TGA advertising system concerns: response from TGA

For background see:

From: SKERRITT, John <>
Sent: Tuesday, 18 September 2018 21:13
Cc: MCLAY, Nicole <>; FRANCIS, Jenny <>; SKERRITT, John <>
Subject: RE: Letter from ACCC – TGA advertising concerns [SEC=UNCLASSIFIED]

Dear Dr Harvey

Thank you for your email.

Like other regulators, including the ACCC, we apply a triaging or categorisation framework to complaints. In this regard I note that the ACCC has, for example, in recent years moved away from using the term ‘complaint’ and encouraged consumers and small business to ‘report’ information that may represent a breach. Noting the importance of concentrating on the most serious complaints the ACCC has also acknowledged that it may not provide a response to each report. Similarly, as you have advised publicly in recent days, the Ombudsman also triages complaints. Like other bodies they focus on genuine, most serious matters.

For our part, our advertising complaints framework takes into account, among other things, the objects of the Therapeutic Goods Act 1989. The objects are clear in their focus.  It is the provision of the establishment and maintenance of the national system of controls of therapeutic goods based on their quality, safety, efficacy and timely availability. The object of the Advertising Code 2015 is also important; to ensure that marketing and advertising of therapeutic goods to consumers is conducted in a manner that promotes the quality use of therapeutic goods, is socially responsible and does not mislead or deceive the consumer.

Accordingly, we have, since our assumption of responsibility for all advertising complaints, applied a risk based framework to manage the receipt and consideration of complaints about therapeutic goods advertisements.

Priority is given to matters that might negatively impact public health including by the unsafe or improper use of the therapeutic goods. It is also important to keep in mind that, consistent with the objects of the Act and Code, we are not a regulator of services provided by “mainstream” or “alternative” health practitioners but a product regulator, and that public health and safety, rather than consumer financial interests, are our primary drivers.

We have noted the response that the Commonwealth Ombudsman’s office sent you in relation to your complaint about the TGA’s advertising complaints handling and their decision not to investigate.  In the 10 weeks since the introduction of the new framework we have been working to continually improve our processes. The intention to do so was discussed during the consultations on advertising over the last almost 18 months and is consistent with best practice public administration.

In the short time that we have been managing all complaints, we have 154 cases currently under investigation as medium category – this is by no means a trivial number –  in addition to low level cases, and 277 closed cases (including 5 critical and 4 medium cases which have been successfully resolved), the outcomes for which have started to appear on our website. As you know, more detailed information is published in relation to medium and higher level cases and as cases with this categorisation are closed more information will become available.

We have also been working to inform consumers and advertisers of the changes to the advertising framework and legislation. We have published detailed draft guidance on the application of the 2018 Code (to take effect from 1 January 2019), and final guidance will be published next month. We have provided information for consumers through the TGA website and social media on complaints handling and advertising requirements generally. We are also preparing face to face and online education activities and materials to equip advertisers with the information they need to ensure compliance with the 2018 Code on 1 January.

We are satisfied that two of the advertisements that you have brought to our attention, the PainErazor and foot patch matters, do not have implications for public health or the unsafe use of therapeutic goods. In considering these complaints, we noted your arguments that a history of a particular type of product with the Complaints Resolution Panel (CRP) is indicative of recalcitrant advertisers, justifying a category of medium or higher. However, I should emphasise clearly to you that while the CRP may have dealt with complaints about these types of products, upon receiving a complaint we look into the particular advertisers concerned and whether the particular advertisers have a history of non-compliance.

Thus, if a particular advertiser identified in a complaint has not come to our attention previously, and there are no public health and safety concerns, the case for that particular advertiser is likely to be assigned a low category.

For low category matters it is also important that we follow the principles of natural justice which are enshrined in Australian public administrative law.  It would be inappropriate to besmirch advertisers by publishing their name or the name of the product when there has been no formal administrative finding on the compliance of the advertising and TGA has not provided the advertiser with an opportunity to respond to such a finding. However, consistent with this approach, two of the advertisers identified in your complaint about detox foot patches are being dealt with as medium category cases (advertisers with prior history), with the remainder as low category.

