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2010
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
SENATE
THERAPEUTIC GOODS AMENDMENT (2010 MEASURES NO. 1) BILL 2010
REVISED EXPLANATORY MEMORANDUM
(Circulated by authority of the Hon Catherine King MP, Parliamentary
Secretary for Health and Ageing)
THIS MEMORANDUM TAKES ACCOUNT OF AMENDMENTS MADE BY THE HOUSE OF
REPRESENTATIVES TO THE BILL AS INTRODUCED
Table of contents
OUTLINE.....................................................................
...........................................................1
FINANCIAL IMPACT
STATEMENT...................................................................
.............3
THERAPEUTIC GOODS AMENDMENT (2010 MEASURES NO. 1) BILL 2010........4
NOTES ON
CLAUSES.....................................................................
.......................................4
SCHEDULE 1 - Exempting medical devices if substitutes are not widely
available..............5
SCHEDULE 1A - Product information for
medicine..............................................................8
SCHEDULE 2 - Other
amendments..................................................................
....................12
OUTLINE
The Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010 (the Bill)
makes a series of amendments to the Therapeutic Goods Act 1989 (the Act).
These include:
. a system for approving the supply of medical devices that are not on
the Australian Register of Therapeutic Goods (the Register) to act as
substitutes for devices that are on the Register but are unavailable
or in short supply;
. a provision to allow listing on the Register of export-only variations
of registered or listed medicines;
. amendments to provisions relating to permissible ingredients for
inclusion in medicines;
. amendments relating to the information that may be considered by the
Minister when reviewing initial decisions under the Act;
. implementing measures to formalise the process for the submission and
approval of product information for medicines;
. making minor changes to the determining by the Minister of ingredients
that can be used in listed medicines;
. clarifying the power of the Secretary to make declarations that goods
are "therapeutic goods" for the purposes of the Act;
. extending 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 Register;
. ensuring that certain elements of the revised business processes to
apply to prescription medicines are appropriately supported;
. clarifying the power of the Secretary to vary entries in the Register;
and
. other minor amendments.
Schedule 1 - Exempting medical devices if substitutes are not widely
available
At present section 19A of the Act allows the Secretary to approve the
import and supply of medicines that can act as a substitute for medicines
on the Register that are unavailable or in short supply. This provision is
used to allow unapproved medicines to be obtained and supplied to cover
transient shortages of approved medicines arising from manufacturing
breakdowns or other supply chain problems. However, such a provision does
not exist for medical devices. This Schedule inserts such a power in
Chapter 4 of the Act, and makes a series of consequential amendments.
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 in 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".
Schedule 2 - Other amendments
Amendments to sections 9D, 25 and 31 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.
Other 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.
This Schedule makes a number of other amendments to the Act, including:
. allowing the Secretary to list export-only variations of medicines
already included on the Register;
. modifying the system for the Minister to make lists of permitted
ingredients for medicines;
. specifying the information that the Minister may consider in reviewing
initial decisions under the Act; and
. clarifying the Secretary's information gathering powers in relation to
medicines.
FINANCIAL IMPACT STATEMENT
The amendments made by this Bill will have a nil financial impact on the
Commonwealth as the Therapeutic Goods Administration, which administers the
Act, operates on a cost recovery basis.
THERAPEUTIC GOODS AMENDMENT (2010 MEASURES NO. 1) BILL 2010
NOTES ON CLAUSES
Clause 1: Short Title
Clause 1 is a formal provision specifying the short title of the Bill, once
enacted, as the Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010.
Clause 2: Commencement
This clause provides that the Bill commences on Royal Assent and that the
various Schedules commence as set out in the table.
Schedule 1 will commence the day after Royal Assent.
Schedule 1A will commence 28 days after Royal Assent.
Part 1 of Schedule 2 will commence 28 days after Royal Assent, to allow
legislative instruments to be made under the amended provisions to come
into force when the amendments to the Act take effect. Part 2 of the
Schedule will commence the day after Royal Assent.
Part 3 of Schedule 2 will commence on the later of:
. immediately after the commencement of the provisions covered by item 2
of the table (ie the day after 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 biological regulatory
scheme commences on 31 May 2011.
Clause 3: Schedules
This clause provides that each Act that is specified in a Schedule to this
Bill is amended or repealed as set out in the relevant Schedule, and any
other item in a Schedule to this Bill has effect in the way set out in the
provision. The Bill makes amendments to the Act and includes application
provisions.
