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

Closed 18 May 2021

Opened 6 Apr 2021

Overview

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on addition of a proposed new required advisory statement for labels of non-prescription medicines containing more than 1.5 per cent lidocaine (lignocaine) for topical oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document.

The required advisory statement “Do not use for teething pain in children” is proposed for preparations for topical oral use containing 1.5 per cent or more of lidocaine, to ensure that consumers and health professionals are aware that these medicines are not suitable for use for teething in children.

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 and that any label changes that would be required for these medicines are made in the most convenient, efficient and cost-effective way.

Consultation paper

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

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