In recognition of the different risks and information requirements associated with medicines prescribed by a medical practitioner (or used in a clinical setting) to those self-selected by consumers, the TGA have revised the the therapeutic goods orders for labelling of medicines. As a result label requirements are now specified in two separate labelling Orders, for the two types of medicines need to reflect the different contexts in which they’re used.
There will be a 4 year transition period for sponsors to implement the labelling requirements of TGO 92 which, together with TGO 91 (Standard for labels of prescription related medicines) , will eventually replace Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69).
- Specific transition period provisions are described in section 4 of the Orders.
- During this time, medicines must comply with either TGO 69 or TGO 91/TGO 92 (whichever is relevant).
- At the end of the transition period, medicines must comply with either TGO 91 or TGO 92, whichever is relevant.
- TGO 69 will cease to exist (‘sunset’) in October 2017. As the transition period extends beyond October 2017, TGO 69 will be remade so that it remains in existence until the end of the 4 years.
For more information and to download TGO 92 – Standard for labels of non-prescription medicines see the TGA website