SCHEDULE 1 - Exempting medical devices if substitutes are not widely
available
Therapeutic Goods Act 1989
Items 1 and 2
These items amend section 41H, setting out what is covered by Part 4-7 of
the Act, to refer to the new exemption to be inserted as section 41HD by
Item 3.
Item 3
This item inserts a new section 41HD at the end of Part 4-7.
Subsection (1) empowers the Secretary to provide an approval to a person to
import, or import and supply, a specified medical device if the Secretary
is satisfied that the kinds of medical devices included in the Register
that could act as a substitute for the specified device are unavailable or
in short supply, and
. the device is registered or approved for market access in at least one
country specified in a determination under new subsection (5), or an
application has been made under section 41FC to include a kind of
device (which includes the device) in the Register;
. the device is specified in a determination under new subsection (6);
and
. the approval is necessary in the interests of public health.
Subsection (2) empowers the Secretary to provide an approval to a person to
import, or import and supply, a specified medical device if the Secretary
is satisfied that there are not any kinds of medical devices included in
the Register that could act as a substitute for the specified device, and
. an application has been made under section 41FC to include the device
in the Register;
. the device is specified in a determination under new subsection (6);
and
. the approval is necessary in the interests of public health.
Subsection (3) provides that an application for approval must be made to
the Secretary and accompanied by any information required by the Secretary,
and subsection (4) requires the Secretary, as soon as practicable after
making a decision on the application, to inform the applicant of the
decision, and the reasons for a negative decision.
Subsection (5) empowers the Secretary to make a legislative instrument
specifying countries for the purpose of subsection (1), and subsection (6)
empowers the Secretary to make a legislative instrument specifying the
medical devices that can be the subject of an approval under this section.
Subsections (7) and (8) provide for the Secretary to impose conditions on
an approval, and specify a period for the approval.
Subsections (9) and (10) deal with when an approval lapses. Under
subsection (9) an approval lapses if the period specified in the approval
expires, or a decision has been made on an application to include in the
Register the kind of medical device that includes the device that is the
subject of the approval. Subsection (10) provides that the approval
lapses if the Secretary is satisfied that either the conditions that led to
the approval no longer apply or that a condition of the approval has been
contravened, and has notified the person to whom the approval was granted.
Subsection (11) explains that the lapsing of an approval through the expiry
of time does not preclude another approval for the same device being
granted before the expiry, to take effect on the expiry of the earlier
approval.
Subsection (12) explains that an approval under subsection (1) or (2) is
not a legislative instrument. This is because the approvals apply the law
to a particular case, and do not create a general exemption.
Item 4
This item inserts a new section 41JFA into Part 4-8 of the Act, which deals
with obtaining information about medical devices covered by exemptions from
the Act. The new section relates to devices given an approval under new
section 41HD (item 3 refers).
Subsection (1) provides for the Secretary to give a person who has been
granted an approval under section 41HD a notice requiring the person to
give the Secretary information or documents relating to the supply,
handling, or monitoring of the device, the results of supply of the device,
and any other matter prescribed by the regulations.
Subsection (2) provides that the notice must specify a reasonable period
(of at least ten working days) for compliance, and subsection (3) provides
that the notice may require information to be given in accordance with
particular software requirements.
Items 5 to 9
These items make consequential amendments to sections 41JG, 41JH, 41JI and
41JJ, which establish criminal offences to failing to comply with a request
for information under Part 4-7, or providing false or misleading
information in response to a request, to include references to new section
41JFA (item 4 refers).
Items 10 to 15
These items make consequential amendments to section 41KA, dealing with the
recall of medical devices in particular circumstances, to allow the recall
of devices approved under section 41HD in those circumstances.
Items 16 to 20
These items make consequential amendments to section 41MI, which
establishes criminal offences for importing, exporting, supplying or
manufacturing devices which are not included in the Register, to provide
that a person does not commit an offence if the device is one covered by an
approval under section 41HD.
Item 21
This item makes a consequential amendment to section 41MIB, which allows
imposition of a civil penalty for importing, exporting, supplying or
manufacturing devices which are not included in the Register, to provide
that a person does not contravene the section if the device is one covered
by an approval under section 41HD.
