that is or contains a prohibited representation (within the meaning of Part 5-1);

unless subsection (5) applies—an indication that refers to preventing, curing or alleviating a disease, ailment, defect or injury.

the indication is a therapeutic use that relates to sun protection; and

the prohibited representation relates to the prevention of skin cancer; and

the use of the prohibited representation is permitted under section 42DK.

the prevention of a dietary deficiency; or

the prevention of skin cancer or sun damage.

give the Secretary such further information in connection with the application as is specified in the notice; and

do so within such reasonable time as is specified in the notice.

the application contains information that is inaccurate or misleading in a material particular; or

information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular.

an application is made under subsection (1); and

any applicable prescribed application fee has been paid; and

if further information is required to be given under subsection (6) within a specified time—the information is given within that time;

maintaining health;

enhancing health;

preventing a dietary deficiency;

a disease, ailment, defect or injury, other than a serious form of the disease, ailment, defect or injury;

sun protection.

notify the applicant in writing of his or her decision; and

state in the notice the reasons for the decision.

by legislative instrument, vary the determination under subsection 26BF(1); or

refuse to vary the determination.

the recommendation made under subsection (8) of this section; and

whether the indication is a therapeutic use that relates to one or more of the matters in paragraphs (9)(a) to (e) of this section.

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

a condition that the sponsor of the goods had, at the time when the claim was made, information or evidence that supported the claim and complied with the requirements (if any) specified in a determination made under subsection 26A(2B);

a condition that the sponsor retains the information or evidence at all times while the goods remain listed;

a condition that, at any time while the goods remain listed, the sponsor will, if asked to do so by the Secretary, give the information or evidence to the Secretary.

a medicine is listed under section 26A; and

an indication is accepted in relation to the inclusion of the medicine in the Register;

a condition that the person in relation to whom the medicine is listed has, at all times while the medicine remains listed, information or evidence that supports the indication and complies with the requirements (if any) specified in a determination under subsection 26A(2B);

a condition that, at any time while the medicine remains listed, the person will, if asked to do so by the Secretary, give the information or evidence to the Secretary.

provide for the periods within which evaluations under section 26BE in relation to recommendations to vary a section 26BB determination are to be completed; and

a person has made an application under section 23 of the Act for the listing of the medicine before the commencement of this Schedule; and

the application has not been finally determined before that commencement; and

after that commencement, the Secretary lists the medicine in relation to the person under section 26A of the Act.

was listed under 11 June 1996; andsection 26 of the Act before

is, immediately before the commencement of this Schedule, listed goods; and

is not subject to a condition that it must not be supplied in Australia; and

is, is intended to be, or has been supplied in Australia.

the medicine is listed in relation to the person under section 26A of the Act;

the medicine is listed in relation to the person under section 26AE of the Act;

the listing of the medicine is cancelled;

an application for the listing of the medicine in relation to the person under section 26AE of the Act that complies with section 23C of the Act has been made, but not yet decided.

during the transition period, an application for the listing of the medicine in relation to the person under section 26AE of the Act has been made; and

after the transition period, the application lapses;

an application is made under section 23 for the listing of medicine in relation to a person; and

the application passes preliminary assessment; and

the requirements of subsections (2), (3), (4) and (6) have been complied with; and

the medicine is not a medicine which may be listed under section 26A; and

the medicine is not export only medicine; and

the medicine is not one that has previously had its registration or listing cancelled;

the medicine is eligible for listing; and

the medicine is safe for the purposes for which it is to be used; and

the presentation of the medicine is not unacceptable; and

the medicine does not contain an ingredient that is not specified in a determination under paragraph 26BB(1)(a); and

if a determination under paragraph 26BB(1)(b) specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; and

the medicine conforms to every standard (if any) applicable to the medicine; and

both of the following are complied with in relation to the medicine:

the applicable provisions of the Therapeutic Goods Advertising Code;

the other requirements (if any) relating to advertising applicable under Part 5-1 or under the regulations; and

if the medicine has been manufactured in Australia—each step in the manufacture of the medicine has been carried out by a person who is the holder of a licence to carry out that step; and

the medicine complies with all prescribed quality or safety criteria that are applicable to the medicine; and

the medicine’s specifications comply with any requirements that are prescribed by the regulations for the purposes of this paragraph and that are applicable to the medicine; and

the medicine’s label:

complies with any requirements that are prescribed by the regulations for the purposes of this subparagraph and that are applicable to the medicine; and

does not make a claim that is inconsistent with any claim made by the applicant in relation to the medicine in, or in connection with, the application; and

the applicant holds information or evidence showing the medicine’s specifications will be maintained under the conditions set out on the medicine’s label until the medicine’s expiry date; and

the applicant has available sufficient information to substantiate each claim and each indication proposed to be accepted in relation to the inclusion of the medicine in the Register; and

