ASMI says Permitted indications legislative reform must progress
26 June 2014 - The Australian Self Medication Industry (ASMI) says it is critically important that legislative reform of Permitted (coded) indications for Listed Medicines be progressed to ensure the sustainability of the complementary medicine sector in the future.
The Office of Complementary Medicines (OCM) has announced that the implementation of the Permitted (coded) indications legislative reform will be delayed pending broader consideration of the implications of the deregulation agenda for the Therapeutic Goods Administration (TGA).
ASMI Regulatory and Scientific Affairs Director, Steve Scarff, said: "It is disappointing that the legislative amendments related to the Permitted indications project will not proceed to Parliament during the scheduled winter sittings. Instead, the TGA will consider a bid during later sitting periods in 2014.
"ASMI and its members have put a substantial amount of work into the reform so it is a shame to see that it has stalled. We urge the TGA to press ahead.
"The OCM has noted that part of the Permitted indications reform can be implemented within the existing regulatory framework without any legislative changes or increased regulation. In particular, the updating of the indications list in the Electronic Listing Facility (ELF) will be progressed.
"In this regard, the TGA intends to continue updating and
expanding the list of indications and will proceed to upload the
list into ELF once finalised and practicable.
"The OCM has advised that this delay will enable the TGA to continue working with industry to ensure the updated, comprehensive list of indications meets the needs of the complementary medicine industry and improves compliance with the regulatory framework.
"Once the indications list is uploaded to ELF, it will make it easier for sponsors to select indications which are both eligible for listing and compliant with the advertising requirements.
"ASMI is reviewing the draft Permitted indications lists and
working with members to ensure the list meets the needs of the
complementary medicines industry.
"The TGA is preparing a draft list for traditional medicine indications and ASMI will work with members and the TGA to ensure a comprehensive list is developed," said Mr Scarff.
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About ASMI: The Australian Self Medication Industry (ASMI) is the peak body representing sponsors of non-prescription medicines - over-the-counter (OTC) and complementary medicines. Its members make up 85 per cent of the $4 billion self care market. Membership totals 60 companies and ASMI members employ approximately 18,000 people with exports estimated at $1.2 billion annually. ASMI's mission is to promote better health through responsible self care. This means ensuring that safe and effective self care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self medication products as part of the national health strategy. www.asmi.com.au