Items 22 and 23
These items make consequential amendments to sections 41MK, establishing a
criminal offence for wholesaling medical devices not included on the
Register, to provide that a person does not commit an offence if the device
is one covered by an approval under section 41HD.
Item 24
This item makes a consequential amendment to section 41MLA, which allows
imposition of a civil penalty for making misrepresentations about medical
devices, to include making a false or misleading representation that a
device is one covered by an approval under section 41HD.
Item 25
This item makes a consequential amendment to subsection 41MN(9), which
establishes a criminal offence for breaching a condition of an exemption
from the Act for medical devices, to include a reference to a condition of
approval under section 41HD.
Item 26
This item makes a consequential amendment to section 46A, which empowers
authorised persons to search certain premises to monitor compliance with
the Act, to extend it to the premises of a person who has been granted an
approval under section 41HD.
Item 27
This item makes a consequential amendment to section 56A, which provides
for the Secretary to provide evidentiary certificate of certain matters, to
allow the Secretary to provide a certificate that there was no approval
granted under section 41HD to a particular person in relation to particular
devices.
Item 28
This items amends section 57, dealing with delegations, to add a new
subsection (9) providing that the Secretary's powers under section 41HD may
only be delegated to the National Manager of the Therapeutic Goods
Administration (TGA) or officers of the TGA specified in the regulations.
This is the same as existing subsection (8) relating to the powers of the
Secretary under section 19A, which is the section on which section 41HD is
based. No regulations have been made under subsection (8), and at this
stage there is no intention to make regulations allowing delegation of the
power under section 41HD.
Schedule 1A - Product information for medicine
Item 1
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.
Item 2
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).
Item 3
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.
Item 4
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.
Item 5
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).
Item 6
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.
Item 7
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.
Item 8
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.
Item 9
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) i.e. 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.
Item 10
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.
SCHEDULE 2 - Other amendments
Part 1- Amendments commencing on the 28th day after Royal Assent
Therapeutic Goods Act 1989
Item 1A
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.
Item 1B
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.
Item 1C
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.
Item 1D
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
planning 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.
Item 1E
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.
Item 1
This item repeals paragraphs 26(1)(ea) and (eb), consequential on the re-
enactment of section 26BB and the repeal of section 26BE made by items 3
and 5 respectively, and the insertion of new subsection 26(1AA) by item 9.
Item 2
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.
Item 3
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 being 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.
Item 4
This item makes a consequential amendment to subsection 26BD(1) to refer to
subsection 26BB(1) rather than section 26BB, following the amendment made
by item 3.
Item 4A
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.
Item 5
This item repeals section 26BE, as an equivalent power has now been
included in section 26BB (item 3 refers).
Item 6
This item makes a consequential amendment to paragraph 30(1)(e) to remove
references to paragraphs 26A(2)(cc) and (cd), which are to be repealed
(item 2 refers).
Item 6A
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
planning 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 planning form" approved by the
Secretary under subsection 9D(6).
Item 7
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 preconditions 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).
Part 2 - Amendments commencing on the day after Royal Assent
Therapeutic Goods Act 1989
Item 7A
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.
Items 8 and 9
These items amend section 26 to provide an explicit path for the listing of
export-only variants of medicines that are already included on the
Register.
Item 8 amends subsection 26(1) to acknowledge that medicines may be listed
in two ways under the section.
Item 9 inserts new subsections (1AA) and (1AB). Subsection (1AA) provides
that the Secretary may list a new medicine in relation to a person if:
. an original medicine is included in the Register in relation to the
person;
. the person applies under section 23 to list a new medicine;
. the Secretary is satisfied that the requirements of paragraphs
26(1)(a) to (ba) have been met; and
. the Secretary is satisfied that the new medicine has the same
characteristics as the original medicine, except characteristics
specified in an instrument under subsection (1AB).
Subsection (1AB) empowers the Minister to make a legislative instrument
specifying characteristics in respect of which the new medicine may differ
from the original medicine. The Government intends that these
characteristics will be colourings, flavourings, and excipients.
Items 10 and 11
These items amend subsection 31(1) which sets out matters in respect of
which the Secretary may seek information from a person who has applied to
register therapeutic goods or a person in relation to whom goods are
registered.
