AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
Provisional registration for certain therapeutics will expire after two years (extendable up to six years), if the sponsor has not submitted confirmatory clinical data during that period. The TGA: • can suspend marketing authorisation/ARTG registration on grounds including safety or quality concerns, non-compliance with conditions, failure to pay annual charges, or the provision of false or misleading information; • can suspend authorisation as an interim measure while concerns are investigated; and • cannot suspend marketing authorisation due to “failure to market”, unlike in the EU – however, the TGA discourages sponsors from leaving their products on the ARTG where they have determined that no further supplies of the product will occur in Australia. 3.4 Procedure for Obtaining a Marketing Authorisation To obtain a marketing authorisation for a registered medicine , a sponsor must submit an application via the TGA Business Services (TBS) portal, supported by a dossier in Common Technical Document (CTD) format. The TGA evaluates the medicine within maxi- mum statutory timeframes, being up to 255 working days, reduced to 175 working days where the medi- cine is already approved by a comparable overseas regulator, and further reduced to 120 working days where manufacturing is acceptable and only labelling/ product information and risk management remain out- standing. The legislation also permits certain “clock stop” periods where the TGA has made a request for information. Once a medicine is registered on the ARTG, no change to the medicine as approved by the TGA can be made without TGA notification or approval – depending on the variation in question. Those changes that will require evaluation of clinical or bioequivalence data will be more significant. Most changes to a sponsor will simply require notification to the TGA. Listed medicines are not individually evaluated by the TGA for quality, safety or efficacy before they can be
supplied in the marketplace. A sponsor must certify that the listed medicine meets applicable require- ments and that all ingredients are found on the Thera- peutic Goods (Permissible Ingredients) Determination (No 1) 2026 (Cth). A new listing or registration on the ARTG (and therefore a new application) must be sought for any medicine that is “separate and distinct” from other therapeutic goods (including any current listings/registrations). This includes where the formulation or composition of the goods is different, the medicines have different dosage forms and strengths, and the product has a different name. For medical devices, sponsors must demonstrate compliance with the Essential Principles and apply appropriate conformity assessment procedures. Inde- pendent certification of the manufacturer’s conformity assessment procedures is required for all classifica- tions except for Class I non-sterile, non-measuring devices and Class 1 IVD devices (which can be self- certified by the manufacturer providing a Declaration of Conformity). Where devices are manufactured out- side Australia, sponsors may be able to rely on cer- tification from EU Notified Bodies or approvals from comparable overseas regulators (US FDA, Health Canada, Japan PMDA, Singapore HSA), as set out in the Therapeutic Goods (Medical Devices – Informa- tion that Must Accompany Application for Inclusion) Determination 2018 (Cth). Where TGA conformity assessment certification is required for a new application, this process must be completed within a statutory timeframe of up to 255 working days. Otherwise, applications for ARTG inclu- sion must be approved or selected for audit within a statutory timeframe of 20 business days. As with medicine applications, the legislation also permits cer- tain “clock stop” periods where the TGA has made a request for information. For medical devices , a single ARTG entry may cover more than one device (and instead covers a “kind of medical device”), provided that they have the same sponsor, manufacturer, device nomenclature system code, medical device classification and, for certain higher risk products (Class 4 IVDs, Class III devices
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