EXPLANATORY STATEMENT
Select legislative instrument No. 214, 2015
Therapeutic Goods Act 1989
Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015
The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy/performance and timely availability of therapeutic goods used in, or exported from, Australia. The Therapeutic Goods Administration (the TGA), part of the Department of Health, is responsible for administering the Act.
Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act or necessary or convenient to be prescribed for carrying out or giving effect to the Act. Amongst other matters, the regulations may prescribe fees in respect of matters under the Act or under regulations made under the Act.
Paragraph 9D(7)(f) of the Act provides for application fees to be prescribed for requests to vary the entry of therapeutic goods on the Australian Register of Therapeutic Goods (the Register), including where the request is of a kind prescribed by the regulations for the purpose of subparagraph 9D(7)(b)(ii) of the Act.
Paragraph 23(2)(a) of the Act provides for fees to be prescribed for applications to register therapeutic goods under subsection 23(1) of the Act, and subsection 24(1) of the Act provides for fees to be prescribed for evaluation of therapeutic goods for registration when an application is made in accordance with section 23 of the Act.
The purpose of the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 (the Regulation) is to amend the Therapeutic Goods Regulations 1990 (the Principal Regulations) to replace the current application and evaluation fees relating to over the counter medicines (OTC medicines) with a new, revised set of such fees. The new fees will be payable in relation to:
- applications made to register new OTC medicines, and for the evaluation of such applications; and
- requests to vary entries in the Register of existing registered OTC medicines.
OTC medicines are medicines which consumers are able to purchase for self-treatment from pharmacies, with some products also available in supermarkets, health food stores and other retailers. Examples include cough and cold remedies, anti-fungal treatments and non-prescription analgesics such as aspirin and paracetamol.
The current fees relating to registered OTC medicines, set out in Schedule 9 to the Principal Regulations, are based largely on the amount of supporting data accompanying an application for registration for one of these products – for example, if such documentation is not over 50 pages, is over 50 pages but not over 250 pages or is over 3,000 pages.
The TGA has improved and streamlined its business processes relating to registered OTC medicines and, consequently, this will now be reflected in the fee structure for these products. The revised business processes commenced in April 2013, following industry consultation. The introduction of the new fee structure complements those business improvements.
Under the revised business processes, there are five categories of applications to register a new OTC medicine and eight categories of applications to change an existing registered OTC medicine. The new fees corresponding to the categories reflect the amount of work required to assess each type of application and ensure best practice cost recovery fee setting.
In order to submit an application for the registration of an OTC medicine, or to request the variation of an entry in the Register for an OTC medicine that is already registered, the applicant can use the guidance and tools provided on the TGA’s website. This guidance material is designed to assist applicants to understand the criteria for each type of application and identify which type of application (and therefore fee) corresponds to their circumstances, so that they can submit their application correctly and pay the appropriate fee. Once an application is submitted, the TGA checks to ensure the correct application type has been selected before commencing an evaluation.
The Regulation refers to instruments made under subsections 23(1) and 9D(6) of the Act. Those subsections provide that the Secretary may approve the manner and/or form of making an application under those sections. The existing subsection 23(1) instrument for OTC medicine applications is being remade to describe the approved form and manner of making an application for each application type. Subsection 9D(6) instruments for each section 9D application type are also being made for this purpose.
Details of the Regulation are set out in the Attachment.
The Act does not specify conditions that need to be satisfied before the power to make the Regulation may be exercised.
The Regulation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The Regulation commences on 1 January 2016.
Consultation
Industry consultations on the business processes, including the proposed fee structure, commenced in 2012 and continued through to June 2015 with the OTC Industry Working Group, whose members include key industry bodies: Australian Self Medication Industry, Generic Medicines Industry Association (now the Generic and Biosimilar Medicines Association) and Accord. Specific consultation on the proposed new fee structure occurred in February 2015. Information about the proposed new fees was published on the TGA website in July 2015 within the cost recovery implementation statement for over the counter medicines. Industry supports the change.
Authority: Subsection 63(1) of the
Therapeutic Goods Act 1989
ATTACHMENT
Details of the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015
Section 1 – Name of regulation
This section provides for the Regulation to be referred to as the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015.
Section 2 – Commencement
This section provides for the Regulation to commence on 1 January 2016.
Section 3 – Authority
This section provides that the Regulation is made under the Therapeutic Goods Act 1989 (the Act).
Section 4 – Schedule
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 this instrument has effect according to its terms.
Schedule 1 – Amendments
Therapeutic Goods Regulations 1990
Item 1 – Regulation 2
Item 1 amends regulation 2 of the Therapeutic Goods Regulations 1990 (the Principal Regulations) to include definitions for each of the new application categories for applications for marketing approval and requests for variations to existing entries in the Australian Register of Therapeutic Goods (the Register) in relation to registered over the counter medicines (OTC medicines).