(n) the medicine does not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and

all the manufacturers of the medicine are nominated as manufacturers in the application; and

the applicant has, with manufacturers of the medicine who are manufacturers of the prescribed kind, written agreements containing such matters as are prescribed; and

the information included in or with the application is complete and correct.

whether the applicant has provided:

if a step in the manufacture of the medicine has been carried out in a country that is a member of the European Community or a member of EFTA—an EC/EFTA attestation of conformity in relation to the medicine; or

if a step in the manufacture of the medicine has been carried out in a country declared by the Minister under section 3B to be covered by a non-EC/EFTA MRA—a non-EC/EFTA attestation of conformity, for the non-EC/EFTA MRA, in relation to the medicine; or

in any other case—an acceptable form of evidence from a relevant overseas authority establishing that the manufacture of the medicine is of an acceptable standard; and

whether the applicant has agreed to provide, if the Secretary considers inspection of the manufacturing procedures used in the manufacture of the medicine to be necessary:

funds for the carrying out of that inspection by the Department; and

evidence that the manufacturer has agreed to such an inspection; and

whether the applicant has complied with any requirements made by the Secretary under section 31 in relation to the manufacture or preparation of the medicine.

a medicine was made outside Australia; and

had the medicine been made in Australia, it would have been exempt from the operation of Part 3-3;

an application is made under section 23 in relation to a medicine for listing under section 26AE; and

the application has passed preliminary assessment.

is due and payable on the day on which the applicant is notified of the amount of the evaluation fee; and

may be recovered by the Commonwealth as a debt due to the Commonwealth.

an application is made under section 23 in relation to a medicine for listing under section 26AE; and

the applicant has paid the whole of the evaluation fee; and

regulations made for the purposes of paragraph 63(2)(daaaa) prescribe a period within which evaluations under section 26AE in relation to the medicine must be completed; and

the evaluation is completed, but not within that period;

any part of the evaluation fee referred to in section 26AC remains unpaid at the end of 28 days after the day on which the amount became due and payable; or

the application contains information that is inaccurate or misleading in a material particular; or

information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular.

regulations made for the purposes of paragraph 63(2)(daaaa) prescribe a period within which evaluations under section 26AE in relation to the medicine must be completed; and

at the end of that period, the evaluation has not been completed;

the Secretary had decided not to list the medicine which is the subject of the application; and

the Minister had made a decision under subsection 60(3) confirming the decision of the Secretary; and

the Minister’s decision had been made on the day on which notice was given to the Secretary under subsection (2).

an application is made under section 23 for the listing of a medicine in relation to a person under this section; and

the application has passed preliminary assessment;

whether the efficacy of the medicine for the purposes for which it is to be used has been satisfactorily established; and

such other matters (if any) as the Secretary considers relevant.

to list the medicine; or

not to list the medicine.

set out the decision under subsection (3) to list the medicine in relation to the person; and

inform the applicant that the medicine will not be included in the Register unless and until the applicant gives the Secretary:

the certificate required under subsection 26B(1); or

a notice (in accordance with a form approved, in writing, by the Secretary) that a certificate under that subsection is not required in relation to the application.

include the medicine in the Register; and

give the applicant a certificate of listing.

an application is made for the listing of medicine in relation to a person; and

the Secretary decides under subsection (3) not to list the medicine;

a medicine is listed under section 26AE; and

an indication is accepted in relation to the inclusion of the medicine in the Register;

a condition that the person in relation to whom the medicine is listed has, at all times while the medicine remains listed, information or evidence that supports the indication;

a condition that, at any time while the medicine remains listed, the person will, if asked to do so by the Secretary, give the information or evidence to the Secretary.

subsection 26A(4) applies in a way corresponding to the way in which it applies for the purposes of subsection 26A(3); and

subsection 26AB(5) applies in a way corresponding to the way in which it applies for the purposes of subsection 26AB(4).

in the case of a medicine listed under the Secretary that any of the certifications under paragraph 26AB(2)(a), (d), (e), (h) or (n) are incorrect or (if applicable) the requirements under subsection 26AB(4) or (6) are not fulfilled; orsection 26AE, it appears to

the Secretary, under section 31, gives to the person a notice requiring the person to give to the Secretary information or documents relating to the medicine; and

the notice is given for the purposes of ascertaining whether any of the certifications by the person under subsection 26AB(2) or (3) in relation to the medicine are incorrect; and

the person fails to comply with the notice within 20 working days after the notice is given.

