Consultation: Proposed Medicines Advisory
Statements Amendment Specification 2015
(corrections and minor changes to the
RASML)
Version 1.0, March 2015
Therapeutic Goods Administration
About the Therapeutic Goods Administration
(TGA)

The Therapeutic Goods Administration (TGA) is part of the Australian Government
Department of Health, and is responsible for regulating medicines and medical devices.

The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management
approach designed to ensure therapeutic goods supplied in Australia meet acceptable
standards of quality, safety and efficacy (performance), when necessary.

The work of the TGA is based on applying scientific and clinical expertise to decisionmaking, to ensure that the benefits to consumers outweigh any risks associated with the use
of medicines and medical devices.

The TGA relies on the public, healthcare professionals and industry to report problems with
medicines or medical devices. TGA investigates reports received by it to determine any
necessary regulatory action.

To report a problem with a medicine or medical device, please see the information on the
TGA website <http://www.tga.gov.au>.
Copyright
© Commonwealth of Australia 2015
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if
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concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box
100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>
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Therapeutic Goods Administration
Version history
Version
Description of change
Author
Effective date
V1.0
Original publication
OTC Medicines Evaluation
Section/ Medicines
Authorisation Branch
March 2015
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Contents
Consultation: Proposed Medicines Advisory Statements
Amendment Specification 2015 (corrections and minor
changes to the RASML) _________________________ 5
Invitation to comment ________________________________________________________ 5
Timetable _______________________________________________________________________ 5
About the consultation ________________________________________________________ 5
Background _____________________________________________________________________ 6
Scheduling of medicines ------------------------------------------------------------------- 6
Advisory statements ------------------------------------------------------------------------ 6
The RASML------------------------------------------------------------------------------------- 7
Background to the proposal -------------------------------------------------------------- 8
Proposal _______________________________________________________________________ 11
Content of submissions ------------------------------------------------------------------ 16
How to respond ______________________________________________________________ 16
What will happen ____________________________________________________________ 17
Privacy information _________________________________________________________ 17
Enquiries ______________________________________________________________________ 17
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Consultation: Proposed Medicines Advisory
Statements Amendment Specification 2015
(corrections and minor changes to the RASML)
Invitation to comment
The TGA is seeking comments from interested parties on proposed minor changes and
corrections to the Required Advisory Statements for Medicine Labels (RASML) documents.
No change will be required to any currently approved medicine label as a result of these
proposals.
Timetable
Document released for consultation on Monday 16 March 2015.
Interested parties should respond by close of business on Friday 10 April 2015.
Feedback will be released following consideration of submissions. (see 'What will happen').
About the consultation
The TGA proposes to correct some minor errors and inconsistencies in the current RASML
documents, and make associated changes that improve the consistency and useability.
It is proposed that the corrections and changes listed under the heading Proposal, below, will be
published as the Medicines Advisory Statements Amendment Specification 2015 (No. 1), which will
amend Schedule 1 (‘RASML No. 1’) and Schedule 2 (‘RASML No. 2’) to the current Medicines
Advisory Statements Specification 2014.
In summary, the corrections and changes are as follows:

RASML No.2: correction of the ‘Conditions’ for the entries for non-steroidal antiinflammatory drugs (NSAIDs) indicated for use in children, to include the age of the affected
children (under 12 years of age)

RASML No.2: correction of the entries for dermal/external indomethacin and ketoprofen
preparations to include the correct wording ‘Unless a doctor or pharmacist has told you to,
do not use this product with other medicines that you are taking regularly’ for the statement
regarding use with other medicines

RASML No. 2: correction of the entries for selenium compounds to require the correct
statement ‘A daily dose of 150 micrograms for adults of selenium from dietary supplements
should not be exceeded’ (instead of ‘A daily dose of 100 micrograms for adults of selenium from
dietary supplements should not be exceeded. Not suitable for use by children under 15 years’)

RASML No. 2: correction of the entries for hydroxyanthracene derivatives from ‘Not
recommended for use by children aged 12 years or under’ to ‘Not recommended for use by
children under 12 years of age’

RASML No. 1 and RASML No. 2: removal of ‘Additional Presentation’ requirement [j] where
it requires the affected statement(s) to be grouped immediately preceding the directions for
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use (this requirement is currently inconsistently applied, and incorrectly applied in a few
cases)

