Over-the-counter (OTC) medicines are sold without a doctor’s prescription and are not complementary medicines (i.e. they do not primarily consist of complementary medicine ingredients such as vitamins, minerals and plant material).
Depending on their level of risk, over-the-counter (OTC) medicines can be bought off the shelf from supermarkets and pharmacies or from pharmacies with the advice of a pharmacist. In general, the risk of a medicine is based on its ingredients (e.g. the access restrictions provided in the Poisons Standard) and/or its therapeutic indications (intended uses).
Most OTC medicines are registered in the Australian Register of Therapeutic Goods (ARTG) and assigned an ‘AUST R’ identification number that must be displayed on the medicine label. Registered OTC medicines are lower risk than prescription medicines but they still require TGA pre-market evaluation of their safety, quality and efficacy.
Most OTC medicines are registered, only a small number are listed (‘lower risk’ medicines) in the ARTG, such as some sunscreen products.
Depending on the level of risk OTC medicines can be sold as:
- General sales medicines: sold in pharmacies and stores such as supermarkets e.g. paracetamol tablets in small pack sizes.
- Pharmacy medicines: sold in pharmacies without needing a pharmacist’s advice e.g. paracetamol tablets in larger pack sizes.
- Pharmacist-only medicines: sold in pharmacies with pharmacist advice on their use e.g. the emergency contraceptive pill.
- The Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
- In response to the COVID-19 pandemic, the TGA is implementing Serious Shortage Medicine Substitution Notices
- Community pharmacists to enforce new limits on dispensing and sales of prescription and over-the-counter medicines