in the case of a medicine listed under the Secretary that any of the certifications under paragraph 26AB(2)(b), (c), (f), (g), (i), (j), (k), (l), (m), (o), (p) or (q) or subsection 26AB(3) are incorrect; orsection 26AE, it appears to

if the goods are or were listed under section 26AE—any of the matters covered by a certification by the person under subsection 26AB(2) or (3) in relation to the medicine;

if the goods are or were listed under section 26AE—the efficacy of the goods in relation to the purposes for which they are to be used;

provide for the periods within which evaluations under section 26AE in relation to specified medicines or specified classes of medicines are to be completed; and

the application has passed preliminary assessment; and

registration of therapeutic goods (including an application for provisional registration of a medicine); or

the listing of a medicine under section 26AE;

the application must be made:

in accordance with the form approved, in writing, by the Secretary for that class of therapeutic goods; or

in such other manner as is approved, in writing, by the Secretary for that class of therapeutic goods;

the prescribed application fee for that class of therapeutic goods must be paid;

the application must be delivered to an office of the Department specified by the Secretary;

the application must be accompanied by information that is:

of a kind determined under subsection (9) for that class of therapeutic goods; and

in a form determined under subsection (10) for that class of therapeutic goods;

if the application is for the registration of restricted medicine—the application must be accompanied by product information, in relation to the medicine, that is in the form approved under section 7D in relation to the medicine;

if the Secretary so requires—the applicant must:

deliver to the Department a reasonable number of samples of the goods; and

do so in a manner approved, in writing, by the Secretary.

has carried out an assessment, under subsection (1), in relation to the application; and

is satisfied that the requirements set out in subsection (2) have been met in relation to the application.

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

the application is made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary for the purposes of this paragraph; and

the application is delivered to an office of the Department specified by the Secretary; and

the prescribed application fee has been paid; and

the applicant has delivered to the office to which the application was made such information, in a form approved, in writing, by the Secretary, as will allow the determination of the application; and

if the Secretary so requires—the applicant has delivered to the office to which the application was made a reasonable number of samples of the goods.

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

an application is made for the registration of therapeutic goods under section 23; and

the goods are goods that are required to be registered; and

the application has passed preliminary assessment.

an application is made for the registration of therapeutic goods in relation to a person under section 23; and

the application has passed preliminary assessment;

the application has passed preliminary assessment; and

the application has passed preliminary assessment; and

the application has passed preliminary assessment; and

the application has passed preliminary assessment; and

the application complies with section 23C; and

the application complies with section 23C; and

the application complies with section 23C; and

the application complies with section 23C; and

the application complies with section 23C; and

the application complies with section 23C; and

the therapeutic good is, or contains, a GM product or a genetically modified organism; and

if the application is for registration—the application has passed preliminary assessment; and

if the application is for the listing of a medicine under section 26AE—the application has passed preliminary assessment.

the application has passed preliminary assessment; and

(a) were made for the purposes of subsection 24(1) of the Therapeutic Goods Act 1989; and

were in force immediately before the commencement of this subitem;

an application under section 32DD has been made for inclusion of the biological in the Register, and the application has passed preliminary assessment; and

either:

an application that complies with section 32DA has been made for inclusion of the biological in the Register; or

an application under section 32DD has been made for inclusion of the biological in the Register, and the application has passed preliminary assessment; and

the application must be made:

in accordance with the form approved, in writing, by the Secretary for that class of biological; or

in such other manner as is approved, in writing, by the Secretary for that class of biological;

the prescribed application fee for that class of biological must be paid;

the application must be delivered to an office of the Department specified by the Secretary;

the application must be accompanied by information that is:

of a kind determined under subsection (9) for that class of biological; and

in a form determined under subsection (10) for that class of biological;

if the Secretary so requires—the applicant must:

deliver to the Department a reasonable number of samples of the biological; and

do so in a manner approved, in writing, by the Secretary.

has carried out an assessment, under subsection (1), in relation to the application; and

is satisfied that the requirements set out in subsection (2) have been met in relation to the application.

