TGA Lists Changes to Permissible Indications for Listed Medicines

The list of permissible indications has been updated by Therapeutic Goods (Permissible Indications) Determination (No. 1) of 2019 [the ‘Second Determination (2019)’]. The changes made are organised into 8 tables of items on the TGA website. Of particular interest to suppliers of listed complementary medicines, the TGA have added a number of new indications to choose from; removed some Traditional Indications; and have re-added or changed some label warning statements.    Source: Permissible indications

(Editor’s note: Please see following story for more information and important dates regarding changes to the indications and warnings that must be displayed for listed complementary medicines).

REMINDER: Very Important Information for All Suppliers of Listed Medicines. Don’t Let Your Product Get Cancelled!

Due to the importance of this information we are repeating the story that we placed in last month’s newsletter. Suppliers of listed complementary medicines will already know that they must now only use indications included in the list of pre-approved 'permitted indications' and must comply with any requirements for the use of these indications in listed medicines. The new permitted indications requirements apply to all medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). This includes complementary medicines and sunscreens. The key transition dates to note are: 6th September 2019 when the 'fee-free' period for sponsors to transition existing listed products ends. After that date an application fee will apply to all transitioning products in accordance with the TGA's Schedule of fees and charges (currently $820 per product); and 6th March 2021 when any ARTG entries that have not transitioned to Permitted Indications will be automatically cancelled. So please ensure that your product’s indications are compliant before these dates, otherwise you will face significant costs or possible cancellation of your product from the ARTG.   Source: Permitted indications

RFA provide training on preparing and reviewing permissible indications for your products so you can make these changes. To book a course, enquire about pricing, or if you have any questions on the topics covered or your suitability for training, contact us at +61 2 96608027; or This email address is being protected from spambots. You need JavaScript enabled to view it.

Required Advisory Statements for Medicine Labels (RASML)

Australian labelling requirements for non-prescription medicines require some over-the-counter and complementary medicine labels to contain particular warning statements ('advisory statements') about specific risks related to use of the medicines. These advisory statements are set out in the TGA document 'Required Advisory Statements for Medicine Labels' (RASML). The specification sets out required advisory statements for over-the-counter medicines and registered complementary medicines. As an example, the entry for fennel oil reads: "Fennel oil - Conditions: For the purpose of exclusion from the schedules to the SUSMP (in preparations or oils containing more than 5 per cent of methyl-chavicol); and packed in containers having a nominal capacity of 25 millilitres or less, fitted with a restricted flow insert. Required statement: KEEP OUT OF REACH OF CHILDREN". Listed complementary medicines are not subject to this specification as they must comply with the different standard, the Permissible Ingredients Determination (see previous stories for more).    Source: RASML 5

TGA Looks at Brexit Implications for Supply of Therapeutic Goods in Australia

In examining the possible implications of Brexit for the supply of therapeutic goods in Australia, the TGA has detailed the consequences of different scenarios. In the event of a 'no deal' exit of the United Kingdom (UK) from the European Union (EU), the TGA will implement transitional arrangements to provide for minimal interruption in the supply of medical devices in Australia. If there is a 'no deal' Brexit, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. There will be no impact on the supply of medicines to Australia from the UK. If there is a Brexit 'deal' or exit extension, then under the proposed Brexit 'deal', UK notified bodies would continue to be recognised for a transition period through to 31 December 2020, so there will also be no immediate impact on manufacturers certified by these notified bodies.   Source: Brexit implications

TGA Provides Application and Submission User Guide for Listed and Assessed Listed Medicines

The TGA Business services (TBS) portal provides an electronic facility for the listing and registration of medicines on the Australian Register of Therapeutic Goods (ARTG). There are two pathways for listing a medicine in the ARTG: AUST L listed medicines which are listed in the ARTG after self-certification by sponsors that all legislative requirements are met; and AUST L(A) assessed listed medicines which are listed in the ARTG after self-certification of quality and safety of the product and pre-market assessment for efficacy evidence to support the product indications. The Act allows for cancellation of a product from the ARTG if a sponsor's certification is incorrect.    Source: User guide

TGA Explores Hosting a 'Drop-In Day' (Sydney) for SMEs

The Therapeutic Goods Administration is seeking expressions of interest for a potential Drop-In Day: an opportunity to meet with TGA representatives one-on-one to discuss the regulatory process with respect to your products and business. Drop-In Day is tentatively open to small-to-medium enterprises (SMEs), researchers and start-ups that are new to therapeutic goods regulation, don't often engage with the TGA, are looking to supply a therapeutic good in Australia for the first time and would like advice about preparing their application for market authorisation. It is important to note that advice will not be provided regarding existing applications or already approved products. Appointments will be 50 minutes in duration. There is no cost to attend. Proposed meetings are to be held on Thursday 11th April 2019 in Parramatta, NSW.   Source: TGA drop-in day

TGA Safety Advisories—   Source: https://www.tga.gov.au/current-year-alerts

Make Coarser Make Bigger capsules: the capsules contain the undeclared substances 2-mercaptobenzothiazole, diclofenac and glibenclamide.

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