Comparing TGO 79 with TGO 69: Changes to the Requirements for Labelling Medicines

Therapeutic Goods Administration

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 decision-making, 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 2014
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Version history

Contents

Changing label requirements 7

Reasons for changing requirements 8

No changes to the medicines covered 9

Transition period 9

Terms used in TGO 69 but not TGO 79 9

Changes which will reduce red tape 9

Grace period for change in sponsor details 9

Labelling small and very small containers 9

Approved product details on labels 10

Changes to label content 10

All medicines 10

Medicine name to be on at least 3 sides of a carton 10

Substances to be declared on labels 10

Quantification of sodium and potassium 11

Declaration of approved routes 11

Expiry date 11

Prescription medicines 11

Machine readable code and space for dispensing label 11

Declaring substances somewhere other than the label 12

Quantity to be on all labels – including medicines for injection 12

Non-prescription medicines 12

Medicine Information panel 12

Use in pregnancy information 12

Homoeopathic medicines 13

Statement describing medicines as homoeopathic 13

Statement no longer required 13

Homoeopathic potency 13

Expression of quantity or proportion of active ingredients 13

Requirement to differentiate homoeopathic and non-homoeopathic active ingredients 13

Medicines with specific ingredients 14

Medicines containing Vitamin A 14

Medicines that contain enzymes 14

Medicines containing herbal material or preparations 14

Medicines applied using specific routes 15

Preparations for the skin or mucous membranes 15

Medicines for injection 15

Medicines packaged in a particular way 15

Medicine kits 15

Medicine starter packs 16

Strip, blister and dial dispenser packs 16

Composite packs 16

Plastic ampoules 16

Individually wrapped medicines 17

Transdermal patches, intrauterine or implanted drug delivery systems 17

Metered dose products 17

Changes to label formatting 18

General requirements of label formatting 18

Uninterrupted names 18

Identification of active ingredients 18

Direction of text 18

Font size 18

Font size on labels of registered medicines with less than four active ingredients 19

Font size on labels of registered medicines with at least four active ingredients 19

Font size on listed medicine labels 19

Font size on homoeopathic medicine labels 19

Font size on small containers: 2.5 - 25 mL containers 19

Font size on sunscreen containers no bigger than 25 mL 20

Font size on very small containers: no bigger than 2.5 mL 20

Other changes to labels 20

Effect of opening packaging on readability 20

Labelling intermediate packaging 20

Labelling delivery devices 20

Durable information 20

Unchanged requirements 21

Displaying the AUST R or AUST L number 21

Metric units 21

Directions for use and preparation before use 21

Dialysis concentrates 21

Changing label requirements

This document compares the new Therapeutic Goods Order 79 (TGO 79) Standard for the labelling of medicines with the current Therapeutic Goods Order 69 (TGO 69) General requirements for labels for medicines. TGO 79 is a standard determined by the Minister (or a delegate of the Minister) under Section 10 of the Therapeutic Goods Act 1989 (the Act).

This document has been prepared to help those who are familiar with TGO 69 quickly see the differences between TGO 69 and TGO 79. The sections and subsections quoted are those of TGO79, unless otherwise specified. To confirm legislative requirements, please check the legislation itself, and do not rely solely on this document.

This document emphasises the differences in requirements between TGO 69 and TGO 79. However, many of the regulatory requirements remain unchanged. Other differences between TGO 79 and TGO 69 include the structure, numbering system and introduction, with the introduction to TGO 79 providing more contextual information than the introduction to TGO 69.

The use of Supplementary Notes, as included in the first hard copy issue of TGO 69, has been discontinued.

Summary table

Reasons for changing requirements

We are changing labelling requirements to:

·  further minimise the risk of prescribing, dispensing and self-selection errors

·  assist consumers to choose appropriate medicines and use them appropriately.

No changes to the medicines covered

There are no changes to the medicines covered: both TGO 69 and TGO 79 apply to the same medicines.

Medicines that are not exempt from TGO 79 must also comply with advertising requirements specified in the Therapeutic Goods Act 1989 (Division 3 Part 5-1) and the Therapeutic Goods Advertising Code.

Transition period

The transition arrangements for the labelling of medicines are to be detailed in section 4 of TGO79. A three or four year transition period will be provided, with the exact time period being determined following consultation.