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

the application has passed preliminary assessment; and

the application has passed preliminary assessment; and

the application must be made:

in accordance with the form approved, in writing, by the Secretary for that classification of medical device; or

in such other manner as is approved, in writing, by the Secretary for that classification of medical device;

the prescribed application fee for that classification of medical device must be paid;

the application must be delivered to an office of the Department specified by the Secretary;

the application must be accompanied by information that is:

of a kind determined under subsection (7) for that classification of medical device; and

in a form determined under subsection (8) for that classification of medical device;

if regulations made for the purposes of section 41EA require the manufacturer of the kind of device to have a conformity assessment certificate relating to the kind of medical device before an application under section 41FC can be made—such a certificate is in force;

the applicant has certified the matters in section 41FD.

has carried out an assessment, under subsection (1), in relation to the application; and

is satisfied that the requirements set out in subsection (2) have been met in relation to the application.

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

an application for a kind of medical device to be included in the Register in relation to a person has passed preliminary assessment; and

the application has not been selected for audit under section 41FH;

is refused under subsection 41FDB(4); or

is refused under subsection 41FF(1A).

when used in relation to a section 23 application for registration—has the meaning given by subsection 23B(3); and

when used in relation to a section 23 application for listing under section 26AE—has the meaning given by subsection 23B(3); and

when used in relation to a section 32DD application—has the meaning given by subsection 32DDA(3); and

when used in relation to a section 41FC application—has the meaning given by subsection 41FDB(3).

a preliminary assessment under section 23B, 32DDA or 41FDB;

a conformity assessment certificate; or

an Australian conformity assessment body certificate; or

an overseas regulator conformity assessment document.

making conformity assessment body determinations; and

there has been a contravention of the requirement; and

the contravention relates, wholly or partly, to that device or its manufacture.

the quality management system applied in the manufacture of the medical device complies with one or more conformity assessment standards that apply to it; and

the contravention is only in respect of a part or parts of the requirement to which that conformity assessment standard, or one or more of those conformity assessment standards, relate.

is established outside Australia; and

is empowered to issue certificates or other documents to the effect that the body is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to medical devices by the manufacturers of the devices.

by one or more countries; or

by another body.

must give notice of an extension to the manufacturer in relation to whom the certificate was issued; and

may give notice of an extension to the applicant for the certificate (if the applicant is not the manufacturer).

all medical devices manufactured by the manufacturer; or

only specified medical devices manufactured by the manufacturer.

unless the certificate is suspended by the Australian conformity assessment body; or

until the end of the period specified in the certificate, or if the Australian conformity assessment body extends that period, until the end of that extended period; or

until the certificate is revoked by the Australian conformity assessment body.

is an Australian conformity assessment body; and

is required by a condition referred to in subsection 41EWA(5) to keep records relating to certification-related activities carried on by the corporation;

the corporation is subject to a requirement under this section; and

the corporation contravenes the requirement.

the corporation is subject to a requirement under this section; and

the corporation contravenes the requirement.

either:

appropriate conformity assessment procedures have been applied to devices of that kind; or

requirements, comparable to the conformity assessment procedures, have been applied to devices of that kind; and

on a conformity assessment certificate that is in force; or

on an Australian conformity assessment body certificate that is in force; or

on an overseas regulator conformity assessment document that is in force.

a section 41FC application is made for a kind of medical device to be included in the Register; and

the application has been selected for audit; and

a person has obtained a certificate issued by an Australian conformity assessment body to the effect that the body is satisfied that an appropriate conformity assessment procedure has been applied to devices of that kind; and

the certificate has been given to the Secretary; and

if the conformity assessment body determination that relates to the body is limited as mentioned in paragraph 41EWA(4)(b)—the Secretary is satisfied that the certificate has been issued consistently with the determination;

an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or

an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.

inform the person in writing that the Secretary proposes the suspension and set out the reasons for it; and

give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.

either:

the suspension referred to in paragraph 41GFA(1)(a) or (b) ends; or

the person in relation to whom the kind of medical device is included in the Register provides the Secretary with another conformity assessment document that applies to the kind of device; and

the Secretary is satisfied that there are no other grounds for suspending the kind of device from the Register.

a conformity assessment document that applies to the kind of device expires; or

either of the following applies:

an Australian conformity assessment body certificate that applies to the kind of device is revoked by the Australian conformity assessment body;

an overseas regulator conformity assessment document that applies to the kind of device is revoked by the overseas regulator.

the certification-related activities carried on by the corporation while the corporation was an Australian conformity assessment body; or

the conditions referred to in subsection 41EWA(5) that applied while the corporation was an Australian conformity assessment body.

the corporation does an act or omits to do an act; and

the act or omission breaches a condition referred to in subsection 41EWA(5); and

the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

the corporation does an act or omits to do an act; and

the act or omission breaches a condition referred to in subsection 41EWA(5).

the corporation does an act or omits to do an act; and

the act or omission breaches a condition referred to in subsection 41EWA(5).

