THE Therapeutic Goods Administration has confirmed that the advertising of Schedule 3 (Pharmacist Only) medicines is to be allowed, along with the implementation of a more timely "switch" process facilitating rescheduling of Schedule 4 medicines to S3 and/or S2.
The moves are part of a new Scheduling Policy Framework (SPF) and Scheduling Handbook, resulting from extensive stakeholder consultation and collaboration with state and territory departments.
The new SPF version has been endorsed by the Australian Health Ministers Advisory Council (AHMAC) and any future changes will require AHMAC endorsement.
A new "Scheduling Working Group" has been established comprising representatives from the states and territories, the medicines and chemical scheduling advisory committees, industry groups and professionals from the medicine, pharmacy and chemicals sectors as well as consumer representatives, to meet in Feb.
This group will provide input to the factors determining suitability for advertising, to be published in the new "Guidelines for advertising substances included in Schedule 3 of the Poisons Standard".
All S3 items will be included in Appendix H by default, with the working group to consider existing S3 items for suitability for advertising when it meets shortly.
Other changes introduced in the Scheduling Handbook include a new appendix in the Poison Standard describing additional controls or requirements for pharmacist-only medicines (S3).
Applicants for scheduling of products will also be required to submit a summary for publication outlining the scheduling proposal, including the name of the substance, the proposed schedule, and a brief description addressing the relevant scheduling factors.
Visit tga.gov.au for details.
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