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Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010
28-06-2011 03:19 PM
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Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010
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THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS AMENDMENT (2010 MEASURES NO. 1) BILL 2010
SUPPLEMENTARY EXPLANATORY MEMORANDUM
Amendments to be Moved on Behalf of the Government
(Circulated by authority of the Hon Catherine King MP, Parliamentary Secretary for Health and Ageing)
AMENDMENTS TO THE THERAPEUTIC GOODS AMENDMENT (2010 MEASURES NO. 1) BILL 2010
These amendments to the Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010 (the Bill) principally implement measures to formalise the process for the submission and approval of product information for medicines through amendments to the Therapeutic Goods Act 1989 (the Act). Other measures in the Bill include amendments to:
- make minor changes to the determining by the Minister of ingredients that can be used in listed medicines;
- clarify the power of the Secretary to make declarations that goods are “therapeutic goods” for the purposes of the Act;
- extend the matters in relation to which the Secretary can request information and documents to be provided by those who have or have had products on the Australian Register of Therapeutic Goods (the Register);
- ensure that certain elements of the revised business processes to apply to prescription medicines are appropriately supported; and
- clarify the power of the Secretary to vary entries in the Register.
Schedule 1A - Product information for medicine
Currently, applications for inclusion of certain medicines in the Register under the Act must include a draft product information document as part of the required registration package. It is also a condition of registration of these medicines that the product information document approved by the Secretary of the Department of Health and Ageing at the time of registration of the medicine can only be varied with the Secretary’s approval.
The product information document contains technical information about the medicine such as the characteristics of the active ingredient, its indications and contraindications, a description of clinical trials that support the indications, precautions, adverse reactions that may occur from the use of the medicine, dosages and storage, and other information relating to its safe and effective use. The purpose of product information document is to assist medical practitioners, pharmacists and other health professionals in prescribing and dispensing the medicine and to assist them to provide patient education about the medicine to support high quality and safe clinical care.
The amendments in Schedule 1A are designed to formalise the process for the approval of product information for medicines. A draft product information document will be required to be lodged in a form approved by the Secretary under the new section 7D of the Act as part of an application for the registration of a “restricted medicine”. The Minister will have the power to make legislative instruments that specify a medicine or medicines or a class of medicine as “restricted medicine”. Restricted medicines will include prescription medicines (see Schedules 4 and 8 of the current Poisons Standard) and medicines only available from a pharmacist (Schedule 3 of the current Poisons Standard). It will be open to the Secretary to require other high risk medicines to have approved product information where appropriate.
Evaluation of restricted medicines or medicines for which a product information document is required to be approved will take into account the product information provided by the applicant in relation to the medicine. Applicants will be formally notified of the approval of the product information at the time of notification of registration. There are provisions for variations to product information and transitional arrangements for product information approved prior to the first legislative instrument specifying “restricted medicines”.
Other amendments will support elements of the revised business procedures for prescription medicines being implemented by the Therapeutic Goods Administration (TGA). Health regulators around the world are being asked for greater transparency in their regulatory processes, earlier access to novel therapies and more cost effective regulatory processes. The TGA is progressing the prescription medicines Business Process Reforms (BPR). A review of the prescription medicine evaluation process identified a number of areas for process improvement that would result in a reduction of the current 500 days for a new prescription medicine to be approved to approximately 300 days by eliminating unnecessary queues and delays in the evaluation process without compromising the scientific rigour of the evaluation process and while ensuring that appropriate standards of quality, safety and effectiveness are maintained.
The key elements of the proposed BPR streamlined process, designed to address these issues, are:
1. clearly articulated and detailed requirements for submissions and the associated information dossier
2. sponsor lodgement of proposed submission details (via a Pre-submission Planning Form) 2½ months prior to lodgement of the complete submission and associated dossier
3. TGA scheduling of resources to handle submissions that have been foreshadowed through the lodging of the Form
4. careful checking of the submission and associated dossier prior to acceptance of the application for evaluation to ensure compliance with application form and Common Technical Document requirements
5. new business processes within TGA to manage workflow and queues effectively
6. consolidation by the TGA of regulatory questions to the sponsor to avoid unnecessary steps in the process
7. requirements for sponsors to answer regulatory questions within a set period to allow the new work processes to proceed within planned timeframes
8. publication of a summary of the regulatory decisions made in relation to evaluation for new prescription medicines, or major variations to existing prescription medicines, and
9. publication of Product Information and Consumer Medicines Information on the TGA website.