the corporation does an act or omits to do an act; and

the act or omission breaches a condition referred to in subsection 41EWA(5).

if the conformity assessment body determination was made in that financial year—on the 28th day after the determination came into force; and

in any other case:

on 1 October in that year; or

if the regulations specify another day for the purposes of this subparagraph—on that other day in that year.

the maximum penalty that a court could impose in respect of an individual for the offence committed by the body corporate; or

if the offence committed by the body corporate is an offence against subsection 41MN(10)—imprisonment for 5 years or 4,000 penalty units, or both.

the maximum civil penalty that a court could impose in respect of an individual for the civil penalty provision contravened by the body corporate; or

if the civil penalty provision contravened by the body corporate is subsection 41MNA(3)—5,000 penalty units.

there was no conformity assessment body determination in force in respect of a particular Australian corporation; or

a conformity assessment body determination was in force in respect of a particular Australian corporation and the determination:

was of general application; or

was limited to the extent specified in the certificate; or

therapeutic goods information;

information relating to Australian conformity assessment bodies and either to conformity assessment body determinations or to certification-related activities of Australian conformity assessment bodies.

a conformity assessment certificate issued on or after the commencement of this item; and

a conformity assessment certificate that was issued before that commencement and was in force immediately before that commencement.

is on the label of the goods; or

is on the package in which the goods are contained; or

is on any material included with the package in which the goods are contained.

the person, by any means, advertises therapeutic goods for an indication; and

the therapeutic goods are included in the Register; and

the indication is not an indication accepted in relation to that inclusion.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

the person, by any means, advertises therapeutic goods for an indication; and

the therapeutic goods are included in the Register; and

the indication is not an indication accepted in relation to that inclusion; and

either:

the use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or

the use of the goods for the advertised indication, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person.

the person, by any means, advertises therapeutic goods for an indication; and

the therapeutic goods are included in the Register; and

the indication is not an indication accepted in relation to that inclusion.

the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the goods and the Secretary is satisfied that the contravention is significant; or

if the person is a body corporate—a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the goods and the Secretary is satisfied that the contravention is significant; or

there is a breach, involving the goods, of an applicable provision of the Therapeutic Goods Advertising Code or any other requirement relating to advertising applicable under the Secretary is satisfied that:Part 5-1 or under the regulations, and

the breach is significant; and

as a result of the breach, the presentation of the goods is misleading to a significant extent; or

the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the goods; or

if the person is a body corporate—a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the goods; or

the person, by any means, advertises a biological for an indication; and

the biological is included in the Register; and

the indication is not an indication accepted in relation to that inclusion; and

either:

the use of the biological for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or

the use of the biological for the advertised indication, if the biological were so used, would result in, or would be likely to result in, harm or injury to any person.

the person, by any means, advertises a biological for an indication; and

the biological is included in the Register; and

the indication is not an indication accepted in relation to that inclusion.

the person, by any means, advertises a biological for an indication; and

the biological is included in the Register; and

the indication is not an indication accepted in relation to that inclusion.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the biological and the Secretary is satisfied that the contravention is significant; or

if the person is a body corporate—a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the biological and the Secretary is satisfied that the contravention is significant; or

there is a breach, involving the biological, of an applicable provision of the Therapeutic Goods Advertising Code or any other requirement relating to advertising applicable under the Secretary is satisfied that:Part 5-1 or under the regulations, and

the breach is significant; and

as a result of the breach, the presentation of the biological is misleading to a significant extent.

the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the biological; or

if the person is a body corporate—a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the biological; or

the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the kind of device and the Secretary is satisfied that the contravention is significant; or

if the person is a body corporate—a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the kind of device and the Secretary is satisfied that the contravention is significant; or

if the person is a body corporate—a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the kind of device; or

either of the following has not been complied with in relation to the kind of device:

an applicable provision of the Therapeutic Goods Advertising Code;

any other requirement relating to advertising applicable under Part 5-1 or the regulations.

the person, by any means, advertises a medical device as being for a purpose; and

the device is of a kind included in the Register; and

the purpose is not a purpose accepted in relation to that inclusion; and

either:

the use of the medical device for the advertised purpose has resulted in, will result in, or is likely to result in, harm or injury to any person; or

the use of the medical device for the advertised purpose, if the medical device were so used, would result in, or would be likely to result in, harm or injury to any person.

the person, by any means, advertises a medical device as being for a purpose; and

the device is of a kind included in the Register; and

the purpose is not a purpose accepted in relation to that inclusion.

the person, by any means, advertises a medical device as being for a purpose; and

the device is of a kind included in the Register; and

the purpose is not a purpose accepted in relation to that inclusion.

