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2008-2009
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS AMENDMENT (2009 MEASURES No. 1) BILL 2009
EXPLANATORY MEMORANDUM
(Circulated by authority of Senator the Hon Jan McLucas, Parliamentary
Secretary to the Minister for Health and Ageing)
THERAPEUTIC GOODS AMENDMENT (2009 MEASURES No. 1) BILL 2009
OUTLINE
The Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009 (the Bill)
makes a series of amendments to the Therapeutic Goods Act 1989 (the Act).
These include:
. introducing a new provision to enable suspension of registered or
listed goods from the Australian Register of Therapeutic Goods (the
Register);
. amending the manufacturing licence provisions for the issuing of
single site licences and enabling the transfer of licences between
owners and variations to licence authorisations;
. amending the monitoring powers to enable the taking of samples of any
therapeutic goods and any thing that relates to therapeutic goods on
manufacturing premises and enabling the taking of any still or moving
image or any recording;
. introducing arrangements for homoeopathic and anthroposophic
medicines;
. introducing provisions to enable the making of lists of permissible
and prohibited ingredients in listed medicines;
. amending references to legislative instruments to reflect current
terminology; and
. clarifying the arrangements for the setting of conditions on
registered and listed goods.
Suspending therapeutic goods from the Register
While the Act presently provides for medical devices to be suspended from
the Register where there are concerns with safety that are likely to be
addressed in the short term, there is no equivalent power for registered or
listed goods. The only power available to stop the supply of these goods
is to cancel their registration or listing.
The Bill will enable all therapeutic goods to be suspended where full
cancellation may not be necessary where the reason for the suspension is
expected to be able to be addressed within a short timeframe. Cancellation
provisions in the Act will continue to be available where concerns are
serious, unresolved or unable to be resolved. Suspension will ensure
therapeutic goods can be withdrawn from supply to prevent potential risks
to public health.
Manufacturing licences
At present a single manufacturing licence may cover facilities that are at
geographically distant locations with disparate roles in the manufacture of
an unlimited range of therapeutic goods. This Bill will improve the
capacity of the Therapeutic Goods Administration (TGA) to monitor
facilities by providing for each site to be individually licensed.
Guidelines to be made under the Act will allow the Secretary to issue a
licence covering more than one site where certain conditions exist, such as
where sites are part of a contiguous campus or where a site is used solely
for storage.
The Bill will provide that current licences that cover more than one site
will be split, reflecting the guidelines that will deal with when a licence
may cover more than one site. All sites currently covered under licences
will continue to be covered under the new licence arrangements.
Further, the Bill provides that each licence is to identify the name of the
licence holder, the site(s) it covers and the step(s) in the manufacturing
process approved to be undertaken as set out in the manufacturing site
authorisation for the licence.
Variations will be able to be made to such authorisations and licences,
including by application from the licence holder. The Bill will further
provide that licences may be transferred to a new licence holder where
currently the Act would require the licence to be cancelled and an
application submitted to re-issue the licence.
Monitoring powers
Presently the Act empowers authorised persons, such as TGA inspectors, to
enter premises associated with therapeutic goods (including manufacturing
sites) to monitor for safety and quality in the manufacture and handling of
therapeutic goods and to ensure compliance with the Act. The Bill will
expand these powers and make them consistent across the Act to ensure all
therapeutic goods and things associated with them such as ingredients can
be assessed fully.
The Bill also provides that in addition to still photographs, video and
other recordings can be made at premises to assist in providing a record of
the observations made.
Homoeopathic and anthroposophic preparation
The Act presently provides for the majority of homoeopathic and
anthroposophic medicines to be exempted from most of the regulatory
requirements of the Act. The Bill will provide a framework for the
improved regulation of these goods as recommended in 2003 by the Expert
Committee on Complementary Medicines in the Health System.
Ingredients in therapeutic goods
Currently the Act enables a list of permitted ingredients in listed
medicines to be provided under the Regulations. A considerable number of
ingredients approved before the Act came into force are covered as a class
in the Regulations, but are not individually identified. The Bill will
make the listing of permitted and prohibited ingredients in listed
medicines more transparent by enabling the Minister to determine by
legislative instrument lists of such ingredients.
Amendments relating to legislative instruments
The Bill will amend the Act to update references in the Act to legislative
instruments to reflect the Legislative Instruments Act 2003 and current
terminology.
Other amendments
Other amendments will be made to the Act by this Bill. The most
significant include clarifying the arrangements for setting of conditions
imposed on registered and listed therapeutic goods, ensuring that the
quality and safety of products are maintained where their manufacture is
moved to an overseas manufacturer, clarifying that decisions may be made
using computer software under the Act such as for the listing of medicines,
clarifying the definition of accessory to a medical device, and clarifying
the arrangements for the Minister to make a code relating to the
advertising of therapeutic goods.
FINANCIAL IMPACT STATEMENT
The amendments made by this Bill will have a nil financial impact on the
Commonwealth as the TGA, who implements the Act, operates on a cost
recovery basis. The amendments will have a nil to low impact on industry
as agreed with the Office of Best Practice Regulation.
THERAPEUTIC GOODS AMENDMENT (2009 MEASURES No. 1) BILL 2009
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 (2009 Measures No. 1) Act 2009.
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.
Schedules 1, 3, 6 and part 1 of Schedule 7 commence the day after Royal
Assent, as it is important that the Government is able to suspend goods
from the Register, fully and effectively monitor manufacturing premises and
products, ensure the legislative instrument provisions in the Act are
consistent with current terminology and implement other minor amendments
immediately following Royal Assent.
Schedules 2, 5 and part 2 of Schedule 7 will commence on a day to be
proclaimed but no later than 6 months after Royal Assent. This will ensure
that systems to provide for compliance with the new arrangements are put in
place before the new arrangements come into force.
Schedule 4 will commence on 1 January 2011. This fixed date will provide
certainty to sponsors of homoeopathic and anthroposophic medicines about
the requirements these products will have to meet at that time and allow
time for them to comply with the new standards. It will also enable
finalisation of consultation and the making of subordinate legislation to
support the new homoeopathic and anthroposophic framework.
Clause 3: Schedule(s)
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 Therapeutic Goods Act 1989
(the Act) and includes application and transitional provisions.
SCHEDULE 1 - SUSPENDING THERAPEUTIC GOODS FROM THE REGISTER
Chapter 4 of the Act currently provides for the suspension of medical
devices included in the Australian Register of Therapeutic Goods (the
Register) where it is considered more appropriate in the circumstances than
cancellation and it is likely that, within the period of suspension, the
necessary action to ensure that the grounds of the suspension are
adequately addressed can be taken.
This arrangement is not currently available in relation to registered and
listed goods under Part 3-2 of the Act. If there are concerns with the
safety of registered or listed goods, even if these are considered
temporary and likely to be able to be addressed within a particular period,
the only option available to the Secretary is to cancel the registration or
listing of those goods from the Register. Where the cancellation occurs,
the product sponsor must re-apply for the listing or registration assuming
the quality, safety or other issues are resolved, and is required to pay
the relevant fees and charges.
This Schedule of the Bill provides for the suspension of the registration
or listing of therapeutic goods under Part 3-2 of the Act.
Item 1
This item inserts an explanatory note at the end of section 29 to explain
that for the purposes of determining the duration of registration or
listing of goods in the Register, therapeutic goods are taken not to be
included in the Register while their registration or listing is suspended.
Item 2
This item inserts new sections 29D, 29E, 29F and 29G setting out the
circumstances and arrangements for suspension of registration or listing of
therapeutic goods in the Register.
New section 29D empowers the Secretary to suspend the registration or
listing of therapeutic goods from the Register in certain prescribed
circumstances. The Secretary may suspend goods (paragraph 29D(1)(a)) if
she or he is satisfied that not doing so would pose a serious health risk
to consumers of the goods through continued availability of the goods and
where it is likely that the reason(s) for the suspension will be able to be
addressed and corrected during the period of the suspension.
The Secretary may also suspend the registration or listing or particular
therapeutic goods if she or he is satisfied that there are grounds for
cancelling the registration or listing of the goods under specified grounds
for cancellation under section 30 of the Act (paragraph 29D(1)(b)). These
specified grounds are limited to the following: paragraph 30(1)(da), (e) or
(f) or subsection 30(1A), (1C) or (2). The decision to suspend the
registration or listing must be given by written notice to the relevant
person.
Before suspending the registration or listing of therapeutic goods from the
Register, subsection (2) requires the Secretary to advise the person in
relation to whom the goods are registered or listed, of the proposed
suspension in writing and set out the reasons for the suspension. The
Secretary must also give the person reasonable opportunity to make
submissions in relation to the proposed suspension.
Subsection 29D(3) provides that the Secretary is not to make a decision
relating to the proposed suspension until the Secretary has had regard to
any submissions given by that person in response to the written notice
given under subsection 29D(2).
Subsection 29D(4) provides that the maximum period of suspension is to be 6
months and that this period must be included in the written notice of the
decision under subsection 29D(1).
The Secretary must cause a decision to suspend goods from the Register to
be published in the Gazette (subsection 29D(5)) as soon as practicable
after notification has been given to the person in relation to whom the
goods are included in the Register. The notice should set out the
particulars of the suspension.
New section 29E specifies when a suspension under section 29D takes effect
and provides for the extension of a suspension.
Where the registration or listing of a particular therapeutic good is
suspended due to the risk of potential death or serious illness or injury,
the suspension is to take effect from the day the notice is given
(paragraph 29E(1)(a)). The effect of the suspension will be to prevent the
goods continuing to be made available while the reason(s) for the
suspension remain. In any other case, the suspension under section 29D
takes effect on the day specified in the notice, that day not being earlier
than 20 working days after the notice is given to the relevant person
(paragraph 29E(1)(b)).
Subsection 29E(2) provides for when a suspension is to cease to have effect
and reflects where the period of suspension is extended under subsection
(3). The suspension is effective until the following occurs: the Secretary
revokes it under section 29F; the period specified in the notice under
subsection 29D(4) ends; or the period of the extension of the suspension
under subsection 29E(3) ends.
Where the period of a suspension is extended under subsection 29E(3) the
Secretary is required to provide written notice to the person, in relation
to whom the goods are included in the Register, advising of the extension
and specifying the period of the extension. The period of extension must
not exceed 6 months.
Subsection 29E(4) provides that as soon as practicable after the Secretary
gives notification of the extension under subsection 29E(3), the Secretary
must cause a notice to be published in the Gazette setting out particulars
of the extension.
New section 29F empowers the Secretary to revoke a suspension under section
29D in circumstances specified under subsection 29F(1). The Secretary is
required to give written notice to the person in relation to whom the
therapeutic goods are included in the Register if the Secretary revokes a
suspension under section 29D. For the Secretary to revoke a suspension
under section 29D, the Secretary must be satisfied that both of the
following are satisfied: the ground on which the registration or listing
was suspended no longer applies; and there are no other grounds for
suspending the registration or listing of the therapeutic goods.
