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Regulatory impact statement (RIS) - update to the Required Advisory Statements for Medicine Labels (RASML)

May 2013

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Appendix 1

Changes having negligible or no impact

The following types of changes are expected to have negligible or no impact on stakeholders.

Advisory statements from the Australian regulatory guidelines for over-the-counter medicines, 1 July 2003 ('ARGOM 2003')

There were 39 substances in the ARGOM 2003 for which TGA guidelines required advisory statements. Only some of these requirements were included in the RASML document at the time of its commencement in 2004. However, it was envisaged that these statements would be incorporated in the RASML at an appropriate later date.

Eleven ARGOM 2003 requirements are being introduced as part of the current RASML update.

The ARGOM has been adopted and used by the TGA and industry for over nine years. Many of the statements in the ARGOM have been required by the TGA for entry of medicines on the ARTG, and consequently the affected products currently on the market already satisfy the labelling requirements as set out in the ARGOM.

Advisory/warning statements required by the ELF

There are currently eight substances for which the ELF has required advisory statements since 2004:

  • aspartame
  • chitosan
  • folic acid
  • hydroxyanthrocene derivatives
  • iron compounds
  • psyllium
  • pyrethrins
  • royal jelly.

Although the advisory statements which apply to these substances were not included in the RASML document at the time of its commencement in 2004, marketed products have already been required to satisfy the labelling requirements as set out in the ELF as a condition of entry on the ARTG.

Advisory statements mandated by new Listing Notices

The Office of Complementary Medicines (OCM), within the TGA, regulates listed medicines containing low risk ingredients. Such medicines may only make low level health claims and must only include ingredients pre-approved by the TGA. The legislative basis for these ingredients falls under Part 1 of Schedule 4 to the Regulations, which identifies all the therapeutically active ingredients intended for use in listed medicines.

There is a mechanism for adding new ingredients to the list of goods or ingredients in Schedule 4 to the Regulations that qualify as 'listable'. Firstly, data submitted by an applicant is evaluated by the OCM. The OCM evaluation of these data focuses on determining whether the substance is of acceptable quality and is safe for use as a new ingredient. Following this, Subsection 9A(5) of the Act authorises the Minister for Health and Ageing to publish a 'listing notice' in the Commonwealth of Australia Gazette. The listing notice is used to notify stakeholders of the approval of a new ingredient eligible for use in listed complementary medicines. Once the listing notice is published, sponsors can include the ingredient in medicines that are eligible for listing.

The Listing Notice may sometimes require the labels of medicines containing the ingredient to include specific advisory statements. Seven of the listing notices published since 2008 include mandatory advisory statements. These listing notices apply to the following substances:

  • bovine whey IG-rich fraction
  • hydrolysed milk protein - alpha casozepine enriched
  • omega-3 fish oil phytosterol esters
  • potassium chloride
  • sodium bicarbonate
  • vegetable oil phytosterol esters
  • wheat dextrin
  • kunzea ambigua (OBPR has confirmed that no RIS is required - OBPR ID: 14808).

As these requirements are already mandatory under the Act, their inclusion in the RASML will not lead to any change that will have a regulatory impact on manufacturers and sponsors of therapeutic goods, or on the public.

Proposal to remove warning statements that are only applicable to S4 medicines from the main body of the document to the archival section

There are a number of existing advisory statements that were included in the original version of the RASML, but which only apply to Schedule 4 ('S4') medicines. These statements will be removed from the main body of the document to the archival section. RASML has no legislative application to S4 medicines.

New advisory statements as a result of recent down-scheduling decisions

In 2012 and 2013 the TGA new requirements have been proposed for famciclovir (as a result of down-scheduling from S4 to S3), azelastine (down-scheduled from S3 to S2), and for particular presentations of loperamide, fexofenadine, loratadine and desloratadine (down-scheduled from S2 to unscheduled). The new requirements for famciclovir are already being enforced as part of the applications to register the new OTC products. In regards to azelastine, there is currently only one sponsor of azelastine products (who is already compliant). In regards to the other products, the proposed advisory statements were published on the TGA website (as consultation documents) shortly after the down-scheduling decision was made in each case. The labels of the affected products would have been approved subsequent to this publication in almost all cases (albeit via 'self-assessable' applications). It is unlikely that there are many non-compliant products on the market.

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