Terms used in TGO 69 but not TGO 79

The following terms are used in TGO 69 but not TGO 79:

·  date of manufacture

·  dispensing pack

·  letter height

·  medicament for injection

·  non-proprietary name

·  proprietary name

·  product name.

Changes which will reduce red tape

Grace period for change in sponsor details

The reference to the ‘address’ of the sponsor has been changed to the ‘contact details’ of the sponsor, with a new definition provided of ‘name and contact details of the sponsor’ in section 6.

The name and contact details of the sponsor are required to be on the label. However, if the name or contact details of the sponsor change, TGO 79 allows a 12 month ‘grace period’ before the updated information is required to appear on the label [subsection 8(1)(i)]; no such grace period exists in TGO 69.

This makes labelling requirements more achievable.

Labelling small and very small containers

There have been practical difficulties associated with labelling small containers, with a limited area available for inclusion of labelling information. TGO 79 has fewer labelling requirements for small and very small containers (defined in section 6 according to their capacity) provided that the primary pack is fully compliant.

By having achievable labelling requirements, the labels on small and very small containers will no longer require exemption from compliance with standards under section 14 and 14A of the Act.

Acceptable font sizes have been reduced for small and very small containers, and less content is required on the labels of very small containers. Labelling requirements are described for:

·  injections in small containers: section 10(4)

·  injections in very small containers: section 10(5)

·  small containers (not including injections): section 10(14)

·  very small containers (not including injections): section 10(15).

Approved product details on labels

Sometimes a medicine is registered with unusual approved product details, such as:

·  a novel storage temperature or condition

·  unusual units of potency.

Inclusion of these approved product details (defined in section6) on a label will be compliant with TGO 79 and will not require an exemption from compliance with standards under section 14 and 14A of the Act.

Changes to label content

All medicines

Medicine name to be on at least 3 sides of a carton

If a medicine is packaged in a primary pack that is a carton, the name of the medicine must appear on at least three non-opposing sides of the carton [subsection 8(1)(r)]. This means that medicines can always be stacked so that the name is visible.

Substances to be declared on labels

Substances that must be declared on the labels of medicines are itemised in Schedule 1 of TGO 79. [See also subsection 8(1)(j).]

In addition to the substances in the first schedule of TGO 69, Schedule 1 of TGO 79 includes:

·  crustacea and crustacean products

·  egg and egg products

·  fish and fish products

·  milk and milk products

·  potassium salts

·  sesame seed and sesame seed products

·  soya beans and soya bean products

·  sucralose

·  tree nuts and tree nut products.

These requirements increase public safety because most of these substances have the potential to cause severe allergic reactions or result in other serious adverse health consequences in sensitive individuals.

Quantification of sodium and potassium

For sodium and potassium in oral medicines, there is a new requirement for quantification in milligrams of elemental sodium or potassium. This requirement applies when the daily dose contains more than 39 mg potassium or more than 120 mg sodium [Schedule 1 of TGO 79].

Providing this information allows individuals to calculate their daily sodium and potassium intake more accurately.

Declaration of approved routes

The approved route(s) of the medicine need to be stated on the label if the medicine is:

·  an injection

·  an infusion

·  contained in an ampoule but is not an injection.

See subsections 8(1)(o), 9(1)f and 10(18)(b) for more detail.

This differs from TGO 69 in that the route of administration was required for most injections, but not for inhalations present in ampoules, oral liquids in ampoules or large volume injections. Declaring the route of administering decreases the likelihood of medication errors.

There is no longer a requirement to include a warning statement when the incorrect route might be hazardous.

Expiry date

The expiry date prefix is to be in the form: 'EXPIRY DATE', 'EXPIRY', 'EXPIRES', 'EXP. DATE', or 'EXP' or words to this effect, including a mixture of lower and upper case letters. It is no longer acceptable to use phrases such as: 'Best by' or ‘Best before’ or ‘Use by’ or ‘Use before’.

These requirements are specified in section 6.

Prescription medicines

Machine readable code and space for dispensing label

A machine-readable code (defined in section 6) must be on the label of medicines in schedules 4 or 8 of the Poisons Standard and blood products in Appendix A of the Poisons Standard [subsection 8(1)(p)].