Registering OTC medicines

TGA registration of Over the Counter Medicines

Over-the counter medicines (OTC) are medicines that are not prescription medicines and are not complementary medicines. Inclusion in the ARTG is required prior to supply in the Australian market.

Over-the counter medicines are available without prescriptions from pharmacies, and some are also available in supermarkets, health food stores and other retailers. Examples include cough and cold remedies, anti-fungal treatments, sunscreens, and non-prescription analgesics such as aspirin and paracetamol. Antibacterial hand washes are also classified as over-the counter medicines.

The level of risk associated with making the product available to consumers is reflected in where the product can be sold and the TGA application level for inclusion in the ARTG as shown in the table below.

otc-products

PharmOut can help you with:

  • regulatory strategy including OTC application level for over-the counter medicines
  • TGA approval requirements including preparation of documents to support the safety, quality and efficacy of the product in CTD format
  • submissions for TGA approval

For further information, read our regulatory white papers, or Contact us.