Nevertheless, we appreciate, within the terms of the object of the Advertising Code 2015, that in some cases like these potentially inappropriate advertising of the products may continue and thus not be conducted in a manner that is socially responsible.  We will analyse data from complaints that will contribute to monitoring, and guidance and educational activities. Part of this work will entail flagging some low priority cases for future review to determine whether the advertriser has complied after contact from the TGA and if not whether the action should be escalated.

Such cases may be identified from clusters of compliance issues, repeat behaviour or the nature of the product and thus possible harm to consumers (whether directly, or indirectly through a potential delay to appropriate diagnosis and/or treatment). Based on these criteria, the advertising of PainErazor would likely be a candidate for such follow up if the advertisers’ compliance following initial contact from TGA is not satisfactory.

I trust that this information demonstrates that advertising complaints handling is one component of a broader advertising compliance framework designed to work synergistically and protect consumers from the public health and safety risks that may arise from advertising.

Yours sincerely
John Skerritt

Adjunct Prof John Skerritt FTSE FIPAA (Vic)
Deputy Secretary for Health Products Regulation
Department of Health

(The Health Products Regulation Group comprises the Therapeutic Goods Administration and the Office of Drug Control)

PO Box 100 Woden ACT 2606 Australia
Phone: (02) 6232 8200  Fax: (02) 6203 1265


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TGA advertising complaint system concerns: response from Minister Hunt and Ombudsman

Minister Hunt (or more likely the TGA) has now responded to my letter that expressed concerns about the new TGA advertising complaint system.

The Minister confirms that the TGA’s advertising complaint system was designed to be non-transparent for low priority complaints (including how this priority is assigned).

There are now 232 complaint “outcomes” posted on the TGA web site. All except 4 have been closed after a “Compliance Notice sent with educational material”. The 4 exceptions were “Warned – Compliance achieved without formal action – closed”. These outcomes do have details of the advertiser and the product if the links are explored but these details cannot be found by the search function.

The Minister said, “We are in the process of establishing the TGA Advertising Consultative Committee, with the first meeting to occur prior to 31 December 2018”.

The response of the Commonwealth Ombudsman to similar concerns is appended. It says, “We cannot instruct the Department of Health to change its existing processes or policies”.

Which makes a mockery of their byline: Influencing systemic improvement in public administration.

From: Adrian <>
Sent: Monday, 17 September 2018 12:52
Subject: Commonwealth Ombudsman – Our reference 2018-710509 [SEC=UNCLASSIFIED]

Dear Dr Harvey

I refer to your complaint of 7 September 2018 about the Department of Health regarding the Therapeutic Goods Administration’s complaints process.

I have considered your complaint and have decided not to investigate it. I have made this decision because The Ombudsman’s Office generally investigates complaints where we are likely to achieve a better practical outcome and I do not believe our Office can achieve a favourable or different outcome in the circumstances.

The Commonwealth Ombudsman’s Office handles complaints about the administrative actions of Australian Federal Government agencies. As part of our role, we monitor complaints about the Department of Health to identify reoccurring themes or trends in complaints (that is, issues affecting multiple complainants over time). We cannot instruct the Department of Health to change its existing processes or policies but we can offer comments and make recommendations on these. We hope to be able to achieve better outcomes and improvements to government administration through ongoing monitoring and analysis.

Even if we do not investigate the individual complaint, we do keep a record of it. This information feeds into our work monitoring complaints for potential systemic issues that we may be able to investigate and improve at the broader level.

For the reasons outlined above, an investigation by our Office is not warranted. We will retain all details of your complaint on file. 

Yours sincerely

Assessment Officer | Intake, Assessment and Early Resolution Team
Commonwealth Ombudsman
Phone: 1300 362 072

Influencing systemic improvement in public administration



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Complaint to Commonwealth Ombudsman – TGA advertising complaint system

Previous Commonwealth Ombudsman – Allan Asher

From 1 July 2018, the Therapeutic Goods Administration took over the complaint system for the advertising therapeutic goods to the public from the Complaint Resolution Panel (CRP).

Many concerns about this TGA takeover were submitted in consultation submissions. They were ignored.

