ATTACHMENT

 

Details of the Therapeutic Goods Legislation Amendment (2018 Measures No.1) Regulations 2018

 

Section 1 - Name

This section provides for the Regulations to be referred to as the Therapeutic Goods Legislation Amendment (2018 Measures No.1) Regulations 2018.

 

Section 2 - Commencement

This section provides for the commencement of the Regulations in accordance with the following:

*                Sections 1 to 4 - the day after the Regulations are registered;

*                Schedule 1 (provisional registration of medicines) - the day after the Regulations are registered;

*                Schedule 2 (complementary medicines) - immediately after the commencement of the provisions in Schedule 1 of the Regulations;

*                Schedule 3 (Australian conformity assessment body certificates and determinations) - the day after the Regulations are registered;

*                Part 1 of Schedule 4 (advertising - enforcement) - immediately after the commencement of Schedule 1 of the Regulations (see above);

*                Part 2 of Schedule 4 (advertising - the removal of pre-approval) - on 1 July 2020;

*                Part 3 of Schedule 4 (advertising - other amendments) - on 1 July 2018;

*                Schedule 5 (infringement notices) - the day after the Regulations are registered;

*                Schedule 6 (preliminary assessment of applications) - the day after the Regulations are registered; and

*                Schedule 7 (miscellaneous amendments) - the day after the Regulations are registered.

 

Section 3 - Authority

This section provides that the Regulations are made under the Therapeutic Goods Act 1989 (the Act).

 

Section 4 - Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Regulations has effect according to its terms.

 

 

Schedule 1 - Provisional registration of medicine

 

Therapeutic Goods Regulations 1990

 

Item 1- Paragraph 9B(1)(d)

Regulation 9B of the Therapeutic Goods Regulations 1990 (the TG Regulations) sets out that a sponsor of therapeutic goods mentioned in Part 1 of Schedule 10 of the TG Regulations (principally, these are prescription medicines) that are registered in the Australian Register of Therapeutic Goods (the Register) commits an offence if they supply their goods knowing that they were manufactured using a human embryo, human embryonic stem cell or other material sourced from a human embryo or human embryonic stem cell and do not supply with the goods written information stating that use of that embryo, embryonic stem cell or sourced material.  The maximum penalty is 10 penalty units.  This item amends regulation 9B(1) with the effect that this offence also applies in relation to provisionally registered medicines that are manufactured using a human embryo, human embryonic stem cell or other material sourced from a human embryo or human embryonic stem cell.

 

Items 2 and 3 - Paragraph 10(a)

These items amend paragraph 10(a) of the TG Regulations to include mention of the part of the Register for goods known as provisionally registered goods.

 

Item 4 - After paragraph 10(a)

This item adds new paragraph 10(aa) to the TG Regulations, to specify that therapeutic goods included in the Register under paragraph 29(2)(c) of the Act will be included in the part of the Register for provisionally registered goods.

 

Item 5 - Paragraph 10(b)
This item amends paragraph 10(b) of the TG Regulations to make the wording of that paragraph consistent with the wording of paragraphs 10(a) and (aa), as amended by items 3 and 4 above.

 

Item 6 - After Part 2C

This item amends the TG Regulations to introduce a new Part 2D to the TG Regulations, relating to provisional determinations for medicines. This part sets out  details of the scheme for provisionally registering medicines, to supplement the scheme set out in Part 3-2, Division 1A of the Act.

 

Regulation 10K - Applications for provisional determinations

New regulation 10K specifies the kinds of medicine in relation to which applications for a provisional determination may be made, for the purposes of subsection 22C(1) of the Act. The effect of this is that a person may only apply for a provisional determination in relation to a new prescription medicine, or new indications for an already-registered medicine, as defined in regulation 2. This means that applications for a provisional determination may only be made for medicines which have not previously been registered (excluding provisionally registered medicines) or which have a new indication.

 

Regulation 10L - Provisional determinations

New regulation 10L sets out the criteria against which applications for provisional determination will be assessed. To obtain a provisional determination for a medicine, all four criteria must be met - these are that:

*                the medicine's indication relates to the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition;

*                either no therapeutic goods intended to treat, prevent or diagnose this condition are registered in the Australian Register of Therapeutic Goods (the Register) (except in the part of the Register for provisionally registered goods), or if such therapeutic goods are already registered (excluding provisionally registered goods), there is early clinical data showing that the new medicine is likely to provide a significant improvement in efficacy or safety compared to those goods;

*                the medicine is likely to provide a major therapeutic advance, based on early clinical data; and

*                the applicant has submitted sufficient evidence of their plan to provide comprehensive clinical data to establish the safety and efficacy of the medicine within six years of the date on which provisional registration might commence.

Items 7 and 8 - Subparagraphs 16J(3)(f)(i) and (ii) and 16J(4)(e)(i) and (ii)

These items amend regulation 16J of the TG Regulations to ensure that when medicines for which orphan drug designation is sought are compared to other medicines that are included in the Register, the medicine for which orphan drug designation is sought will not be compared against provisionally registered medicines.

 

Item 9 - Subparagraphs 16R(2)(c)(i) and (ii)

This item amends regulation 16R to ensure that when medicines for which a therapeutic goods (priority applicant) determination is sought are compared to other medicines that are included in the Register, the medicine for which a therapeutic goods (priority applicant) determination is sought will not be compared against provisionally registered medicines.

 

Item 10 - After regulation 43AD

This item introduces new regulation 43AE to the TG Regulations, which has the effect that where a person applies for the designation of a medicine as an orphan drug before, or at the same time as, they apply for a provisional determination for the medicine, and the Secretary designates the medicine as an orphan drug, the Secretary must refund the application fee for the provisional determination to the person (whether or not the application for a provisional determination is successful).

 

Item 11 - Before paragraph 45(12)(c)

This item introduces new paragraphs 45(12)(a) and (b) to the TG Regulations, with the effect of requiring the Secretary to waive the fee for applying for a provisional determination for a medicine, and the fee for applying for an extension of a provisional determination, where the medicine in question has been designated as an orphan drug.

 

Item 12 - in the appropriate position in Part 9

This item adds new Division 7 to Part 9 of the TG Regulations, with the effect of explaining when the above measures in these Regulations will take effect. New regulation 60 provides that:

*                the amendment to regulation 9B made by item 1 of this Schedule applies to the supply of goods on or after the commencement of new regulation 60;

*                the amendments to regulation 16J made by items 7 and 8 of this Schedule apply to applications made on or after the commencement of new regulation 60;

*                the amendments to regulation 16R made by item 9 of this Schedule apply in relation to applications made on or after the commencement of this regulation; and

*                new regulation 43AE applies in relation to applications made on or after the commencement of this regulation.

 

Item 13 - Schedule 3 (heading)

This item substitutes a new heading for Schedule 3 of the TG Regulations, to refer both to goods that are registered, and that are provisionally registered, in the Register.

 

Item 14 - Clause 3 of Schedule 9 (after table item 1)

This item introduces the following new fees to the table in clause 3 of Schedule 9 of the TG Regulations, in relation to the new scheme of provisional registration:

*                new item 1AA, setting out the fee for applying for a provisional determination, in the amount of $12,300;

*                new item 1AB, setting out the fee for applying for an extension of a provisional determination, in the amount of $4,440;

*                new item 1AC, setting out the fee for applying for the registration of a medicine in relation to which a provisional registration is in force, in the amount of $47,000 where such a medicine is a new prescription medicine and $28,000 where the medicine is for new indications for a currently-registered medicine;

*                new item 1AD, setting out the fee for evaluating an application for the registration of a medicine in relation to which a provisional determination is in force, in the amount of $245,500 where the medicine is a new prescription medicine (1AD(a)) and $161,900 where the medicine is for new indications for a currently-registered medicine (1AD(b));

*                new item 1AE, setting out the fee for applying for the registration of a medicine that is provisionally registered (i.e. this is the application fee that applies where a sponsor of a provisionally registered medicine seeks the inclusion of their product in the part of the Register for registered medicines, as distinct from the part of the Register for provisionally registered medicines), in the amount of $28,000;

*                new item 1AF, setting out the evaluation fee for a medicine in the same circumstances, in the amount of $118,100; and

*                new item 1AG, setting out the fee for applying for an extension of the period of time that a medicine may remain provisionally registered in the Register, in the amount of $16,900.  

 

In each instance, the above amounts for these new fees reflect the expected effort involved for staff of the  Department's Health Products Regulation Group  in processing and considering these applications.

 

The comparatively higher application and evaluation fees for new prescription medicines as compared with medicines for new indications for a currently-registered medicine reflect the  greater novelty of the former, whereas new indications medicines are (as defined in regulation 2 of the TG Regulations) prescription medicines that have the same chemical, biological or radiopharmaceutical ingredient or fixed combination of such ingredients as an existing medicine in the Register, for which a new indication is sought.

 

The comparatively lower application and evaluation fees that apply where a sponsor applies to register a medicine that is provisionally registered principally reflects the greater level of familiarity with the existing product.