RASML No. 1 and RASML No. 2: editorial changes in regards to the way the requirements
currently indicated by ‘Additional Presentation’ requirements [a], [e] and [h] are indicated
in the RASML (removal of these square bracketed letters from the RASML – but with no
actual change to the respective requirements).
No new requirements will be introduced by these proposed amendments.
With this consultation the TGA is requesting stakeholder comment to help ensure that the
identified errors and inconsistencies in the RASML are corrected in the most convenient, costeffective way.
Background
Scheduling of medicines
The Standard for Uniform Scheduling of Medicines and Poisons (SUSMP)1 sets out classifications
(‘Schedules’) which determine the level of control on the availability of medicines and poisons in
Australia. The majority of medicines that are included in the SUSMP fall under either Schedule 2,
3, 4, 5 or 6, as shown below.
Schedule 2 - available from a pharmacy without a prescription (PHARMACY MEDICINE)
Schedule 3 - available from a pharmacist without a prescription (PHARMACIST ONLY
MEDICINE)
Schedule 4 - available from a pharmacist with a prescription (PRESCRIPTION MEDICINE)
Schedule 5 –substances with low potential for causing harm (CAUTION)
Schedule 6 –Substances with moderate potential for causing harm (POISON)
The SUSMP requires that these medicines are labelled on the first line of the main label with the
appropriate ‘signal heading’, indicating the medicine’s schedule (e.g. PHARMACY MEDICINE),
together with the words KEEP OUT OF REACH OF CHILDREN written immediately below the
signal heading.
Medicines that are not included in the SUSMP may be available from both pharmacies and other
general retail outlets, and are referred to as 'unscheduled' medicines.
Medicines that are either unscheduled or included in Schedule 2, 3, 5 or 6 of the SUSMP are
collectively referred to as 'non-prescription' or 'over-the-counter' (OTC) medicines.
Advisory statements
Consumers rely on information from their health practitioner, pharmacist and/or medicine label
in order to use medicines safely and effectively. The enhanced access and availability of OTC
medicines means that consumers may not always receive comprehensive advice from a health
1
previously known as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
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practitioner or pharmacist. Therefore, the label needs to contain the directions and advisory
statements that are appropriate for the safe and effective use of the medicine.
The need for new advisory statements to be present on the labels of particular medicines is
typically identified as a result of circumstances such as the registration of a new medicine, or a
review of the safety of an existing medicine; or a change in the SUSMP scheduling that reduces
the level of control and makes the medicine more widely available to consumers for selfselection or available without a prescription.
The RASML
The RASML was established in July 2004 so that there could be one single source document that
other items of legislation such as the Labelling Order2 could refer to when specifying mandatory
advisory statements for medicine labels.
The RASML is defined in the legislation as ‘the document made under section 3(5A) of the
Therapeutic Goods Act 1989 by the Therapeutic Goods Administration’. This section 3(5A)
Legislative Instrument, the Medicines Advisory Statements Specification 2014 was registered on
the Federal Register of Legislative Instruments (FRLI) in June 2014. The instrument
incorporates the RASML No. 1 and RASML No. 2 as its Schedules 1 and 2, respectively.
RASML ‘Additional presentation requirements for some advisory
statements’
In some cases the RASML applies specific presentation requirements to advisory statements such as font, letter size etc. Where such additional requirements apply to a statement in a
RASML entry, they may be indicated by letters in square brackets shown next to the statement
(the reader of the RASML needs to cross-reference to the introductory section titled ‘Addition
presentation requirements for some advisory statements’ on the first page of the RASML to find
the meaning of each of these letters).
The square-bracketed letters [a], [e], [h] and [j] are affected by the currently proposed RASML
amendment. The meaning of these square-bracketed letters, as currently stated in the RASML, is
set out below:
2
[a]:
Statement(s) must be included on the label in capital letters.
[e]:
Statement(s) must be included on the label in bold face letters.
[h]:
The heading ‘SAFETY DIRECTIONS’, written in bold-face capital letters, must
preface this/these statements, which are to be grouped together as a distinct
section of the label.
[j]:
Statement(s) must:
(i)
be grouped with any other statements marked with this additional
requirement; and
(ii)
if the heading ‘SAFETY DIRECTIONS’ is required on the label, be included
immediately after that heading; or
currently Therapeutic Goods Order 69 General requirements for labels for medicines (TGO 69)
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(iii)
if the heading ‘SAFETY DIRECTIONS’ is not required on the label, be
included immediately preceding the directions for use.
The RASML also includes requirements designated by the letters [c], [f], [g], [k] and [l] that are
not affected by this current proposal.
In other cases the RASML simply indicates the requirement in the statement itself, for example
by use of the relevant fonts (e.g. ‘WARNING – This medication may be dangerous when used in
large amounts or for a long period’).
Background to the proposal
The background to the proposed corrections and changes is as follows.
Oral NSAIDs indicated for use in children – correction of error in RASML No.
2
The RASML No. 2 currently requires the OTC NSAIDs diclofenac, flurbiprofen, ibuprofen,
ketoprofen and naproxen to carry the advisory statement ‘Ask your doctor or pharmacist
before use of the medicine in children suffering from dehydration through diarrhoea and
vomiting’ if they are for oral use in children. The TGA proposes to correct this to only
require this statement if the medicine is for oral use in children under 12 years of age.
This age limit was inadvertently omitted from the ‘Conditions’ in column 2 of the entries
in RASML No. 2. Its inclusion will be consistent with advice the TGA gave to industry
during consultation (in the 2012 TGA response to submissions for RASML updates 5 &
6), that the statement would only apply to medicines that have paediatric doses.
To correct this error in column 2 of RASML No. 2, it is now proposed that