the person, by any means, advertises a medical device as being for a purpose; and

the device is of a kind included in the Register; and

the purpose is not a purpose accepted in relation to that inclusion.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

on the label of specified therapeutic goods; or

on the package in which specified therapeutic goods are contained; or

on any material included with the package in which specified therapeutic goods are contained;

advertising the therapeutic goods; or

causing the advertising of the therapeutic goods;

the person:

advertises, by any means, therapeutic goods; or

causes the advertising, by any means, of therapeutic goods; and

subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement; and

either:

the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or

the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person.

the person:

advertises, by any means, therapeutic goods; or

causes the advertising, by any means, of therapeutic goods; and

subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.

the person:

advertises, by any means, therapeutic goods; or

causes the advertising, by any means, of therapeutic goods; and

subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement.

no permission under section 42DK is in force in relation to the prohibited representation;

a permission under section 42DK is in force in relation to the prohibited representation but the use of the prohibited representation is not in accordance with the permission or a condition of the permission.

neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation;

an approval under section 42DF or a permission under section 42DK is in force in relation to the restricted representation but the use of the restricted representation is not in accordance with the approval or permission or a condition of the approval or permission.

a statement of the availability of the goods as a pharmaceutical benefit; or

a statement, pictorial representation or design authorised or required by a government or government authority (not including a foreign government or foreign government authority); or

a statement, pictorial representation or design prescribed by the regulations for the purposes of this paragraph.

the Secretary has given a notice to the person under section 42DKB in relation to therapeutic goods; and

the person does an act or omits to do an act; and

the act or omission contravenes the notice; and

either:

the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or

the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and

the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because of the contravention.

the Secretary has given a notice to the person under section 42DKB; and

the person does an act or omits to do an act; and

the act or omission contravenes the notice.

the Secretary has given a notice to the person under section 42DKB; and

the person does an act or omits to do an act; and

the act or omission contravenes the notice.

the person:

advertises, by any means, therapeutic goods; or

causes the advertising, by any means, of therapeutic goods; and

subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

no permission under section 42DK is in force in relation to the prohibited representation;

a permission under section 42DK is in force in relation to the prohibited representation but the use of the prohibited representation is not in accordance with the permission or a condition of the permission.

neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation;

an approval under section 42DF or a permission under section 42DK is in force in relation to the restricted representation but the use of the restricted representation is not in accordance with the approval or permission or a condition of the approval or permission.

a statement of the availability of the goods as a pharmaceutical benefit; or

a statement, pictorial representation or design authorised or required by a government or government authority (not including a foreign government or foreign government authority); or

a statement, pictorial representation or design prescribed by the regulations for the purposes of this paragraph.

the person is a broadcaster, a datacaster, the SBS or a person of a kind prescribed by the regulations for the purposes of this paragraph; and

as a result of steps taken by the person, it was reasonable for the person to assume that subsections (2) to (9) did not apply to the advertisement.

the Secretary has given a notice to the person under section 42DKB; and

the person does an act or omits to do an act; and

the act or omission contravenes the notice.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

the person:

advertises, by any means, therapeutic goods; or

causes the advertising, by any means, of therapeutic goods; and

the advertisement does not comply with the Therapeutic Goods Advertising Code; and

either:

the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or

the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person.

the person:

advertises, by any means, therapeutic goods; or

causes the advertising, by any means, of therapeutic goods; and

the advertisement does not comply with the Therapeutic Goods Advertising Code.

the person:

advertises, by any means, therapeutic goods; or

causes the advertising, by any means, of therapeutic goods; and

the advertisement does not comply with the Therapeutic Goods Advertising Code.

the person:

advertises, by any means, therapeutic goods; or

causes the advertising, by any means, of therapeutic goods; and

the advertisement does not comply with the Therapeutic Goods Advertising Code.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

the person is a broadcaster, a datacaster, the SBS or a person of a kind prescribed by the regulations for the purposes of this paragraph; and

as a result of steps taken by the person, it was reasonable for the person to assume that the advertisement complied with the Therapeutic Goods Advertising Code.

the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and

the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.

the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and

the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.

the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and

the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

within the period, of not less than 14 days after the day the notice is given, specified in the notice or within such longer period as the Secretary allows; and

in the form specified in the notice.