 

Item 15 - Clause 3 of Schedule 9 (table item 4, paragraph (a))

This item amends paragraph (a) of table item 4 in clause 3 of Schedule 9 of the TG Regulations, to make it clear that the evaluation fee at paragraph (a) does not apply in respect of an application for registration to which new table items 1AD(a) or 1AF (outlined above) apply.

 

Item 16 - Clause 3 of Schedule 9 (table item 4, paragraph (b))

This item amends paragraph (b) of table item 4 in clause 3 of Schedule 9 of the TG Regulations, to make it clear that the fee at paragraph (b) does not apply in respect of an application for registration to which new table items 1AD(b) or 1AF (outlined above) apply.

 

 

Schedule 2 - Complementary medicines

 

Therapeutic Goods Regulations 1990

 

Item 1 - Regulation 2

This item introduces a number of new definitions to the TG Regulations, for the purposes of supporting the introduction of timeframes within which the Secretary must make certain decisions under the Act in relation to complementary medicines, and also for the purposes of specifying certain fees in relation to these products.

 

These definitions principally relate to new, risk-based, categories of applications of registerable complementary medicines and applications for the listing of a complementary medicine under the new pathway for listed complementary medicines that have been evaluated for efficacy (new section 26AE of the Act).

 

Item 2 - At the end of regulation 3AA

Paragraph 3(5)(ca) of the Act has the effect that the presentation of a medicine is unacceptable if it is included in a class of medicines prescribed in the regulations for the purposes of that paragraph, and its label does not include any warning statements required by the legislative instrument made by the Minister under subsection 3(5A) of the Act.

 

This item introduces an additional paragraph in regulation 3AA to make it clear that medicines listed under section 26A will not be a prescribed class if the medicine (in addition to complying with paragraphs 26BB(1)(a) and (b) of the Act that relate to permissible ingredients) satisfies the following requirements:

(a)     the medicine only has indications that are specified in a determination under paragraph 26BF(1)(a) of the Act; and

(b)     if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the medicine's indications - none of those requirements have been contravened.

 

Item 3 - At the end of subregulation 10AA(1)

Under section 9D of the Act, a sponsor of therapeutic goods that are entered in the Register may ask the Secretary to vary the entry in the Register in relation to their goods, for example, to correct an error in the entry or to reduce the class of persons for whom the goods are suitable. Subparagraph 9D(7)(b)(ii) of the Act provides that if the Secretary has approved a form for, and the manner of making, such requests, and if the request is one which is of a kind prescribed by the regulations, then the request will not be effective unless a number of requirements are met (e.g., that the request is in the correct form and manner).  Regulation 10AA of the TG Regulations prescribes requests for the purposes of subparagraph 9D(7)(b)(ii).

 

This item amends subregulation 10AA(1) to refer to requests under section 9D that relate to the new application categories for variations to registered complementary medicines so that they are subject to the requirements set out in subregulation 9D(7).

 

Item 4 - Subparagraph 11(2)(b)(v)

Subregulation 11(2) of the TG Regulations defines what is meant by a 'restricted ingredient' for the purposes of subregulation 11(1) in relation to the characteristics that, for the purposes of paragraph 16(1A)(d) of the Act, make listed medicines (other than export only listed medicines) separate and distinct from one another.  Such medicines will be taken to be separate and distinct from one another if  for example they contain a restricted ingredient and have a different concentration of that ingredient or different directions for use.

 

This item repeals subparagraph 11(2)(b)(v) of the TG Regulations, with the effect that a substance will not be a restricted ingredient for the purposes of subregulation 11(1) if the TGA document the 'Required Advisory Statements for Medicines Labels' includes a restriction relating to its quantity or concentration.

 

Items 5 and 6 - Subparagraph 15(1)(c)(ii) and subregulation 15(2)

Item 5 amends paragraph 15(1)(c) of the TG Regulations to differentiate medicines that are listed in the Register under section 26AE of the Act from other listed goods, and to require that medicines listed under section 26AE have a listing number on their label that is immediately preceded by 'AUST L(A)', principally to ensure that that these assessed listed medicine products can be easily identified in the market.

 

Item 6 makes a minor, consequential amendment to subregulation 15(2) of the TG Regulations, to replace the words 'or (ii)' with '(ii) or (iii)'. This allows the Secretary, under certain circumstances, to give a written direction to allow for an alternative manner in which to set out the listing number and letters of a product listed under the new assessed listed medicines pathway.

 

Item 7 - At the end of Part 3A

This item introduces a new Division 4 to Part 3A of the TG Regulations, principally to specify a range of new timeframes within which the Secretary must notify a person who has applied to register a complementary medicine in the Register or list a complementary medicine in the Register under new section 26AE of the Act that their application has passed preliminary assessment, and to specify a range of new timeframes within which the Secretary must complete an evaluation of such applications - if certain circumstances reflected in the new definitions that would be introduced by item 1 above apply.

 

Implementing legislated timeframes for these products is designed to improve predictability for sponsors and thereby allow sponsors to better plan the commercial introduction  of new products to market. The timeframes align with the risk-based application categories. Lower risk application levels have shorter assessment timeframes due to the  need for less information to be evaluated in comparison to higher risk categories.

 

Where an applicant submits a report relating to their product from an overseas regulatory authority with their application, the evaluation may be streamlined and a reduced timeframe apply. Where a full, new evaluation is needed, a longer timeframe applies to reflect the greater time needed to complete such an evaluation.

 

Regulation 16GG

Regulation 16GG is authorised under paragraphs 63(2)(de) and 63(2)(df) of the Act, and applies to RCMC1 (section 9D), RCMC2 (section 9D), RCMC3 (section 9D)  and RCMC4 (section 9D) requests to vary the information in the Register under section 9D of the Act for a registered complementary medicine.

 

Subregulation 16GG(1) requires the Secretary to notify the person making the request, within 20 working days of receiving an RCMC1 (section 9D) request, of his or her decision on the request. Subregulation 16GG(2) requires the Secretary to notify the person making the request, within 40 working days of receiving an RCMC2 (section 9D), RCMC3 (section 9D) or RCMC4 (section 9D) request, as to whether the request is effective.

 

Where the request has been accepted as effective, subregulation 16GG(2) also requires the Secretary to notify the applicant of his or her decision on the request within:          

*                for an RCMC2 (section 9D) request - 64 working days after notifying the applicant that the request has been accepted;

*                for an RCMC3 (section 9D) request - 120 working days after notifying the applicant that the request has been accepted; and

*                for an RCMC4 (section 9D) request - 170 working days after notifying the applicant that the request has been accepted.

 

New subregulation 16GG(3) specifies that the Commonwealth, the Secretary, or a delegate of the Secretary, is not liable for any loss, damage or injury arising out of a failure to make a decision on a request within the times specified. This is consistent with the approach for prescription medicines (regulation 16E of the TG Regulations refers).  Item 15 below also requires that the Secretary refund 25 per cent of the application fee if the Secretary makes a decision on an RCMC2, RCMC3 or RCMC4 (section 9D) request but does not do so within the period specified in new regulation 16GG.

 

Regulation 16GH

This regulation is authorised under paragraphs 63(2)(de), 63(2)(da) and 63(2)(daaaa) of the Act and applies to the following kinds of applications:

*                L(A)1, L(A)2 and L(A)3 applications for new assessed listed complementary medicines;

*                RCM1, RCM2, RCM3, RCM4 and RCM 5 applications for registered complementary medicines; and

*                RCMC1 (section 23 application), RCMC2 (section 23 application), RCMC3 (section 23 application) and RCMC4 (section 23 application) for variations to a registered complementary medicine.

 

Paragraph 16GH(1)(a) requires the Secretary to notify an applicant, within 40 working days of receiving the application, as to whether the application has passed preliminary assessment.

 

Where an application passes preliminary assessment, paragraph 16GH(1)(b) requires the evaluation of the medicine to be completed within a range of specified periods after the applicant has been notified, depending on the category of application.

           

Subregulation 16GH(2) specifies that the Commonwealth, the Secretary, or a delegate of the Secretary, is not liable for any loss, damage or injury arising out of a failure complete an evaluation within the times specified.

 

Regulation 16GI

Regulation 16GI is authorised under paragraphs 63(2)(de) and 63(2)(daaa) of the Act and applies to IN1, IN2, IN3 and IN4 applications to vary a section 26BB determination to add a new ingredient to the list of permissible ingredients.

 

Paragraph 16GI(1)(a) requires the Secretary to notify an applicant, within 40 working days of receiving the application, of his or her decision to accept or reject the application.

 

Where the application is accepted, paragraph 16GI(1)(b) requires that the Secretary make a recommendation on the application within a range of specified periods, depending on the category of application.

 

Subregulation 16GI(2) specifies that the Commonwealth, the Secretary, or a delegate of the Secretary, is not liable for any loss, damage or injury arising out of a failure to make a decision on an application within the times specified.

 

Regulation 16GJ

Regulation 16GJ allows the Secretary to determine a competent regulatory authority of a foreign country or foreign jurisdiction (e.g. agencies of the European Union) in relation to the evaluation of an IN1, 1N2, IN3, LA(2), RCM2, RCM3 or RCM4 application.

 

A list of such competent regulatory authorities will be published on the TGA website, and will form part of the framework to be put in place to formalise arrangements regarding acceptance of evaluation reports from competent regulatory authorities for complementary medicines.

