Sch 10Therapeutic goods for evaluation

Schedule 10—Therapeutic goods for evaluation Note: See regulations 16C, 16D, 16F, 16G and 45. ## Part 1 Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch ## Part 1—Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch | Column 1Item | Column 2Product | | ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 1 | therapeutic goods (except therapeutic goods mentioned in another Part of this Schedule), that:(a) contain a substance mentioned in Schedule 4, 8 or 9 to the Poisons Standard; or(b) contain a substance not mentioned in any of those Schedules but which meets the criteria for mention in any of those Schedules | | 2 | a medical gas | | 3 | a vaccine | | 4 | an allergen, except an allergen for skin patch testing on unbroken skin | | 5 | a biotechnology medicine | | 6 | an immunoglobulin | | 7 | a radio contrast agent, except barium sulphate preparation for radiological use | | 8 | a radiopharmaceutical | | 9 | a dialysis solution, except a haemodialysis solution | | 11 | a special dosage form, such as a transdermal system or osmotic pump | | 12 | an injectable medicine dosage form | | 13 | a blood product | | 14 | therapeutic goods referred to the Prescription Medicines Authorisation Branch of the Therapeutic Goods Administration within the Department for the purpose of evaluation as a prescription medicine | | 15 | an excipient in therapeutic goods mentioned in this Part | ## Part 2 Evaluation of complementary medicines by the Complementary and OTC Medicines Branch ## Part 2—Evaluation of complementary medicines by the Complementary and OTC Medicines Branch The following therapeutic goods, if the sponsor has satisfied the Secretary that the goods do not meet the criteria for mention in Schedule 4, 8 or 9 of the Poisons Standard: | Column 1Item | Column 2Product | | ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------- | | 1 | a complementary medicine | | 2 | an excipient in complementary medicine | | 3 | therapeutic goods referred for evaluation to the Complementary and OTC Medicines Branch of the Therapeutic Goods Administration within the Department | ## Part 3 Evaluation of non‑prescription and other medicines by the Complementary and OTC Medicines Branch ## Part 3—Evaluation of non‑prescription and other medicines by the Complementary and OTC Medicines Branch The following therapeutic goods, if the sponsor has satisfied the Secretary that the goods do not meet the criteria for mention in Schedule 4, 8 or 9 of the Poisons Standard: | Column 1Item | Column 2Product | | ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 1 | an antiseptic | | 2 | a sunscreen preparation | | 3 | all other therapeutic goods not mentioned in another Part of this Schedule | | 4 | an excipient in therapeutic goods mentioned in this Part | | 5 | therapeutic goods referred to the Complementary and OTC Medicines Branch of the Therapeutic Goods Administration within the Department for the purpose of evaluation as a non‑prescription medicine | ## 1 General requirements #### 1 General requirements A consumer medicine information document about a medicine must: (a) be written in English; and (b) be clearly legible; and (c) be written in language that will easily be understood by patients; and (d) be consistent with product information about the product. ## 2 Specific requirements—document enclosed within packaging etc. #### 2 Specific requirements—document enclosed within packaging etc. Also, if the consumer medicine information document about a medicine is enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine, it must set out all of the information required by the “TGA Consumer Medicine Information (Prescription Medicine) Template” (published by the Therapeutic Goods Administration on its website) but: (a) it is not required to set out the information in the same order as the Template; and (b) it is not required to include any Consumer Medicine Information (CMI) summary that forms part of that Template. ## 3 Specific requirements—document not enclosed within packaging etc. #### 3 Specific requirements—document not enclosed within packaging etc. Also, if the consumer medicine information document about a medicine is not enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine: (a) it must set out all of the information required by the “TGA Consumer Medicine Information (Prescription Medicine) Template” (published by the Therapeutic Goods Administration on its website) in the same order as the Template; and (b) if it is supplied in electronic form, it must be in the form of a PDF file or an HTML file.