the word ‘children’ will be replaced with ‘children under 12 years of age’, and

the word ‘adults’ will be replaced with ‘adults and children 12 years of age and over’
(or similar wording as appropriate).
The TGA already interprets ‘children’ to mean ‘children under 12 years of age’ in the
context of the application of this statement. Therefore, any currently approved labels
that are labelled in accordance with the current conditions should already comply with
this proposal.
Indomethacin and ketoprofen – correction of error in RASML No. 2
In the 2012 TGA response to submissions for RASML updates 5 & 6, it was agreed that
the statement ‘Unless a doctor has told you to, do not use [this product /insert name of
product] with other medicines that you are taking regularly’ would apply to diclofenac,
ibuprofen, indomethacin and ketoprofen, in medicines for dermal/external use.
However, for indomethacin and ketoprofen the RASML No. 2 unintentionally substituted
the more extensive statement that is required for oral NSAID medicines (‘Unless advised
by your doctor or pharmacist, do not use [this product/insert name of product] with
products containing indomethacin/ketoprofen, aspirin, or other anti-inflammatory
medicines, or with medicines that you are taking regularly’ ).
It is now proposed to correct this statement, in line with the current wording for the
other dermal/external NSAID entries (diclofenac and ibuprofen), to
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‘Unless a doctor or pharmacist has told you to, do not use this product with other
medicines that you are taking regularly’.
The proposed corrected statement is less extensive that the current statement, but is in
line with it. Consequently any labels that include the more extensive statement will be
considered to already comply with this proposal.
Selenium – correction of error in RASML No. 2
In relation to selenium compounds, the RASML No. 2 has inadvertently incorporated the
outdated requirements of the 2004 RASML instead of the updated requirements of the
2008 RASML.
It is now proposed to correct the statements from ‘A daily dose of 100 micrograms for
adults of selenium from dietary supplements should not be exceeded’ and ‘Not suitable
for use by children under 15 years’ to
‘A daily dose of 150 micrograms for adults of selenium from dietary supplements
should not be exceeded’
Correction of this error is not expected to have any impact, as the correct statements
were in force for six years between 2008 and June 2014.
In the unlikely case that any sponsor has changed a selenium medicine label since July
2014 to be compliant with the incorrect requirements, the TGA would consider the label
to also be compliant with the correct (less restrictive) requirements.
Hydroxyanthracene derivatives
In relation to hydroxyanthracene derivatives, the RASML No. 2 incorrectly includes the
statement ‘Not recommended for children aged 12 years and under’ rather than the
correct statement ‘Not recommended for children under 12 years of age’.
The requirement for a statement to the effect that ‘Use in children under 12 years is not
recommended’ was originally recommended by the TGA’s Complementary Medicines
Evaluation Committee (CMEC) in August 2006, and proposed in the RASML Update 5
consultation. In the 2012 TGA response to submissions for RASML updates 5 & 6 it was
then concluded that the following statement would be adopted:
‘RASML statement 4: “Use in children under 12 years is not recommended”.
Consequently, ‘statement 4’ of the 2008 RASML was adopted in RASML No. 2. However,
the definition of statement 4 in the 2008 RASML is ‘Not recommended for children aged
12 years and under’ . This error was unintentional.
The proposed corrected statement is less restrictive that the current statement, but is in
line with it. Consequently any labels that include the more restrictive statement will be
considered to already comply with this proposal.
Removal of [j] - where it requires the affected statements to be grouped
immediately preceding the directions for use
The [j] requirement is incorrectly applied in RASML No. 2 in a few cases. In particular, it
has inadvertently been incorrectly omitted from ibuprofen entries 1, 3 and 5, as well as
from oxymetazoline entries 3 and 4, and from the entry for pantoprazole. It has also
incorrectly been included in the entry for cetirizine.
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The [j] requirement is also inconsistently applied in the RASML. This situation has arisen