 

This framework is based on a pragmatic approach that allows technical data from a wide range of regulators to be utilised and adapted to meet Australian requirements, provided that a robust set of criteria in relation to how foreign regulators conduct their evaluations are met. This is designed to support the appropriate use of such reports to conduct abridged evaluations that focus on issues most likely to be specific to the Australian regulatory context, such as product labels. Where foreign regulatory reports are used, the Secretary will continue to be responsible for making the final regulatory decision, ensuring that quality and safety are not compromised and that the Australian context is taken into account.

 

Items 8 - 11 - Subparagraph 23(2)(a)(ii), paragraphs 25(3)(b) and (c) and subregulations 26A(1), 31(1A) and 31A(2)

These items make minor, consequential amendments to regulations 23, 25, 26A and 31 of the TG Regulations, to replace references to subsection 28(5A) of the Act with references to paragraph 28(5)(h) of the Act. These changes are required as a result of amendments that were made to section 28 of the Act in relation to conditions of listing or registration by Schedule 9 of the Amendment Act.

 

Item 12 - After paragraph 43(1)(a)

Regulation 43 of the TG Regulations prescribes fees relating to medicines (among other things) by reference to items in Schedule 9 to the TG Regulations. Item 12 amends subregulation 43(1) by adding a new paragraph (aa) to prescribe the fee amounts for applications in relation to complementary medicines by reference to new Part 4 of Schedule 9 (item 33 below refers).

 

Item 13 - At the end of regulation 43A

Sponsors of existing listed medicines need a period to transition their products to comply with the new requirements for permitted indications. A 3 year transition period commences from the day the Amendment Act receives Royal Assent.

 

This item introduces new subregulation (4) to regulation 43A, to provide a fee free period of 18 months from the commencement of Schedule 2 of the Amendment Act, where an application is made for the listing of a new medicine under section 26A of the Act that would (principally) replace an existing such medicine for the same sponsor and that the only way in which the new medicine would differ from the existing product is in relation to having different indications.

 

Items 14 - 17 - New regulations 43ACA and 43AF, subregulations 45(3A) and (3B) and paragraph 45(4)(aa)

These items amend the TG Regulations to provide for circumstances where fees may be refunded or waived, and support the introduction of legislated timeframes.

 

Item 14 introduces new regulation 43ACA to provide for a refund of fees for a request to vary a registered complementary medicine where an evaluation is not required, with the following amounts required to be refunded to the applicant in such circumstances:

*                $3,960 for an RCMC2 (section 9D) request;

*                $6,190 for an RCMC3 (section 9D) request; and

*                $9,160 for an RCMC4 (section 9D) request.

 

Item 15 requires that a refund of 25 per cent of the application fee associated with an RCMC2 (section 9D), RCMC3 (section 9D) or RCMC4 (section 9D) request to vary an entry in the Register for a registered complementary medicine must be refunded to the applicant if the Secretary or his or her delegate fails to make a decision within the timeframe specified for the request in new regulation 16GG (item 7 above refers) (i.e. this would apply where the Secretary has made a decision on the request, but not within the specified timeframe, and the refund would be mandated by new regulation 43AF).

 

Item 16 introduces new subregulations 45(3A) and (3B), with the effect of permitting the Secretary to waive or reduce application and evaluation fees in new Part 4 of Schedule 9 of the Regulations for medicines assessed via the listed assessed or registered complementary medicines pathways in certain circumstances. Those circumstances are where:

*                the applicant makes one or more additional applications of the same kind;

*                each application relates to goods with the same therapeutically active ingredient; and

*                the information in support of each application is sufficiently common to enable a simultaneous assessment of the applications for the goods to be made.

 

Item 17 also amends subregulation 45(4) to extend the ability to waive or reduce an evaluation fee for medicines to be listed under the new listed assessed medicines pathway (under section 26AE of the Act) and an evaluation fee for a request to vary an entry in the Register for such a medicine, where the Secretary has information to enable an evaluation procedure to be abridged.

 

Item 18 - In the appropriate position in Division 7 of Part 9

This item amends Division 7 of Part 9 of the TG Regulations to make it clear that the amendments that would be made by items 7, 14, 15, 16 and 33 of this Schedule, which relate to timeframes and fees for the new application categories for complementary medicines, only apply to requests or applications made on or after the commencement of these Regulations.

 

This item also clarifies that the amendments made by items 26 to 32 of this Schedule, which amend the table of fees other than for applications covered by Part 3 or 4, do not apply in relation to requests or applications made before the commencement of these Regulations.

 

Items 19 - 21 - Schedule 4, table items 3, 4A and 5

The purpose of Schedule 4 of the TG Regulations (which is made for paragraph 9A(4)(a) of the Act and regulation 10 of the TG Regulations), is to specify the medicines that are required to be included in the part of the Register for listed goods.

 

Schedule 2 of the Amendment Act includes amendments to section 26A of the Act (under which most listed complementary medicines are entered in the Register) to require that when persons apply to list their medicines in the Register under that provision, they must certify that (among other things) their medicine only has indications permitted under the determination made by the Minister under new paragraph 26BF(1)(a) of the Act and does not contravene any requirements in that determination in relation to any such indication.  The introduction of these provisions in the Act by the Amendment Act is intended to ensure that medicines listed under section 26A of the Act may only make pre-approved, low level claims of therapeutic use that are appropriate for these products, noting that they are not assessed prior to their release into the market.

 

Items 19 - 21 make consequential amendments to Schedule 4 to reflect that compliance with the new permitted indications determination is also a component of eligibility for listing for these kinds of medicines.

 

Item 22 - Schedule 4, after table item 7

This item amends Schedule 4 of the TG Regulations to introduce a new item 8 which would describe the medicines that may be listed in the Register under new section 26AE of the Act.  This is to ensure that medicines entered in the Register under that provision are eligible for listing in the Register (as opposed to having to be registered in the Register).

 

Item 23 - Schedule 5A (table item 1A)

Schedule 5A of the TG Regulations lists certain therapeutic goods (principally, medicines or biologicals) that are exempt from the requirement to be registered, listed or included in the Register, subject to specified conditions.

 

This item makes a consequential amendment to column 2 of item 1A of the table in Schedule 5A (which refers to therapeutic goods imported into Australia and held under the direct control of the sponsor until a decision is made in relation to whether or not to approve their entry in the Register) to include a reference to medicines under the new assessed listed medicines pathway (new section 26AE of the Act).

 

Items 24 - 33 - Amendments relating to fees

These items amend Schedule 9 of the TG Regulations in relation to fees for complementary medicines - in particular, item 33 introduces a new Part 4 to Schedule 9 to set out a new fee structure for applications, evaluations and requests for these products.

 

This new Part contains a range of fees relating to applications to list or register complementary medicines in the Register or applications for the approval of new ingredients for use in listed complementary medicines, as well as fees payable for requests under section 9D of the Act to vary entries in the Register for complementary medicines.  The new fee structure aligns with the new application categories, evaluation procedures and legislated timeframes for complementary medicines outlined above. The amount of the fees reflects the amount and type of information that is required to be assessed in each case.

 

Items 24 - 32 make minor consequential amendments to Part 2 of Schedule 9 to, principally, reflect the introduction of new Part 4 in Schedule 9 and the moving of a number of items relating to complementary medicines from Part 2 to Part 4 of Schedule 9.

 

 

Schedule 3 - Australian conformity assessment body certificates and determinations

 

Part 1 - Main amendments

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Item 1 - Before Division 4.2

This item introduces a new Division 4.1B into Part 4 of the MD Regulations to provide for the content of conformity assessment certificates.

 

New Regulation 4.3F of the MD Regulations largely sets out equivalent amendments in relation to the content of conformity assessment certificates (i.e. those issued by the Secretary under section 41EE of the Act) as those that are introduced for Australian conformity assessment body certificates by new regulation 4A.31 (item 5 below refers).

 

A conformity assessment certificate issued by the Secretary is required to contain all of the following information:

*                a unique identification number;

*                the day on which the certificate is issued;

*                the name and address of the manufacturer of the medical devices;

*                the conformity assessment procedures applied to the medical devices by the manufacturer;

*                the unique product identifier given to the devices by the manufacturer where the certificate covers medical devices mentioned in paragraph 1.6(a), (b) or (c) of the MD Regulations;

*                the conditions to which the certificate is subject;

*                the day on which each certificate is issued where one or more conformity assessment certificates have previously been issued in respect of the medical devices;

*                the signature and name of the person issuing the certificate.

 

Item 2 - After Part 4

This item introduces new Part 4A to the MD Regulations to provide for Australian corporations to apply for a conformity assessment body determination (i.e. to become an Australian conformity assessment body) and to specify the requirements for becoming such a body.  Among other things, this Part also provides for application and assessment fees in relation to applying for a determination and specifies the conditions that apply to conformity assessment body determinations.

 

These amendments relate to  allowing the conformity assessment of medical devices to be undertaken by private bodies designated by the Secretary (and under appropriate oversight by the Therapeutic Goods Administration) to appraise the suitability of the manufacturing process for medical devices, and to assess whether such devices meet the required  standards of safety and performance (against the intended purpose).

