TGA Issues Guidance for TGO 101 (Standard for tablets, capsules and pills)

This guidance includes clarification on, and information relating to, mandatory requirements. It also includes additional information to assist medicine sponsors in meeting their obligations and best practice recommendations. This information may also assist other stakeholders to understand how sponsors and manufacturers assure that medicines that are tablets, capsules or pills are of good quality. When the words 'must' or 'required' are used, a legal requirement is being described. The TGO 101 requirements that apply to pills commence on 31 March 2021.The delayed commencement allows sponsors two years to update their manufacturing documentation and ensure that their goods will comply with the new requirements.   Source: TGO 101 guidance 

TGA Issues GMP Clearance Guidance

This guidance is for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site used in the manufacture of a medicine intended for supply in Australia.   Source: GMP clearance

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 previous 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 Regulatory Affairs provides 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.

TGA Lists Important Dates for Suppliers of Complementary Medicines

May 2019 - TGA notifies of fees and charges for 2019-20 (becoming effective from 1 July 2019);

1 July to 22 July 2019 – Period for sponsors to submit their declarations of $0 turnover for any relevant ARTG entries;

1 August 2019 – Annual charge invoices for all non-exempt ARTG entries will be issued;

15 September 2019 – Deadline to pay annual charges invoices.    

TGA Updates the Permissible Ingredients Determination for Listed Medicines

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in April 2019. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2019. A total of 16 changes have been made in the updated Determination. These changes include: Addition of 8 new ingredient entries; and changes to 8 existing ingredient entries, including making requirements clearer and less restrictive. For more details go to: Permissible ingredients update

TGA Consultation: Proposed New Medical Device Classification for Substances Introduced Into the Body via a Body Orifice or Applied to the Skin

Medical devices are regulated in Australia having regard to the risks (to the individual or public health) considered in the context of the device’s intended use. The TGA periodically reviews classification rules for medical devices to ensure they continue to be appropriate. When undertaking such reviews, the TGA has regard among other things, to the international best regulatory practice and any emerging issues. This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification.    Source: Medical devices consultation

TGA Consultation: Proposed Amendments to the Poisons Standard (SUSMP)

The TGA is inviting comment on The Poisons Standard which is also referred to as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Of particular relevance to some suppliers of complementary medicines are the proposed changes related to *arbutin and sanguinarine from Sanguinaria Canadensis ('bloodroot'). This consultation closes on 13 May 2019.    Source: SUSMP consultation    (Editor’s note: *Arbutin is a constituent of a number of herbs, however the scheduling has particularly affected the supply of herbal preparations of Bearberry (Arctostaphylus uva ursi) and Damiana (Turnera diffusa)).

TGA Safety Advisories—   Source:

Meizitang Botanical Soft Gel Capsules: contain the undeclared substance Sildenafil & Sildenafil N-Oxide.

JOYSMI Capsules: contain the undeclared substances sibutramine, phenolphthalein and frusemide.

X Power 3 Tablets: contain the undeclared substance Sildenafil.

BMSW 4600MG Black Ant Capsules: contain Sildenafil.

Double Maxx D.B.M. Capsules: contain Sildenafil.

Japan Tengsu tablets: contain Sildenafil.

Magnum XXL Capsules: contain the undeclared substance Tadalafil.

Horny Little Devil Capsules: contain both Sildenafil and Tadalafil.

Lotus Flower Capsules: contain a derivative of fenfluramine. (Fenfluramine is a prescription-only (S4) synthetic anorexic drug, which is no longer available for sale in Australia following its withdrawal from the U.S. market in 1997 after reports of heart valve disease and pulmonary hypertension were associated with its use).

TGA Safety Advisory - Fallopia multiflora (he shou wu)

Fallopia multiflora (also called Polygonum multiflorum, Fo ti, Reynoutria multiflora and Chinese fleece-flower root) is a herb, also known by the Chinese name 'he shou wu'. Although it is still permitted for use in listed medicines in Australia Fallopia multiflora has been associated with a low risk of liver damage in rare cases. As a consequence, it is a requirement that listed medicines containing Fallopia multiflora for oral use to have the following warning on the product label: 'Warning: Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional.' The TGA has received reports of nine cases of liver damage in consumers taking products containing Fallopia multiflora, in the period spanning 2008 to 2018.    Source: fallopia-multiflora-he-shou-wu

Significant Decrease in the Amount of Codeine Supplied to Australians

The up-scheduling of codeine to a Prescription Only Medicine (Schedule 4) in February 2018 has resulted in a significant decrease in the amount of codeine supplied to Australian patients. The decision to up-schedule codeine products to prescription only was taken after evidence showed that medicines containing low-dose codeine combined with paracetamol or nonsteroidal anti-inflammatory drugs (NSAIDs) - such as ibuprofen or aspirin - were generally no more effective than other non-codeine medicines. The codeine-containing combinations were also associated with a number of health risks including addiction leading to misuse, liver damage, gastrointestinal perforations, blood potassium imbalances and respiratory depression. These risks were judged to be too high for the codeine combination products to be supplied without oversight from a doctor.    Source: Codeine consumption drops

Thinking of importing a medicine for personal use in Australia?

Answer: Yes, you can! Provided all appropriate rules are followed, you can import many medicines for personal use.  This includes some medicines that have not been approved for supply in Australia. Usually, it depends on the ingredients in the medicine. There are more restrictions on higher risk ingredients such as ingredients with potential for abuse. This article from the TGA, explains the rules around importing medicines for personal use, including how to find out whether you will be able to import a particular product.    Source: Personal use importation

Do You Need an Australian Sponsor for Your Complementary Medicine or Medical Device?

The TGA requires that any therapeutic product supplied in Australia must be supplied by an Australian “sponsor”. The sponsor may be an individual resident in Australia, or an entity incorporated in Australia and conducting business in Australia where the representative of the entity also resides in Australia. The label of any medicine supplied in Australia must include the name and contact details of the Australian sponsor or distributor. For overseas companies, appointing an independent distributor as your sponsor may potentially present a serious disadvantage. Independent distributors may act for any number of companies supplying similar therapeutic products, which can potentially become a conflict of interest.  The Australian sponsor/distributor controls the product registrations and can cancel or amend them at any time. The sponsor also has access to confidential product information held by the TGA. RFA Regulatory Affairs can help you set up your own independent Australian sponsor company.

Consumer Story: Tim and Selective Androgen Receptor Modulators (SARMS)

Selective androgen receptor modulators (SARMs) are a group of experimental, prescription-only medicines sometimes used illegally by bodybuilders. People who use SARMs purchased online risk their health because SARMS haven't been approved for human use (they are still being researched, and have documented health risks), they are an illegal medicine sold online and may not contain what the seller says it will (It could contain other, potentially dangerous ingredients, or a different dose to the one on the label), and access to SARMs without a valid prescription, license or authority is illegal, and in some cases may result in fines and/or jail time. SARMs also require a permit to import. Tim's story explains the risks of using SARMs, and how to find reliable information about the safety, effectiveness and legality of a medicine. Read Tim's story here: Tim's story

TGA Suggests Three Questions to Ask Natural Health Practitioners About Testing Services

If you are thinking about visiting a natural health practitioner for a diagnosis, some practitioners may offer to diagnose a range of health conditions using tests like live blood analysis, bioresonance, electrodermal testing or hair analysis. Before you consent to this type of test, it's important to do your research about the test and the practitioner offering it. Here are three questions to get you started. Who is conducting the test? Is the test conducted in an accredited laboratory? What are the risks?    Source: Three questions

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