Proposed minor changes to Required Advisory Statements for Medicine Labels (RASML): Chlorhexidine, hydrocortisone, ibuprofen
Results updated 17 Nov 2021
Introduction
We asked for comments from interested parties on proposed minor changes to advisory statement requirements for labels of over the counter (OTC) medicines containing chlorhexidine, hydrocortisone or ibuprofen, for inclusion in the Required Advisory Statements for Medicine Labels (RASML).
Summary and discussion of responses
The TGA would like to thank those who responded to the consultation. We received four submissions, which were mostly supportive. In relation to chlorhexidine, one respondent considered that adding “more” to the warning “Mild skin irritation may occur; stop use if it becomes more severe” does not add value and the change creates unnecessary inconvenience to sponsors. While agreeing that the change is relatively minor, the TGA consider that a warning to stop use only if irritation becomes “severe” is inappropriate and that the proposed wording is appropriate.
Outcome
The TGA will include the proposed changes in the next update of the RASML, to occur in late 2021 or early 2022. A transition period of 18 months from commencement of the new RASML will allow for existing medicines that do not comply with new requirements to have their labelling updated.
Overview
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed minor changes to advisory statement requirements for labels of over the counter (OTC) medicines containing chlorhexidine, hydrocortisone or ibuprofen, for inclusion in the Required Advisory Statements for Medicine Labels (RASML). The proposed changes involve minor changes to existing RASML entries to correct or clarify intended requirements and in most cases should not require changes to existing product labels.
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.
Consultation paper
Providing feedback
We invite you to provide your feedback by clicking 'Make a submission' below and responding to the consultation question (by free text and/or file upload).
What happens next
All feedback will be considered after the consultation period ends and will be published on the TGA website if your consent is given.
Finalised advisory statements will be included in the next version of RASML, RASML No. 6. A transition period of 18 months from commencement of the new RASML is provided to allow for existing medicines that do not already comply with new requirements to have their labelling updated.
Audiences
- Academics
- Non-government organisations
- State government agencies
- Commonwealth agencies
- Health professionals
- General public
- Community groups
- HPRG (TGA) Staff
- Complementary medicines
- Over-the-counter medicines
Interests
- Non-prescription medicines
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