The remaining amendments will clarify the operation of a number of provisions in the Act.
The powers of the Secretary in section 7 will be clarified to ensure that goods, despite being covered by a food standard under the Food Standards Australia New Zealand Act 1991 , or despite having a tradition of use as food for humans in the form presented in
either Australia or New Zealand, can continue to be regulated as “therapeutic goods” in appropriate cases.
Changes to section 26A give operational effect to the Minister’s power under section 26BB to determine what ingredients may be included in listable medicines and any requirements relating to such ingredients when they are incorporated in listable medicines. Applicants seeking to list their medicines in the Register under section 26A will need to certify that their products contain only ingredients that are specified in a ministerial determination, and that any ingredients included in the medicine comply with any requirements contained in a ministerial determination applying to those ingredients.
Persons may apply to the Minister to vary any determination made under section 26BB about ingredients permitted to be included in listable medicines, or any requirements relating to those ingredients. A new provision has been inserted to provide that the Minister must consider the quality and safety of the ingredient or ingredients concerned when coming to a decision on such an application, but is not limited to considering those matters.
Changes made to section 31 also make clear the offence of failing to comply with a request made by the Secretary under that section for information or documents is limited to persons in relation to whom products are already included in the Register or that were at any time in the 5 years prior to the request, included in the Register. Other changes made to section 31 clarify the kinds of information or documents that the Secretary may request under a section 31 notice.
FINANCIAL IMPACT STATEMENT
The amendments have no financial impact.
AMENDMENTS TO THE THERAPEUTIC GOODS AMENDMENT (2010 MEASURES NO. 1) BILL 2010
NOTES ON AMENDMENTS
Amendment (1) [ commencement ]
This amendment inserts new item 2A into the table in clause 2 of the Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010 (the Bill) by providing that the amendments contained under Schedule 1A, dealing with or related to product information, will commence 28 days after the Bill receives Royal Assent.
Amendment (2) [ commencement ]
This amendment inserts new item 5 at the end of the table in clause 2 of the Bill to provide that new Part 3 of Schedule 2 of the Bill, containing amendments about product information related to biologicals, is to commence on the later of:
· immediately after the commencement of the provisions covered by item 2 of the table (ie the day after the Act receives the Royal Assent), or
· immediately after the commencement of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010, which will insert the new biological regulatory scheme into the Therapeutic Goods Act 1989 (the Act) to commence on 31 May 2011.
This will ensure that the amendments to be made to section 9D relating to biologicals will not come into effect before the new biologicals regulatory scheme commences on 31 May 2011.
This amendment inserts new Schedule 1A into the Bill containing measures about product information for medicines.
Schedule 1A - Product information for medicine
This item inserts into subsection 3(1) the definition of product information currently found in subsection 9D(5) of the Act ( item 5 refers ). There is no change to the definition. It means, in relation to therapeutic goods, information concerning the safety and effective use of the goods and includes information about the usefulness and limitations of the goods.
Although the definition is broad, the scope of a product information document is limited by the application of new paragraph 23(2 )(ba) ( item 6 refers ) and new section 7D ( item 4 refers ), new subparagraph 25(4)(d)(ia) ( item 8 refers ), new section 25AA ( item 9 refers ) and section 28 of the Act which provides for conditions to be attached to the registration of goods.
The effect of these provisions is to ensure that at the end of the registration process for prescription medicines and other high risk medicines in relation to which the Secretary requires a draft product information document to be provided, there will be an approved
product information document in relation to that medicine that cannot be varied without the Secretary’s approval.
This item inserts into subsection 3(1) a definition of a restricted medicine . This will be either a medicine specified by the Minister under a legislative instrument under new subsection 3(2A), or a medicine included in a class of medicine specified by the Minister under a legislative instrument made under new subsection 3(2B) ( item 3 refers ).
