Permitted Indications - Reminder
The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after this period will be cancelled. It is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice!
Update list of Ingredients permitted in Listed Medicines
An update to the list of permitted ingredients - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2020) - was released on 16th December. A link to the updated list and a summary of changes can be found here.
Guidance for Declaration of Conformity for Class I non-sterile non-measuring and Class 1 in vitro diagnostic (IVD) medical devices
The Therapeutic Goods Administration (TGA) has released a guidance document to assist manufacturers in completing the relevant Declaration of Conformity and to assist sponsors confirming that documentation prepared by the manufacturer is complete. Source: Guidance for Declaration of Conformity
How to Respond to a Post Market Review for a Medical Device
This compliance dashboard gives very detailed guidance on how to review and reply to a TGA notification. Source: TGA
Listed medicines required to be tested for Aristolochic acids
For safety reasons Aristolochic acids and all plant species that might contain Aristolochic acids are prohibited from supply, sale or use in medicines in Australia. Some listed medicines are at risk of containing aristolochic acids due to inadvertent substitution. To address this risk, the Therapeutic Goods Administration (TGA) places a condition of listing which requires that sponsors of these medicines confirm the absence of aristolochic acids in their medicine and get TGA approval before releasing each batch of the medicine. If you are the sponsor of listed medicines which have the aristolochic acids condition of listing, you should review your records and ensure that you:
- hold evidence to confirm the absence of aristolochic; and
- provide this evidence to us at the TGA for evaluation and approval, prior to supply of each batch in Australia.
Source: Presence of aristlochic acids
Changes to requirements for listed medicines – Magnesium and Andrographis paniculata
The Therapeutic Goods Administration has published ‘Outcomes: Low-negligible risk changes to Permissible Ingredients - 2020-2021’. This impacts magnesium salts and Andrographis paniculate. The changes will commence on 1 March 2021. Source: Outcomes of Consultation.
Applications now open for the Manufacturing Modernisation Fund Round 2
The Modern Manufacturing Strategy is funding $1.5 billion for eligible manufacturers. Manufacturers can apply for co-funding under the initiative. To be eligible for grants businesses will need to demonstrate expected job growth and the upskilling of their existing employees. Applicants will also need to demonstrate alignment with the National Manufacturing Priorities. The Manufacturing Modernisation Fund is the first program to open under the Modern Manufacturing Strategy which will assist Australian manufacturers to scale-up, improve their competitiveness and to build resilient supply chains. Subscribe to updates at the Department of Industry, Science and Energy – here.
Therapeutic Goods Administration COVID-19 Proceedings
The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). There is now a TGA page which lists all face masks that have been cancelled from the ARTG during the review. Source: Cancelled face masks
Man fined $10,656 for alleged unlawful advertising of cannabidiol including COVID-19 claims
Infringement notices totalling $10,656 have been issued to a West Australian man, for alleged unlawful advertising of cannabidiol (CBD). The man allegedly advertised, on websites and a social media platform, various oils containing CBD that were prescription only medicines. The Act prohibits consumer advertising of substances included in Schedule 4 (prescription only medicine) or Schedule 8 (controlled drug) of the Poisons Standard. The TGA alleges that the man referred to prohibited representations in promoting the CBD oils on a social media platform as a treatment for cancer and a cure for brain tumours. Source: TGA media release
GMP annual report
The TGA has released its annual GMP report for the financial year 2019-2020. This includes information on the number of different types of GMP licensing applications received and inspections carried out, processing times for both local and overseas manufacturers, and outcomes of the inspections. On page 13 there is a list of common deficiencies. Interestingly, 29 local manufacturers were given an A1 compliance rating based on inspections conducted during the 2019¬20 financial year. Source: TGA news release
Laboratory Testing Results
The TGA has posted their database of laboratory testing results. Although numerous products passed the tests applied, many did not, and results included bacterial contamination, presence of prohibited substances such as Aristolochic Acid and Amygdalin. Source: TGA.
Country of Origin
On 10th December the country of origin regulations were updated, providing clarity to manufacturers of complementary medicines as to what is a “process of substantial transformation”. The updated legislation can be viewed here.
Alkaloids of Australia Pty Ltd and its former export manager, Christopher Kenneth Joyce, have each been charged with 33 criminal cartel offences, contrary to the Competition and Consumer Act 2010, formerly the Trade Practices Act 1974, following a criminal investigation by the ACCC. The ACCC alleges that Alkaloids of Australia and other overseas suppliers of SNBB made and gave effect to arrangements to fix prices, restrict supply, allocate customers and/or geographical markets, and/or to rig bids for the supply of SNBB to international manufacturers of generic antispasmodic medications. Alkaloids of Australia produces and supplies the active pharmaceutical ingredient SNBB (scopolamine N-butylbromide, also known as hyoscine butylbromide), which is the active pharmaceutical ingredient in antispasmodic medications taken to relieve stomach pain and bowel cramps. Source: ACCC media release
Unlawful Importation of Cosmetic Injectables
The Magistrates Court of Victoria has convicted a Melbourne woman on three charges of unlawful importation of therapeutic goods, namely dermal filler medical devices (pre-filled syringes containing hyaluronic acid) and hyaluronidase (enzymes that can be used to dissolve dermal fillers), which is a therapeutic good for cosmetic use in humans. At the time of importation, the woman had not included the goods in the Australian Register of Therapeutic Goods (ARTG). Fines were issued but were unpaid. Criminal prosecutions are an enforcement tool the TGA can use to address serious non-compliance and in cases where infringement notices have not been paid. Source: TGA
Down-schedule of low dose cannabidiol (CBD) preparations
The Therapeutic Goods Administration (TGA) has down-scheduled certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine). Low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults that have been approved by the TGA, to be supplied over-the-counter by a pharmacist, without a prescription. The decision limits over-the-counter supply to only those products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG). The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child resistant closures. Source: TGA media release
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