127 results
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NOTIFICATION FORM: Transition arrangements for medical devices that record patient images, and anatomical models
This form should be used by manufacturers and sponsors of medical devices that record patient images or that are anatomical models, and that will be reclassified by the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for transition if: they are medical devices intended to record patient images that are acquired using a method that relies on energy outside the visible spectrum; or they... MoreOpened 21 September 2020 -
Notice of interim decisions to amend (or not to amend) the current Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS meeting, June 2020
Scheduling amendments referred to expert advisory committee This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the scheduling in the Poisons Standard, following advice sought at the 23-25 June 2020 meetings of the Advisory Committee on Medicines Scheduling (ACMS) , and the Advisory Committee on Chemicals Scheduling (ACCS) . All submissions received will be... MoreOpened 9 September 2020 -
Consultation on the new Therapeutic Goods Order 106 - Data matrix codes and serialisation of medicines
The Therapeutic Goods Administration (TGA) is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain. To make sure the standard is clear, meaningful and fit for purpose. We are seeking feedback on its suitability and potential impacts. Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020 Guidance for TGO... MoreOpened 2 July 2020 -
TGA SME Assist Workshop: Meeting Your Obligations (Perth)
Navigating the re gulatory maze can be a challenge, especially if you're new to regulation. SME Assist in partnership with The Western Australian Health Translation Network presents Meeting Your Obligations: a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation. This may include: small to medium enterprises (SMEs) start-ups researchers If you are making therapeutic claims about a product or... MoreOpened 12 August 2019 -
GMP Forum 2018 - Survey
TGA Conference Evaluation online form 2018 GMP Forum 26 June 2018 MoreOpened 28 June 2018 -
AusPAR Survey
The TGA would like to know what you think about the Australian Public Assessment Reports (AusPARs) for prescription medicines. This questionnaire should only take a couple of minutes to complete and will help us to understand who the audience of an AusPAR is, what AusPARs are used for and how useful their content is to our external stakeholders. MoreOpened 2 May 2016 -
Questionnaire for continuing panel members
We want to know what you think about the TGA so we can enhance our support for all panel members. This questionnaire should only take you about 7-10 minutes to complete. The questionnaire focuses on key issues such as: the quoting process administrative correspondence the guidance and direction received from the TGA delegate interaction with the TGA during the evaluation phase; and TGA feedback. Responses to this questionnaire will be used... MoreOpened 10 December 2014
127 results.
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