This item inserts new subsections 3(2A) and 3(2B) allowing the Minister, by legislative instrument, to specify a particular medicine or medicines or a class or classes of medicine for the purpose of the definition of restricted medicine in subsection 3(1) ( item 2 refers ).
Restricted medicines will include prescription medicines (see Schedules 4 and 8 of the current Poisons Standard) and medicines only available from a pharmacist (Schedule 3 of the current Poisons Standard). All of these medicines are currently required to be included in the Register before they can be marketed in Australia, unless an exemption from this requirement applies to the goods under the Act.
This item inserts a new section 7D. Subsection 7D(1) authorises the Secretary to specify and approve a form for product information for a medicine for the purposes of new paragraph 23(2)(ba) ( item 6 refers ). Subsection 7D(2) allows the Secretary to approve different forms for different medicines or different classes of medicine.
This item repeals the current definition of product information in subsection 9D(5) as it has now been included in subsection 3(1) ( item 1 refers ).
Subsection 23(2) of the Act sets out what is required for an effective application to be made to register or list therapeutic goods in the Register. This item adds new paragraph 23(2)(ba) to require that an application for the registration of a restricted medicine must be accompanied by product information in the approved form, consistent with new section 7D ( item 4 refers ).
This makes no change to current practice as a draft product information is already required to be lodged by an applicant seeking to register most prescription medicines under section 23 of the Act. Paragraph 23(2)(ba) now makes it a formal requirement for a draft to be lodged in a form approved by the Secretary under the new section 7D of the Act.
This item adds to the list of matters set out in subsection 25(1) which the Secretary must take into account when determining whether to include therapeutic goods in the Register. The effect of including goods in the Register is that sponsors of such goods may lawfully manufacture, import, export and supply the goods. A new paragraph
25(1)(da) is inserted by this item to provide that when determining applications to register either restricted medicines, or other high risk medicines that are required by the Secretary to be accompanied by product information, another criteria the Secretary must consider is the product information supplied by the applicant as part of the evaluation of that medicine under section 25.
This item inserts a new subparagraph 25(4)(d)(ia) to provide that where the Secretary decides to register a therapeutic good which is a restricted medicine ( item 2 refers ), or a medicine required by the Secretary to be accompanied by product information, the Secretary must notify the applicant in writing of the product information that has been approved for that medicine for the purpose of its inclusion in the Register.
This item adds a new section 25AA that sets out how the product information is approved, and how approved product information can be varied.
Subsection (1) provides that if the Secretary includes in the Register a restricted medicine or a medicine that the Secretary has notified an applicant must be accompanied by product information under paragraph 25(1)(da), the product information that is approved under new section 25AA is the product information referred to in subparagraph 25(4)(d)(ia) ( item 8 refers ) ie that the Secretary has notified to the applicant.
Subsection (2) is a transitional provision for product information approved by the Secretary for a medicine included in the Register prior to the commencement of section 25AA. Where the Secretary approved the product information for that medicine (including approving any variation to that approved product information) before the day on which the first instrument under either of proposed subsection 3(2A) or 3(2B) takes effect, then the product information as previously approved or varied is taken to be the product information that is approved under section 25AA in relation to that medicine.
Subsection (3) provides that before the date the first instrument under either of proposed subsection 3(2A) or 3(2B) takes effect (the “relevant date”), if a person applies to include a medicine in the Register and the product information for that medicine was approved by the Secretary before the relevant date (including any variation to that product information that has been approved) but the medicine was not included on the Register until after the relevant date, then that product information is taken to be the product information that is approved under section 25AA in relation to that medicine.
Subsection (4) applies to cases where product information, in relation to a medicine that is included in the Register, has been approved for that medicine under section 25AA. Where the Secretary varies information in the Register about that medicine under section 9D or where there is a change to any condition applying to the entry of that medicine in the Register and as a result the Secretary is satisfied that changes to the approved product information for that medicine is required, then the Secretary may, by giving the sponsor of the medicine written notice, make such variations to the approved product information for that medicine as the Secretary considers appropriate.