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.

the person is given a notice under section 42DR; and

the person fails to comply with the notice.

the person is given a notice under section 42DR; and

the person fails to comply with the notice.

the person is given a notice under section 42DR; and

the person gives information or produces a document in compliance or purported compliance with the notice; and

the information or document is false or misleading in a material particular.

the person is given a notice under section 42DR; and

the person gives information or produces a document in compliance or purported compliance with the notice; and

the information or document is false or misleading in a material particular.

the person is given a notice under section 42DR; and

the person gives information or produces a document in compliance or purported compliance with the notice; and

the information or document is false or misleading in a material particular.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

the information given or the document produced; and

giving the information or producing the document; and

any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document;

in criminal proceedings, except proceedings for an offence against subsection 42DS(4) or (5); or

in civil proceedings, except proceedings under section 42Y for a contravention of section 42DT.

cease the advertisement;

make a retraction;

make a correction;

recover any advertisement that is still in circulation;

destroy the advertisement;

cease making a particular claim or representation made by the advertisement.

withdraw the generic information;

make a retraction;

make a correction;

recover any generic information that is still in circulation;

destroy the generic information;

cease making a particular claim or representation made by the generic information.

the period for doing a thing the subject of the direction;

in relation to the making of a retraction or correction, either or both of the following:

the form and manner of the retraction or correction;

the period for which the retraction or correction must be made publicly available;

the reporting to the Secretary of compliance with the direction.

the Secretary has given a direction to the person under subsection 42DV(1) or (2) in relation to therapeutic goods; and

the person does an act or omits to do an act; and

the act or omission contravenes the direction or a condition of the direction; and

either:

the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or

the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and

the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because of the contravention.

the Secretary has given a direction to the person under subsection 42DV(1) or (2); and

the person does an act or omits to do an act; and

the act or omission contravenes the direction or a condition of the direction.

the Secretary has given a direction to the person under subsection 42DV(1) or (2); and

the person does an act or omits to do an act; and

the act or omission contravenes the direction or a condition of the direction.

the Secretary has given a direction to the person under subsection 42DV(1) or (2); and

the person does an act or omits to do an act; and

the act or omission contravenes the direction or a condition of the direction.

for an individual—5,000 penalty units; and

for a body corporate—50,000 penalty units.

the Secretary reasonably suspects that there has been a contravention of this Act or the regulations in relation to:

the advertising of the therapeutic goods; or

the dissemination of generic information about the therapeutic goods to the public or a section of the public; and

the Secretary is satisfied that it is in the public interest to issue the notice.

(a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and

the person fails to comply with the substantiation notice; and

the Secretary is satisfied that it is in the public interest to issue a notice under this subsection;

an advertisement first-mentioned in that subsection that occurs on or after the commencement of this item; and

an advertisement first-mentioned in that subsection that occurs in the 60 days ending at the end of the day before the commencement of this item, where no notice had been given under subsection 42DKB(1) of that Act in relation to the advertisement before that commencement.

an advertisement published or broadcast before that commencement; and

an advertisement published or broadcast on or after that commencement, where a notice was given under section 42DKB of that Act before that commencement.

advertisements occurring before, on or after the commencement of this item; and

the dissemination of generic information about therapeutic goods occurring before, on or after the commencement of this item.

(a) definition of approval number;

(b) definition of approved advertisement;

(c) definition of broadcaster;

(d) definition of broadcast media;

(e) definition of mainstream media;

(f) definition of publisher;

(g) definition of publishing;

(h) definition of specified media;

(i) definition of visual broadcast media.

the person makes a statement; and

the statement is made in or in connection with a request under section 9D for the variation of an entry in the Register in relation to therapeutic goods; and

the statement is false or misleading in a material particular.

the person imports therapeutic goods into ; and

the goods are imported without the consent in writing of the Secretary; and

the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging).

the person supplies therapeutic goods for use in ; and

the goods are supplied without the consent in writing of the Secretary; and

the goods do not conform with a standard applicable to the goods.

the person exports therapeutic goods from ; and

the goods are exported without the consent in writing of the Secretary; and

the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in ).

the person does an act or omits to do an act; and

the act or omission breaches a condition of a consent.

the person:

imports into therapeutic goods for use in humans; or

exports from therapeutic goods for use in humans; or

manufactures in therapeutic goods for use in humans; or

supplies in therapeutic goods for use in humans; and

none of the following subparagraphs applies in relation to the goods:

the goods are registered goods or listed goods in relation to the person;

the goods are exempt goods;

the goods are exempt under section 18A;

the goods are the subject of an approval or authority under section 19;

the goods are the subject of an approval under section 19A.

the person is the sponsor of therapeutic goods for use in humans; and

the person:

imports the goods into ; or

exports the goods from ; or

manufactures the goods in ; or

supplies the goods in ; and

the person has not, at the time of the importation, export, manufacture or supply, properly notified to the Secretary either or both of the following:

the manufacturer of the goods;

premises used in the manufacture of the goods.

