Medicines Advisory Statements Amendment Specification 2015 (No.1)
Therapeutic Goods Act 1989
 
I, JOHN SKERRITT, National Manager of the Therapeutic Goods Administration and delegate of the Minister for Health, make this Specification under subsection 3 (5A) of the Therapeutic Goods Act 1989.
 
 
Dated this 11th day of May 2015
(Signed by)
Dr John Skerritt
Delegate of the Minister for Health
 
 
1      Name of Specification
This Specification is the Medicines Advisory Statements Amendment Specification 2015 (No.1).
2      Commencement
This Specification commences on the day after it is registered on the Federal Register of Legislative Instruments.
3      Amendment of Medicines Advisory Statements Specification 2014
The Medicines Advisory Statements Specification 2014 is amended as set out in Schedule 1 to this Specification.
 
 
 
 
 
 
Schedule 1        Amendments
                             (section 3)
[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]       Schedule 1, 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”,
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]       Schedule 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 below”,
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”.
[4]       Schedules 1 and 2, Additional presentation requirements for some advisory statements
Omit “[a]:  Statement(s) must be included on the label in capital letters.”
[5]       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.”
[6]       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.”
 
 
 
 
[7]       Schedules 1 and 2, Additional presentation requirements for some advisory statements
Omit “[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
(iii)            if the heading “SAFETY DIRECTIONS” is not required on the label, be included immediately preceding the directions for use.”  
[8]       Schedules 1 and 2, Table 1: Medicines to which advisory statements apply
Omit “[a]”, “[e]”, “[h]” and “[j]”, wherever occurring.
[9]       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”.
[10]     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”.
[11]     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”,
substitute “In oral preparations that do NOT include indications for use in children under 12 years of age”.
[12]     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”.
[13]     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”.
[14]     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”.
[15]     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”.
[16]     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”,
substitute “a.  the preparation includes indications for use in children under 12 years of age”.
[17]      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”.
[18]      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”.
[19]     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”.
[20]     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”
[21]     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.”
[22]     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.”
[23]     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.”
[24]     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”.
[25]     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”.
[26]     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.
•         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, 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.”
[28]     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.”
[29]     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.”
[30]     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.
•         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, 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.”
 
[32]     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.”