Proposed changes to Required Advisory Statements for Medicine Labels (RASML)

Overview

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed changes to the Required Advisory Statements for Medicine Labels (RASML). RASML sets out advisory statements that are required to be included on the labels of specified OTC and registered complementary medicines.

The proposed changes to RASML are:

• addition of entries for three new substances not currently included in RASML - celecoxib, methenamine and naratriptan
• a new entry for immediate-release melatonin preparations for short term treatment of jet lag
• changes to existing entries for sedating antihistamines, cetirizine and levocetirizine, dextromethorphan, and ibuprofen, and
• deletion of the entry for aspartame, minor changes to existing entries for benzoyl peroxide and Chelidonium majus, and other minor editorial changes.

The proposed changes are further detailed in the Consultation document.

To respond to this consultation please click the 'Online Survey' link below.

You can respond to any or all of the proposed changes. Responses can be entered directly into the text boxes provided, or submitted as a single PDF or Word document upload. 

Privacy and your personal information

The TGA collects your personal information in this submission in order to:

1. Contact you if the TGA wants to seek clarification on any issues raised in your submission or to confirm whether you consent to certain information being made publicly available.
2. Help provide context about your submission. For example, whether you are responding as an individual, a director of a company or representing an interest group.

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 identified individual or an individual who is reasonably identifiable from the information or opinion. The TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.

Online publication of submissions

The TGA may disclose your full name, work title, company/organisation and submission on the Internet (i.e. make this information publicly available) with your consent.

You may specify whether there is anything in your submission which you would prefer to not be published online (e.g. names, email addresses, proprietary information) by:

1. Providing an additional, redacted copy of your submission; or
2. Providing details of content not to be published e.g. “Do not publish pages 3-5”, “Please redact contact details”; or
3. Identifying any text within your submission to remain confidential by having it clearly marked 'IN CONFIDENCE' and highlighted in grey.

Why your views matter

The TGA is requesting comments that will help ensure that the proposed advisory statements are appropriate and support the quality use of the medicines.