the person makes a statement; and

the statement is made in or in connection with a certification of any matter under subsection 26A(2) or 26AB(2); and

the statement is false or misleading in a material particular.

therapeutic goods are registered or listed in relation to the person; and

the person does an act or omits to do an act; and

the act or omission breaches a condition of the registration or listing of the goods.

the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and

the person supplies those goods; and

any of the following applies:

the supply is not in accordance with the authority;

the supply is not in accordance with the conditions to which the authority is subject;

the supply is not in accordance with regulations made for the purpose of subsection 19(7).

the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and

the person supplies those goods; and

any of the following applies:

the supply is not in accordance with the authority;

the supply is not in accordance with the conditions to which the authority is subject;

the supply is not in accordance with regulations made for the purpose of subsection 19(7).

the person is a health practitioner; and

the person is included in a class of health practitioners specified in subsection 19(7A) rules; and

the person supplies:

therapeutic goods specified in those rules; or

therapeutic goods included in a class of therapeutic goods specified in those rules; and

any of the following applies:

the supply is not in accordance with those rules;

the supply is not in the circumstances specified in those rules;

the supply is not in accordance with the conditions specified in those rules.

the person uses therapeutic goods; and

the goods are used:

in the treatment of another person; or

solely for experimental purposes in humans; and

the goods are not:

exempt goods; or

listed goods; or

registered goods; or

goods exempt under section 18A; or

goods that are the subject of an approval under section 19A; and

the goods are not used in accordance with:

an approval or authority under section 19; or

a condition applicable under regulations made for the purposes of subsection 19(4A).

the person uses therapeutic goods; and

the goods are used:

in the treatment of another person; or

solely for experimental purposes in humans; and

the goods are not:

exempt goods; or

listed goods; or

registered goods; or

goods exempt under section 18A; or

goods that are the subject of an approval under section 19A; and

the goods are not used in accordance with:

an approval or authority under section 19; or

a condition applicable under regulations made for the purposes of subsection 19(4A).

the person makes a statement; and

the statement is made in or in connection with an application for registration of therapeutic goods; and

the statement is false or misleading in a material particular.

the person does an act or omits to do an act; and

the act or omission breaches a requirement imposed on the person under section 30EA.

the Secretary gives a notice to the person under subsection (2); and

the notice specifies a particular requirement mentioned in subsection (3); and

the person fails to comply with that requirement.

either:

the person is given a notice under subsection (1) and the person is covered by paragraph (1)(ab) or (ac); or

the person is given a notice under subsection (2) and the person is covered by paragraph (2)(ab) or (ac); and

the person fails to comply with the notice.

the person is given a notice under this section in relation to therapeutic goods; and

the person gives information or a document in compliance or purported compliance with the notice; and

the information or document is false or misleading in a material particular.

the person is given a notice under this section in relation to therapeutic goods; and

the person gives information or a document in compliance or purported compliance with the notice; and

the information or document is false or misleading in a material particular.

the person is given a notice under section 31A, 31AA, 31B or 31BA; and

the person fails to comply with the notice.

the person gives information to the Secretary in compliance or purported compliance with the notice; and

the information:

is false or misleading; or

omits any matter or thing without which the information is misleading.

the person produces a document to the Secretary; and

the document is false or misleading; and

the document is produced in compliance or purported compliance with a notice given under section 31A, 31AA, 31B or 31BA.

civil proceedings, except proceedings under section 42Y for a contravention of section 31AAA.

the person imports into Australia a biological for use in humans; and

none of the following subparagraphs applies:

the biological is included in the Register in relation to the person;

the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

the biological is exempt under section 32CB;

the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological;

the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person.

the person exports from Australia a biological for use in humans; and

none of the following subparagraphs applies:

the biological is included in the Register in relation to the person;

the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

the biological is exempt under section 32CB;

the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological.

the importation or exportation of a biological is an offence under subsection 32BA(1), (4) or (4A) or 32BB(1), (4) or (4A); and

(b) the Secretary notifies the Comptroller-General of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;

prohibited imports within the meaning of that Act; or

prohibited exports within the meaning of that Act;

the person manufactures in Australia a biological for use in humans; and

none of the following subparagraphs applies:

the biological is included in the Register in relation to the person;

the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

the biological is exempt under section 32CB.

the person supplies in Australia a biological for use in humans; and

none of the following subparagraphs applies:

the biological is included in the Register in relation to the person;

the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

the biological is exempt under section 32CB;