In ongoing global recognition of the low risk safety profile of cannabidiol (commonly called 'CBD') and broad spectrum hemp extracts, the Republic of South Africa have gazetted a change to the Schedules of the MEDICINES AND RELATED SUBSTANCES ACT, 1965, to make two cannabis preparations for internal therapeutic use available as 'Category D' complementary medicines that can only make lower level therapeutic claims - the south African equivalent of listed complementary medicines in Australia.
The change means that two different preparations are now permitted:
- A low dose cannabidiol (currently in Australia this is the equivalent of a Schedule 4 registered medicine preparation; and proposed by the TGA to be a Schedule 3 Pharmacist Only registered medicines preparation);
- A cannabis extract with naturally occurring quantities of cannabiniods (other than cannabidiol) in the finished product (currently in Australia this preparation is the equivalent of a Schedule 9 prohibited substance - Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with the approval of Commonwealth and/or State or Territory Health Authorities).
Members can view the development and a comparison to current Australian down-scheduling proposals in today's technical alert.
The TGA have issued a warning to Sponsors of cold and flu medicines that advertising cannot conflict with current public health campaigns, in particular, the messaging should not promote out-of-home activities such as work/school/other activities with (suppressed) symptoms, which would conflict with Government COVID-19 guidance.
The Federal Court have fined GSK and Novartis $4.5m for the misleading advertising of two OTC gels for joint pain that had the same active ingredient.
Members are reminded that the requirement to have pre-approval for advertisements appearing in specified media ends on June 30 2020.
The TGA have guidance available for advertisers on social media platforms.