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Consultation: Azelastine: proposed advisory statements for medicines

Version 1.0

9 November 2012

This consultation closed on 7 December 2012

Invitation to comment

The TGA sought comments from interested parties on the proposed advisory statement for azelastine when included in non prescription medicines for topical ophthalmic and nasal use for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document when it is next updated.


Document released for consultation on Friday, 9 November 2012

Interested parties should respond by close of business Friday, 7 December 2012

Feedback will be released following consideration of submissions (see 'What will happen')

About the consultation

The proposed advisory statement for azelastine when included in non prescription medicines for topical ophthalmic and nasal use would be required on the 'label' of non prescription products containing this medicine. Advisory statements on the label of medicines assist in the quality use of medicines by consumers.

Through the consultation process, the TGA is requesting comment that will help ensure that the proposed advisory statement are appropriate and supports the quality use of medicines for non-prescription products containing azelastine when included in non prescription medicines for topical ophthalmic and nasal use.

This consultation will contribute to the update of the RASML document.

Note: 'Label' means a display of printed information upon, or securely affixed to, the container and any primary pack containing the goods.

What will happen

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA's Internet site.

The proposed advisory statements will then be included in the next update of the RASML document.


All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.


Enquiries should be directed via email to or by telephone to 1800 020 653.


The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) sets out 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 one of the following classifications.

Schedule 2 - Pharmacy Medicine (available from a pharmacy without a prescription)

Schedule 3 - Pharmacist Only Medicine (available from a pharmacist without a prescription)

Schedule 4 - Prescription Only Medicine (available from a pharmacist with a prescription)

Medicines that are not included in the SUSMP are freely available from both pharmacies and other retail outlets, and are referred to as 'unscheduled' medicines. Medicines that are unscheduled or included in Schedule 2 or Schedule 3 of the SUSMP are collectively referred to as 'non-prescription' or 'over-the-counter' (OTC) medicines.

Consumers rely on information from their health practitioner, pharmacist and medicine 'label' in order to use medicines safely and effectively. In the case of non prescription medicines, the label of the medicine contains information and directions for appropriate use, as well as any advisory statements (warnings) that are needed for safe and effective use of the medicines.

The need for a new advisory statement might arise from:

  • The registration of a new medicine
  • When new risks for currently available medicines have been identified
  • A request from external stakeholders and/or expert advisory committees is received
  • When a medicine undergoes a change in scheduling, hence reducing the level of control and making it more widely available to consumers for self-selection or available without a prescription

Under these circumstances there may be a need to ensure that appropriate advisory statements are included on the labelling of these medicines to ensure consumers are able to self-select (where applicable) and use these medicines safely and effectively.

Note: 'Label' means a display of printed information upon, or securely affixed to, the container and any primary pack containing the goods.


The TGA scheduling delegate decided, in February 2012, to reschedule azelastine in topical eye preparations containing ≤ 0.05% azelastine from Schedule 3 to Schedule 2 in the SUSMP, with an implementation date of 1 May 2012. The scheduling delegate's decision followed consideration of the scheduling of azelastine in topical eye preparations by the Advisory Committee on Medicines Scheduling (ACMS) at its October 2011 meeting.

Azelastine is now in Schedule 2 for (a) preparations for nasal use and (b) in topical eye preparations containing ≤ 0.05 per cent or less of azelastine. The proposed advisory statement will apply to both nasal and eye preparations.

Azelastine is in pregnancy category B31. The Australian regulatory guidelines for OTC medicines (ARGOM) states, in Chapter 5B, that the labels of OTC products that contain active ingredient(s) in any pregnancy category other than category A should include a statement advising consumers who are pregnant or who may become pregnant to check with their doctor or pharmacist before use.

The Advisory Committee on Medicines Scheduling (ACMS) confirmed that although systemic absorption following application of azelastine to the eye would be low, the labels should include a TGA-proposed pregnancy warning.


Following advice from the Advisory Committee on Non prescription Medicines (ACNM), the TGA proposes the following advisory statement for azelastine when supplied as a non-prescription medicine under the conditions stated (See Table 1).

Table 1. Proposed advisory statements for azelastine
Which Meet The Following Conditions ... Required advisory statement(s)
When included in non-prescription medicines for topical ophthalmic and nasal administration. If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine


  1. Pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

Version history

Version Description of change Author Effective date
V1.0 Original publication Office of Medicines Authorisation 09/11/2012

About the Therapeutic Goods Administration

  • The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, 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 Reporting problems on the TGA website.

© Commonwealth of Australia 2012
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