Subsection 29F(2) provides that the revocation of the suspension can be
made by the Secretary on her or his own initiative or following an
application from the person in relation to whom the goods are included in
the Register.
Subsection 29F(3), requires that a notice be published in the Gazette
setting out the particulars of the revocation of the suspension, as soon as
practicable, after notice is given to the relevant person under subsection
29F(1).
Subsection 29F(4) also requires a written notification to be provided to a
person in relation to whom goods are included in the Register where they
make application for revocation of the suspension under paragraph
29F(2)(a), and the Secretary decides not to revoke the suspension. The
notification must include reasons for the decision.
New section 29G explains the effect of suspension under section 29D. Where
the registration or listing of therapeutic goods is suspended under section
29D, the goods are to be taken not to be included in the Register while the
suspension is in operation, except in relation to certain provisions set
out in subsection 29G(1) that continue to apply. Subsection (1) specifies
the provisions that continue to apply as if the registration or listing
were not suspended from the Register. These sections are:
. section 28 - which authorises the Secretary to impose conditions on
the registration or listing of therapeutic goods and sets out
conditions applying automatically;
. section 29A and 29AA - which set out requirements for the provision of
information such as those relating to adverse effects, and the
criminal offence and civil penalty provisions (respectively) for
failing to notify of adverse effects etc. of therapeutic goods;
. section 29E and 29F - relating to the suspension of the goods from the
Register;
. section 30 - which provides that the Secretary may cancel the
registration or listing of the therapeutic goods including while a
suspension on registration or listing is in place (where the criteria
for cancellation under this section are met); and
. section 31 - which authorises the Secretary to give written notice to
a relevant person (including those persons to whom the goods are
registered or listed) to require that person to provide information or
documents relating to matters set out in subsection 31(1).
Item 3
This item inserts a new item (6A) in the table at subsection 30EA(1) to
empower the Secretary to impose requirements relating to therapeutic goods
on a person, in relation to whom the goods were included in the Register,
where the registration or listing of those goods has been suspended. This
new item has the effect of allowing the Secretary to impose requirements
set out in subsection 30EA(2) on that person, for example, the requirement
to recover those therapeutic goods that have been distributed and to inform
the public or a specified class of persons that the registration or listing
of the therapeutic goods has been suspended under Part 3-2 of the Act.
Item 4
This item amends section 30ED to reflect the inclusion of new section 29D,
relating to the Secretary's power to suspend the registration or listing of
therapeutic goods. This amendment has the effect of restating that the
imposition of a requirement under section 30EA (e.g. recovery of goods and
public notification about the suspension) does not affect the power of the
Secretary to cancel or suspend the registration or listing of therapeutic
goods under Part 3-2 of the Act.
Item 5
This item amends paragraph (g) under subsection 56A(1) to reflect the
inclusion of section 29D, relating to the suspension of the registration or
listing of therapeutic goods under Part 3-2 of the Act. This amendment has
the effect of extending the circumstances in which the Secretary or her or
his delegate may certify certain matters under section 56A to now include
when the registration or listing of therapeutic goods are suspended from
the Register, in addition to cancellation under section 30 as currently
provided for.
Item 6
This item amends paragraphs (b) and (ba) of subsection 61(4) to enable the
Secretary to release information in relation to the suspension of the
registration or listing of therapeutic goods, and the suspension of the
inclusion of kinds of medical devices, respectively, to a national
regulatory authority of another country that has national responsibility
relating to therapeutic goods. This is to ensure other countries, where
the therapeutic goods that are the subject of the suspension decision are
being supplied or are currently the subject of a regulatory approval, are
aware of the suspension and able to consider any public health implications
for that country.
Item 7
This item sets out the application of the amendments made by item 2 of this
Schedule. It provides that sections 29D (suspension of registration or
listing), 29E (when suspension takes effect), 29F (revocation of
suspension) and 29G (effect of suspension) apply to all registered and
listed goods under Part 3-2 of the Act on the commencement of those
provisions (the day after Royal Assent).
Application of the suspension provisions to goods registered or listed
prior to the commencement of this Schedule would not disadvantage persons
in relation to whom goods are registered or listed before the commencement
date of the above provisions as it enables the registration or listing of
these goods to be suspended from the Register temporarily, where this is
appropriate, as an alternative to the cancellation of the registration or
listing of these goods under section 30 of the Act. Once the registration
or listing of the goods is officially cancelled under section 30, the only
option for the sponsor of those goods would be to re-apply for registration
or listing. This would require the payment of appropriate application fees
under section 23 of the Act and, if applicable, the appropriate evaluation
fees.
SCHEDULE 2 - MANUFACTURING LICENCES
Part 3-3 of the Act, subject to some exceptions, requires a person who
manufactures therapeutic goods (other than medical devices) to hold a
manufacturing licence. Section 37 provides that application for a licence
must, amongst other things, identify the therapeutic goods that the
applicant proposes to manufacture, identify the manufacturing premises that
will be used in the manufacture of the goods and identify the steps in the
manufacture of the goods that the applicant proposes to carry out. Section
38 provides for the granting of the licence to carry out the steps in the
manufacture of therapeutic goods at the premises identified in the
application. Section 40 provides that the Secretary may impose conditions
on a licence and also sets out a number of statutory conditions that apply
to all licences.
At present, the TGA issues single manufacturing licences that authorise the
manufacture of goods at more than one manufacturing site or location. This
is permitted by the current definition of "manufacturing premises" which
makes it clear that such premises can comprise two or more sites.
This Schedule amends Part 3-3 of the Act to modify and clarify a number of
matters relating to the issuing and the varying of manufacturing licences.
In particular, it provides that manufacturing licenses are to be issued on
a per site/location basis unless allowed for in the guidelines determined
by the Secretary. It also provides for the transfer of licences where
ownership of a manufacturing operation changes and to allow for variations
to matters authorised in a manufacturing licences, such as the
manufacturing sites, on the Secretary's own initiative or on the
application by the licensed holder.
Items 1 and 2
These items repeal the current definition of manufacturing premises at
subsection 3(1) and insert a new definition of manufacturing site to
support the issuing of manufacturing licences on a per site basis only
under section 38, unless the granting of a licence that covers two or more
manufacturing sites are allowed for under new section 38A.
Item 3
This item inserts a new definition of manufacturing site authorisation at
subsection 3(1).
The definition relates to new subsections 38(2B) and 40B(4) (items 11 and
19 refer). These provisions empower the Secretary to authorise the holder
of a manufacturing licence to carry out certain specified steps in the
manufacture of specified therapeutic goods at a specified manufacturing
site.
Item 4
This item amends paragraph (c) of subsection 37(1), relating to
applications for manufacturing licences, to reflect the new definition of
manufacturing site and requires that applications be made in accordance
with new subsections 37(1A) and (1B) (item 5 refers).
Item 5
This item inserts two new subsections under section 37 to require that
applications for manufacturing licences must be in respect of single sites
only (new subsection 37(1A)), unless the applicant has a view that the
guidelines made by the Secretary under new section 38A would allow a
licence to be granted covering 2 or more sites (new subsection 37(1B)). If
the applicant for a multi-site licence believes that a licence could be
granted for more than one manufacturing site or location, having regard to
the guidelines made by the Secretary under new section 38A (item 12
refers), the applicant should identify those sites in the application and
state the reasons for the applicant's view (new subsection 37(1B))
Items 6 and 7
These items amend paragraph 37(2)(b) to reflect the new definition of
manufacturing site, as a consequence of the repeal of the definition of
manufacturing premises (item 1 refers).
Items 8, 9 and 10
These items amend subsection 38(1), including paragraphs (a) and (f), to
reflect the new definition of manufacturing site (item 1 refers).
Item 11
This item inserts two new subsections (subsections 38(2A) and (2B))
regarding the granting of manufacturing licences.
New subsection 38(2A) provides that the Secretary in granting a licence
must have regard to the guidelines for multiple site licences made under
new section 38A (item 12 refers). This means that where an application for
a manufacturing licence is made under new subsection 37(1B) (specifying
multiple sites to be included on the licence), the assessment of the
manufacturing licence application against the criteria set out in section
38 must now take into consideration the matters set out in the guidelines
for the issuing of multiple site licences.
New subsection 38(2B) requires that for each manufacturing site covered by
a granted licence, the Secretary must specifically authorise, in the
licence, the identity of the licence holder who is to carry out the
specified steps in the manufacture of specified therapeutic goods at that
manufacturing site. This means that the authorisation under the licence is
on a per manufacturing site basis.
Item 12
This item inserts new sections 38A and 38B to provide for circumstances in
which multiple sites may be included on the same licence and arrangements
for splitting existing multi-site licences to single site licences.
New section 38A requires the Secretary to make guidelines by legislative
instrument setting out the circumstances when a licence can be issued to
cover two or more sites. The guidelines will provide for certain limited
circumstances wherein a licence can be granted under section 38 that covers
two or more manufacturing sites or locations. Examples of circumstances
that would allow for multi-site licences include the following:
manufacturing sites located on a contiguous campus undertaking elements of
the same manufacturing process; where a manufacturing site undertakes a
minor role in the manufacturing process and is associated with a primary
manufacturing site such as a warehouse for storage of therapeutic goods or
starting materials manufactured at the primary site.
New section 38B sets out the arrangements under which current ("old")
licences for multiple sites will be split to provide each site covered by
licence that was in force or suspended prior to the commencement of the
amendments ("the old licence") with a site-specific ("new") licence.
New subsection 38B(1) provides that section 38B applies if a licence that
was in force under Part 3-3 or was suspended under Part 3-3 prior to the
commencement of section 38B (a date to be proclaimed but no later than six
months after Royal Assent) and the licence authorises the manufacture of
therapeutic goods at premises or relates to premises that comprise more
than one manufacturing site or location ("the old licences").
Subsection 38B(2) sets out the requirement for the Secretary to revoke
licences identified under subsection 38B(1) and grant new single site
licences in respect of all sites previously covered under the old licence,
except where multiple sites may be included on a single manufacturing
licence in accordance with the guidelines (subsection 38B(3)). As soon as
practicable after the commencement of section 38B, the Secretary must, in
writing, simultaneously revoke the old licences and grant new licences to
the holder of the old licence which, when considered together, cover all
old sites. The Secretary is required to give the holder of the licence
notice of the revocation and grant of the new licence.
New subsection 38B(4) explains for the avoidance of doubt that subsection
38(2B), subsection 38(4) and sections 39 to 41A apply to a new licence in
the same way as they apply to a licence granted under section 38. This
means that the Secretary must give a manufacturing licence authorisation in
relation to each manufacturing site covered by the licence, and the
Secretary is required to publish particulars of the decision in the Gazette
as soon as practicable after the decision to split the licence is made.