If an application was made to include a medicine in the Register before the date the first instrument under either of proposed subsection 3(2A) or 3(2B) takes effect and the Secretary had not approved the product information for that medicine before that day, then new subparagraph 25(4)(d)(ia) will apply (see sub-item (2) of item 10 below) so that the approved product information will be notified to the applicant by the Secretary in accordance with that subparagraph.
Subsection (5) provides that to avoid doubt, if product information that is approved in relation to a medicine is varied under section 25AA, that product information as varied becomes the approved product information in relation to the medicine.
This item sets out how the amendments made by items 6 to 9 of Schedule 1A will be taken to apply.
Sub-item (1) states that new paragraph 23(2)(ba) and subparagraph 25(1)(da)(i) will apply to applications to register restricted medicines that are made the day after the commencement of the first instrument made by the Minister under subsections 3(2A) or 3(2B) of the Act, specifying what medicines or classes of medicines are “restricted medicines”.
Sub-item (2) provides that new subparagraph 25(1)(da)(ii) will apply to applications to register non-restricted medicines on or after the commencement of the Minister’s first subsection 3(2A) or 3(2B) instrument, being a non-restricted medicine for which the Secretary has required in writing that product information be provided.
Sub-item (3) states that the requirement for the Secretary to notify an applicant of the product information that has been approved for the applicant’s medicine inserted by item 8 will commence to operate on and after the day the Minister’s first instrument made under subsections 3(2A) or 3(2B) commences to operate. This is the first legislative instrument the Minister may make to specify what are restricted medicines, or classes of restricted medicines.
Sub-item (4) provides that new section 25AA inserted by item 9 will apply to medicines that are included in the Register on or after the day after the first instrument made under subsections 3(2A) or (2B) of the Act takes effect, subject to subsection 25AA(3) - that is, only if the Secretary’s notification approving product information referred to in subparagraph 25(4)(d)(ia) also occurred on or after that day.
Amendment (4) inserts four new items into Part 1 of Schedule 2 of the Bill.
This item removes the word “product” from subsection 9D(2)(a) so that the subsection applies to requests for variations to information in an entry in the Register. Proposed section 25AA will provide the mechanism by which product information of a medicine can be varied if required as a result of variations made under section 9D to the entry of the medicine in the Register.
This item inserts new subsection 9D(2A) to clarify the interaction between section 9D (variations to entries in the Register) and section 16 of the Act. Section 16 sets out the matters that can make goods ‘separate and distinct’ from each other, and therefore a different product for the purposes of the Act, one of which is different indications (paragraph 16(1)(d)). One of the criteria for requesting a variation to an entry under subsection 9D(2) is that the class of persons for whom the particular therapeutic good may be suitable is reduced. In a case where this is a consequence of a reduction in the indications for the medicine, there is an argument that section 16 requires such a variation to be treated as a “separate and distinct good” thus requiring a new application for registration to be made under section 23 of the Act.
Because a reduction in the class of persons for whom the goods are suitable would not create any safety issues or otherwise justify a fresh assessment of the “new” or “different” product under section 23, new subsection 9D(2A) makes it clear that if a sponsor requests a reduction in the class of persons, this can be assessed under subsection 9D(2) notwithstanding that it might otherwise be treated as a separate and distinct good under subsection 16(1) and otherwise require an application under section 23.
This item inserts new subsections 9D(3C) and (3D) which replicates subsections 9D(2) and (3) so that the same arrangements available under subsections 9D(2) and (3) for changing information about medicines included in the Register will now be available in relation to medical devices that are included in the Register.
This item inserts new subsections 9D(6), (7) and (8). Under proposed subsection (6) the Secretary can approve a form, or different forms, for particular kinds of requests under section 9D. It is anticipated that a form will be approved for requests under subsection 9D(3) to which the new Business Process Reform streamlined procedures will apply to. As a result, in the case of variations to an entry to which the revised business procedures apply (see below), the Secretary can require a ‘pre-submission’ form to be provided as part of that application. Subsection (7) provides that where a form has been approved for a particular kind of request, any request of that kind must be made in accordance with the form.
