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

Information for health professionals

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