Sections 39 (term of the licence), 40 (imposition of conditions on a
licence and statutory conditions under subsection 40(4)), 41(revocation and
suspension of a licence) and 41A (requirement to publish a list of
manufacturers) apply to the new licences granted as a result of the
splitting of an old multi-site licence to new licences.
For the purposes of existing subsection 39(1) and to ensure continuous
licensure, subsection 38B(5) sets out the commencement day of the new
licence granted to the holder of an old licence and refers to it as the
transition day. Subsection 38B(5) provides that new licences issued under
this section will commence on the day after they are granted (the
transition day) and subsection 38B(6) specifies that old licences will
cease to have effect immediately before this day.
Where an old licence (paragraph (1)(a)(ii)) is suspended immediately before
the commencement of section 38B and the period of suspension of the old
licence is due to end at the end of the day after the transition day, new
subsection 38B(7) provides that the Secretary may choose to, on the day
that the Secretary grants a new licence to the holder of the old licence
and by notice in writing given to the holder, suspend the new licence for a
period starting on a transition day and ending on a day after the
transition period (the relevant day). In effect the suspension of the
manufacturing licence can be carried across to the new licence(s) and
continue for the remaining period of the suspension of the old licence
under section 41 which may have occurred prior to the decision of the
Secretary to split the old licence to new licences.
New subsection 38B(8) provides that in deciding to carry across the
suspension from the old to the new licence, the Secretary does not need
conform to the requirements set out in existing subsection 41(2). These
requirements include the need to give written notice to the licence holder
of the proposal to suspend the licence and the reasons for the proposed
action. This is because such notification would have been provided
previously in relation to the suspension of the old licence and the holder
would have already been notified under subsection 38B(7) that the
suspension is to be carried across.
Subsection 38B(8) further explains that subsections 41(4) and (6) of the
Act continue to apply to the new licence as they would to the old licence.
This means the licence can be revoked notwithstanding that the licence is
suspended, the suspension can be revoked and the requirement to publish in
the Gazette the decision and particulars of the decision relating to the
revocation of the licence or the suspension of the licence will apply.
New subsection 38B(9) makes it clear that subsection 38B(7) does not
prevent subsection 41(1) of the Act from applying to new licences as
subsection 41(1) prescribes the circumstances in which the Secretary may
suspend or revoke a licence.
Subsection (10) explains that the new licence will not incur an annual
charge in the financial year in which it is issued. Therefore, where an
annual charge has been payable for a multiple site licence and in the same
financial year this licence is replaced by several single site licences, no
annual charge will be payable in respect of these new licences in that same
financial year.
Subsection (11) advises that the revocation of old licences is not an
initial decision for the purposes of section 60 of the Act (review of
decisions). This is a declaratory provision as it explains that the
decision is not subject to section 60. This is because the initial
decision attaches to the original decision to grant the old licence under
section 38. This section simply provides for licences previously granted
under section 38 to be split to new licences without remaking the decision
to grant the licence.
The effect is to provide that all premises covered under existing licences
will continue to be covered under the new licences (per paragraph
38B(2)(b)) and no premises previously licensed will cease to be authorised
under the new licenses issued under this section. However, the suspension
or revocation of these new licences under section 41 will be subject to a
review under section 60 of the Act.
Item 13
This item amends subparagraph 40(4)(b)(i) to reflect the repeal of the
definition of manufacturing premises and the inclusion of a new definition
of manufacturing site, and the issuing of single site licences provided
under new subsections 37(1A) and (1B) (item 5 refers).
Item 14
This item repeals subparagraph 40(4)(b)(ii) and inserts two new
subparagraphs (ii) and (iii) to better enable safety and quality
assessment. This item is associated with the amendments made under
Schedule 3.
The new subparagraph 40(4)(b)(ii) expands current powers under this section
to enable any therapeutic goods at the site or any thing relating to any
therapeutic goods to be examined, have measurements taken or be tested.
These enhanced powers are necessary to ensure full assessment can be
undertaken of therapeutic goods manufacturing standards and practices at
licensed sites to ensure safety and quality are maintained for all
therapeutic goods.
These amendments have become necessary to reflect the situations identified
in practice by authorised persons under the Act, such as unauthorised
manufacture of therapeutic goods that pose safety concerns. Under the
existing provisions authorised persons have not been empowered to respond
to these situations despite the risks to public safety.
In practice this will enable, for example, authorised persons (TGA
inspectors) to take a sample of a starting ingredient used in the
manufacture of a medicine and test its quality and safety in addition to
the final product. For some herbal complementary medicines it is not
possible to assess fully the strength of the final mixed-ingredient product
and therefore testing the strength of the individual ingredients is
necessary to confirm that the final product is of the strength and quality
approved to be manufactured and consistent with the product details on the
label.
There have also been instances where inspectors have found therapeutic
goods at manufacturing sites for which the site is not licensed to
manufacture such goods. New subparagraph 40(4)(b)(ii) will allow the
taking of samples of these other therapeutic goods to assess their safety
and quality and enable appropriate measures to be taken to ensure
compliance with the regulatory requirements for manufacture of these goods.
The new subparagraph 40(4)(b)(iii) will enable authorised persons, while
inspecting licensed manufacturing premises, to, in addition to taking still
photographs, take video or other recordings of the site, the therapeutic
goods or processes involved in the manufacture as part of the inspection.
As manufacturing processes are a sequence of events it is often the
sequence and manner in which these processes are conducted that is critical
to assure quality. Video recording would enable such sequences of events
to be captured, rather than a single event as would occur with still
photography.
By way of example, the manufacture of sterile products requires that a
sterile zone be maintained as sterile components are exposed during the
sequence of manufacture. Staff involved in the manufacture of the goods
may occasionally be required to enter the zone and it is the way that they
prepare for this and behave in the sterile zone that is critical in
assessing the maintenance of sterile conditions for manufacture. Video
recording of the events would provide a better and more objective record of
the manufacture process than would still photographs and will support
comprehensive assessment of the manufacturing process.
Items 15, 16, 17 and 18
These items amend subsection 40(4) in relation to conditions imposed on
manufacturing licences to reflect the new definition of manufacturing site
in place of manufacturing premises.
Item 19
This item inserts new sections 40A and 40B to enable manufacturing site
authorisations to be varied by the Secretary and on application from the
licence holder.
New subsection 40A(1) empowers the Secretary to vary a manufacturing site
authorisation (item 3 refers) in relation to a manufacturing licence and to
give notice of the variation, in writing, to the holder of the licence
being varied. New subsection 40A(2) sets out when the variation is to take
effect. A variation will have effect on the day the notice is given to the
licence holder where the variation is necessary to prevent imminent risk of
death, serious illness or serious injury (paragraph 40A(2)(a)). Paragraph
40A(2)(b) identifies that in other cases the variation takes effect no
sooner than 28 days after the notice is given to the holder on a day stated
in the notice.
Despite not being specified, a notification under section 40A(2)(b) of a
decision to vary a manufacturing site authorisation will, in practice,
include a statement of reasons.
New section 40B enables manufacturing licence holders to apply to the
Secretary to vary their licence.
Subsection 40B(1) allows licence holders to apply for a variation of the
manufacturing licence to cover more than one site, if the holder is of the
view that, having regard to the guidelines under section 38A (item 12
refers), the licence could cover one or more additional sites.
A decision under section 40B to refuse an application to vary a
manufacturing licence is an initial decision for the purposes of section 60
of the Act and therefore will be subject to an internal review under that
section.
New subsection 40B(2) sets out the application requirements for the
variation of licences. Where the applicant seeks the licence to cover
steps in the manufacture of blood or blood components the application must
include information relating to the manufacturing steps as set out in the
regulations made under paragraph 37(1)(da). This ensures that the
requirements for manufacturing licence applications under paragraph
37(1)(da) are consistent with the requirements for applicants seeking to
vary a manufacturing licence for these products.
New subsection 40B(3) provides that if an application is made in accordance
with subsection (1) and any applicable prescribed assessment fees have been
paid, the Secretary may, by notice in writing, vary the licence so that the
licence covers each additional manufacturing site set out in the notice.
New subsection 40B(4) provides that for each manufacturing site specified
in subsection 40B(3), the Secretary must vary the licence to authorise the
holder of the licence to carry out specified steps in the manufacture of
specified therapeutic goods at that manufacturing site. Therefore, each
manufacturing site will have specific authorisation attached to it setting
out what specified steps in the manufacture of specified therapeutic goods
at that particular site can be carried out by the licence holder.
New subsection 40B(5) provides that an approved variation takes effect on
the day the notice of the approval is given to the manufacturing licence
holder.
New subsections 40B(6) to (7) allow for applications to be made by the
holder of the licence in respect of seeking a variation to the
manufacturing site authorisations (item 3 refers). New subsection (7) sets
out the application requirements. New subsection 40B(8) provides for the
consideration of the application by the Secretary and where the variation
sought is approved, provides for the manufacturing site authorisation to be
varied in respect of the licence. The licence holder must be given a
written notice of the variation.
New subsection 40B(9) provides that an approved variation to the
manufacturing site authorisation takes effect on the day the notice of the
approval is given to the manufacturing licence holder.
New subsection 40B(10) authorises the Secretary, by giving written notice
to the holder of the licence who has made an application under subsection
(1) or (6), to require the holder to:
a) give to the Secretary further information concerning the application
that is specified in the notice and within the time specified in the
notice; or
b) allow an authorised person, at any reasonable time specified in the
notice, to inspect the manufacturing site identified in the
application and the equipment, processes and facilities that will be
used in the manufacture of therapeutic goods.
These are similar requirements applying to an application for a
manufacturing licence (refer to current subsection 37(2)).
New subsection 40B(11) explains that the approval of the forms to seek a
variation under paragraphs 40B(2)(a) or (7)(a) by the Secretary and the
notice given by the Secretary to the licence holder under subsection
40B(10) may require or permit an application or information to be given in
accordance with specified software requirements, i.e. in electronic format.
In practice this may mean that an applicant may be permitted to lodge
electronically an application to seek variation of their licence to cover
more than one site but that this application would need to be in a specific
software format such as Portable Document Format (PDF).
Item 20
This item inserts a new paragraph (ea) at subsection 41(1) in relation to
revocation and suspension of manufacturing licences to provide that where a
licence holder contravenes a manufacturing site authorisation (item 3
refers), the Secretary may, by notice in writing, suspend or revoke the
licence.
In practice, where an inspection of a manufacturing site under subparagraph
40(4)(b)(ii) (item 14 refers) identifies that a therapeutic good is being
manufactured at the site at which that therapeutic goods is not authorised
to be manufactured, this would constitute a contravention of the
manufacturing site authorisation. Where this occurs, new paragraph
41(1)(ea) provides that the Secretary may then decide to suspend or revoke
the manufacturing licence.