The Therapeutic Goods Regulations 1990 currently impose application and evaluation fees in relation to requests for variations made under section 9D. Proposed subsection (8) formally requires any application for a variation under the section to be accompanied by any prescribed application fee or evaluation fee or both.
Amendment (5) inserts a new item 1E into Part 1 of Schedule 2 of the Bill.
This item amends subsection 25(1) by removing two of the three preconditions otherwise applying to an application to register therapeutic goods under that provision before the goods are evaluated. One is that there is no part of an evaluation fee payable
under section 24 that remains unpaid. Section 24 already provides that in such a case the application lapses so the precondition is unnecessary. The other precondition is that the applicant has complied with any requirements of the Secretary to provide information or documents under section 31. Under the Business Process Reforms for prescription medicines, it will be open for the Secretary to evaluate the goods if the applicant has not provided all the information or documents within the relevant period so that the registration process can proceed on the basis of the information provided to date.
Amendment (6) substitutes items 2 and 3 in Part 1 of Schedule 2 of the Bill to make some minor drafting changes.
This item replaces paragraphs 26A(2)(ca) to (cd) with new paragraphs (ca) and (cb). The effect of the amendment is that the persons applying to list medicines under the section must certify, under new paragraphs (ca) and (cb), that the medicine:
· does not contain an ingredient that is not specified in a ministerial determination under paragraph 26BB(1)(a) (ie the only ingredients it contains are specified in such a determination); or
· if a ministerial determination under paragraph 26BB(1)(b) specifies requirements on the inclusion of ingredients in the medicine, none of the requirements have been contravened (ie if such a determination states that a particular plant can only be used in a particular form eg the roots or leaves, that the medicine does not contain any form of the plant that is not roots or leaves).
Under the new paragraphs 26A(ca) and (cb) a person making an application under section 23 for listing of a medicine, will be required to certify that the medicine does not contain any ingredient that is not specified in a paragraph 26BB(1)(a) determination and that no requirements in any determination made under paragraph 26BB(1)(b) in relation to any ingredients in the medicine have been contravened.
This item replaces the current section 26BB in the Bill with a new section 26BB, the only substantive change being a reference to the Minister being able to specify “requirements” rather than “restrictions”.
Subsection (1) empowers the Minister to make a legislative instrument specifying ingredients (paragraph (a)), and requirements in relation to those ingredients being contained in medicines (paragraph (b)).
Subsection (2) provides that, the requirements may relate to particular ingredients not been contained in particular medicine.
Subsection (3) provides that the requirements in paragraph (1)(b) may relate to permitted concentrations or permitted total amounts of ingredients.
Subsection (4) provides that subsections (2) and (3) do not limit paragraph (1)(b).
Subsection (5) provides that a determination under paragraph (1)(b) may make different provision for different classes of medicine.
Subsection (6) empowers the Minister, by legislative instrument, to make a determination specifying ingredients that must not be specified under paragraph (1)(a) (paragraph (a)) and specifying requirements that must not be specified under paragraph (1)(b) (paragraph (b)). Such a determination is a mechanism by which potential applicants under section 26BD(1) for a variation to a determination under section 26BB can be made aware that the Minister has already determined that some ingredients, or requirements in relation to particular ingredients, are not permitted. A person applying to list medicines under subsection 26A(1) is not required to certify as to the matters determined by the Minister under subsection 26BB(6).
Subsection (7) provides that a determination under paragraph (1)(b) may make different provision for different classes of medicine.
Subsection (8) provides that notwithstanding subsection 14(2) of the Legislative Instruments Act 2003 , determinations made under this section may refer to other instruments or documents as in force from time to time.
The effect of these provisions is that the Minister may make a determination specifying, for example, that an ingredient may only be used in topical preparations at less than a particular concentration and cannot be used in other forms of medicine, or may be used in both topical and oral preparations but at different maximum concentrations.
