Pharmacy Daily | TGA launches codeine consultation

With the Therapeutic Goods Administration (TGA) decision to defer the final decision around up-scheduling of products containing codeine (PD 19 Nov), the TGA has re-opened the consultation seeking further submissions from stakeholders on specific proposal schedules (PD breaking news Friday). Schedule 2 relating to cough and cold preparations proposes pack size reductions and label warnings as one option. A second proposal for these products is to up-schedule S2 to S3, reduce the pack size and add label warnings, while the third option is to retain the interim decision to up-schedule them to S4. Under Schedule 3, which relates to but is not limited to codeine containing analgesics, pack size reductions and label warnings are proposed or alternatively, the interim decision to up-schedule to S4 is retained. Interested parties should respond by COB 29 Jan 2016. Australian Self Medication Industry (ASMI) Regulatory and Scientific Affairs Director Steve Scarff said the organisation welcomes the opportunity to resubmit saying, “The TGA’s proposed amendments take a more sophisticated and transparent approach and enable stakeholders to make more informed comment.” Scarff called for “an appropriate balance ... to be achieved between managing the risk of misuse of OTC codeine-containing analgesics, whilst maintaining appropriate pharmacy access” given that the overwhelming majority of consumers use these products “safely and responsibly”.

---

The above article was sent to subscribers in Pharmacy Daily's issue from 14 Dec 15
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 14 Dec 15