Item 21
This item inserts a new section 41AAA to provide for manufacturing licences
to be transferred to another licence holder. New subsection 41AAA(1)
enables regulations to be made for the transfer of licences. New
subsection 41AAA(2) provides that the regulations made for the purposes of
subsection (1) may make provision for the making of application for the
transfer, the payment of a fee, the assessment of the application and the
conditions of a licence upon the transfer and the review of decisions made
under the regulations. New subsection 41AA(3) makes it clear that that the
sort of things the regulations may provide for as identified at subsection
(2) does not limit the scope of the regulations that may be made under
subsection (1) in regard to the transfer of licences.
Item 22
This item amends section 41A to replace the term premises with site to
reflect the new definition of manufacturing site (item 2 refers).
Items 23 and 24
These items amend paragraph 58(3)(b) to reflect the use of the terms
manufacturing site and site in place of the term manufacturing premises
that has now been repealed (item 1 refers).
Item 25
This item sets out the application of the amendments made by this Schedule
to sections 37, 38, 40, 41 and 58.
It provides that the amendments to section 37 (applications for
manufacturing licences) (items 4-7), will apply to applications for
manufacturing licences made on or after the commencement of these
amendments (a day to be proclaimed but no later than six months after Royal
Assent). This means that the requirements relating to single site licences
will apply to all applications received on or after the commencement date
of these amendments, unless allowed for in circumstances set out in
guidelines made by the Secretary under new section 38A
The amendments made to section 38 (items 8-11), relating to the granting of
manufacturing licences, apply to new applications for licences made on or
after the commencement of these amendments and to applications made before
the commencement but which have not been decided by the Secretary before
the commencement (a day to be proclaimed but no later than six months after
Royal Assent). This is consistent with the application of new section 38B
which allows for the splitting of multi-site licences.
Licence applications submitted prior to commencement of item 9 which have
not been decided by the Secretary before the commencement of that item (a
day to be proclaimed but no later than six months after Royal Assent) and
which have identified more than one manufacturing sites in the application
are to be taken to be and assessed by the Secretary as a multi-site licence
application. If the Secretary is satisfied the licence covering one or
more manufacturing sites (taking into consideration the guidelines made
under section 38A) and all other criteria under section 38 are satisfied,
then the licence can be granted covering one or more of those manufacturing
sites, despite the application being received prior to the commencement
date of the amendments made under section 38.
The amendments to section 40 (conditions of licences), new sections 40A and
40B, sections 41 (revocation and suspension of licences) and 41AAA will
apply to licences granted before, on or after the commencement of those
amendments (items 13-22) (a day to be proclaimed but no later than six
months after Royal Assent).
The application of these items to licences granted prior to their
commencement ensures all licensed manufacturers are subject to the same
conditions and ensures equal levels of safety and quality checking at all
sites licensed to manufacture therapeutic goods. It also confers a benefit
upon existing licence holders to enable them to apply for variations to the
authorisations of their licence (including the addition of new
manufacturing sites allowed under the guidelines) or for licence holders to
be allowed to seek transfer of the licence. There is currently no
provision allowing for the transfer of manufacturing licences from an
existing holder to a purchaser of the business or where there is a business
merger which includes manufacturing activities.
Item 26
This item makes it clear that existing manufacturing licences that are in
force or were suspended prior to the commencement date of this item can be
the subject of a variation of a manufacturing site authorisation under new
sections 40A or 40B. This item provides for the application of sections
38(2B), 40A and 40B to an existing manufacturing licence that covers a
single manufacturing site.
The manufacturing site authorisation only refers to authorisations referred
to under subsection 38(2B) and 40B(4) (item 3).
However, subsection 38(2B) only applies to new applications for a
manufacturing licence and those licences (either in force or suspended)
that cover 2 or more manufacturing sites as described under subsection
38B(1). Subitem 26(4) provides that the Act applies to a single site
licence as if a manufacturing site authorisation had been granted as per
subsection 38(2B) in respect of the site covered by the licence. The
application of new section 40A or 40B is put beyond doubt by subitem 26(5).
Subitem (1) sets out the application of the transitional provisions for
existing licences prior to the commencement of item 26. Subitem (1)
provides that it applies to the following licence:
a) a licence that was in force under Part 3-3 immediately before the
commencement of this item; or
b) a licence that was suspended under Part 3-3 immediately before the
commencement of this item.
Subitem (2) provides that the Act applies in relation to existing licences
on or after the commencement of this item and will be taken to cover the
manufacturing site(s) which constitute the manufacturing premises covered
by the licence granted under section 38. Existing licences that cover more
than one manufacturing site will be subject to the splitting of
manufacturing licences in accordance with section 38B (item 12 refers).
Subitem (4) provides that where an existing licence is not subject to
splitting into individual site licences under section 38B (such as existing
single site licences), the Act is to apply to the licence, on and after
commencement of this item, as if the licence authorised the licence holder,
at the site constituted by the manufacturing premises to which the licence
related immediately before commencement, to carry out the steps in the
manufacture of therapeutic goods that the licence allowed immediately
before commencement under a manufacturing site authorisation under
subsection 38(2B) of the Act (item 3 refers).
Subitem (5) explains that existing licence authorisations applied by
subitem (4) remain subject to variation under new section 40A or 40B of the
Act (item 19 refers).
SCHEDULE 3 - MONITORING POWERS
The Act provides for authorised persons under the Act to enter and inspect
manufacturing premises (sites) and other premises at which relevant persons
regulated under the Act deal with therapeutic goods that are included in
the Register, and while at those premises to take samples of therapeutic
goods.
These provisions allow authorised persons to monitor the safety and quality
of goods and compliance with other regulatory requirements under the Act,
and apply specifically to manufacturers and to therapeutic goods that are
registered, listed or included in the Register. These provisions include
the following;
. subsection 28(5) and subparagraph 41FN(1)(a)(ii) that provide for
inspection and sampling of therapeutic goods from premises for
registered or listed goods and included medical devices in the
Register, respectively; and
. subsections 40(4) and 41EJ(1) that provide for such powers as part of
the inspection of facilities manufacturing medicines and other
therapeutic goods, and medical devices respectively, as conditions of
a manufacturing licence or a conformity assessment certificate.
However, the powers accorded to an authorised person under these provisions
are inconsistent and dated. In addition to making the powers accorded to
authorised persons under those provisions consistent, the amendments will
allow the taking of samples of any therapeutic goods on those premises or
any thing on those premises that relates to any therapeutic goods.
These provisions will also now include the power of authorised persons to
take still or moving images or any recording of those premises or any thing
on those premises. These amendments reflect the practical requirements for
effective monitoring for safety and quality, and compliance with other
regulatory requirements under the Act.
Items 1, 2, 3, 5, 6, 7, 8 and 9
These items amend subsection 28(5) to make it clear that therapeutic goods
that are registered or listed are taken to be the goods subject to the
conditions specified under section 28.
Items 4, 10, 12
These items repeal the following subparagraph and paragraphs and insert new
provisions for the inspection of premises that include the extension of
these powers relating to the taking of samples of any therapeutic good or
related thing and the making of relevant recordings in the relevant
premises:
. item 4 repeals subparagraph 28(5)(a)(ii) and inserts new subparagraphs
28(5)(a)(ii) and (iii) to provide for enhanced monitoring of premises
at which a person (in relation to whom registered or listed goods are
included in the Register) deals with the goods;
. item 10 repeals subparagraphs 41EJ(1)(a)(ii) and (iii) and inserts new
subparagraphs 41EJ(ii) and (iii) to provide for enhanced monitoring of
premises involved in the manufacture of medical devices covered by a
conformity assessment certificate; and
. item 12 repeals subparagraph 41FN(1)(a)(ii) and inserts new
subparagraphs (ii) and (iii) to provide for enhanced monitoring of
premises at which a person (in relation to whom a medical device is
included in the Register) deals with the device.
A similar amendment to subsection 40(4) is made by item 14 of Schedule 2 to
the Bill.
These items are considered together as they align the monitoring powers
under the Act and enable any therapeutic goods at the site or any thing
relating to any therapeutic goods to be examined, have measurements taken
or be tested. These enhanced powers are necessary to ensure full
assessment can be undertaken on therapeutic goods including standards and
practices to ensure safety and quality are maintained for all therapeutic
goods.
These amendments have become necessary to reflect the situations identified
in practice by authorised TGA officers. For example, under the existing
provisions, samples of ingredients or other starting materials of the
relevant therapeutic goods cannot be taken and tests cannot be conducted on
them, even though such testing may be more useful in identifying safety
concerns than test on the finished goods. In addition, officers becoming
aware of the presence of unregistered or unlisted therapeutic goods on
premises being inspected are not empowered to take samples of these goods.
In practice, the enhanced provisions will enable, for example, authorised
TGA officers to test temperature levels of refrigeration equipment used in
the storage of medicines that require cold chain management to maintain
their safety and efficacy, such as vaccines. It would also enable, for
example, authorised TGA officers to take samples of other therapeutic goods
that may be at the premises which may not be included in the Register.
This would provide for appropriate measures to be taken to ensure
compliance with the regulatory requirements for therapeutic goods.
The new provisions will also enable authorised persons inspecting premises
to take video or other recordings of the premises or any thing on the
premises in addition to still photographs. For example, an inspector may
use a digital video recorder to film cleaning processes of an area used to
store goods to provide an objective record and to enable assessment of the
appropriateness of the cleaning for those premises. Still photographs
would not enable the sequence or detail of the process to be recorded.
In particular, video recordings enable sequences of processes to be
recorded objectively where still photography would not enable such
sequences to be captured fully.
Item 11
This item amends subparagraph 41EJ(1)(b)(i) to clarify that the provision
to require documents to be provided is in relation to medical devices
covered by a conformity assessment certificate.
Item 13
This item amends paragraph 41FN(1)(b) to reflect that medical devices of
the kind that are included in the Register are taken to be the kind of
medical devices that are subject to the conditions specified.
Item 14
This item repeals existing paragraphs 46A(1)(b) and (c) and replaces them
with new paragraphs 46A(1)(b) and (c). This item does not make substantive
changes to the power of an authorised person under existing subsection
46A(1) of Part 6-2 (entry, searches and warrants) of the Act but merely
makes the wording of these paragraphs consistent with the wording of
similar powers under new subparagraphs 28(5)(a)(ii)-(iii), 41EJ(1)(a)(ii)-
(iii) and 41FN(1)(a)(ii)-(iii)
Item 15
This item repeals existing paragraphs 48(1)(b) and (c) and replaces them
with new paragraphs 48(1)(b) and (c). This item does not make substantive
changes to the power of an authorised person under existing subsection
48(1) of Part 6-2 (entry, searches and warrants) of the Act but merely
makes the wording of these paragraphs consistent with the wording of
similar powers under new subparagraphs 28(5)(a)(ii)-(iii), 41EJ(1)(a)(ii)-
(iii) and 41FN(1)(a)(ii)-(iii).