On 16 August 2018, I sent a letter to Health Minister Hunt. I was concerned that:

  1. The TGA’s new complaint system was much less transparent than the one it replaced.
  2. The promised Therapeutic Goods Advertising Committee to oversee the new system had yet to be established.

I have yet to receive a response from Minister Hunt, presumably because he has been too engaged with the recent leadership turmoil within the Liberal Party.

I now have more unsatisfactory “outcomes” of the TGA’s new complaint system:

The lack of transparency of the new TGA complaint system provides no help to consumers concerned that they may have purchased a product with upheld complaints, or consumers who wish to check the status of a product currently being advertised, even if the product has been the subject of a “critical” complaint.

While this is convenient for industry and the TGA, it is appalling consumer protection.

I have corresponded with the Australian Competition and Consumer Commission (ACCC) about this matter. They suggested I contact the Commonwealth Ombudsman.  This has now been done.

I have asked the Ombudsman to request the TGA ensures:

  1. The product name and advertiser of all complaints judged to breach of the Therapeutic Goods Advertising Code be reported and be searchable on the TGA web site.
  2. The TGA follow up “educational letters” and other interventions and report if compliance has been achieved.
  3. The TGA report outcomes for the large numbers of complaints sent by the CRP to the TGA because regulatory action was needed.


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Another ineffective TGA complaint outcome: Detox Foot Pads Scams

Image purporting to show toxins withdrawn by detox foot pads. From (6/9/18):

This product is on the ARTG no: 148412, sponsor: Rebark Trading Pty Ltd – Absorbent; Intended purpose: to absorb (to draw into itself) undesired toxins from the body.

My complaint about Detox Foot Pads / Patches noted there have been at least 33 complaints upheld by the CRP about this well-known scam.

This including two referrals to the Secretary (2010-10-016) and (2017/09/010).  I can find no outcome on the TGA web site for the latter. However, the former resulted in a “Regulation 9 order” against Happy Feet Detox Foot Patches. The delegate of the Secretary ordered the sponsor:

“to withdraw any representations that the advertised product can detoxify the body, remove or “draw out” toxins from the body, help the body function more effectively, or offer therapeutic benefits in relation to stress, excessive alcohol intake, nicotine consumption, poor diet, environmental contaminants, pollutants or harmful chemicals.”

More recently, the CRP sent an additional 22 complaints to the TGA because they required regulatory action rather than repeatedly upholding complaints with determinations that had no effect. The TGA appears to have taken no action about these referrals.

I now have the “outcome” of seventeen additional documented complaints I sent to the TGA (AC-UA26W8I4/2018); all were regarded as “low priority” and closed by sending an educational letter.  Meanwhile, the promotion complained about continues, e.g.

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Letter to The Age 5/9/18 Spotlight on regulators

Your editorial (2/9) says the government should have a more rigorous process to protect consumers from ineffective treatments and products. There are government regulators that are meant to do this job but they are weak and ineffective.

The Australian Health Practitioner Regulation Authority refuses to state that certain practices should not be performed because they lack evidence, waste scarce health resources and are potentially harmful. These include surgeons performing arthroscopy for osteoarthritis and chiropractors manipulating the newborn to correct “birth trauma”. AHPRA refuses to lay down standards of practice because this might limit innovation.

The Therapeutic Goods Administration has recently taken over all complaints about advertising medicines and medical devices to the public. It closes complaints about ineffective products by sending an “educational” letter to the offender without checking to see if this has any effect; usually it does not. It also fails to publicly disclose the company or product that had an upheld complaint. The TGA appears more concerned with industry assistance than consumer protection. I suggest The Age puts its investigative spotlight on the regulators of therapeutic goods and services.

Associate Professor Ken Harvey, Monash University

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Non-transparent outcome of TGA complaint: Sawyer Extractor™ Pump for Snake Bite, AC-22VHXCSG/2018

Screen shot 03/09/2018:

On 30/07/ 2018 I submitted that this was a “critical” complaint because it undermined accepted public health messages about the treatment of snakebite and was likely to lead to harm or injury if the claims were relied upon.

I noted the product was advertised in a number of publications:

  • (not in Australian jurisdiction)
  • Etc.