because the [j] requirements have their origins in the SUSDP. Consequently they typically
apply to statements for SUSMP-scheduled medicines, or to medicines that are specifically
excluded from the schedules to the SUSMP. RASML entries and statements that do not
have their origins in the SUSDP are typically not subject to these requirements.
The TGA and its Expert Committees have not considered it necessary to apply the [j]
requirement to other advisory statements that were included in the original version of
the RASML in 2004, or to any statements that have been subsequently included.
Consistency with the requirements of the SUSDP was necessary in 2004 because the
SUSDP Appendix F (the list of warning statements required by the SUSDP) had not yet
adopted the exclusion in relation to ‘medicines for human use when compliant with the
RASML’ that applies to these requirements in Appendix F of the current SUSMP. This
need for consistency no longer applies in the context of the current SUSMP and the
Medicines Advisory Statements Specification.
The function of the [j] requirement is to ensure that warning statements relating to the
use of the product are grouped together, and placed in a position on the label where they
are likely to be read by the consumer prior to use. The TGA does not intend that
removal of the [j] should imply a change to the expectation that statements are
appropriately placed and grouped on medicine labels. However, the position
immediately before the directions for use is not the only location on a medicine label that
can serve this function.
Appropriate placement of advisory statements is important for all medicines. The
current inconsistent application of the [j] requirement in the RASML could be taken to
imply that the need for appropriate placement and grouping of statements is only
important for the scheduled medicines to which the [j] requirement currently applies.
This implication is unintentional - and is not the case.
OTC medicine labels are typically complex in design, and subject to multiple
requirements for mandatory content. In the absence of comprehensive guidelines
regarding labelling design, the most appropriate placement of any required advisory
statements is expected to be considered by the applicant when the label is designed, and
is assessed by the TGA prior to approval.
Consequently the TGA proposes to take this opportunity to remove the [j] requirements
completely from the RASML (both RASML No. 1 and RASML No. 2) rather than correcting
the identified errors individually. However, the statements are expected to continue to
be appropriately placed and grouped.
In relation to statements that are safety directions for SUSMP Schedule 5 or Schedule 6
medicines it is appropriate and necessary to continue to group these directions after the
heading SAFETY DIRECTIONS. However, the format of the current RASML makes this
clear without the need for the cross-referenced [j] instruction.
Removal of [h]
Requirement [h] has essentially the same meaning as requirement [j], in relation to
statements that are safety directions. Therefore, for consistency with the removal of the
[j] requirements (detailed above), it is proposed to also remove the square-bracketed
letter [h], as well as the cross-referenced instructions that currently appear in the
introductory section headed ‘Additional presentation requirements for some advisory
statements’.
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The explicit cross-referenced statement of the [h] requirement is not necessary; as the
relevant requirements for placement of the affected statements (grouped after the
SAFETY DIRECTIONS heading) are self-evident from the placement and grouping of the
actual statements in the RASML.
Removal of [a] and [e]
It is also proposed to remove the square-bracketed letters [a] and [e], and replace the
specific cross-referenced instructions that currently appear in the introductory section
headed ‘Additional presentation requirements for some advisory statements’ with a
general instruction to the effect that the statements that are written in capital
letters/bold face letters in the RASML should be written in this font on the medicine
labels.
The letter [a], which indicates that the statement(s) must be included on the label in
capital letters, is currently only used for the statements ‘KEEP OUT OF REACH OF
CHILDREN’ and ‘NOT TO BE TAKEN’. This is inconsistent with the situation in other