Item 16
This item sets out the application of the amendments made by this Schedule
to sections
28, 41EJ and 41FN.
It provides that the amendments to section 28, relating to conditions of
registration or listing of goods, will apply in relation to registered or
listed goods before, on or after the day after the Act receives the Royal
Assent, which is the commencement date of the amendments set out under this
Schedule.
This item sets out that amendments to section 41EJ, relating to conditions
of medical device conformity assessment certificates, will apply in
relation to conformity assessment certificates issued before, on or after
the day after the Act receives the Royal Assent.
This item also sets out that the amendments to section 41FN, relating to
medical devices included in the Register, will apply in relation to devices
so included in the Register before, on or after the day after the Act
receives the Royal Assent.
The application of the amendments to goods that (and persons in respect of
whom goods) have been registered, listed or included in the Register and
who were issued manufacturing licences or conformity assessment
certificates before the commencement does not alter the conditions required
to be complied with under sections 28, 40, 41EJ and 41FN. The enhanced
powers only expand the options available to monitor for compliance with
these conditions to ensure safety and quality in therapeutic goods.
The enhanced monitoring powers will only apply to inspections undertaken
following commencement of this Schedule (the day after Royal Assent).
SCHEDULE 4 - HOMOEOPATHIC AND ANTHROPOSOPHIC PREPARATIONS
The Act and regulations presently provide for the majority of homoeopathic
and anthroposophic medicines to be exempted from most of the regulatory
requirements of the Act. This Schedule provides the framework for the
improved regulation of these goods as recommended in 2003 by the Expert
Committee on Complementary Medicines in the Health System.
Item 1
This item inserts a new definition of anthroposophic pharmacopoeia at
subsection 3(1) to provide for standards to be established for
anthroposophic preparations under new section 3AB(3) (item 9 refers).
Anthroposophic pharmacopoeia is a publication or a part of a publication
specified by the Minister, by legislative instrument, under new paragraphs
3AB(3)(a) or (b), respectively. The publication or part of a publication
specified in the legislative instrument is a publication or part of a
publication as in force from time to time. The legislative instrument
therefore applies, adopts or incorporates, with or without modification any
matter contained in the publication or part of the publication specified in
the instrument as in force from time to time.
Items 2 and 3
These items insert new definitions of anthroposophic preparation and
anthroposophic standard at subsection 3(1) and provide that these are as
defined under new subsections 3AB(1) and (2) (item 9 refers).
Item 4
This item inserts a new definition of homoeopathic pharmacopoeia at
subsection 3(1) to provide for standards to be established for homoeopathic
preparations under new section 3AA(3) (item 9 refers). Homeopathic
pharmacopoeia is a publication or a part of a publication specified by the
Minister, by legislative instrument, under new paragraphs 3AA(3)(a) or (b),
respectively. The publication or part of a publication specified in the
legislative instrument is a publication or part of a publication as in
force from time to time. The legislative instrument therefore applies,
adopts or incorporates, with or without modification any matter contained
in the publication or part of the publication specified in the instrument
as in force from time to time.
Items 5 and 6
These items insert new definitions of homoeopathic preparation and
homoeopathic standard at subsection 3(1) and provide that these are as
defined under new sections 3AA(1) and (2) (item 9 refers).
Item 7
This item inserts a new definition of mother substance at subsection 3(1)
and specifies the things that may be a mother substance for the purposes of
new sections 3AA and 3AB (item 9 refers). A mother substance is used in
the manufacture of a homoeopathic or anthroposophic preparation.
Item 8
This item amends the definition of standard at subsection 3(1) by inserting
two new paragraphs to reflect inclusion under the Act of homoeopathic and
anthroposophic standards (items 3 and 6). The numbering of these new
paragraphs (e) and (f) reflects amendments proposed by the Therapeutic
Goods Amendment (Medical Devices and Other Measures) Bill 2008 [2009] (item
6 of Schedule 4 of that Bill).
Item 9
This item inserts new sections 3AA and 3AB that set out the requirements
for homoeopathic and anthroposophic preparations and standards, as referred
to under the new definitions for these products (items 2, 3, 5 and 6
refer).
New subsection 3AA(1) defines homoeopathic preparation (item 5 refers) by
setting out that preparations are homoeopathic if they are made from a
mother substance (item 7 refers) and manufactured according to requirements
set out in a homoeopathic pharmacopoeia (item 4 refers).
New subsection 3AA(2) establishes the standard for homoeopathic
preparations. Subsection 3AA(2) provides that there is an applicable
homeopathic standard to particular therapeutic goods if they are a
homoeopathic preparation, and those goods are subject to one or more
monographs in a homeopathic pharmacopoeia (other than a monograph exempt
under subsection (4)) describing the manufacturing procedure that the
preparation was manufactured in accordance with. The homoeopathic standard
applying to those goods is constituted by the statements (other than those
exempt under subsection (5)) and is to be interpreted in accordance with
the interpretation sections of the homoeopathic pharmacopoeia.
New subsection 3AA(3) empowers the Minister to specify, by legislative
instrument, a publication and/or a parts of publications as the
homoeopathic pharmacopoeia for the purposes of the definition of that term
(item 4 refers).
New subsections (4) and (5) empower the Minister to determine, by
legislative instrument, that monographs or specified statements in
specified monographs in specified pharmacopoeia are not to be applicable as
standards for the purposes of paragraph (2)(b). In practice this will
provide that, for example, if compliance with monographs or parts of
monographs would result in unsafe homoeopathic preparations, these
references can be excluded from applying as standards for homoeopathic
preparations in Australia.
New section 3AB defines anthroposophic preparation (item 2 refers) by
setting out that preparations are anthroposophic if they are made from a
mother substance (item 7 refers) and made according to requirements in an
anthroposophic pharmacopoeia (item 1 refers).
Subsection (2) establishes the standard for anthroposophic preparations.
Subsection 3AB(2) provides that there is an applicable anthroposophic
standard to particular therapeutic goods if they are an anthroposophic
preparation, and those goods are subject to one or more monographs in an
anthroposophic pharmacopoeia (other than a monograph exempt under
subsection (4)) describing the manufacturing procedure that the preparation
was manufactured in accordance with. The anthroposophic standard applying
to those goods is constituted by the statements (other than those exempt
under subsection (5)) and is to be interpreted in accordance with the
interpretation sections of the anthroposophic pharmacopoeia.
Subsection (3) empowers the Minister to specify, by legislative instrument,
a publication and/or parts of a publication is an anthroposophic
pharmacopoeia for the purposes of the definition of anthroposophic
pharmacopoeia (item 1 refers).
Subsections (4) and (5) empower the Minister to determine, by legislative
instrument, that specified monographs or statements in specified monographs
in specified pharmacopoeia are not to be applicable as standards for the
purposes of paragraph (2)(b). In practice this will provide that, for
example, if compliance with monographs or parts of monographs would result
in unsafe anthroposophic preparations, these references can be excluded
from applying as standards for anthroposophic preparations in Australia.
The note under subsection (4) explains that subsection 13(3) of the
Legislative Instruments Act 2003 applies to this subsection and has the
effect that a legislative instrument made under this subsection may, in
specifying monographs in specified anthroposophic pharmacopoeia, do so by
reference to a class or classes of monographs or anthroposophic
pharmacopoeia.
Items 10 and 11
These items amend subsection 10(1) and subparagraph 10(2)(a)(iv) to include
reference to homoeopathic and anthroposophic pharmacopeia for the purposes
of determining standards.
Item 12
This item inserts new section 13A to make special provisions relating to
homoeopathic and anthroposophic standards.
New subsection 13A(1) provides that where a monograph in a homoeopathic or
anthroposophic pharmacopoeia refers to a statement in another publication,
this other statement has the same effect as if it were included in the
pharmacopoeia monograph itself. This in practice provides that
homoeopathic and anthroposophic preparations that are prepared according to
a monograph in a pharmacopoeia must also comply with any specifications in
a document referred to in that monograph.
Subsection (2) provides that where a Ministerial determination in relation
to applicable standards exists under section 10 that applies to a
homoeopathic or anthroposophic preparation, and there is also an
anthroposophic or homoeopathic standard applicable (items 3 and 6 refer),
then the Ministerial determination is to have priority and the
anthroposophic or homoeopathic standard to be disregarded to the extent
there is an inconsistency between the two.
The note at the end of new section 13A advises that the heading to section
13 is amended, to include reference to default standards, to be "Special
provisions relating to standards and default standards" to clarify the
matters provided for under the section.
Item 13
This item amends section 56 to expand the pharmacopoeia of which courts are
to take judicial notice to include homoeopathic and anthroposophic
pharmacopeia.
SCHEDULE 5 - INGREDIENTS IN THERAPEUTIC GOODS
Currently regulations made under the Act set out a list of permitted
ingredients in listed medicines to be provided under the Regulations.
However, many ingredients approved before the Act came into force are
covered as a class in the Regulations, but are not individually identified.
This Schedule enables the Minister to determine by legislative instrument
lists of such ingredients, thus improving clarity and transparency of these
requirements.
Item 1
This item inserts new paragraphs (ea) and (eb) at subsection 26(1), which
provides for the listing of medicines for export only and other therapeutic
goods.
New paragraphs (ea) and (eb) provide, respectively, that the Secretary is
able to refuse to list goods where she or he is satisfied that the goods
contain a component or an ingredient that is prohibited under new
subsection 26BE(1) (item 3 refers) or where the permissible amount or
concentration of a permitted ingredient or component, pursuant to new
subsection 26BE(2), is exceeded (item 3 refers).
Item 2
This item inserts new paragraphs (ca), (cb), (cc) and (cd) at subsection
26A(2), which provides for the certifications an applicant must make in an
application for listing of medicines.
The new paragraphs require applicants to certify the following, additional
to existing certification requirements under subsection 26A(2) in relation
to the medicine:
. new paragraph (ca) requires that applicants certify that all the
active ingredients contained in the medicine, which is the subject of
the listing application, are those specified in the determination made
by the Minister under new section 26BB (item 3 refers);
. new paragraph (cb) provides that if the medicine contains an active
ingredient that is specified in a determination under new section 26BB
that applies to that medicine, and the determination specifies a
permitted concentration of the active ingredient or a permitted total
amount of the active ingredient, the applicant is required to certify
that the active ingredients do not exceed the permitted concentration
or permitted total amount as specified in the determination (item 3
refers);
. new paragraph (cc) provides that if new subsection 26BE(1) applies in
relation to the medicine, the applicant is required to certify that
the medicine does not include any prohibited ingredients or components
specified in a determination under new subsection 26BE(1) (item 3
refers); and
. new paragraph (cd) provides that if the medicine contains a component
or ingredient that is specified in a determination under new
subsection 26BE(2) that applies to the medicine, the applicant is
required to certify that the medicine does not include amounts of
ingredients or components that exceed the limited permissible
concentration or amount (pursuant to new subsection 26BE(2)) of an
otherwise prohibited ingredient (item 3 refers).
