Over the counter medicine
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.
- Metal fragment found in an Ultra Potent-C Chewable TabletBioCeuticals is recalling one Batch 220380 (exp 02/2024) of Ultra Potent-C Chewable (60s) (AUST L 208690) following a consumer report of a metal fragment found in one tablet.
- PholcodineThe TGA has decided to cancel the registration of pholcodine-containing medicines and is recalling them from pharmacies.
- How to find out what’s in your medicineWant to know what’s in your medicines? The obvious place to start is with the medicine’s label, but there may be more to it.
- GMP Clearance: Extension processing timesDelays in processing timeframes of applications to extend GMP Clearances.
- GMP Clearance: Additional countries added to MRA pathwayMore applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2021The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
- Required Advisory Statements for Medicine Labels (RASML)The new Therapeutic Goods (Medicines Advisory Statements) Specification 2021 commences 1 January 2022
- Mandatory requirements for an effective over-the-counter medicines applicationThe requirements for an effective OTC medicines application commences 1 March 2016