Ingredient requirements for non-prescription medicines
Ingredient requirements for non-prescription medicines.
For information about the use of ingredients in general, see Ingredient basics.
Non-prescription medicines cannot contain ingredients found in Schedules 4, 8 and 9 of the Poisons Standard. If medicines contain these ingredients, they must be prescription medicines.
Listed and assessed listed medicines
Listed and assessed listed medicines (including listed therapeutic sunscreens) may only use low-risk ingredients which are included in the Therapeutic Goods (Permissible Ingredients) Determination.
Sponsors should consult the Permissible Ingredients Determination for restrictions that apply for each ingredient in their product. The product’s label must include the Australian Approved Name (AAN) for each active ingredient.
Registered complementary medicines and over the counter (OTC) medicines
Registered complementary and over the counter (OTC) medicines typically contain higher-risk ingredients, which are scheduled in the Poison Standard (Standard for the Uniform Scheduling of Medicines and Poisons). Registered complementary and OTC medicines may use any ingredient, provided it is not in Schedules 4, 8 or 9 of the Poisons Standard.
Guidance and resources
- GuidanceThis guidance is to assist sponsors of listed and assessed listed medicines to understand ingredient requirements for market authorisation
- GuidanceThis guidance helps sponsors and manufacturers of therapeutic goods to understand and use the Poisons Standard to determine if any restrictions apply to their product