 

Division 4A.1 - Preliminary

Regulation 4A.1

This regulation clarifies that new Part 4A (other than Division 4A.7) is made for the purposes of section 41EWA of the Act, which enables regulations to be made to empower the Secretary to effectively designate Australian organisations  as conformity assessment bodies. These may potentially be Australian subsidiaries or affiliates of international companies and organisations that currently undertake conformity assessment or free-standing Australian organisations. The regulation further explains that Division 4A.7 (which deals with the content of Australian conformity assessment body certificates) is made for section 41EWB of the Act.

 

Division 4A.2 - Making conformity assessment body determinations

Regulation 4A.2

This regulation sets out the requirements for making an effective application for a conformity assessment body determination. The application must be in the approved form and manner, must not contain false or misleading information and the application fee must have been paid.

 

Regulation 4A.3

This regulation empowers the Secretary to require an applicant to provide further information or documents to enable the Secretary to consider the application, within a specified period which is not less than 10 working days.

 

This regulation also enables the Secretary, for the purposes of assessing an application, to require an applicant, or a contractor of an applicant, to allow an authorised person to inspect premises (including premises outside Australia) that are being, or will be used in the future, by the applicant or contractor to carry on certification-related activities. Certification-related activities are the activities of an Australian conformity assessment body that consist of, or relate to, the issue of Australian conformity assessment body certificates.

 

Regulation 4A.4

This regulation provides that all documents provided by an applicant in relation to an application for a conformity assessment body determination must be in English (and may also be provided in another language).

 

Regulation 4A.5

This regulation sets out the situations in which an application for a conformity assessment body determination will lapse. These include a failure to provide information or allow an authorised person to inspect premises in accordance with regulation 4A.3, the provision of false or misleading information, and failure to pay outstanding conformity assessment body determination assessment fees.

 

Regulation 4A.6

This regulation sets out matters that the Secretary must consider in determining an application for a conformity assessment body determination. These include that the Secretary is satisfied that it is likely the applicant will be able to comply with the requirements of Schedule 3AA while the determination is in effect (item 10 below refers). The Secretary must also consider whether the applicant, a manager or major interest holder falls within any of the categories set out at subparagraphs (3)(iv) to (x) (e.g. whether such a person has, in the ten years before the application, been convicted of an offence against a law of the Commonwealth or a State or Territory involving fraud or dishonesty). In addition, the Secretary may consider any other relevant matter.

 

Regulation 4A.7

This regulation sets out the procedure to be followed if the Secretary decides to make a conformity assessment body determination. The Secretary must notify the corporation of the decision within 20 working days, and the conformity assessment body determination must specify the scope of the determination. When all fees that are due and payable in connection with the application for the conformity assessment body determination have been paid, the Secretary is required to make the determination, including specifying the scope of the determination and its commencement and duration. Regulation 4A.7 also highlights that the determination may specify conditions to which it is subject (subregulation 4A.7(5) refers).

 

Regulation 4A.8

This regulation specifies how the duration of a conformity assessment body determination is to be determined.  A determination would commence on the day specified in the determination and has effect until the end of the specified period, unless revoked or suspended.  A determination has effect for a maximum period of 5 years.

 

Regulation 4A.9

This regulation sets out the procedure to be followed if the Secretary decides not to make a conformity assessment body determination. The Secretary must notify the corporation of the decision within 20 working days, and give reasons for the decision.

 

Division 4A.3 - Conditions on  conformity assessment body determinations

Regulation 4A.10

This regulation provides that a conformity assessment body determination is automatically subject to conditions set out in new Subdivision A (regulations 4A.10 to 4A.18).

 

Regulation 4A.11

This regulation provides that an Australian conformity assessment body must comply with the requirements specified in Schedule 3AA (item 10 below refers).

 

Regulation 4A.12

This regulation sets out conditions that require an Australian conformity assessment body to notify the Secretary and its clients of certain matters, including if there are substantial changes to a body's compliance with the requirements in Schedule 3AA. Examples of such substantial changes are those relevant to its determination, particularly in relation to any aspect of its status and operations that relate to:

*                its legal, commercial, organisational and ownership status;

*                its organisational structure, executive management or key personnel;

*                its main policies and procedures in relation to its certification-related activities;

*                its resources, premises and critical location;

*                the scope of its determination; and

*                other matters that may affect the abilities of the body to fulfil the requirements of its determination.

 

The body must also notify the Secretary and relevant clients where it plans to cease carrying on one of more kinds of certification-related activities covered by its determination.

 

Regulation 4A.13

This regulation sets out conditions that relate to entry and inspection of premises. Subregulation (1) is expressly provided for by paragraph 41EWA(6)(a) of the Act, and requires an Australian conformity assessment body to allow an authorised person to inspect premises it uses to carry on certification-related activities. Subregulation (2) requires the body to have procedures in place to require its contractors, to whom it has outsourced certification-related activities, to allow an authorised person to inspect premises used by the contractor to carry on those activities.

 

Regulation 4A.14

This regulation specifies conditions relating to the provision of information and documents. Subregulation (1) is expressly provided for by paragraph 41EWA(6)(b) of the Act, and requires a body to give the Secretary information or documents that concern its certification-related activities within 20 working days of a request by the Secretary. Subregulation (2) requires the body to have procedures in place to require its clients and contractors (to whom it has outsourced certification-related activities) to make available information or documents that have been requested by the Secretary under subregulation (1).

 

Regulation 4A.15

This regulation requires an Australian conformity assessment body to cooperate in any review by the Secretary of its certification-related activities or its compliance with conditions of its determination.

 

Regulation 4A.16

This regulation requires an Australian conformity assessment body to keep all records required by Schedule 3AA, as well as any other records necessary to demonstrate its compliance with the requirements of Schedule 3AA. Section 41EWD of the Act provides that if a body is required by a condition prescribed in the regulations to keep records relating to its certification-related activities, it must keep such records at all times while it remains an Australian conformity assessment body. Where a corporation ceases to be such a body, it must retain records relating to its certification-related activities for 15 years after cessation. Subsections 41EWD(3) and (4) of the Act also contain offences where an Australian conformity assessment body contravenes a requirement under that section.

 

Regulation 4A.17

This regulation specifies conditions relating to the issue of Australian conformity assessment body certificates by the body.  Subregulation (1) provides that an Australian conformity assessment body must be satisfied that an appropriate conformity assessment procedure has been applied, before issuing an Australian conformity assessment body certificate in relation to a kind of medical device. The conformity assessment procedures are set out in Schedule 3 of the MD Regulations.

 

Under subregulation (2) a body must vary, suspend or revoke an Australian conformity assessment body certificate it has issued, or give the manufacturer a relevant notice, if the body is no longer satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate.

 

Subregulation (5) provides that an Australian conformity assessment body must notify the Secretary within 10 working days if the body:

*                decides not to issue a certificate for a medical device manufacturer because it is not satisfied that the manufacturer has applied an appropriate conformity assessment procedure to their medical devices;

*                suspends or revokes a certificate it had issued;

*                varies a certificate in particular circumstances; or

*                becomes aware of a matter of significant concern in relation to the safety of any medical device covered by a certificate that it has issued.

 

Regulation 4A.18

This regulation specifies conditions that apply to an Australian conformity assessment body in relation to dealings with its clients. A client is a manufacturer with whom the body has an agreement under which the body will carry on certification-related activities, including issuing Australian conformity assessment body certificates to the manufacturer. 

                                         

Subregulation (1) provides that a body must notify its clients within 10 working days if the Secretary varies or suspends its determination.  Where a client informs the body that it is planning to terminate its agreement with the body and enter into a new agreement with another Australian conformity assessment body, subregulation (2) requires the body to enter into an agreement with the new body that deals appropriately with the transfer of responsibility for carrying on certification-related activities for the client.  Subregulation (3) requires a body to make reasonable enquiries as to whether the manufacturer has applied to another Australian conformity assessment body for the issue of a certificate in relation to a kind of medical device, before accepting an application to issue a certificate in relation to that kind of device.

 

Regulation 4A.19

This regulation principally makes it clear that a conformity assessment body determination is subject to any conditions specified in the determination under subregulation 4A.7(5) when it is issued (noting that a determination may also be subject to conditions imposed (or varied) after it has been issued under regulation 4A.28 (see below)).

 

Division 4A.4 - Suspension of conformity assessment body determinations

This Division deals with matters relating to the suspension of an Australian conformity assessment body's determination, and is made in reliance on amendments to subsection 41EWA(7) of the Act made by the Amendment Act, and on section 4 of the Acts Interpretation Act 1901.

 

Regulation 4A.20

This regulation gives the Secretary power to suspend an Australian conformity assessment body's determination, for not more than 12 months, if satisfied that it is likely that there are grounds for revoking the determination under regulation 4A.27 and that the body will be able to take action within the suspension period so that the grounds for revocation will likely no longer exist.

 

Regulation 4A.21

This regulation provides that a body must be given notice of a proposed suspension and a reasonable opportunity to make a submission to the Secretary in relation to it. The Secretary must have regard to any submissions by the body before making a decision in relation to the proposed suspension.

