Update to remote GMP inspections during the pandemic.
This includes a summary of the options for the Compliance Verification (CV) pathway and the Mutual Recognition Agreement (MRA) pathway. Source: TGA
Amendment to the independent report on the therapeutic use of psilocybin and MDMA
A final decision may be published the first week of December 2021. Source: TGA
Compliance enforcement
Criminal cartel charges - a follow up to last month’s story about an individual pleading guilty to criminal cartel charges: on the 16th November the company itself, Alkaloids of Australia Pty Ltd, also pleaded guilty to criminal cartel conduct. Alkaloids of Australia produces and supplies SNBB (scopolamine N-butylbromide, also known as hyoscine butylbromide). SNBB is manufactured from the Duboisia plant, which is native to Australia. Source: ACCC
Ivermectin – A chiropractor in New South Wales has been issued an infringement notice for $2,664 for alleged importation of ivermectin product not included on the Australian Register of Therapeutic Goods. Source: TGA
Counterfeit erectile dysfunction medicines - Performance Online Services Pty Ltd fined $53,280 for exporting, supplying and advertising Xcalibur XXX Gold 8000 and Wicked Triple Platinum – products that were not entered in the Australian Register of Therapeutic Goods (ARTG). The products contained the undeclared ingredient sildenafil, a prescription only substance. Source: TGA
Adulterated products seized and destroyed by customs
S.W.A.G II Platinum 33K - undeclared substance sildenafil. Source: TGA
Panther Power Platinum 11000 – same as above. Source: TGA
777K – as above. Source: TGA
One Night Love tablets – as above. Source: TGA
COVID – Queensland individual issued infringement notice for $2,664 for advertising a homeopathic product for the treatment and prevention of COVID-19. Source: TGA
Nicotine vaping products (Source for items below: TGA):
Australia Utopia issued with 7 infringement notices totalling $93,240 for alleged advertising breaches of nicotine vaping products on its website
RV Global Ecommerce Pty Ltd fined $39,960 – same as above
Sydney company Mason Online Pty Ltd fined $106,560 for alleged advertising breaches – as above
Melbourne individual responsible for the Vapespot website has been issued seven infringement notices totalling $18,648
Melbourne-based individual fined $7,992 for alleged unlawful importation of nicotine vaping products
Reclassification of some medical devices
On the 25th November a number of medical devices were re-classified, including active medical devices for therapy with a diagnostic function; spinal implants for motion preservation; devices in direct contact with the heart, central circulatory system, central nervous system; devices that administer medicines or biologicals by inhalation; active medical devices; and substances introduced into the body, body orifice or applied to the skin. Source: TGA
Medicinal cannabis
Regulations are being refined. Here some links to various relevant topics:
New streamlined process for medicinal cannabis applications
Changes to Special Access Scheme (SAS) and Authorised Prescriber applications
Changes to sponsor requirements for supplying unapproved medicinal cannabis products in Australia
Importation, manufacture and supply of unapproved medicinal cannabis products