Amendment (7) inserts new item 4A into Part 1 of Schedule 2 of the Bill
This item inserts a new subsection 26BD(3A) into section 26BD to provide criteria to assist the Minister in determining an application from a person to vary a determination made under section 26BB, to specify what ingredients may be included in listable medicines, and what requirements may be placed in relation to those ingredients included in listable medicines. In determining whether to vary the section 26BB determination, the Minister will be required to take into account the quality and safety of the ingredient concerned. However this requirement does not limit any other matters the Minister may appropriately consider in deciding whether or not to vary a section 26BB determination.
Amendment (8) inserts new item 6A into Part 1 of Schedule 2 of the Bill
Under subsection 31(1) of the Act the Secretary can request a person who is an applicant for the registration of therapeutic goods or a person in relation to whom therapeutic goods are included on the Register to provide information and documents about specific matters in relation to those goods. The subsection requires the Secretary to specify a “reasonable” period within which the information or documents must be provided.
This item inserts new subsections 31(1B) and (1C) that determines the time period within which a person must provide the information or documents requested by the Secretary under subsection 31(1) where the application is covered by the new revised business procedures for prescription medicines. Under those procedures an applicant
will have the option of nominating one of two set periods within which to provide any information or documents requested by the Secretary under section 31 of the Act during the evaluation of an application for registration made under section 23 or for a variation to an existing entry in the Register made under section 9D.
New subsection 31(1B) provides that if an applicant applies to register therapeutic goods under section 23 of the act in accordance with a form approved by the Secretary under that section including a “pre-submission form” in which the applicant has specified the number of days by which any information or documents which may be sought by the Secretary under subsection 31(1) must be provided, then the period specified in the notice within which the information or documents must be provided in response to any such request from the Secretary must be the period nominated. That period will be taken to be a “reasonable time” for the purposes of subsection 31(1). New subsection 31(1C) has the same effect in relation to requests for variations to an entry in the Register made under subsection 9D(3) using a “pre-submission form” approved by the Secretary under subsection 9D(6).
Amendment (9) inserts substitutes a new item 7 at the end of Part 1 of Schedule 2 of the Bill which deals with the application of various amendments.
This item contains application provisions setting out when the amendments made by items 1A to 1D, items 1 and 2 and item 6A apply.
Sub-item (1) provides that the amendments made to section 9D (variations to information about goods included in the Register) set out under items 1A to 1D will apply to requests for variations made under section 9D on or after the commencement of those items (ie 28 days after Royal Assent).
Sub-item (2) provides that the amendments made to subsection 25(1) by item 1E (which removes the pre-conditions attaching to the requirement of the Secretary to commence an evaluation of an application to register goods in the Register under section 25) will apply to applications for registrations made on or after the date item 1E commences to operate (ie 28 days after Royal Assent).
Sub-item (3) provides that the amendments made to sections 26 and 26A by items 1 and 2 in Part 1 of Schedule 2 of the Bill apply in relation to applications for listing of goods in the Register made on or after the commencement of those items (ie 28 days after Royal Assent).
Sub-item (4) provides that the amendment made to section 31 by item 6A applies to a notice given on or after the commencement of that item whether the application or request was made before or after commencement of the item (ie 28 days after Royal Assent).
Amendment (10) inserts a new item 7A into Part 2 of Schedule 2 of the Bill.
This item amends subsection 7(1) of the Act. Section 7 enables the Secretary to make a determination determining whether or not something is, or is not, a therapeutic good, where for instance there may be uncertainty as to whether a thing or product falls within, or outside, the definition of “therapeutic goods” in subsection 3(1) of the Act.
Paragraph (e) of the definition of” therapeutic goods” in subsection 3(1) of the Act has the effect of excluding goods that would otherwise come within paragraphs (a) or (b) of the definition if they are goods for which there is a food standard made under the Food Standards Australia New Zealand Act 1991 but not if the goods are the subject of a declaration under section 7 that they are therapeutic goods. Similarly, the effect of paragraph (f) of the definition is to exclude goods that would otherwise come within paragraph (a) or (b) of the definition if in Australia or New Zealand they have a tradition of use as food for humans in the form they are presented but not if the goods are the subject of a declaration under section 7 that they are therapeutic goods.