 

Regulation 4A.22

This regulation sets out when a suspension takes effect and the duration of a suspension. If the body can show that it has taken steps to address the grounds for revocation of the determination but the some of the grounds for suspension continue to be in place, the Secretary can extend the suspension for one further period not exceeding 12 months.

 

Regulation 4A.23

This regulation provides that the Secretary must revoke a suspension when satisfied that the grounds for suspension no longer apply and there are no other grounds for suspending. It also gives the Secretary the discretion to revoke a suspension on his or her own initiative or on application by the body.  Notice of the decision on the revocation must be given within 20 working days.

 

Regulation 4A.24

This regulation confirms that the Secretary's powers to revoke an Australian conformity assessment body determination under Division 4A.5 are unaffected by this Division.

 

Division 4A.5 - Revocation of conformity assessment body determinations

Regulation 4A.25

This regulation provides for the automatic revocation of an Australian conformity assessment body determination where the determination has been suspended and the period applying to the suspension expires before the suspension is revoked under regulation 4A.23.

 

Regulation 4A.26

This regulation provides that the Secretary may revoke a determination if the body requests its revocation or notifies the Secretary that it plans to completely cease carrying on certification-related activities.

 

Regulation 4A.27

This regulation sets out the situations in which the Secretary may revoke an Australian conformity assessment body determination after having first given notice of the proposed revocation.  These are where the body refuses or fails to comply with a condition to which the determination is subject and where the body, a manager or major interest holder falls within one of the categories set out in subparagraphs (1)(iv) to (x).

 

Subregulation (4) provides that a body must be given notice of a proposed revocation and a reasonable opportunity to make a submission to the Secretary in relation to it. The Secretary must have regard to any submissions by the body before making a decision in relation to the proposed revocation.

 

Division 4A.6 - Variation of conformity assessment body determinations

Regulation 4A.28

This regulation empowers the Secretary to impose new conditions on a determination after it has been made.  The Secretary may also vary or remove conditions that have been imposed. These powers may be exercised on application by the Australian conformity assessment body or on the Secretary's own initiative.

 

Regulation 4A.29

This regulation allows the Secretary to vary an Australian conformity assessment body determination to limit, or further limit, the scope of the determination. This power may be exercised on application by the Australian conformity assessment body or on the Secretary's own initiative.

 

In relation to the possible exercise of this power on the Secretary's own initiative, it is expected that this would only occur where it appears there are significant issues with the body's capacity to undertake some conformity assessment procedures, or conformity assessment procedures in relation to some kinds of medical devices, that are within the scope of its determination.

 

Regulation 4A.30

This regulation provides that a body must be given written notice of a proposed variation and a reasonable opportunity to make a submission to the Secretary in relation to it. The Secretary must have regard to any submissions by the body before making a decision in relation to the proposed variation.

 

Division 4A.7 - Australian conformity assessment body certificates

This item also inserts Division 4A.7 into new Part 4A of the MD Regulations, to provide for the content of Australian conformity assessment body certificates.

 

Regulation 4A.31

This regulation sets out the information that must be contained in an Australian conformity assessment body certificate for the purposes of subsection 41EWB(2) of the Act. This is broadly equivalent to the information that must be set out in a conformity assessment certificate (refer item 1 above) and is as follows:

*                the body's name and address;

*                the body's ACN;

*                the body's unique identification number;

*                a unique identification number for the certificate;

*                the day on which the certificate is issued;

*                the name and address of the manufacturer of the medical devices;

*                the conformity assessment procedures applied to the medical devices by the manufacturer;

*                the unique product identifier given to the devices by the manufacturer where the certificate covers medical devices mentioned in paragraph 1.6(a), (b) or (c);

*                the day and details of the variation where the certificate has been varied; and

*                where one or more Australian conformity assessment body certificates have previously been issued in respect of the medical devices by the body, the above details in relation to each of those certificates.

 

Item 3 - Subregulation 5.3(2)

Subregulation 5.3(1) of the MD Regulations prescribes the applications that must always be selected for auditing for the purposes of paragraph 41FH(1)(a) of the Act. However, subregulation 5.3(2) provides that subregulation 5.3(1) does not apply to an application for a medical device for which a conformity assessment certificate has been issued (provided that certificate has not been suspended or revoked).  This item amends subregulation 5.3(2) of the MD Regulations to provide that this exemption to subregulation (1) also applies to applications for a device for which an Australian conformity assessment body certificate has been issued (and remains in force).

 

Item 4 - Subregulation 7.2(1B)

This item repeals subregulation 7.2(1B), which is no longer necessary because of the insertion of new regulation 10.6B.

 

Item 5 - Before regulation 9.1

This item introduces the heading 'Division 9.1- Fees' before regulation 9.1, to reflect the addition of new Division 9.2 in Part 9 by the next item.  This new Division deals with conformity assessment body determination assessment fees.

 

Item 6 - After regulation 9.1

This item introduces new Division 9.2 to the MD Regulations, which would provide for conformity assessment body determination assessment fees.

 

Regulation 9.1A

This regulation explains that this Division is made for paragraph 41EWA(3)(g) of the Act, which enables the making of regulations to set out an assessment fee for the assessment by the Secretary of whether a conformity assessment body determination should be made in response to an application.

 

Regulation 9.1B

This regulation principally specifies that the following fees are payable:

*                fee for assessment of an application for full designation conformity assessment body determination;

*                fee for assessment of application for partial designation conformity assessment body determination (full QMS);

*                fee for assessment of application for partial designation conformity assessment body determination (partial QMS or partial devices).

 

Subject to regulation 9.1C, the fee amount payable by the applicant is set out in column 4 of the table in Part 1 of Schedule 5 for the relevant item. The Secretary may notify the applicant in writing when the fee is due and payable.

 

Regulation 9.1C

This regulation provides for an abridged conformity assessment body determination assessment fee if the Secretary considers that there is sufficient information to allow for an abridged assessment to be undertaken.

 

Regulation 9.1D

This regulation allows the Secretary to approve payment of a conformity assessment body determination assessment fee in instalments in a case of financial hardship where the circumstances specified in subregulation (1) are met.  These include the applicant providing reasons and supplying documentation to support the application. Applications must be decided within 30 days of the application and supporting documentation being received. The decision is reviewable under regulation 10.7 of the MD Regulations.  If an application is approved, and any amount of the instalment is not paid when it becomes due, the balance of the fee then becomes due for payment.          

 

Regulation 9.1E

This regulation provides that a conformity assessment body determination assessment fee may be recovered as a debt due to the Commonwealth.

 

Regulation 9.1F

This regulation enables the applicant to apply for a refund of the conformity assessment body determination assessment fee if the applicant withdraws the application after all or part of the fee becomes due and payable and before the Secretary decides whether to make the conformity assessment body determination under subregulation 4A.6(1).

 

The Secretary must decide whether to refund an amount of the fee within 20 working days of receiving the application. Subregulation (3) makes it clear that there is no provision for refunding the application fee (as distinct from the assessment fee) for an application.

 

Item 7 - After regulation 10.6A

This item introduces new regulation 10.6B to the MD Regulations, which allows the approval of a form or manner of giving an application, notice or other document to require or permit the application, notice or document to be given in accordance with specified software requirements on a specified kind of data processing device or by way of a specified kind of electronic transmission.

 

Item 8 - Subregulation 10.7(1)

This item introduces new paragraph (aba) to the definition of initial decision in subregulation 10.7(1) of the MD Regulations, to provide that specified decisions of the Secretary in relation to conformity assessment body determinations are 'initial decisions' for the purposes of subregulation 10.7(1) and therefore subject to review by the Minister (a person who requests such a review may, if dissatisfied with the Minister's decision on reconsideration of the initial decision, apply to the Administrative Appeals Tribunal for a review of the Minister's decision).  These include, for example, the imposition of conditions on an Australian conformity assessment body determination under new subregulation 4A.7(5).  The existing requirements of regulation 10.7 for requests to the Minister to review an initial decision would apply, including in particular that a person whose interests are affected by an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person's notice.

 

Item 9 - Subregulation 10.7(1)

This item introduces new paragraph (ae) to the definition of initial decision in subregulation 10.7(1) to provide that specified decisions of the Secretary in relation to conformity assessment body determination assessment fees are also subject to review.

 

Item 10 - After Schedule 3

This item introduces new Schedule 3AA to the MD Regulations, which sets out the requirements that the Secretary must be satisfied that an Australian conformity assessment body will likely be able to comply with when assessing an application for an Australian conformity assessment body determination under regulation 4A.6. These requirements are those set out in the following European regulations as modified by clause 2 of this Schedule:

*                Annex VII to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force from time to time (the EU Medical Devices Regulation); and

*                Annex VII to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force from time to time (the EU IVD Regulation).

These regulations can be found at the following link (and there is no charge to access these):

http://eur-lex.europa.eu/legal-content/EN/TXT/PDuriF/?=OJ:L:2017:117:FULL&from=EN

A link to the most recent version of these European regulations is also available on the TGA website (www.tga.gov.au).

Subsection 63(4) of the Act allows instruments to be incorporated as in force from time to time, and so the most recent versions of these regulations will automatically apply.