The categories for applications to register a ‘new’ OTC medicine made under section 23 of the Act are called N1, N2, N3, N4, N5, with ‘N’ denoting ‘new medicine application’. For applications to ‘change’ an existing registered OTC medicine there are four levels of application called C1, C2, C3 and C4, with ‘C’ denoting ‘change application’. At each level from C1 to C4 there are two application categories, section 9D or section 23, as change applications are made under either section 9D or section 23 of the Act, depending on the nature of the change. In each case the new definitions in regulation 2 refer to the definitions to be included in Part 1 of Schedule 9 to the Principal Regulations by item 15 below.
Item 2 – Requests for variations of entries in the Register
Under section 9D of the Act, a sponsor of therapeutic goods that are entered in the Register may ask the Secretary of the Department of Health (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.
Under subsection 9D(7) of the Act, if the Secretary has approved a form for, and the manner of making, such requests, and if either the request is one which, under the Principal Regulations, the Secretary must decide within a specified period of time or is of a kind prescribed, then the request will not be valid unless the applicant has completed a number of steps (used the correct form and manner, provided any required supporting information and paid any prescribed application fee).
The Principal Regulations do not currently prescribe any kinds of section 9D requests for the purposes of subsection 9D(7) of the Act.
Item 2 therefore introduces a new regulation 10AA for this purpose, to prescribe requests to vary an entry in the Register in relation to registered OTC medicines for the purposes of subsection 9D(7) of the Act. The effect of this amendment is to ensure that a request to vary an entry in the Register in relation to a registered OTC medicine will only be valid if, among other things, the request is accompanied by the relevant application fee (to be introduced by item 20 below).
Item 3–7 – Division 2 of Part 7 – fees and costs relating to therapeutic goods
Items 3–7 amend subregulations 43(1)(a), 43(2), 43A(1) and (2), 43AA(a) 43AB(1) of the Principal Regulations to make minor, editorial amendments consequential on the amendments made by items 14, 16, 17, 18 and 20 below.
Item 8 – Refund of evaluation fee
Item 8 introduces a new provision, regulation 43AC, to Division 2 of Part 7 of the Principal Regulations, to provide for refunds for section 9D requests to vary an entry in the Register in relation to a registered OTC medicine, in specified circumstances. Those circumstances are, principally, where the sponsor of the medicine has paid the prescribed application fee, and where no evaluation of the documentation relating to the request has occurred.
This amendment provides for the refund of the portion of the application fee for a 9D request that corresponds to the evaluation of the request, and will be available to sponsors in the event that the evaluation is not undertaken - for example when the application is regarded as ineffective under subsection 9D(7) or is withdrawn by the applicant before evaluation commences.
Items 9–11, and item 13 – Regulations 45 and 45AA and Schedule 5A
Items 9–11 make minor amendments to subregulations 45(8)(e) and (10)(e) and subregulation 45AA(1) of the Principal Regulations, and item 3 of Schedule 5A to the Principal Regulations, as a consequence of the amendments made by items 14, 16, 17, 18 and 20 below. As a result of the amendments made by those items, Schedule 9 will have two fee tables.
A new Part 3 is introduced specifically for certain fees payable in relation to applications to register OTC medicines and the evaluation of such applications, and fees payable for requests under section 9D of the Act to vary the Register entries of registered OTC medicines. The existing Part 2 of Schedule 9 is amended by item 16 below so it will no longer apply to application and evaluation fees to register an OTC medicine or to vary a registered OTC medicine that will be covered in the new Part 3.
Item 12 – Application of this Amendment Regulation
Item 12 introduces a new Division 3 to Part 9 of the Principal Regulations. The new Division makes it clear that the amendments introduced by Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 will apply in relation to applications for the registration of OTC medicines, and requests to vary an entry in the Register in relation to a registered OTC medicine, that are made on or after 1 January 2016.
Item 14 – Part 1 of Schedule 9 (heading)
Item 14 amends the heading of Part 1 of Schedule 9 to the Principal Regulations, to reflect the introduction by item 20 of a new Part 3 in Schedule 9 (containing a table of particular fees for registered OTC medicines). The current heading of Part 1 of Schedule 9 refers to “Interpretation of table” – however, the changes made by item 20 mean there will be 2 tables in Schedule 9 (the table in the current Part 2 of Schedule 9, and the table in the new Part 3). The new heading therefore simply refers to Part 1 – Interpretation, without referring to any tables.
Item 15 – Subclause 1(1) of Part 1 of Schedule 9
Item 15 amends Part 1 of Schedule 9 to the Principal Regulations to introduce definitions for the new categories of applications for marketing approval and variations in relation to registered OTC medicines.