Item 3
This item inserts new sections 26BB, 26BC, 26BD and 26BE to provide for the
Minister to determine lists of permitted and prohibited ingredients and
components in listed medicines, by legislative instrument.
New section 26BB empowers the Minister under subsection (1) to determine,
by legislative instrument, active ingredients and permitted concentrations
and/or amounts of active ingredients that can be included in listed
medicines under section 26A. Subsection (2) provides that determinations
may be made for different classes of medicines. In practice this may
enable different concentrations of an active ingredient to be specified for
different classes of medicines to reflect the relative risk profile of the
medicine classes.
Subsection (3) specifies that, as provided for under subsection 14(2) of
the Legislative Instruments Act 2003, a determination under subsection (1)
may refer to a matter in an instrument or other writing as in force or
existing from time to time.
A decision under this section will apply to all medicines seeking section
26A listing in the Register and will be a criterion for assessing the
suitability of a particular medicine to be entered in the Register.
Decisions made by the Minister under this section will be based upon expert
advice regarding the safety and suitability of ingredients in medicines.
The determination under this section will apply to all sponsors and
applicants for the listing of goods and not a particular individual. As a
result, determinations under this section would not be suitable for merits
review.
New section 26BC empowers the Minister to vary a list of permitted
ingredients (determined under new section 26BB) on her or his own
initiative, by legislative instrument.
New section 26BD provides that applications can be made to the Minister
under subsection (1) to seek a variation to the list of permitted active
ingredients and the permitted concentrations and/or permitted total amounts
of those active ingredients made under new section 26BB. Subsection (2)
sets out the requirements for an application for seeking variation (e.g.
that a new active ingredient be included on the list). If an application
is made and any applicable prescribed application fee has been paid, the
Minister may, by legislative instrument, vary the determination under new
section 26BB (subsection 26BD(4)).
The Minister, under subsection (4), on receiving an application may, by
written notice to the applicant, seek further information from the
applicant which is to be provided in the time specified in the notice.
Subsection (5) provides that an approval of an application form or notice
given under subsection (4) may require or allow the application or
information to be submitted in a particular electronic format.
Applications made under new subsection 26BD(1) will be determined by the
Minister based on advice from an expert committee regarding the safety and
suitability of ingredients in medicines. Decisions made under this
section, to vary a determination made under new section 26BB, apply to all
applications for the listing of medicines containing the ingredient and are
not limited to the applicant's goods. As a result, decisions under this
section are legislative and would not suitable for merits review.
New section 26BE empowers the Minister to specify, by legislative
instrument under subsection (1), components or ingredients that therapeutic
goods for listing must not contain. Subsection (2) empowers the Minister to
determine, by legislative instrument, that only ingredients or components
in specified limited amounts or concentrations can be included in listed
therapeutic goods.
Medicines seeking listing are subject to determinations under new section
26BE, pursuant to new paragraphs 26(1)(ea) and (eb) and 26A(2)(ca), (cb),
(cc) and (cd) (items 1 and 2 refer).
Subsection (3) explains that determinations made under subsections (1) and
(2) may make different provisions for different classes of goods.
Subsection (4) specifies that, as provided for under subsection 14(2) of
the Legislative Instruments Act 2003, a determination under subsection (1)
may refer to a matter in an instrument or other writing as in force or
existing from time to time. For example, in practice this would enable the
Minister to determine that listed medicines are prohibited from containing
active ingredients specified in the national medicine schedules (Standard
for the Uniform Scheduling of Drugs and Poisons) as this is updated from
time to time by new editions.
Subsection (5) empowers the Minister to vary a determination that lists
prohibited ingredients or components (made under subsection (1)) or listing
ingredients or components permitted in limited amounts or concentrations
(made under subsection (2)).
Item 4
This item amends paragraph 30(1)(e), which provides for the cancellation of
registration or listing of a therapeutic good where a certification made
under section 26A is incorrect, to reflect new certification requirements
provided for by new paragraphs 26A(2)(ca), (cb), (cc) and (cd) (item 2
refers).
Item 5
This item sets out the application of the amendments made by this Schedule
to sections
26 and 26A, that provide for the listing of therapeutic goods.
It provides that the amendments to these sections apply to applications for
listings that are made on or after the commencement of those items (on a
day to be proclaimed but no later than 6 months after Royal Assent).
SCHEDULE 6 - AMENDMENTS RELATING TO LEGISLATIVE INSTRUMENTS
This Schedule provides for references in the Act to legislative instruments
be updated to reflect the application of the Legislative Instruments Act
2003 and current terminology. This Schedule also removes references to
section 46A of the Acts Interpretation Act 1901 which has already been
repealed.
Items 1 and 2
These items amend subsection 10(1) to make it clear that the making of
Ministerial orders establishing a standard for therapeutic goods is a
legislative instrument.
Item 1 specifies that an order made by the Minister under this subsection
is a legislative instrument, replacing the reference to publication of the
order in the Gazette.
Item 2 inserts a note at the end of the subsection to explain that section
12 of the Legislative Instruments Act 2003 provides when a legislative
instrument takes effect and this applies to the order made by the Minister
under this section.
Item 3
This item amends section 10 by inserting a new subsection 10(3A) empowering
the Minister to vary or revoke an order determining a standard for
therapeutic goods made under subsection (1). The power to revoke or vary
an order determining a standard for therapeutic goods is already provided
for under current subsection 10(4) and section 12. This new subsection
merely reiterates the power to vary or revoke the order determining
standards. This item also inserts a note explaining that, as with the
original order made under subsection (1), section 12 of the Legislative
Instruments Act 2003 applies and provides when a legislative instrument
takes effect in regard to the revocation or variation to the order made by
the Minister.
Item 4
This item amends subsection 10(4) consequential to the amendments made
under item 1, to reflect that Ministerial orders made under subsection (1)
are legislative instruments for the purposes of the Legislative Instruments
Act 2003. The item therefore replaces references to "standard" with the
term "order" to reflect that orders are legislative instruments.
Item 5
This item repeals sections 11 and 12 as they are no longer necessary
following clarification of orders (formerly referred to as standards) as
legislative instruments under the Legislative Instruments Act 2003.
Section 11, dealing with date of effect of standards, is no longer required
as section 12 of the Legislative Instruments Act 2003, dealing with date of
effect of legislative instruments, applies to orders made under section 10
(items 1 and 3 refer).
Section 12, dealing with disallowance of standards, is also no longer
required as disallowance of orders as legislative instruments is provided
for under the Legislative Instruments Act 2003.
Item 6
This item amends subsection 19A(5) to reflect that determinations made
under this section to exempt goods are legislative instruments and subject
to the Legislative Instruments Act 2003. This explains rather than changes
the nature of determinations made under section 19A.
Item 7
This item amends subsection 36(4) to reflect that Ministerial
determinations establishing applicable manufacturing principles are
legislative instruments and subject to the Legislative Instruments Act
2003. This explains rather than changes the nature of determinations made
under this section.
Items 8 and 9
These items amend subsection 41CB(1) to reflect that a Ministerial order,
determining applicable medical device standards, are legislative
instruments and subject to the Legislative Instruments Act 2003. This
explains rather than changes the nature of determinations made under this
section.
Item 9 inserts a note at the end of the subsection to explain that section
12 of the Legislative Instruments Act 2003 provides when a legislative
instrument takes effect and this applies to the order made by the Minister
under this section.
Item 10
This item repeals subsections 41CB(2) and (3) and inserts a new subsection
(2) making it clear that the Minister can vary or revoke an order
determining a standard for medical devices made under subsection (1).
Previous subsections (2) and (3), which dealt with when a standard takes
effect and specifying that a standard is disallowable, are no longer
required as item 8 explains that Ministerial orders determining medical
device standards are legislative instruments and, as such, are subject to
the Legislative Instruments Act 2003 which provides for these matters.
Items 11 and 12
These items amend subsection 41DC(1) to reflect that Ministerial orders
determining applicable medical device conformity assessment standards are
legislative instruments and subject to the Legislative Instruments Act
2003. This explains rather than changes the nature of determinations made
under this section.
Item 12 inserts a note at the end of the subsection to explain that section
12 of the Legislative Instruments Act 2003 provides when a legislative
instrument takes effect and this applies to the determinations made by the
Minister under this section.
Item 13
This item repeals subsections 41DC(3) and (4) and inserts a new subsection
(3) empowering the Minister to vary or revoke an order determining
conformity assessment standards for medical devices made under subsection
(1).
Previous subsections (3) and (4), which dealt with when a standard takes
effect and specifying that a standard is disallowable, are no longer
required as item 11 explains that orders determining applicable conformity
assessment standards are legislative instruments and, as such, are subject
to the Legislative Instruments Act 2003 which provides for these matters.
Item 14
This item sets out the saving and transitional provisions applying to the
amendments made by this Schedule to sections 10, 11, 41CB and 41DC.
Subitem (1) provides that the amendment to section 10 made by item 1,
explaining that orders that determine standards are legislative
instruments, will not affect the validity of an order made under that
section before commencement of this item (on the day after the Act receives
the Royal Assent). This is as item 1 explains rather than changes the
nature of the decision.
Subitem (2) provides that the repeal of section 11 of the Act (item 5
refers) will not apply to an order under section 10, to determine standards
for therapeutic goods, made before the commencement of this item (on the
day after the Act receives the Royal Assent). The repeal of section 11
does not affect the validity and effective dates of orders made under
section 10 prior to the commencement date of item 5.
Subitem (3) provides that the amendment made by item 8, explaining that an
order made under subsection 41CB(1) is a legislative instrument, does not
affect the validity of an order made under that section before the
commencement of this item (on the day after the Act receives the Royal
Assent).
Subitem (4) provides that, despite the repeal of subsection 41CB(2) (item
10), that subsection will continue to apply on and after commencement of
this item (the day after the Act receives the Royal Assent) to an order in
force under that section prior to the commencement of this item. The
repeal of subsection 41CB(2) does not affect the validity and effective
dates of orders made under section 41CB prior to the commencement date of
item 10. Therefore, the effect of the repeal of that subsection will apply
only to orders made on or after commencement of this item, as such orders
will be expressed to be legislative instruments and subject to section 12
of the Legislative Instruments Act 2003 providing when the order is to take
effect.
Subitem (5) provides that the amendment made by item 11 to declare that
orders made under section 41DC, to determine conformity assessment
standards, are legislative instruments does not affect the validity of an
order made under that section before the commencement of this item (on the
day after the day this Act receives the Royal Assent).
Subitem (6) provides that, despite the repeal of subsection 41DC(3) (item
13), that subsection will continue to apply on and after commencement of
this item (the day after the Act receives the Royal Assent) to an order in
force under that section prior to the commencement of this item. The
repeal of subsection 41DC(3) does not affect the validity and effective
dates of orders made under section 41DC prior to the commencement date of
item 13. Therefore, the effect of the repeal of that subsection will apply
only to orders made on or after commencement of this item, as such orders
will be expressed to be legislative instruments and subject to section 12
of the Legislative Instruments Act 2003 providing when the order is to take
effect.
