AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
Personal Importation Individuals may import a limited supply of an unap- proved medicine for their own personal use, subject to conditions. Compassionate use programmes typically apply to medicines (or devices) after they have received mar- ket authorisation (registered on the ARTG) but before (or separate from) reimbursement on the PBS. It is an offence to advertise unapproved therapeutic goods to the public. 3.6 Ongoing Obligations Imposed by Marketing Authorisations The Therapeutic Goods Act 1989 (Cth), Therapeu- tic Goods Regulations 1990 (Cth) and Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) impose standard conditions on the person in rela- tion to whom a medicine is registered or listed, or in relation to whom a medical device is included, on the ARTG. These include obligations relating to post- marketing surveillance, including pharmacovigilance and technovigilance, as well reporting requirements. Pharmacovigilance (Medicines) It is a condition on registration or listing that the person in relation to whom a medicine is registered or listed on the ARTG must comply with the record-keeping and reporting requirements set out in the document pub- lished by the TGA titled Pharmacovigilance Respon- sibilities of Medicine Sponsors (as in force from time to time, and given force by the Therapeutic Goods Regulations). Sponsors must report adverse events to the TGA in accordance with those requirements, including reporting serious/unexpected events within 15 calendar days and significant safety issues within 72 hours. Sponsors must also maintain updated risk management plans and adhere to any TGA-imposed post-market conditions (especially if provisionally reg- istered). Technovigilance (Medical Devices) It is a condition on inclusion that the person in relation to whom a device is included on the ARTG must give certain information to sponsors and must comply with the record-keeping and reporting requirements set out in the Therapeutic Goods (Medical Devices) Regula- tions. Sponsors must report adverse events involving
and IVD companion diagnostics), the same unique product identifier. Transfer of a sponsorship for a medicine or medical device is permitted. The legislation provides that the change of sponsor occurs automatically upon the happening of certain events – however, in practice, the process requires: • notification to the TGA of the change in sponsor; • updating the ARTG to reflect the new sponsor’s details; and • the new sponsor applying for a variation to update the product information and labelling with the new sponsor details. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations There are four main pathways for accessing therapeu- tic goods that do not have applicable market authori- sation (ie, that are not on the ARTG) in Australia. Special Access Scheme This allows registered health practitioners to access unapproved medicines, devices or biologicals for indi- vidual patients on a case-by-case basis. There are three subcategories: • immediate access for seriously ill patients (cat- egory A); • TGA pre-approval (category B); and • immediate access for products with an established history of use (category C). Authorised Prescriber Scheme This allows medical practitioners to prescribe a speci- fied unapproved good to a class of patients with the same condition, without needing individual approv- als, subject to Human Research Ethics Committee approval or specialist college endorsement. Clinical Trials These allow unapproved goods to be supplied to patients enrolled in an approved clinical trial conduct- ed under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) scheme, provided that specified requirements for the supervision and conduct of the clinical trial can be met.
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