The Australian regulatory system for medical devices is already closely aligned with the European system in a number of respects, and the Expert Panel Review of Medicines and Medical Devices Regulation recommended that, wherever possible, the regulation of medical devices in Australia be aligned with the European framework. Applying these European regulations in this context would be consistent with that recommendation.  It is also expected that entities currently undertaking conformity assessments elsewhere in the world who may be interested in becoming an Australian conformity assessment body, would be familiar with Annexes VII of the EU Medical Devices Regulation and EU IVD Regulation.

Clause 3 sets out the general modifications that are to apply to both the EU Medical Devices Regulation and the EU IVD Regulation, and clauses 4 to 6 set out additional requirements and specific modifications to each regulation.

 

Item 11 - Part 1 of Schedule 5

This item amends the table in Part 1 of Schedule 5 of the MD Regulations, to provide for a number of application fees for applications for a conformity assessment body determination (from $2,410 to $4,400), and conformity assessment body determination assessment fees for the assessment of an application to become an Australian conformity assessment body (from $51,500 to $71,700).

 

In each case, the fees that apply principally reflect the expected staff effort for officers of the Department's Health Products Regulation Group in processing (in the case of the application fees) and evaluating (in the case of the assessment fees) such applications.

 

Item 12 - Dictionary

This item introduces a number of definitions to the MD Regulations' Dictionary, to support the above measures.

 

Part 2 - Amendments consequential on the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Items 13 to 23, 25 to 39, 41 to 48, 50 to 57 and 59

Section 41DA of the Act provides that the regulations may set out requirements relating to the obligations of manufacturers of medical devices, known as conformity assessment procedures. Regulation 3.4 of the MD Regulations provides that the conformity assessment procedures are set out in Schedule 3 of the MD Regulations.

 

The conformity assessment procedures currently set out in Schedule 3 relate to circumstances where a conformity assessment certificate is to be, or has been, issued to a manufacturer by the Secretary, and so are drafted on the basis that the Secretary will be determining whether the relevant conformity assessment procedure has been applied by a manufacturer.

 

Under amendments made to the Act by the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017, and supported by further amendments made by the Amendment Act, private bodies can apply for designation by the Secretary to appraise the suitability of the manufacturing process for medical devices and to assess whether such devices meet the minimum standards of safety and performance. Where such a body (an Australian conformity assessment body) is satisfied that an appropriate conformity assessment procedure has been applied to a kind of medical devices, the body may issue an Australian conformity assessment certificate to a manufacturer (however, conformity assessment certificates issued by the Secretary will still be required in relation to certain kinds of medical devices in accordance with regulation 4.1).

 

There is therefore a need for consequential amendments to Schedule 3 to address circumstances where an Australian conformity assessment body certificate is to be, or has been, issued to a manufacturer by an Australian conformity assessment body.

                                                    

These items make a number of amendments to Parts 1 to 5 of Schedule 3 to address circumstances where an Australian conformity assessment body is to determine whether the relevant conformity assessment procedure has been applied by the manufacturer rather than the Secretary - principally, by inserting references to 'Australian conformity assessment body' at appropriate places.

 

Items 24, 40, 49, 58 and 60

These items also make consequential amendments, to paragraphs 1.8(2)(f), 3.5(2)(e), 4.7(2)(f), 5.7(2)(g) and 6.6(2)(h) of Schedule 3, to insert references to Australian conformity assessment body certificates in addition to conformity assessment certificates.

 

These items also remove references to approvals and certificates issued outside Australia as these are no longer necessary due to amendments made to the Act by the Amendment Act in relation to overseas regulators.

 

Item 61 - Paragraph 6(1)(c) of Schedule 3A

This item makes a minor amendment to paragraph 6(1)(c) to also refer to requirements that are comparable to conformity assessment procedures (that may be applied to a medical device to the satisfaction of an overseas regulator).

 

 

Schedule 4 - Advertising

 

Part 1 - Enforcement

 

Therapeutic Goods Regulations 1990

 

Item 1 - Paragraphs 5L(1)(d) and (e)

This item repeals paragraphs 5L(1)(d) and (e) from the TG Regulations, which allow the Secretary to withdraw an approval from a person to whom the Secretary has given approval for an advertisement about therapeutic goods, if the Secretary is satisfied that because of a change to the facts or circumstances in place when the advertisement was approved, or because of a change to the Therapeutic Goods Advertising Code (the Code), the advertisement no longer complies with the Code.

 

This item replaces these two paragraphs with a new paragraph 5L(1)(d) which refers simply to where an advertisement does not comply with the Code.  The new paragraph 5L(1)(d) covers the same scenarios as the previous paragraphs 5L(1)(d) and (e), but also allows the Secretary to withdraw approval from an advertisement that did not comply with the Code when approval for the advertisement was sought, and that was inadvertently approved.

 

Item 2 - Regulation 6

This item repeals regulation 6. Regulation 6 provides that Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code ("the Code") is prescribed for the purposes of subsection 42DD(1) of the Act. This regulation is of no effect as section 42DD of the Act is not divided into subsections, and does not rely on anything being prescribed.

 

Item 3 - At the end of regulation 6AA

This item inserts references to two committees on the list of committees prescribed for paragraph 42DF(4)(b) of the Act. In making a decision under section 42DF of the Act to approve or refuse to approve the use of a restricted representation in the advertising of therapeutic goods, the Secretary must take into consideration any advice given by a prescribed committee. Specifically, the additional committees are the Advisory Committee on Medical Devices and the Advisory Committee on Vaccines.

 

Item 4 - Regulation 6A

This item repeals regulation 6A. Regulation 6A provides that Part 2 of Appendix 6 to the Code is prescribed for the purposes of paragraph 42DF(4)(c) of the Act. Paragraph 42DF(4)(c) requires the Secretary, in making a decision under section 42DF of the Act to approve or refuse to approve the use of a restricted representation in the advertising of therapeutic goods, to take into consideration the public interest criteria mentioned in the part of Code dealing with restricted representations. That paragraph does not require any part of the Code to be prescribed.

 

Item 5 - Regulation 7

This item repeals regulation 7 of the TG Regulations, which prescribes therapeutic goods and medical devices for the purposes of advertising offences under subparagraph 42DL(1)(h)(i) of the Act, and substitutes a new regulation 7 which prescribes therapeutic goods for the purposes of subsections 42DL(12) and 42DLB(9) of the Act as amended by the Amendment Act. The Amendment Act repeals and replaces section 42DL, setting out general advertising offences and inserts section 42DLB setting out civil penalties. Both the previous and new regulation 7 have the effect that the advertising of certain unapproved goods is prohibited.

 

This item also introduces new regulation 7A to the TG Regulations, which sets out the persons, in addition to broadcasters, datacasters and the SBS (Special Broadcasting Service), who are covered by an exception to the civil penalty provisions in sections 42DLB and 42DMA of the Act if, as a result of steps taken by the person, it was reasonable for them to assume that an advertisement complied with the relevant requirements. A person who is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia would be covered by this exception.

 

Item 6 - Regulation 8

This item amends regulation 8 of the TG Regulations, which specifies matters for section 42DO of the Act. That section previously provided that generic information must comply with principles of the Code specified in regulations as if those principles applied to generic information in the same way they apply to advertisements. The Amendment Act amends section 42DO to refer instead to provisions of the Code prescribed by the regulations. This item amends regulation 8 to align its wording with section 42DO as amended.

 

The Code is a legislative instrument made under section 42BAA of the Act. In accordance with section 14 of the Legislation Act 2003, it is incorporated by reference as in force from time to time. The Code may be viewed, free of charge, on the Federal Register of Legislation or the TGA website.

 

Item 7 - Regulation 8A

This item repeals regulation 8A of the TG Regulations, which provides that the principles stated in subsections 4(1), (2), (3), (4), (5) and (6) of the Code are specified for paragraph 42DP(1)(b) of the Act. The Amendment Act repeals and substitutes section 42DP. Instead of requiring principles to be specified, the new section refers to the provisions of the Code prescribed for the purposes of section 42DO.

 

Item 8 - Division 5 of Part 2

This item repeals Division 5 of Part 2 of the TG Regulations. That Division consists of regulation 9, which allows the Secretary to give certain orders to a person in relation to an advertisement or generic information, on the recommendation of the Complaints Resolution Panel, which is established by regulation 42R. This provision is redundant as the Amendment Act introduces a new section 42DV to the Act, allowing the Secretary to give a direction in relation to the advertising of therapeutic goods or the dissemination of generic information, without the need for a recommendation. Under item 13 below, the Complaints Resolution Panel is to be abolished, and the Department of Health through the Secretary will be the single body responsible for the handling of all complaints about the advertising of therapeutic goods to the public in the future.

 

Item 9 - Subregulation 47(3)

This item makes a consequential amendment to subregulation 47(3) of the TG Regulations to omit the reference there to subregulation 9(3), as regulation 9 is within Division 5 of Part 2 of the Regulations, which is repealed by item 7 above.