SCHEDULE 7 - OTHER AMENDMENTS
This schedule contains a number of miscellaneous amendments intended to
improve the operation of the Act, give legislative effect to current
administrative practice, improve transparency and accountability, and
remedy minor errors in current provisions.
Part 1 - Amendments commencing on the day after Royal Assent
Item 1
This item repeals and replaces the definition of an accessory to a medical
device contained in subsection 3(1) of the Act. The new definition makes
it clear that a thing that is an accessory to an accessory to a medical
device is not a medical device for the purposes of section 41BD. This
intent is affected by removing a reference to paragraph 41BD(1)(b) (an
accessory to a medical device) in the definition of accessory under
subsection 3(1) of the Act. Item 1 now defines an accessory in relation to
a medical device covered by paragraph 41BD(1)(a), (aa) or (ab), to mean a
thing that the manufacturer of the thing specifically intended to be used
together with the device to enable the device to be used as the
manufacturer of the device intended.
Item 2
This item substitutes an incorrect reference in the definition of listable
goods in subsection 3(1) to subsection 17(5) (which was repealed by the
Therapeutic Goods Amendment (Medical Devices) Act 2002) with a reference to
subsection 9A(5).
Item 3
This item inserts a new section 7C. Subsection 7C(1) allows the Secretary
to arrange for the use of computer programs, under the Secretary's control,
for any purpose for which the Secretary may make a decision under the Act
or regulations, and subsection (2) provides that a decision made by the
operation of such a program is taken to be a decision of the Secretary.
Subsections (3) and (4) allow the Secretary to substitute her or his own
decision for an initial decision made by the operation of the computer
program within 60 days of that initial decision being made if the Secretary
is satisfied that the initial decision is incorrect.
(Item 25 amends section 60 to provide that a decision by the Secretary to
substitute a decision is subject to review by the Minister.)
Item 4
This item corrects an error in subsection 24D(5) by amending it to refer to
subsection 25(4) as well as subsection 25(3) as setting out when an
applicant is notified of the Secretary's decision on an application to
register a therapeutic good.
Item 5
This item amends paragraph 26A(1)(c) to refer to new subsections (2A) and
(4A) to be added by items 9 and 10.
Item 6
This item amends paragraph 26A(2)(e) to remove a reference to a
manufacturing licence "granted under section 38" as, following the
amendments in Schedule 2, authority for carrying out particular steps in
the manufacturing process will be derived from manufacturing site
authorisations.
Item 7
This item amends paragraph 26A(2)(f) to clarify that applicants for listing
a medicine are required to certify that the medicine complies with all
prescribed quality or safety criteria "applicable to the medicine", rather
than all the criteria that are prescribed.
Item 8
This item amends subsection 26A(2) to add three new paragraphs setting out
matters that applicants for listing a medicine must certify:
. paragraph (fa) - that the medicine complies with any applicable
specifications prescribed by the regulations;
. paragraph (fb) - that the medicine's label complies with any
applicable requirements prescribed by the regulations and does not
make a claim inconsistent with the claim made in or in connection with
the application for the listing of the medicine; and
. paragraph (fc) - that the applicant holds evidence showing that the
medicine's specifications will be maintained, as long as the medicine
is kept in the conditions specified on the label, until the expiry
date.
Items 9 and 10
These items add to section 26A:
. a new subsection (2A) requiring applicants for listing a medicine to
certify any other matters prescribed by the regulations; and
. a new subsection (4A) requiring that the Secretary must have certified
the safety of any ingredient of animal origin included in a medicine
before an application for listing is made.
Items 11 to 13
These items amend section 30, dealing with the cancellation of registration
or listing, to refer to new paragraphs 26A(2)(fa) to (fc) and new
subsections 26A(2A) and (4A) inserted by items 8 to 10.
Item 11 allows the Secretary, if it appears to her or him that the
requirements of new subsection 26A(4A) were not fulfilled, to cancel the
listing of the goods under subsection 30(1), without the requirement to
give opportunity to provide a submission to the Secretary in relation to
that decision. New subsection 26A(4A) requires a certification by the
Secretary, prior to the application being made, that she or he is satisfied
of the safety of the ingredient.
Items 12 and 13 allow the Secretary, if it appears to her or him that
certifications under new paragraphs 26A(2)(fa) to (fc) or new
subsection 26A(2A) were not correct, to cancel the listing of the
therapeutic good. However, as subsection 26A(2) is subject to subsection
26A(3), the Secretary is required to inform the person in writing that the
Secretary proposes to cancel the listing, setting out the reasons for the
proposed decision, and to give the person reasonable opportunity to make
submissions to the Secretary in relation to that proposed action. The
Secretary must take into account submissions made by the person before
making a decision relating to the cancellation of the listing of the goods.
Item 14
Under paragraph 30(1)(c), the person in relation to whom therapeutic goods
are listed or registered may apply to the Secretary to cancel the
registration or listing. On occasion such applications are made in error,
and if the person wishes to continue the registration or listing they must
re-apply.
This item inserts a new section 30A allowing a person to apply to the
Secretary to revoke a cancellation made on the basis of paragraph 30(1)(c),
as long as the person applies in writing to the Secretary within 90 days of
the goods ceasing to be registered or listed. If the Secretary revokes the
cancellation, it is taken never to have occurred (new subsection 30A(2)).
The new section 30A applies to cancellations occurring before, on or after
commencement of this item (the day after the Act receives the Royal Assent)
as provided for by item 27. This will confer a benefit upon persons who,
prior to commencement of this item, applied for an application they
previously submitted for registration or listing of a therapeutic good to
be treated as cancelled. This is because section 30A will enable such
persons to submit a request that this be revoked enabling the initial
application for registration or listing to be considered.
Item 15
This item replaces an incorrect reference in subsection 30EA(1) to
subsection 42EA(1) with the correct reference to section 42EA.
Items 16 to 19
These items amend the definition of medical device in subsection 41BD(1).
Item 16 replaces the term "handicap" with the term "disability" in line
with accepted modern usage.
Item 17 amends the definition of medical device in subsection 41BD(1) by
inserting new paragraphs (1)(aa) and (ab). Paragraph 1(aa) allows for any
instrument, apparatus, appliance, material or other article to be medical
devices, in addition to those covered by the definition set out in
paragraph (1)(a), if they are specified under new subsection 41BD(2A) (item
21 refers). Paragraph (1)(ab) allows for any instrument, apparatus,
appliance, material or other article to be medical devices, that is
included in a class of instruments, apparatus, appliances, materials or
other articles in addition to those covered by the definition set out in
paragraph (1)(a), if they are specified under new subsection 41BD(2B) (item
21 refers).
Items 18 and 19 make consequential amendments to reflect the inclusion of
the above new paragraphs.
Item 20
This item repeals and replaces subsection 41BD(2) to provide that the
purpose of an instrument, apparatus, appliance, material or other article
may be ascertained from any technical documentation describing its
mechanism of action as well as its labelling, instructions for use or
advertising.
The item clarifies that new subsection (2) applies to other medical devices
such as instrument, apparatus, appliance, and material as referred to in
paragraph 41BD(1)(a) and not just to articles, when ascertaining the
purpose for which devices are to be used from the information supplied by
the person under whose name those devices would be supplied. This
amendment does not expand the application of this subsection but simply
clarifies its application. As such, there will not be a negative impact
upon those covered under the subsection.
Item 21
This item inserts new subsections:
. 41BD(2A) empowering the Secretary, by notice in the Gazette, to
specify that a particular instrument, apparatus, appliance, material
or other article is a medical device for the purpose of new paragraph
42BD(1)(aa); and
. 41BD(2B) empowering the Secretary, by legislative instrument, to
specify that a particular class of instruments, apparatus,
appliances, materials or other article is a medical device for the
purpose of new paragraph 42BD(1)(ab).
The effect of these new subsections would be that any instrument,
apparatus, appliance, material or other article specified by the Secretary
under these new subsections is a medical device.
Item 22
This item repeals and replaces subsection 41BE(3) and allows the Minister,
by legislative instrument, to determine device nomenclature codes. These
codes are at present specified under the regulations.
However, the regulations for the purposes of subsection 41BE(3) remain in
force even after the commencement of new subsection 41BE(3), until the
first determination made by the Minister under subsection 41BE(3) takes
effect (item 28 refers).
Item 23
This item amends the definition of a manufacturer of a medical device in
section 41BG by including a person who assigns a purpose to a device by
means of information supplied in technical documentation describing its
mechanism of action (refer to new subparagraph 41BG(2)(f)(iv)). This item
also adds a new subparagraph in paragraph 41BG(3)(c) to make it clear that
a person is not a manufacturer of a medical device if the person assembles
or adapts a device, that has already been supplied by another person, for
use by an individual patient and the assembly or adaptation does not change
the purpose intended for the device by means of information supplied by
that other person based on the any of the matters set out in paragraph (c),
including technical documentation describing its mechanism of action (new
subparagraph (iv)).
Item 24
This item adds subsection 41BG(4) to provide for regulations to be made
prescribing classes of persons who are not manufacturers of medical
devices. It is intended that this power will be used to clarify that
persons undertaking the sterilisation of devices intended for multiple uses
and reuse of the device are not manufacturers.
Item 25
This item amends the list in subsection 60(1) of initial decisions by the
Secretary which are subject to review by the Minister, to include a
decision by the Secretary to substitute a decision for a decision reached
by a computer under new section 7C (item 3 refers).
Item 26
This item provides that the amendments to section 26A made by items 5 to
10, changing the certification requirements for applicants for listing,
apply to applications made on or after the commencement of the items (the
day after Royal Assent).
Item 27
This item provides that the new section 30A (item 14 refers), allowing
persons to apply for revocation of a cancellation they have initiated,
applies to cancellations occurring before, on or after the commencement of
the item (the day after Royal Assent).
Item 28
This item provides that despite the repeal of subsection 41BE(3) by item
22, regulations in force made for the purpose of that subsection continue
in force after the commencement of the item (the day after Royal Assent)
until the first determination made under the new subsection 41BE(3) takes
effect.
Part 2 - Amendments commencing on a day to be fixed by Proclamation
Item 29
This item repeals and replaces the definition of the Therapeutic Goods
Advertising Code in subsection 3(1), which is the definitions section of
the Act. The new definition refers to the Code to be made under new
section 42BAA (item 51).
Items 30 to 33 and item 35
These items amend the current system of imposing conditions of registration
or listing on therapeutic goods included in the Register. Under the
current system the conditions the Secretary imposes on new registrations
under subsection 28(1) includes a standard set of conditions as well as
conditions specific to the particular goods. To improve transparency and
accountability, these standard conditions will now be determined by the
Minister by legislative instrument.