cases where capital letters are required (e.g. statements such as ‘DERIVED FROM
SEAFOOD’ [see entry for squid oil] or ‘WARNING – This medication may be dangerous
when used in large amounts or for a long period’ [see entry for zinc compounds]).
The letter [e], which indicates that the statement(s) must be included on the label in bold
face text, is currently only used for the statements that are required for medicines
containing Vitamin A.
The explicit cross-referenced instructions for [a] and[e] are not necessary in the context
of the current RASML format (the required font is self-evident from the bold and/or
uppercase font is used in the actual statements in the RASML).
This change will make the method of indicating requirements for the use of upper case
font and bold font simple and more consistent throughout the RASML.
Proposal
The proposed amendments to RASML No. 1 and RASML No. 2 (‘Schedule 1’ and ‘Schedule 2’,
respectively, to the Medicines Advisory Statements Specification 2014) are set out in the
numbered list below.
It is proposed that this list of amendments will be published on the FRLI as the Medicines
Advisory Statements Amendment Specification 2015.
No change will be required to any currently approved medicine label as a result of these
proposals.
[1]
Schedules 1 and 2, Advisory statements
After the words ‘next to the statement’, insert ‘or, in the case of a requirement to use upper case
and/or bold face, by use of upper case and/or bold face letters in the statement itself’.
[2]
Schedules 1 and 2, Additional presentation requirements for some advisory
statements
Omit ‘Where such additional requirements apply, they are indicated by a letter in square
brackets (e.g. [a]) shown in column 3 of the Table 1 below’,
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substitute ‘Where such additional requirements apply, they are indicated in Column 3 of Table 1
below either by a letter in square brackets (e.g. [c]) or, in the case of a requirement to use upper
case and/or bold face, by use of upper case and/or bold face letters in the statement itself’.
[3]
Schedules 1 and 2, Additional presentation requirements for some advisory
statements
Omit ‘[a]: Statement(s) must be included on the label in capital letters.’
[4]
Schedules 1 and 2, Additional presentation requirements for some advisory
statements
Omit ‘[e]: Statement(s) must be included on the label in bold face letters.’
[5]
Schedules 1 and 2, Additional presentation requirements for some advisory
statements
Omit ‘[h]: The heading ‘SAFETY DIRECTIONS’, written in bold-face capital letters, must preface
this/these statements, which are to be grouped together as a distinct section of the label.’
[6]
Schedules 1 and 2, Additional presentation requirements for some advisory
statements
Omit ‘[j]: Statement(s) must:
[7]
(i)
be grouped with any other statements marked with this additional
requirement; and
(ii)
if the heading ‘SAFETY DIRECTIONS’ is required on the label, be included
immediately after that heading; or
(iii)
if the heading ‘SAFETY DIRECTIONS’ is not required on the label, be
included immediately preceding the directions for use.’
Schedules 1 and 2, Table 1: Medicines to which advisory statements apply
Omit ‘[a]’, ‘[e]’, ‘[h]’ and ‘[j]’, wherever occurring.
[8]
Schedule 2, Table 1: Medicines to which advisory statements apply, Diclofenac
(Entry 2 of 4), Column 2 Conditions
Omit ‘In preparations for oral use in adults when NOT indicated exclusively for the treatment of
dysmenorrhoea’,
substitute ‘In preparations for oral use in adults and children aged 12 years and over, when NOT
indicated exclusively for the treatment of dysmenorrhoea’.
[9]
Schedule 2, Table 1: Medicines to which advisory statements apply, Diclofenac
(Entry 3 of 4), Column 2 Conditions
Omit ‘In preparations indicated for oral use in children’,
substitute ‘In preparations indicated for oral use in children under 12 years of age’.
[10] Schedule 2, Table 1: Medicines to which advisory statements apply, Flurbiprofen
(Entry 1 of 2), Column 2 Conditions
Omit ‘In oral preparations for use in exclusively in adults’,
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substitute ‘In oral preparations that do NOT include indications for use in children under 12
years of age’.
[11] Schedule 2, Table 1: Medicines to which advisory statements apply, Flurbiprofen
(Entry 2 of 2), Column 2 Conditions
Omit ‘In oral preparations that include indications for use in children’,
