AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
6.2 Different Classifications Applicable to Pharmaceuticals Australia classifies medicines for supply purpos- es through the Poisons Standard (SUSMP), which assigns active ingredients to Schedules determining the level of how freely the product can reach consum- ers. The relevant categories are as follows. • Unscheduled: available for general sale, accessible at supermarkets, health food stores and general retail (eg, low-dose vitamins). • Schedule 2 – Pharmacy Medicine: available from pharmacy shelves without a prescription, though a pharmacist must be available for advice (eg, ibu- profen or paracetamol, depending on the strength and pack size, and where specified conditions are met). • Schedule 3 – Pharmacist-Only Medicine: available only directly from a pharmacist behind the counter, who must provide advice at point of sale. No pre- scription required (eg, emergency contraception, salbutamol inhalers). • Schedule 4 – Prescription-Only Medicine: requires a prescription from an authorised health practition- er and dispensing by a pharmacist (eg, antibiotics, antidepressants, antihypertensives). • Schedule 8 – Controlled Drug: requires a prescrip- tion with additional controls on prescribing, dis- pensing, storage and record-keeping, with some states requiring prescriber permits (eg, opioids such as morphine and oxycodone, amphetamines). • Schedule 9 – Prohibited Substance: illegal to produce, possess, sell or use except for approved research, with limited therapeutic exceptions (eg, since July 2023 for MDMA and psilocybin under psychiatric supervision) (ie, most illicit drugs). 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The Therapeutic Goods Act 1989 (Cth) is the primary legislation governing both importation and exportation of therapeutic goods. It is supported by the Thera-
Manufacturers of medical devices must operate under a certified quality management system (QMS) con- forming to ISO 13485. This is verified through the con- formity assessment process rather than a separate manufacturing licence. Sponsors of medical devices are required to hold evidence or have a written agree- ment with the manufacturer of a medical device that will enable it to obtain (within a legislated timeframe) evidence relating to compliance with essential princi- ples and conformity assessment procedures. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices Wholesale of scheduled medicines is regulated pri- marily at the state and territory level, not by the TGA. Each Australian state or territory has its own legisla- tion that requires wholesalers to hold a licence issued by its health department under local poisons and ther- apeutic goods legislation. For example, in New South Wales, wholesale licenc- ing is issued by NSW Health under the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW). An application is lodged with NSW Health and can take up to four weeks to approve. All licences expire on September 30th each year and must be renewed annually by payment of the renewal fee. A wholesal- ing licence will specify the premises from which the business is licensed to wholesale goods, and the categorisation (by reference to the Schedule on the Poisons Standard) of the poisons or medicines that the business is permitted to wholesale. While each state or territory governs licence valid- ity and renewal periods, wholesalers must comply with the Australian Code of Good Wholesaling Prac- tice for Medicine in Schedules 2, 3, 4 and 8 (CGWP). The CGWP imposes requirements on storage, stock handling, security, cold chain management, record- keeping and recall procedures.
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