On 31/08/2018 I was notified by the TGA of the following outcomes of my complaint about Sawyer Extractor Bite and Sting Kit AC-22VHXCSG/2018:

AC-22VHXCSG/2018The action taken in relation to this complaint was: Formal contact requiring immediate action, Warned – Compliance achieved without formal action – closed, (Advertiser not specified

AC-22VHXCSG/2018Warned – Compliance achieved without formal action – closed, Outdoor You (Sawyer in Australia), 

AC-22VHXCSG/2018, Warned – Compliance achieved without formal action – closed, Backpacking Light, 

Today (03/09/2018) I note this product is still being advertised by:


Compliance has been achieved on some sites complained about; others may be in progress.

But if the complainant notes there are additional sites  involved (as above via etc.) does the TGA actually perform a search for additional offending product themselves? It appears they do not.

More importantly, even for what the TGA agreed was a critical complaint warranting immediate action by formal contact, there is no useful transparency about the product complained about.

The TGA “outcomes” web pages  merely list 190+ cryptic reference numbers of which all except three are assigned “low priority” with the note, “Compliance Notice sent with educational material”.  Low priority complaints neither list the advertiser (responsible entity) or the therapeutic good complained about.

Because a compliance notice was sent, I presume that the advertisements complained about were judged to have breached the Therapeutic Goods Advertising Code. However, it is impossible for consumers or health professionals to find out what products were involved, let alone whether compliance was achieved.

The three outcomes listed above for “critical” complaints, merely state, “Warned – Compliance achieved without formal action – closed. Two outcomes listed the advertiser, but to find out the product complained about one had to click on the reference number link.

Neither the search function provided in the “outcomes” web pages or the main TGA search allow a search for a particular product complained about or even the category of “critical” complaints.

This means that the TGA provides no help to consumers concerned that they have  purchased a product with upheld complaints, or consumers who wish to check the status of a product currently being advertised, even if the product has been the subject of a “critical” complaint.

In short, the TGA’s new complaint system provides much less transparency than the old Complaint Resolution Panel (CRP).

In addition, the TGA has failed to provide outcomes for large numbers of complaints sent by the CRP to the TGA because it was thought that regulatory action was needed.

This is appalling consumer protection.

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TGA new complaint system: compliance notices ineffective

Two outcomes (of 16) TGA complaints have now been received.

AC-E7JS15BB/2018, submitted 3/8/18,  Brand Developers Australia Pty Ltd – Pain Erazor


“Pain Erazor” (ATG no: 276939) won a 2017 Choice “Shonky” award, was the subject of a scathing N.Z. Consumer review, and also a TGACRP complaint (26/03/2018), sent to the TGA, for which I can find no outcome.

Another complaint was submitted to the new TGA advertising portal on 3 August 2018 (see above). In 16 August 2018 I was notified that the complaint was regarded as low priority and had been closed on 7 August 2018 by a “Compliance Notice sent with educational material”.

On 22 August 2018 I informed the TGA that the advertising appeared unchanged and asked what I should do now. The answer is appended.

AC-KD45638R/2018, submitted 15/8/18, Au Remedial, Pain®Gone and Pain®Gone Plus

I suggested this was a “high priority” complaint because the sponsor (&/or other advertisers) were recalcitrant, this type of product had previous upheld complaints, and the sponsor (and others) continued to make claims that I alleged breach the Therapeutic Goods Advertising Code 2017.

On 21 August 2018 I was notified that the complaint was regarded as low priority and had been closed on 7 August 2018 by a “Compliance Notice sent with educational material” sent to a number of advertisers.

On 22 August 2018 I informed the TGA that the advertising by Au Remedial Pty Ltd (the sponsor) appeared unchanged and asked what I should do now. The answer follows:

From: MCLAY, Nicole <>
Sent: Friday, 24 August 2018 14:29
To: ‘Ken Harvey’ <>
Subject: RE: Outcome of therapeutic goods advertising complaint regarding Brand Developers and Transcutaneous electrical stimulation probe [SEC=UNCLASSIFIED]

Hi Ken

Our model allows for low level complaints to be handled primarily through an educative approach. Low level complaints will usually relate to an advertiser who hasn’t had contact with the TGA advertising section in the past.