 

Item 10 - Subregulation 48(1) (paragraph (a) of the definition of initial decision)

This item makes a consequential amendment to regulation 48 of the TG Regulations, which makes certain decisions subject to reconsideration by the Minister and decisions on reconsideration subject to review by the Administrative Appeals Tribunal, to repeal paragraph (a) of the definition of initial decision in subregulation 48(1). That paragraph refers to decisions under subregulation 9(1), which is repealed by item 7 above.

 

Item 11 - In the appropriate position in Division 7 of Part 7

This item introduces new regulation 62 into Division 6 of Part 9 of the TG Regulations, which provides that Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of this Schedule, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement. This enables an order given before that commencement to remain in force, and to remain subject to reconsideration and review, after that commencement, but does not enable the making of any new orders under regulation 9.

 

Part 2--Removal of requirement for advertisements to be approved

 

Therapeutic Goods Regulations 1990

 

Item 12 - Regulation 2

This item repeals three definitions in regulation 2 of the TG Regulations, as these defined terms are only used in provisions repealed by items 13 to 16 below.

 

Item 13 - Division 2 of Part 2

This item repeals Division 2 of Part 2 of the TG Regulations. Division 2 of Part 2 relates to the approval of advertisements under Division 2 of Part 5-1 of the Act, which is repealed by the Amendment Act.

 

Item 14 - Subregulation 47(3)

This item makes a consequential amendment to regulation 47 of the TG Regulations, to repeal subregulation 47(3). Subregulation 47(3) - as it is amended by item 9 above - provides that the Secretary's power to delegate a function or power under the regulation 47 does not affect his or her power to delegate a power or function under regulation 5Q. As regulation 5Q is within Division 2 of Part 2 of the Regulations, which is repealed by item 12 above, there is a need to also repeal subregulation 47(3).

 

Item 15 - Subclause 1(1) of Schedule 9

This item repeals various definitions in subclause 1(1) of Schedule 9 to the TG Regulations, as the defined terms are only used in items of that Schedule that are repealed by item 16.

 

Item 16 - Clause 3 of Schedule 9 (table items 17 and 17A)

This item repeals table items 17 and 17A in clause 3 of Schedule 9 to the TG Regulations. Those items prescribe fees for applications under regulation 5F for the approval of advertisements. Regulation 5F is within Division 2 of Part 2 of the Regulations, which is repealed by item 12 above as part of the removal of the requirement for advertisements to be pre-approved.

 

Part 3--Other amendments

 

Item 17 - Regulation 2 (definition of Complaints Resolution Panel)

This item amends regulation 2 of the TG Regulations to remove the definition of the Complaints Resolution Panel (the Panel).  This reflects that the effect of item 23 below includes repealing Division 3 of Part 6 of the TG Regulations, which establishes the Panel.

 

Items 18 - 22

These items make a small number of minor consequential amendments to regulations 5L, 5M, 5N and 5Q of the TG Regulations, to remove references to the Panel and to the Therapeutic Goods Advertising Code Council, to reflect the effect of item 23 below.

 

Item 23 - Divisions 2 and 3 of Part 6

This item repeals Divisions 2 and 3 of Part 6 of the TG Regulations. Division 2 establishes, and sets out machinery provisions in relation to, the Therapeutic Goods Advertising Code Council; and Division 3 establishes, and sets out machinery provisions relating to, and provisions relating to the procedures of, the Complaints Resolution Panel. Both of those bodies are to be disbanded, and their functions performed by the Department, although a non-statutory advisory committee advises on the advertising code and trends in advertising complaints received by the Department.

 

 

Schedule 5 - Infringement notices

 

Therapeutic Goods Regulations 1990

 

Items 1-3 - Part 7A, Subregulation 47(1A) and Schedule 15

Items 1 and 3 of this Schedule repeal Part 7A and Schedule 15 of the TG Regulations, to reflect the repeal of Part 5A-2 of the Act by Schedule 7 of the Amendment Act, as part of the replacement of the previous infringement notices scheme in the Act and TG Regulations with a new such scheme introduced by Schedule 7.

 

Item 2 of this Schedule makes a minor, consequential amendment to remove subregulation 47(1A) of the TG Regulations, as this refers to the delegation of powers and functions of the Secretary under Schedule 15 of the TG Regulations (which is repealed by item 3 of this Schedule).

 

 

Schedule 6 - Preliminary assessment of applications

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Items 1 to 5 - Regulations 5.4C and 5.4D

Items 1 to 5 amend subregulations 5.4C(2) and 5.4D(1) of the MD Regulations, to reflect the new preliminary assessment process for applications to include medical devices in the Register. Schedule 4 of the Amendment Act repeals section 41FC of the Act, which identifies when an application is not effective, and inserts new section 41FDB of the Act, which provides for preliminary assessment of applications. As a result, items 1 and 4 amend subregulations 5.4C(2) and 5.4D(1) to omit references to an "effective" application, and items 2 and 4 insert references to passing preliminary assessment. Items 3 and 5 repeal and substitute the notes to subregulations 5.4C(2) and 5.4D(1), respectively, to reflect the new process.

 

Item 6 - Subregulation 11.1(1) (note)

This item repeals the note to the definition of listed or registered transitional device in regulation 11.1 of the MD Regulations. That note refers to subsection 23(2) of the Act to explain when an application under Part 3-2 of the Act is effective. The note is no longer accurate as Schedule 4 to the amending Act repeals section 23 of the Act and removes the concept of an effective application.

 

Item 7 - Subregulations 11.8(2), 11.17(2) and 11.18(2) (note)

This item repeals the note  at each of subregulations 11.8(2), 11.17(2) and 11.18(2) of the MD Regulations. This note refers to subsection 41FC(2) of the Act to explain when an application under Chapter 4 of the Act is effective. The notes are no longer accurate as Schedule 4 to the amending Act repeals section 41FC of the Act and removes the concept of an effective application.

 

Item 8 - Part 1 of Schedule 5 (cell at table item 1.5)

This item omits a reference to paragraph 41FC(2)(b) of the Act in item 1.5 of the table in Part 1 of Schedule 5 of the MD Regulations, and replaces it with a reference to paragraph 41FDB(2)(b) of the Act. Item 1.5 sets out application fees for the inclusion of kinds of medical devices in the Register. Application fees for the inclusion of kinds of medical devices in the Register are prescribed under paragraph 41FDB(2)(b) of the Act, rather than paragraph 41FC(2)(b) as was previously the case. The nature of the fees is unchanged, and the basis on which the amount of the fees is determined remains applicable. Accordingly, this amendment does not change the amount of the fees.

 

Therapeutic Goods Regulations 1990

 

Item 9 - Subregulation 16C(2)

This item repeals and substitutes subregulation 16C(2) of the TG Regulations, which prescribes the period within which a notification that an application for registration of a prescription medicine has passed preliminary assessment must be sent. This reflects the repeal of section 23 of the Act and the insertion of section 23B, by Schedule 4 to the Amendment Act.

 

Item 10 - Subregulation 16C(3)

This item amends subregulation 16C(3) of the TG Regulations, to replace a reference to the application being effective with a reference to the application passing preliminary assessment.

 

Item 11 - Regulation 16GA (heading)

This item repeals and replaces the heading to regulation 16GA of the TG Regulations. The previous heading refers to evaluation other than evaluation under subsection 9D(1), (2) or (3) of 24(1) of the Act. The Amendment Act repeals and replaces subsection 24(1) of the Act. The new subsection 24(1) does not provide for evaluation. The relevant evaluation is carried out under section 25 of the Act.

 

Items 12 to 14 - Regulations 16GB, 16GC and 16GD

Items 12 to 14 repeal regulations 16GB, 16GC and 16GD of the TG Regulations, and substitute new regulations 16GC and 16GD.  As with regulations 16C and 16D, these new regulations set out the period within which the Secretary must send a notification that an application has passed preliminary assessment, or is effective, respectively, as well as the period within which an evaluation must be completed.

 

Item 15 - Regulation 16GE

This item makes a consequential amendment to regulation 16GE of the TG Regulations, to reflect the numbering in the new regulation 16GD.

 

Item 16 - Regulation 16GF (heading)

This item repeals and replaces the heading to regulation 16GF of the TG Regulations. The previous heading refers to evaluations other than evaluation under subsections 9D(1), (2) or (3), or section 32DD, of the Act. The Amendment Act repeals and replaces section 32DD of the Act, with the new section 32DD not providing for evaluation as the relevant evaluation is now to be carried out under section 32DE of the Act.

 

Items 17 to 21 - Subregulations 16GS(2) and 16GT(1)

Items 17 to 21 amend subregulations 16S(2) and 16T(1) of the TG Regulations to reflect the new preliminary assessment process for applications to register medicines in the Register. Schedule 4 of the Amendment Act repeals section 23 of the Act, which identifies when an application is not effective, and introduces new section 23B of the Act, which provides for the preliminary assessment of applications. As a result, these items (taken together) amend subregulations 16S(2) and 16T(1) of the TG Regulations to replace references to an "effective" application with references to an application that has passed preliminary assessment, and to repeal and substitute the notes to subregulations 16S(2) and 16T(1) to also reflect the new process.

 

Item 22 - Subregulation 43A(3)

This item repeals subregulation 43A(3) of the TG Regulations. This subregulation provides that an application fee is taken not to have been payable in relation to certain applications under section 23 made during periods ending on or before 1 July 2011, and is now redundant as all applications made during those periods have been dealt with.

