Federal Register of Legislation - Australian Government

Primary content

Orders/Other as made
This order amends the Therapeutic Goods Order No.91 - Standard for labels of prescription and related medicines (TGO 91) to correctly reference the recently re-made Therapeutic Goods Order No.69 –General Requirements for Labels for Medicines 2017, remove from the scope of TGO 91 medicines that are not required to be entered in the Australian Register of Therapeutic Goods because they are authorised for supply by way of health practitioner notifications under new subsection 19(7A) of the Therapeutic Goods Act 1989, and make other minor editorial changes to Schedule 1 to TGO 91.
Administered by: Health
Registered 14 Aug 2017
Tabling HistoryDate
Tabled HR15-Aug-2017
Tabled Senate16-Aug-2017
Date of repeal 16 Aug 2017
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

 

 

 

 

Therapeutic Goods Order No. 91A - Therapeutic Goods Order No. 91 (Standard for labels of prescription and related medicines) Amendment Order 2017

I, JANE COOK, a delegate of the Minister for Health, make this order under section 10 of the Therapeutic Goods Act 1989.

 

Dated Seventh August 2017

 

(Signed by)

JANE COOK

Delegate of the Minister for Health


Contents

1........ Name........................................................................................... 3

2........ Commencement........................................................................... 3

3........ Schedules.................................................................................... 3

Schedule 1—Amendments                                                                                           4

Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines         4

 


1  Name

This instrument is the Therapeutic Goods Order No. 91A - Therapeutic Goods Order No. 91 (Standard for labels of prescription and related medicines) Amendment Order 2017.

2  Commencement

This instrument commences on the day after it is registered.

3  Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.


Schedule 1Amendments

  

Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines

Section 4      Transition arrangements

1          Subsection 4(1)

Omit subsection 4(1), substitute:

(1)      On and from 31 August 2016 and before 1 September 2020, each medicine to which this Order applies must comply with either:

(a)    the requirements  specified in this Order; or

(b)   the requirements specified in:

(i)     Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69), up until 30 June 2017 (inclusive); or

(ii)   Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2017 (TGO 69 (2017)), on or after 1 July 2017.  

 

2          Subsection 4(3)

Omit subsection 4(3), substitute:

(3)   Notwithstanding subsections (1) and (2), medicines imported into or manufactured in Australia before 1 September 2020 but supplied by a person other than the sponsor after that date must comply with TGO 69 (2017) if at the time of their release for supply they complied with TGO 69 (2017).

 

Section 5      Exemptions - Medicines to which this Order does not apply

3          Subsection 5(1)

Insert in subsection 5(1), after paragraph (c):

(ca)  intended for use in the treatment of humans in accordance with rules specified for the purposes of subsection 19(7A) of the Act; or

 

 

 

 

Schedule 1 - Substances or Groups of substances present in medicines that are required to be declared on the label of medicines

4          Schedule 1 (introductory text box)

Insert, after the final sentence under the paragraph starting ‘Column 4’:

Where more than one name (as set out under Column 4) is required to be declared, they may be combined to form simple sentences where appropriate.

 

5          Schedule 1 (table, Substance name or Group of substances name ‘potassium salts, including: potassium bicarbonate             potassium chloride’, Column 2, Circumstances (if any) and additional requirements (if any))

Omit ‘Circumstance: Where the total potassium content of the maximum recommended daily dose is greater than 39 mg (1mmol) elemental potassium per dose

Requirement: To declare on the label (in mg) the quantity of elemental potassium per dose unit.’,

 

substitute:

Circumstance: Where the total potassium content of the maximum recommended daily dose is greater than 39 mg (1mmol) elemental potassium.

Requirement: To declare on the label (in mg) the quantity of elemental potassium per dosage unit or in a stated weight or volume of the medicine.’

 

6          Schedule 1 (table, Substance name or Group of substances name ‘sodium salts, including: sodium bicarbonate                         sodium chloride’, Column 2, Circumstances (if any) and additional requirements (if any))

Omit Circumstance: Where the total sodium content of the maximum recommended daily dose of the formulation is greater than 120 mg of elemental sodium per dose.

Requirement: To declare on the label (in mg) the quantity of elemental sodium per dose unit.’,

 

substitute:

Circumstance: Where the total sodium content of the maximum recommended daily dose is greater than 120 mg of elemental sodium.

Requirement: To declare on the label (in mg) the quantity of elemental sodium per dosage unit or in a stated weight or volume of the medicine.’

 

7          Schedule 1 (table, Column 1, Substance name or Group of substances name ‘sorbates, including: potassium sorbate    sorbic acid’)

Omit ‘sorbates, including: potassium sorbate  sorbic acid’, substitute: ‘sorbic acid and sorbic acid salts, including: potassium sorbate’.

 

8          Schedule 1 (table, Column 1, Substance name or Group of substances name ‘sugar alcohols’)

Insert, after ‘sugar alcohols’, ‘(see Note 5A)’.

 

9          Schedule 1 (Notes)

Insert, after Note 5, ‘Note 5A: Sugar alcohols – It is generally accepted that while glycerol is a sugar alcohol, it does not have a laxative effect. Therefore, glycerol is not required to be declared in relation to sugar alcohols and their associated laxative effect.’