For a section 7 declaration to be made that particular goods are therapeutic goods, the Secretary must be satisfied that the goods are in fact therapeutic goods. If there is already a food standard in existence in relation to particular goods, it is not possible for the Secretary to be so satisfied and therefore to make a declaration. The exclusion in paragraph (e) can therefore only operate as intended if the declaration is made before there is a food standard.
The amendment to section 7 will allow the Secretary to make a declaration that certain goods are therapeutic goods if the only reason that they are not therapeutic goods is because of the existence of a food standard or because they have a tradition of use as food for humans in the form they are presented. This would provide some flexibility and allow such goods to continue to be regulated as therapeutic goods in appropriate cases.
Amendment (11) removes the proposed change to paragraph 31(2)(f) to add “efficacy”.
Amendment (12) substitutes item 14 in Part 2 of Schedule 2 of the Bill.
This item adds two new paragraphs to subsection 31(2). This subsection allows the Secretary to require a sponsor to provide information and documents about listed goods (which are low risk medicines). Proposed paragraph 31(2)(fa) will enable the Secretary to request documents and information from a sponsor of listed goods about certifications made by that sponsor under paragraph 26A(2)(j) of the Act in the application to include the goods on the Register. Under subsection 26A(2), a person applying to list goods in the Register must certify as to a number of matters in order for the goods to be automatically listed. One of these is whether the sponsor holds information or evidence to support any claim made in relation to the medicine by the sponsor at the time of applying for listing (paragraph 26A(2)(j) of the Act). Paragraph 31(2)(fb) (already included in the Bill) will enable the Secretary to also seek information about whether any conditions applying to the listing of the goods in the Register are being, or have been, met.
Amendment (13) inserts a new item 15A into Part 2 of Schedule 2 of the Bill.
By amending paragraph 31(4)(a), this item has the effect of ensuring that the offence of failing to comply with a section 31 notice will only apply to persons who already have goods registered or listed in the Register or persons who had goods registered or listed in the Register at any time within the previous 5 years. Prior to 2009, the offence in subsection 31(4) was limited in its application to persons in relation to whom the relevant therapeutic goods were on the Register. The intention of the amendment made to the subsection by the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2009 was to extend its application to cover persons to whom a request was made in relation to whom goods had been on the Register in the previous 5 years but unintentionally covered those to whom a request was made in relation to an application for registration. Following the amendment made by item 15A, the offence provision will be limited in its coverage to those persons with goods on the Register or those who had goods on the Register within the 5 years immediately prior to the date on which the section 31 notice was issued, as had been intended .
Amendment (14) inserts a new sub-item (2A) into item 21 in Part 2 of Schedule 2 of the Bill the effect of which is that the amendments made by item 15A, relating to the offence for a failure to comply with a section 31 notice, will apply to section 31 notices issued by the Secretary on and after the day item 15A commences to operate (ie the day after Royal Assent).
Amendment (15) inserts a new Part at the end of Schedule 2 of the Bill.
Part 3 - Amendments relating to biologicals
Therapeutic Goods Act 1989
This item inserts new subsection 9D(3AA) to mirror subsection 9D(2) that currently allows a person to request a so-called “safety-related notification” in relation to an entry for other therapeutic goods. Subsection 9D(3AA) will enable a sponsor whose biological is included in the Register to request the Secretary to vary information about that biological in the Register where the only effect of the variation is to reduce the class of persons for whom the biological is suitable, or to add a warning or precaution that does not include any comparisons of the biological with any other therapeutic goods by reference to quality, safety or efficacy. Where such a request is made, the Secretary must make the variation in accordance with the request. The new biologicals framework that will come into operation on 31 May 2011 already contains (in new subsections 9D(3A) and (3B)) provisions that are the equivalent of subsections 9D(3) (requests for variations that are not safety-related) and 9D(4) (moving therapeutic goods to different parts of the Register).
This item inserts a new paragraph (aa) into subsection 9D(3A) described above to ensure that that subsection cannot apply where a sponsor can request a “safety-related notification” to be made to an entry in the Register in relation to a biological.