 

Items 23 to 31 - Certain definitions in Schedule 9

Items 23 to 31 amend a number of definitions in subclause 1(1) of Schedule 9 of the TG Regulations, to reflect the repeal of section 23, and the introduction of new section 23B, of the Act by Schedule 4 of the Amendment Act. The affected definitions refer to applications made in the form and manner approved for the relevant kinds of applications. The power to approve the form and manner in which an application must be made is in section 23 of the Act as in force before the commencement of the amendments, and section 23B of the Act as amended.

 

Item 32 - Clause 3 of Schedule 9 (table item 2)

This item amends table item 2 in clause 3 of Schedule 9 of the TG Regulations to reflect the repeal of section 23, and insertion of section 23B, of the Act by Schedule 4 of the Amendment Act, and to remove a reference to table item 2AA which is repealed by item 33. Table item 2 sets out application fees for the registration of therapeutic goods. Application fees for registration are  prescribed under paragraph 23B(2)(b) of the Act as amended, rather than paragraph 23(2)(a) as was previously the case. The nature of the fees is unchanged, and the basis on which the amount of the fees is determined remains applicable. Accordingly, this amendment does not change the amount of the fees.

 

Item 33 - Clause 3 of Schedule 9 (table item 2AA)

This item repeals table item 2AA in clause 3 of Schedule 9 of the TG Regulations. The item is no longer required following amendments to the Act made by the Therapeutic Goods (2016 Measures No. 1) Act 2017, which enabled the cancellation of registration on the grounds of non-payment of annual charge to be revoked without requiring a new application for registration.

 

Item 34 - Clause 3 of Schedule 9 (table item 3)

This item amends table item 3 in clause 3 of Schedule 9 of the TG Regulations to reflect the repeal of section 23, and insertion of section 23C, of the Act by Schedule 4 of the Amendment Act, and to remove a reference to table item 3AA which is repealed by item 35. Table item 3 sets out application fees for the listing of therapeutic goods. Application fees for listing are prescribed under paragraph 23C(2)(c) of the Act as amended, rather than paragraph 23(2)(a), as was previously the case. The nature of the fees is unchanged, and the basis on which the amount of the fees is determined remains applicable. Accordingly, this amendment does not change the amount of the fees.

 

Item 35 - Clause 3 of Schedule 9 (table item 3AA)

This item repeals table item 3AA in clause 3 of Schedule 9 of the TG Regulations. The item is no longer required following amendments to the Act made by the Therapeutic Goods (2016 Measures No. 1) Act 2017, which enabled the cancellation of listing on the grounds of non-payment of annual charge to be revoked without requiring a new application for listing.

 

Item 36 - Clause 3 of Schedule 9 (table item 3A)

This item amends table item 3A in clause 3 of Schedule 9 of the TG Regulations to reflect the repeal of section 23, and insertion of section 23B, of the Act by Schedule 4 of the Amendment Act. Table item 3A sets out application fees for the registration of therapeutic devices. Application fees for registration are prescribed under paragraph 23B(2)(b) of the Act as amended, rather than paragraph 23(2)(a) as was previously the case. The nature of the fees is unchanged, and the basis on which the amount of the fees is determined remains applicable. Accordingly, this amendment does not change the amount of the fees.

 

Item 37 - Clause 3 of Schedule 9 (table items 3B, 4, 5A, 5B, 6 and 9D)

This item amends table items 3B, 4, 5A, 5B, 6 and 9D in clause 3 of Schedule 9 of the TG Regulations to reflect the repeal of subsection 24(1), and insertion of subsection 24(1A) of the Act by Schedule 4 of the Amendment Act. These table items set out evaluation fees for the registration of therapeutic goods. Evaluation fees are prescribed under subsection 24(1A) of the Act as amended, rather than subsection 24(1) as was previously the case. The nature of the fees is unchanged, and the basis on which the amount of the fees is determined remains applicable. Accordingly, this amendment does not change the amount of the fees.

 

Items 38 to 41 - Clause 4 of Schedule 9 (table items 1 - 4)

Items 38 to 41 amend table items 1 to 4 in clause 4 of Schedule 9 of the TG Regulations to reflect the amendments made to the Act by Schedule 4 to the Amendment Act. These items prescribe application fees and evaluation fees under the amended sections of the Act. The nature of the fees is unchanged, and the basis on which the amount of the fees is determined remains applicable. Accordingly, the amount of each fee is unchanged.

 

Item 42 - Part 2 of Schedule 9A (table item 2)

This item  amends table item 2 in Part 2 of Schedule 9A of the TG Regulations, which prescribes application fees for the inclusion of biologicals in the Register, to reflect the repeal of section 32DD, and the insertion of section 32DDA, of the Act by Schedule 4 of the Amendment Act. Application fees for the inclusion of biologicals in the Register are prescribed under paragraph 32DDA(2)(b) of the Act as amended, rather than paragraph 32DD(2)(e) as was previously the case. The nature of the fees is unchanged, and the basis on which the amount of the fees is determined remains applicable. Accordingly, the amount of the fees is unchanged.

 

 

Schedule 7 - Miscellaneous

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Item 1 - Paragraph 6A.2(2)(a) of Schedule 3

This item makes a minor amendment to paragraph 6A.2(2)(a) of Schedule 3 of the MD Regulations, to clarify that the Secretary's power under that paragraph to approve a notification form for the purposes of subclause 6A.2(1) of Schedule 3 must be exercised in writing.

 

Item 2 - Part 2 of Schedule 4 (table item 2.3)

This item makes a minor amendment to make it clear that the reference in subparagraph (a)(i) of table item 2.3 (in column 3) to the form approved by the Secretary for sponsors to use when notifying the Secretary that the sponsor intends to support a clinical trial using its unapproved medical device in reliance on item 2.3, is a reference to such a form that is approved by the Secretary in writing.

 

Items 3 and 4 - Dictionary

These items make minor amendments to the MD Regulations Dictionary, to make it clear that a number of expressions used in the MD Regulations are defined in the Act (and are therefore not replicated in the Dictionary) and to remove a number of such definitions from the Dictionary.

 

 

Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

The Therapeutic Goods Legislation Amendment (2018 Measures No.1) Regulations 2018 (the Regulations) are made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act) and amend the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations). 

 

The Therapeutic Goods Amendment (2017 Measures No.1) Act 2018 (the Amendment Act) amended the Act to support the implementation of several key recommendations of the Expert Panel Review of Medicines and Medical Device Regulation (the Review) agreed to by the Australian Government. The Expert Panel was established to, principally, identify areas of medicines and medical devices regulation which could be streamlined while maintaining the safety and quality of therapeutic goods in Australia and made 58 recommendations, of which the Australian Government supported 56. The Amendment Act addressed a second tranche of these recommendations (following on from the Therapeutic Goods Amendment (2016 Measures No.1) Act 2017), including in particular the introduction of a pathway for the granting of provisional marketing approval for promising new medicines that are supported by early clinical data, to allow for their faster approval and availability.

 

The Regulations amend the TG Regulations to support the following Review measures in the Amendment Act:

*                providing a pathway for the provisional marketing approval of prescription medicines that, principally, are for the treatment of life-threatening or seriously debilitating conditions, where there is preliminary clinical data of a major therapeutic advance);

*                a number of reforms relating to advertising of therapeutic goods, including removing of the requirement for therapeutic goods advertisements to be pre-approved by the Secretary, from 1 July 2020;

*                enabling the Minister to make a list of permitted indications (statements of a medicine's therapeutic uses) for listed complementary medicines. This means that such medicines may only use indications from that list - while allowing some of these medicines to have additional indications if supported by evidence; and

*                broadening the Act's enforcement powers.

 

The Regulations also amend the TG Regulations, and the MD Regulations, to support two Review measures in the Therapeutic Goods Amendment (2016 Measures No.1) Act 2017, relating to:

*                empowering the Secretary of the Department of Health to make conformity assessment body determinations, to allow Australian companies (with appropriate TGA oversight) to appraise the suitability of medical device manufacturers' evidence and processes, as an alternative to the TGA undertaking this role. The power to prescribe such matters was introduced by the Therapeutic Goods Amendment (2016 Measures No.1) Act 2017, and enhanced by measures in the Amendment Act; and

*                introducing a power to make regulations specifying timeframes within which the Secretary must complete functions or make decisions under the Act - this was principally designed to set such timeframes for the review of complementary medicine ingredients and products.

 

The Regulations also make a small number of minor, consequential changes to the TG and MD Regulations not connected to the Review, to reflect measures in the Amendment Act relating to issues raised in the Federal Court decision in Nicovations Australia Pty Ltd v Secretary of the Department of Health [2016] FCA 394 and to make it clear the Secretary may refuse an application before evaluating it if it does not meet the requirements for a proper application, including for a particular class of medicines (such as over-the-counter versus prescription-only).

Human rights implications

As the Regulations do not introduce any changes to the TG Regulations or MD Regulations other than to implement the changes outlined above, they do not appear to engage any of the applicable rights or freedoms.

 

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

 

Greg Hunt, Minister for Health