Item 30 repeals existing subsections 28(1) and (2), and replaces them with
new subsections 28(1), (2), (2A) and (2B) allowing the Minister to
determine, by legislative instrument, conditions of registration or
listing. New subsection 28(1) provides that registration or listing of
therapeutic gods is subject to the conditions set out in a determination
under new subsection 28(2). New subsection 28(2A) allows the Minister to
make different determinations setting out conditions for registered goods,
listed goods, or different classes of goods. New subsection 28(2B) allows
the Secretary to impose specific conditions on particular goods at the time
of registration or listing.
Item 31 amends subsection 28(3) to refer to new subsection 28(2B) which
authorises the Secretary to impose conditions at the time of registration
or listing, and to refer to a specific power to remove or vary conditions
imposed under new subsection 28(2B). The Secretary cannot override
conditions determined by the Minister under subsections 28(2) and (3).
Item 32 amends subsection 28(4) to refer to the removal of a condition
under subsection (3) as well as imposition or variation of a condition, and
items 33 and 35 amend subsections 28(5) and (5A), respectively, which
impose statutory conditions, to provide that these conditions are
additional to those imposed under subsections (1), (2B) and (3). Items 33
and 35 are consequential amendments relating to the inclusion of new
subsection 28(2B) (item 30 refers).
Item 34
This item amends subsection 28(5) to add two new conditions of registration
or listing: that the person in relation to whom goods are registered or
listed:
. not supply or export the goods after their expiry date (paragraph
(aa)); and
. not advertise the goods for an indication that has not been accepted
in including the goods in the Register (paragraph (ab)).
Items 36 and 37
These items enhance scrutiny of Australian and overseas manufacture of
listed medicines.
Item 36 inserts new subsection 28(5B), providing that the listing of a
medicine under section 26A is subject to the condition that:
. each step in the manufacture of the medicine carried out in Australia
is carried out by the holder of a manufacturing licence under Part 3-3
of the Act (paragraph (a)); and
. each step in the manufacture of the medicine carried out outside in
Australia is the subject of a certification under subsection 26A(3) or
new subsection 28A(2) (paragraph (b)).
Applicants for listing of a medicine under section 26A proposing that steps
in the manufacture of the medicine be carried out outside Australia must
have obtained certification from the Secretary under subsection 26A(3)
before the application is made, that the manufacturing and quality control
procedures are acceptable.
Subsection 28(5B) ensures that requirements relating to the manufacture of
the medicines continue to apply even after the goods are listed in the
Register and in circumstances where the sponsor changes the manufacturers
of the goods.
Item 36 also inserts new subsection 28(5C) providing that subsection 28(5B)
does not apply if the medicine is exempt from the operation of Part 3-3.
Item 37 inserts new section 28A. Subsection 28A(1) provides that a person
in relation to whom a medicine is listed under section 26A may apply to the
Secretary for a certification that the manufacturing and quality control
procedures of a step in the manufacture of the medicine to be carried out
outside Australia are acceptable, and subsection 28A(2) allows the
Secretary to make such a certification. The Secretary is required to give
notice of such certification. Subsection 28A(3) applies the procedure
under subsection 26A(4) for the Secretary to follow in deciding whether to
give a certificate. These provisions would normally apply where the person
in relation to whom a medicine is listed in the Register under section 26A
changes its overseas manufacturer from those assessed during the listing
process.
Items 38 and 39
Item 38 adds new paragraph 41JA(1)(ba), which adds to the list of people
who the Secretary may ask to give information about medical devices, a
person who held a conformity assessment certificate for a medical device at
any time during the notice period set out in subsection 41JA(2), and item
39 makes a consequential amendment to paragraph 41JA(1)(d) in view of the
inclusion of new paragraph 41JA(1)(da) (item 40 refers).
Item 40
This item adds new paragraph 41JA(1)(da). This is not a new provision as
it merely refers to a person that was previously referred to in paragraph
41JA(1)(d), i.e. a person in relation to whom a kind of medical device was
included in the Register at any time during the notice period set out in
subsection 41JA(2).
Item 41
This item adds new paragraphs 41JA(1)(ia) and (ib), which add to the
information the Secretary may seek under subsection 41JA(1), to now include
information about the safety and efficacy of medical devices and
information about their overseas regulatory history.
Item 42
This item adds new subsections 41JA(1AA) and (1AB), providing that the
persons covered by new paragraphs 41JA(1)(ba) and (da) (items 38 and 40
refer) may only be asked to provide information set out in paragraphs
(1)(e) to (j) (to the extent to which they are relevant) in relation to the
period during which they held a conformity assessment certificate or the
device was included in the Register.
Item 43
This item amends subsection 41JA(2) consequential to the changes made by
items 38 and 40 that are the inclusion of new paragraphs 41JA(1)(ba) and
(da). Paragraph 41JA(1)(d) is no longer relevant.
Items 44 to 50
These items amend section 42AA which provides that Part 5-1 of the Act,
dealing with advertising, does not apply to advertisements directed
exclusively to certain health professionals.
The effect of the amendments is that paragraph 42AA(1)(a) will list those
health professionals covered by the proposed national registration scheme
and paragraph 42AA(1)(c) will list those health professionals covered by
State or Territory registration.
A new paragraph 42AA(1)(d) and new subsection 42AA(1A) will allow the
Minister, by legislative instrument, to determine other classes of persons.
Advertisements directed exclusively to those persons will be excluded from
the application of Part 5-1 (items 49 and 50, respectively).
Dieticians and scientists working in medical laboratories, which are
presently covered by paragraph 42AA(1)(a), will no longer be referred to in
the Act (item 46). The Government intends that they will be covered by an
instrument under new subsection 42AA(1A).
Veterinary surgeons will also be removed from paragraph 42AA(1)(a) as the
Act does not regulate veterinary medicines (item 44).
Item 51
This item inserts new section 42BAA, allowing the Minister, by legislative
instrument, to make a code relating to advertisement about therapeutic
goods called the Therapeutic Goods Advertising Code (see item 29).
Items 52 and 54
These items amend references to the Therapeutic Goods Advertising Code in
section 42DD and paragraph 42DF(4)(c). These provisions currently refer to
parts of the Code prescribed by regulations. As the relevant sections of
the Code are readily identifiable by reference, the requirement that they
be identified by prescription in the regulations is being removed,
obviating the need to make new regulations if the Code is amended.
Item 53
This item replaces paragraph 42DF(4)(b), which presently requires the
Secretary, in deciding whether to approve or refuse to approve the use of a
restricted representation, to take into consideration any advice from one
of two named committees: the Complementary Medicines Evaluation Committee
established under Part 6-4 of the Act and the Medicines Evaluation
Committee established under the regulations. However, item 55 repeals Part
6-4 of the Act. While the Government is intending to amend the regulations
to establish a replacement committee, it also intends to change the names
of existing committees established under the regulations. The replacement
paragraph 42DF(4)(b) thus refers to the Secretary taking any advice from a
committee established under the regulations and prescribed for the purpose
in the regulations.
Item 55
This item repeals Part 6-4 of the Act. The only purpose of this Part is to
establish the Complementary Medicines Evaluation Committee. As all other
similar advisory committees are established under the regulations, the
Government intends to establish a replacement advisory committee on
complementary medicines under the regulations. This Part of the Act would
then be redundant.
Item 56
This item contains savings provisions related to the Therapeutic Goods
Advertising Code.
Subitem (1) provides that the Code in existence at the time of commencement
of this item (a day to be proclaimed but no later than six months after
Royal Assent) continues in force until the first instrument made under new
section 42BAA comes into effect (item 51 refers).
Subitems (2) and (3) provide that, despite the amendments made by items 52
and 54 respectively, regulations made under section 42DD and paragraph
42DF(4)(c) continue in force until the first instrument made under new
section 42BAA comes into effect (item 51 refers).
Item 57
This item contains application and transitional provisions relating to
conditions of registration or listing.
Subitem (1) provides that conditions of registration or listing, determined
by the Minister under subsection 28(1) of the Act (item 30 refers), apply
to the registration or listing of therapeutic goods before, on or after
this item commences (a day to be proclaimed but no later than six months
after Royal Assent).
Subitem (2) provides that conditions of registration or listing, determined
by the Secretary under subsection 28(2B) (item 30 refers), apply to the
registration or listing of therapeutic goods on or after this item
commences (a day to be proclaimed but no later than six months after Royal
Assent).
Subitem (3) provides that conditions of registration or listing, determined
by the Secretary under subsection 28(1), before the commencement of this
item (a day to be proclaimed but no later than six months after Royal
Assent) continue in force as if they had been imposed, on that
commencement, under new subsection 28(2B) (item 30 refers).
Subitem (4) provides that subitem (3) does not prevent the variation or
removal of these conditions of registration or listing under subsection
28(3).
Subitem (5) provides that the amendment made by item 31, relating the
Secretary's power to vary or remove conditions of registration or listing
imposed under subsection 28(2B), applies to conditions imposed under
subsection 28(2B) (including conditions taken to have been imposed under
that subsection because of subitem (3)) on or after the commencement of the
item, and conditions imposed under subsection 28(3) before, on or after the
commencement of the item (a day to be proclaimed but no later than six
months after Royal Assent).
Subitems (6) and (7) provide that the new conditions or registration or
listing imposed by new paragraphs 28(5)(aa) and (ab) and new subsection
28(5B) apply to the registration or listing of the therapeutic goods or
medicine before, on or after commencement of the item (a day to be
proclaimed but no later than six months after Royal Assent).
Subitem (8) provides that this item does not affect the conditions of
registration or listing applying to therapeutic goods before the
commencement of the item (a day to be proclaimed but no later than six
months after Royal Assent).
Item 58
This item contains application provisions relating to information gathering
powers for medical devices.
Subitem (1) provides that the amendments made by items 38 and 40, requiring
persons who held conformity assessment certificates or in relation to whom
medical devices were included in the Register to provide information, apply
in relation to periods beginning before, on or after the commencement of
those items (a day to be proclaimed but no later than six months after
Royal Assent).
Subitem (2) provides that the amendment made by item 41, requiring persons
to provide information about the safety and efficacy of medical devices and
information about their overseas regulatory history, apply to things
occurring before, on or after the commencement of the item (a day to be
proclaimed but no later than six months after Royal Assent).
Subitem (3) provides that regulations made for the purpose of subsection
41JA(2), setting out the notice period for subsection 41JA(1), in force
before the commencement of this item continue in force for the purpose of
subsection 41JA(2) after commencement (a day to be proclaimed but no later
than six months after Royal Assent).
Item 59
This item provides that the amendments made by items 44 to 50, relating to
health professionals to whom advertisements may be directed without regard
to the provisions of Part 5-1 of the Act, apply to advertisements published
or broadcast after the commencement of those items (a day to be proclaimed
but no later than six months after Royal Assent).