A reasonable amount of time should be afforded the advertiser to review the requirements and adjust their advertising. They may get in contact with us to clarify certain aspects of the Code or their ad. Where a complaint is resubmitted within a short period of time we may choose not to proceed with that complaint.

The escalated approach to complaints, based on risk as well as advertising history, ensures our resources are focussed on the higher level cases, both in terms of public harm but also the influence on other advertisers.

The records from low level complaints become part of our data analysis. We’ll use analysis of advertising complaints to determine where further education is required.

Analysis will also be used to determine where we need to do an assurance review of a closed case.

I hope that helps.
Kind regards

Nicole McLay FCPA
A/g First Assistant Secretary, Regulatory Practice and Support
Regulatory Practice and Support Division
Health Products Regulation Group, incl the TGA
Australian Government Department of Health
Location: Symonston, ACT
PO Box 100, Canberra ACT 2601, Australia


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Further experience of submitting complaints to TGA portal

On 9 August 2018, the Assistant Director, Advertising Complaints and Compliance Section, TGA requested more information about a complaint I made on 6 July 2018 about Pharmacare FatBlaster products (AC-GBKDH2XG/2018).

I believe this request was unreasonable as the information requested could have readily been ascertained by TGA staff. They are paid to investigate complaints, I am not.

Regardless, since it appeared unlikely that the TGA would satisfactorily progress my complaint without the information requested, this was provided under protest:

A formal complaint about the TGA request, and the failure of the TGA to address longstanding misleading and deceptive claims for listed weight loss products, has been sent to the Health Secretary and Health Minister.

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Launch of TGA Advertising Hub – Initial experience of submitting complaints

The TGA Advertising hub has noted:

“We are experiencing intermittent IT issues that are impacting this form. If you experience an error lodging a complaint, please try again later. We are working to fix this issue as a matter of priority”.

This problem now seems to have been fixed.

However,  [30/07/2018, from TGA Advertising Complaints and Compliance Unit]:

“Thank you for your email and notifying us of the issue with ARTG entries in complaints submitted via the web portal. We are aware that there are certain ARTG entries which will not come up when searched for and this issue is being investigated.”

 Regardless, I’ve now been able to submit the following complaints that I’ve suggested are high priority (with nos 11, 12, 14 & 17 suggested to have critical priority).

They are mainly based on previous complaints upheld by the CRP but whose sponsor (and others) continue to make claims that were determined to breach the Therapeutic Goods Advertising Code. Exceptions are 14, 17, 18 & 19.

  1. 5 July 2018, Pharmacare Laboratories Ease-a-cold products, AL-B81GN1V3/2018
  2. 6 July 2018, Pharmacare Laboratories Promensil Menopause products, AC-4I7BPN1V/2018.
  3. 6 July 2018, Pharmacare Laboratories FatBlaster FatMagnet products, AC-GBKDH2XG/2018
  4. 7 July 2018, Pharmacare Laboratories Nature’s Way Magnesium Products, AC-GOZU449N/2018
  5. 9 July 2018, Pharmacare Laboratories Sambucol Products, AC-FR55H9ST/2018
  6. 10 July 2018, Weleda Arnica Homeopathic Products, AC-I9WC23OP/2018
  7. 12 July 2018, Pretorius, Bioglan, Healthy Care Homeopathic Products,  AC-9NXC9UV6/2018
  8. 13 July 2018, Brauer (Homeopathic) Products, AC-PDKHURWV/2018
  9. 15 July 2018, Au Remedial, Pain®Gone and Pain®Gone Plus,  AC-KD45638R/2018
  10. 24 July 2018, Numerous sponsors, The ongoing and dangerous promotion of ear candles, AC-5TMWIYHC/2018
  11. 30 July 2018, Sawyer Extractor™ Pump for Snake Bite, AC-22VHXCSG/2018
  12. 30 July 2018, BioRevive® Hydrodol® Hangover Relief Products, AC-MW9QQH4F/2018
  13. 3 August 2018, Brand Developers Australia Pty Ltd – Pain Erazor, AC-E7JS15BB/2018
  14. 7 August 2018, Multiple Hangover products: Plus Daily Ltd Recoverthol, Clever Health Rejoove, Body Armour Pty Ltd Hangover Relief, D & X Pty Ltd Hey! King Premium Hangover Relief; AC-JY0FXQ3S/2018
  15. 16 August 2018, Pharmacare Laboratories Weight Loss Products, Additional information requested, AC-NJ15VLQ9/2018.
  16. 21 August 2018, Detox Foot Patches / Pads, AC-UA26W8I4/2018
  17. 10 September 2018, Phoenix Pharmaceuticals Rapid Recovery Hangover Relief, AC-EN0KHC4U/2018
  18. 11 September 2018, PINPOINT Bright Brains (Bacopa Monnieri), AC-X0BCJTUU/2018
  19. 20 September 2018, New Life Health Products 14 Day Smart Cleanse, AC-8ZECEICA/2018
  20. 20 September 2018, Export Corporation Australia Pty Ltd, Hydroxycut Hardcore Elite, AC-SDS3HO9Q/2018