These categories are denoted by the references C1 to C4 (section 23), C1 to C4 (section 9D) and N1 to N5, and each definition refers to the relevant application as made in accordance with and/or in the manner approved by the Secretary under subsection 9D(6) or paragraph 23(1)(a) of the Act. The fees to be set out in Part 3 of Schedule 9 by item 20 refer to these definitions.
Item 16 – Part 1 of Schedule 9
Item 16 makes a minor, consequential amendment to Part 1 of Schedule 9 to the Principal Regulations, to make it clear that the fees set out in Part 2 of Schedule 9 do not apply in relation to applications and evaluations covered in the new Part 3 of Schedule 9 relating to registered OTC medicines. This is to reflect that item 20 introduces a new Part 3 in Schedule 9 to list application and evaluation fees for such medicines.
It is important to note that this will only have the effect of no longer applying those fees in Part 2 of Schedule 9 that relate to applications for the registration or variation of OTC medicines that are covered in the new Part 3 of Schedule 9. Some fees in Part 2 of Schedule 9, such as application fees for the consent of the Secretary to import, supply or export goods that do not conform with an applicable standard, will continue to apply to registered OTC medicines as well as to other registered or listed therapeutic goods.
Items 17 and 18 – Part 2 of Schedule 9 (heading and before the table)
Items 17 and 18 make minor, consequential amendments to the heading of Part 2 of Schedule 9, and to Part 2 of Schedule 9, to the Principal Regulations to make clear that the existing table of fees in Part 2, to the extent that it refers to application and evaluation fees, will not apply to applications to register OTC medicines or to requests to vary Register entries of registered OTC medicines that are covered in the new Part 3 of Schedule 9.
Item 19 – Part 2 of Schedule 9 (table item 9D)
Item 19 amends table item 9D in Part 2 of Schedule 9 to the Principal Regulations to ensure that the fees applying under that item for the evaluation of data relating to the device component in relation an application to register or vary a registered OTC medicine that incorporates a device component continue to apply in addition to the application and evaluation fees in new Part 3 of Schedule 9.
Item 20 – New Part 3 of Schedule 9
Item 20 amends Schedule 9 of the Principal Regulations to introduce a new Part 3 – Table of particular application and evaluation fees in relation to certain OTC medicines. The new Part 3 contains fees payable in relation to applications to register OTC medicines and the evaluation of such applications, and fees payable for requests under section 9D of the Act to vary the Register entries of registered OTC medicines.
The amounts of the fees are designed to reflect the amount of work required to complete the relevant applications and evaluations, based on the circumstances of the different application categories and the level of documentation associated with them. For example, the fees for an N1 application are much lower than for an N5 application as N1 applications, which are to register additional trade names, only require evaluation by the TGA of labelling and administrative information, whereas N5 applications require evaluation of toxicological, clinical and quality data, in addition to the labelling and administrative information.
The table of fees in new Part 3 also includes lower fees for certain application types where multiple, concurrent applications are made at the same time for products in the same category by the same sponsor, and where each application involves medicines containing the same active ingredient and the supporting information for each application is sufficiently common as to allow the Secretary to evaluate each of the applications concurrently.
Regulation 45(2) of the Principal Regulations currently provides the Secretary with the power to waive or reduce an evaluation fee for concurrent applications by the same sponsor. Where the lower evaluation fees apply to OTC medicines under the table of fees in new Part 3, it is expected that there would not be further reduction or waiver of fees under subregulation 45(2).
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015
The Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 (the Regulation) is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Bill/Legislative Instrument
The Regulation is made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act), and amends the Therapeutic Goods Regulations 1990 (the Principal Regulations).
Over the counter (OTC) medicines are medicines which consumers are able to purchase for self-treatment – principally from pharmacies, with some products also available in supermarkets, health food stores and other retailers (examples include cough and cold remedies, anti-fungal treatments and non-prescription analgesics such as aspirin and paracetamol).
The current fees applying under the Principal Regulations to applications to register new OTC medicines in the Australian Register of Therapeutic Goods (the Register), or to vary an entry in the Register for an existing registered OTC medicine, are based on the number of pages of supporting information associated with the application (whether under 50 pages, or between 50 and 250 pages etc.).
The TGA has, however, implemented streamlined business processes for applications to register or vary registered OTC medicines and, as a result, there is now a need to replace the current page-based fee structure with a new fee structure that better aligns the applicable fees with the amount of work involved for the TGA in processing and considering these applications.
The Regulation therefore provides for new fee categories and dollar amounts in relation to OTC medicines for which registration is sought and for requests to vary entries in the Register for OTC medicines that already registered.
The Regulation introduces fees for five different categories of applications to register a new OTC medicine (denoted N1-N5) and eight different categories of application to ‘change’ an existing registered OTC medicine (four levels denoted C1-C4 having two categories within each level). Principally, the different categories reflect differences in the amount of work required to process and evaluate the relevant applications.
Human rights implications
This legislative instrument does not 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.
Fiona Nash, Minister for Rural Health