substitute ‘In oral preparations that include indications for use in children under 12 years of
age’.
[12] Schedule 2, Table 1, Medicines to which advisory statements apply,
Hydroxyanthracene derivatives such as those from: - Aloe -Buckthorn -Cascara -Frangula
-Rhubarb -Senna (Entry 1 of 3), Column 3 Required Statement(s)
Omit ‘Not recommended for use by children aged 12 years or under’,
substitute ‘Not recommended for use by children under 12 years of age’.
[13] Schedule 2, Table 1, Medicines to which advisory statements apply,
Hydroxyanthracene derivatives such as those from: - Aloe -Buckthorn -Cascara -Frangula
-Rhubarb -Senna (Entry 2 of 3), Column 3 Required Statement(s)
Omit ‘Not recommended for use by children aged 12 years or under’,
substitute ‘Not recommended for use by children under 12 years of age’.
[14] Schedule 2, Table 1, Medicines to which advisory statements apply,
Hydroxyanthracene derivatives such as those from: - Aloe -Buckthorn -Cascara -Frangula
-Rhubarb -Senna (Entry 3 of 3), Column 3 Required Statement(s)
Omit ‘Not recommended for use by children aged 12 years or under’,
substitute ‘Not recommended for use by children under 12 years of age’.
[15] Schedule 2, Table 1: Medicines to which advisory statements apply, Ibuprofen (Entry
2 of 6), Column 2 Conditions
Omit ‘a. NOT indicated for use in children’,
substitute ‘b. NOT indicated for use in children under 12 years of age’.
[16] Schedule 2, Table 1: Medicines to which advisory statements apply, Ibuprofen
(Entry 3 of 6), Column 2 Conditions
Omit ‘b. NOT indicated for use in children’,
substitute ‘b. NOT indicated for use in children under 12 years of age’.
[17] Schedule 2, Table 1: Medicines to which advisory statements apply, Ibuprofen
(Entry 4 of 6), Column 2 Conditions
Omit ‘a. the preparation includes indications for use in children’,
substitute ‘a. the preparation includes indications for use in children under 12 years of age’.
[18] Schedule 2, Table 1: Medicines to which advisory statements apply, Ibuprofen
(Entry 5 of 6), Column 2 Conditions
Omit ‘a. the preparation includes indications for use in children’,
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substitute ‘a. the preparation includes indications for use in children under 12 years of age’.
[19] Schedule 2, Table 1: Medicines to which advisory statements apply, Ketoprofen
(Entry 2 of 4), Column 2 Conditions
Omit ‘b. NOT indicated for use in children’,
substitute ‘b. NOT indicated for use in children under 12 years of age’.
[20] Schedule 2, Table 1: Medicines to which advisory statements apply, Ketoprofen
(Entry 3 of 4), Column 2 Conditions
Omit ‘When the preparation is for oral use and includes indications for use in children’,
substitute ‘When the preparation is for oral use and includes indications for use in children
under 12 years of age’.
[21] Schedule 2, Table 1: Medicines to which advisory statements apply, Naproxen
(Entry 2 of 3), Column 2 Conditions
Omit ‘b. NOT indicated for use in children’,
substitute ‘b. NOT indicated for use in children under 12 years of age’.
[22] Schedule 2, Table 1: Medicines to which advisory statements apply, Naproxen
(Entry 3 of 3), Column 2 Conditions
Omit ‘When the preparation includes indications for oral use in children’,
substitute ‘When the preparation includes indications for oral use in children under 12 years of
age’
[23] Schedule 2, Table 1: Medicines to which advisory statements apply, Indomethacin
in preparations for external use, Column 3 Required statement(s)
Omit ‘Unless advised by your doctor or pharmacist, do not use [this product/insert name of
product] with products containing indomethacin, aspirin, or other anti-inflammatory medicines,
or with medicines that you are taking regularly’,
substitute ‘Unless a doctor or pharmacist has told you to, do not use this product with other
medicines that you are taking regularly’.
[24] Schedule 2, Table 1: Medicines to which advisory statements apply, Ketoprofen in
preparations for dermal use, Entry 4 of 4, Column 3 Required statement(s)
Omit ‘Unless advised by your doctor or pharmacist, do not use [this product/insert name of
product] with other products containing ketoprofen, aspirin, or other anti-inflammatory
medicines or with medicines that you are taking regularly’,
substitute ‘Unless a doctor or pharmacist has told you to, do not use this product with other
medicines that you are taking regularly’.
[25] Schedule 2, Table 1: Medicines to which advisory statements apply, High selenium
yeast, Column 3 Required statement(s)
Omit

‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not
be exceeded.
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Therapeutic Goods Administration

Not suitable for use by children under 15 years’
substitute

‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not
be exceeded.’
[26] Schedule 2, Table 1: Medicines to which advisory statements apply, Selenium yeast
– high, Column 3 Required statement(s)
Omit

‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not
be exceeded.

Not suitable for use by children under 15 years’
substitute

‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not
be exceeded.’
[27] Schedule 2, Table 1: Medicines to which advisory statements apply,
Selenocysteine, Column 3 Required statement(s)
Omit

‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not
be exceeded.

Not suitable for use by children under 15 years’
substitute

‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not
be exceeded.’
[28] Schedule 2, Table 1: Medicines to which advisory statements apply,
Selenomethionine, Column 3 Required statement(s)
Omit

‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not
be exceeded.

Not suitable for use by children under 15 years’
substitute

‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not
be exceeded.’
[29] Schedule 2, Table 1: Medicines to which advisory statements apply, Sodium
selenate, Column 3 Required statement(s)
Omit

‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not
be exceeded.
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and minor changes to the RASML)
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Therapeutic Goods Administration

Not suitable for use by children under 15 years’
substitute

‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not
be exceeded.’
[30] Schedule 2, Table 1: Medicines to which advisory statements apply, Sodium
selenite, Column 3 Required statement(s)
Omit

‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not
be exceeded.

Not suitable for use by children under 15 years’
substitute

‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not
be exceeded.’
[31] Schedule 2, Table 1: Medicines to which advisory statements apply, Yeast – high
selenium, Column 3 Required statement(s)
Omit

‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not
be exceeded.

Not suitable for use by children under 15 years’
substitute

‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not
be exceeded.’
Content of submissions
Submissions may address the proposed changes and other identified issues. In addition,
submissions might include:

Whether or not you support the proposed changes. If you do not support the changes you
may make suggestions for an alternative acceptable to you.

An assessment of how the proposed change will impact on you. That is, what do you see as
the likely benefits or costs to you (these may be financial or non-financial). If possible,
please attempt to quantify these costs and benefits.
How to respond
All submissions should be accompanied by a TGA submission cover sheet;. Submissions must
include full personal or organizational contact details (including address, telephone number and
email).
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Therapeutic Goods Administration
Electronic submissions are preferred and should be emailed to rasml@tga.gov.au. Please include
‘Consultation: Proposed Medicines Advisory Statements Amendment Specification 2015
(corrections and minor changes to the RASML)’ in the subject line of the email.
Alternatively, hard copy submissions may be mailed to:
RASML Officer
OTC Medicines Evaluation
Medicines Authorisation Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
What will happen
All submissions will be placed on the TGA Internet site unless marked confidential or indicated
otherwise in the submission cover sheet (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through
the TGA Internet site.
It is proposed that the advisory statements will then be included in the next update of the
RASML.
Privacy information
The TGA collects your personal information in this submission in order to:

contact you if the TGA wants to seek clarification of issues raised in your submission or to
check whether you consent to certain information that you have provided being made
publicly available.

help provide context about your submission (e.g. to determine whether you are an
individual or a director of a company or representing an interest group).
The TGA will disclose your name and (if applicable) your designation/work title on the TGA
Internet site (i.e. make this information publicly available) if you consent to the publication of
your name on the TGA Internet site (please complete the cover sheet).
Any text within the body of your submission that you want to remain confidential should be
clearly marked 'IN CONFIDENCE'.
Please do not include personal information about other individuals in the body of your
submission. Personal information in this context means information or an opinion about an
individual whose identity is apparent, or can reasonably be ascertained, from the information or
opinion.
Enquiries
Enquiries should be directed via email to rasml@tga.gov.au.
Consultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections
and minor changes to the RASML)
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Therapeutic Goods Administration
PO Box 100 Woden ACT 2606 Australia
Email: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605
http://www.tga.gov.au
Reference/Publication #