No 12, “BioRevive® Hydrodol® Hangover Relief Product” complaint is also a nice example of the failure of the TGA’s new “permissible indications” determination to make any impact on sponsors.

ARTG 304289 HYDRODOL Hangover Relief, Jumbo was listed on 14/06/2018 and uses several of the new “permissible indications” for “cleansing/detoxification”.

These have the caveat, “Product presentation must not imply or refer to drugs/alcohol”, which the sponsor duly added to the ARTG summary but then ignored in their ongoing promotion!

There are now numerous complaint “outcomes” appearing on the TGA web site . Most appear to have been assessed by the TGA as “low priority” and closed with ‘Compliance notice sent with educational material”.

There are no details of the complaint, product or sponsor that would enable one to check the priority assigned, let alone see if the “notice” actually achieved compliance!  As predicted, very convenient for the sponsor and the TGA .

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TGA’s new complaint system fails the Ease-a-cold test; Outcomes of Advertising Complaints Investigations Specification 2018 enacted

Stimulated by an article in today’s “The Conversation” on Pharmacare Laboratories Ease-a-Cold (below), I decided to try the TGA’s new complaint system.As I mentioned in a comment on this article, this product has been the subject of a previous article in “The Conversation” in 2015:

It has also had six upheld complaints by the now abolished Therapeutic Goods Advertising Complaint Resolution Panel (CRP) from 2005 to 2016 and a recommendation to the Secretary from the CRP in 2017 for failure to withdraw misleading representations that the product had “been ‘clinically trialed’ in the sense of being demonstrated to have effects such as reducing the duration, impact on daily life, or severity of symptoms of a cold”. Typically, I could find no outcome of this recommendation to the Secretary (TGA) on the TGA web site.

In addition, there was a decision to withdraw advertising approval (in specified media only, not the internet) by the TGA on 11 Oct 2017, see:

Regardless, this product continues to be advertised with claims that have been repeatedly judged to be misleading and deceptive.

Furthermore, Pharmacare Laboratories has the unenviable reputation of the having the most upheld complaints of any sponsor of complementary medicines over the 10-year life of the CRP.

However, upon submission of the attached complaint I received the following error message:

This is the same error I reported to the TGA when I tested their system on Thursday 17/05/2018. It’s a pity it remained when the system went live.

I submitted that this complaint should be assessed as “high priority” because the sponsor is recalcitrant, the product has had numerous upheld complaints and the varied advertising claims by the sponsor (and many others) continue to state or imply that that the product will shorten the duration and severity of a cold when it will not.

I alleged (repeated) breaches of the Therapeutic Goods Advertising Code 2017, sections 4(1)(b), 4(2)(a) and 4(2)(c). In addition, specific indications on  ARTG Public Summary Documents are equally misleading and deceptive.

I asked for an immediate response from the TGA to me as to the priority allocated to this complaint, and subsequently, the measures taken by the TGA to achieve compliance and the outcome (for publication).

I am concerned that the recently enacted Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2018 only states that,

“The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act….”.

It remains to be seen what we get back from the TGA for the attached test complaint.


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