Item 10 adds new paragraph (ga), allowing the Secretary to seek information
relating to compliance with conditions of registration, and item 11 adds
new paragraph (ha), allowing the Secretary to seek information on whether
the goods are being supplied, imported or exported. This information is
important to ensuring compliance with the Act, and in assessing the extent
of risk if problems with a medicine are detected.
Items 12, 14 and 15
These items amend subsection 31(2) which sets out matters in respect of
which the Secretary may seek information from a person who has applied to
list therapeutic goods or a person in relation to whom goods are listed.
Item 12 adds new paragraph (ca), allowing the Secretary to seek information
relating to the quality of the goods. Regulations made under paragraph
31(2)(h) already allow the Secretary to seek this information, and this
power is now being included in the Act for greater transparency.
Item 14 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) 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.
Item 15 adds new paragraph (ga), allowing the Secretary to seek information
on whether the goods are being supplied, imported or exported. This
information is important in ensuring compliance with the Act, and in
assessing the extent of risk if problems with a medicine are detected.
Item 15A
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.
Item 16
This item amends paragraph 41EG(f) to provide that an application for a
conformity assessment certificate lapses if the applicant fails to pay the
fee in accordance with regulations made under Part 4-10 of the Act, dealing
with payment of fees. The paragraph presently only requires payment after
an applicant is notified of the decision on the application for a
certificate. This had led to some applicants refusing to pay after been
notified of an adverse decision, even though the TGA has incurred costs in
conducting the audit of the application. While recovery action can be
pursued in such cases, it is costly and may be ineffective.
Item 17
This item amends paragraph 41FK(e) to provide that an application to
include a device in the Register lapses if the applicant fails to pay an
assessment fee in accordance with sections 41LB and 41LC. The paragraph
presently only requires payment after an applicant is notified of the
decision on the application. This had led to some applicants refusing to
pay after been notified of an adverse decision, even though the TGA has
incurred costs in conducting the audit of the application. While recovery
action can be pursued in such cases, it is costly and may be ineffective.
Items 18 to 20
These items amend section 60, dealing with reconsideration by the Minister
of initial decisions under the Act made by the Secretary.
Item 18 adds a new subsection (2A) to provide that a request for
reconsideration under subsection (2) may be accompanied by supporting
information.
Item 19 adds a new subsection (3A) to provide that, subject to the
requirements of subsection 60A(2) dealing with reconsideration of decisions
relating to the registration of therapeutic goods or the inclusion of
medical devices in the Register, the Minister in reconsidering the
decision, must
. take into account any information supplied under subsection (2A) by
the person making the request (paragraph (a)); and
. must not take into account any other information supplied by or on
behalf of the person after the request is made, other than information
supplied in response to a request or information indicating that the
quality, safety or efficacy of therapeutic goods is unacceptable
(paragraph (b)).
The amendment at item 19 to prevent supporting information from being
considered where it is provided after the request for reconsideration is
made is necessary as such information is often complex and highly
technical. As a result, it can require detailed consideration, assessment
and analysis. This cannot readily occur where the Minister, or her or his
delegate, is afforded less than the full 60 days in which to consider it.
This is a particular problem in cases involving an initial decision on an
application for registration, as the original information supplied in such
cases often includes voluminous technical data and supporting information.
This item does not affect the 90 day period in which applicants may lodge a
request for reconsideration of an initial decision.
Item 19 also adds a new subsection (3B) to provide that paragraph (3A)(a)
does not limit the information the Minister may take into account.
Item 20 makes a technical amendment to subsection 60(4).
Item 21
This item sets out the application of various items in the Part.
Sub-item (1) provides that the amendment to subsection 26(1) made by item 8
and the new subsection 26(1AA) inserted by item 9 apply to applications for
listing made on or after the commencement of that item.
Sub-item (2) provides that the amendments to section 31 made by items 10,
11, 12, 14 and 15 apply in relation to requests for information made by the
Secretary on or after the commencement of those items.
Sub-item (3) provides that the amendments to sections 41EG and 41FK made by
items 16 and 17 apply to applications for conformity assessment
certificates and inclusion in the Register made on or after the
commencement of those items.
Sub-item (4) provides that the amendments to section 60 made by items 18
and 19 apply to initial decisions made on or after the commencement of
those items.
Part 3 - Amendments relating to biologicals
Therapeutic Goods Act 1989
Item 22
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).
Item 23
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.
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