Direction about advertisements: Dispensed Pty Ltd

THERAPEUTIC GOODS ACT 1989

DIRECTION UNDER SECTION 42DV

ISSUED TO:

Dispensed Pty Ltd
ACN 654 096 983

ON: 20 August 2025

ABOUT: Advertising of medicinal cannabis to Australian consumers

BY:

[REDACTED]
Delegate of the Secretary of the Australian Department of Health, Disability and Ageing

Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

Contact Officer Name: [REDACTED]

Contact Officer Telephone: [REDACTED]

Contact Officer Email: [REDACTED]

DIRECTION ABOUT AN ADVERTISMENT

Made Under Section 42DV of the Therapeutic Goods Act 1989

TO:

Dispensed Pty Ltd
ACN 654 096 983
Shop L01, 122 Walker Street
Dandenong VIC 3175

By express post and email:

I, [REDACTED], delegate of the Secretary of the Australian Department of Health, Disability and Ageing in the Therapeutic Goods Administration (TGA), being satisfied, that there have been contraventions of the Therapeutic Goods Act 1989 (the Act) by the advertising of therapeutic goods by Dispensed Pty Ltd (Dispensed) as follows:

Dispensed did advertise, or caused the advertising of, therapeutic goods, being medicinal cannabis, in contravention of section 42DLB(1) of the Act where subsection 42DLB(7) applies. The advertisements included references to substances or goods containing substances included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard. Those references were neither authorised nor required by a government or government authority.

DIRECT Dispensed, as the person apparently responsible for that advertising or for causing the advertising of the therapeutic goods, to:

1. Cease the advertising of medicinal cannabis at the following Uniform Resource Locators (URLs):
   1. https://www.dispensed.com.au/
   2. https://www.instagram.com/dispensed.au/
   3. https://www.facebook.com/dispensed.au/
2. Cease the advertising of medicinal cannabis on all websites, social media accounts or other advertising platforms managed by third parties through or involving the use of:
   1. web graphics referring to products or services provided by or on behalf of Dispensed
   2. links redirecting to any website or web application operated by or on behalf of Dispensed
   3. social media posts promoting any products or services provided by, through or on behalf of Dispensed.
3. Cease the advertising of medicinal cannabis on digital kiosks, being interactive physical devices that display Dispensed marketing materials or allow users to engage with websites, services or web applications operated by or on behalf of Dispensed.
4. Cease the advertising of medicinal cannabis on printed materials promoting products or services provided by, through or on behalf of Dispensed, including, but not limited to:
   1. flyers
   2. posters
5. Take all reasonable steps to recover any printed materials distributed by or on behalf of Dispensed that advertise medicinal cannabis and are still in circulation, including, but not limited to:
   1. flyers
   2. posters

In each of the above directions, the phrases advertising of medicinal cannabis and advertise medicinal cannabis include all advertising of therapeutic goods that refers to therapeutic goods that contain cannabidiol as included in Schedule 4 to the current Poisons Standard or cannabis as included in Schedule 8 to the current Poisons Standard (medicinal cannabis products). For the avoidance of doubt, this includes both advertisements that refer to medicinal cannabis products by:

1. name, using terms such as ‘medicinal cannabis’ or ‘cannabinoid-based therapies’; and also
2. alternative terms, including but not limited to ‘plant medicine’, where the surrounding context of the relevant webpage, social media post or account, printed material, digital kiosk or other advertising platform (whether or not Dispensed has authored or is otherwise responsible for creating, controlling or bringing about that surrounding context, and including the physical surroundings of posters and digital kiosks) may allow a reasonable person to infer that the goods being referred to are, or include, medicinal cannabis products.

CONDITIONS

under subsection 42DV(3) of the Act

This Direction is subject to the following conditions that you must:

1. complete the action you are directed to carry out, in paragraph 1 to 4, including as required by these conditions within 14 days of the date of this Direction.
2. complete the action you are directed to carry out, in paragraph 5, including as required by these conditions within 30 days of the date of this Direction.
3. cease, for an indefinite period all advertising referred to at paragraphs 1 to 4 above, and
4. email evidence of compliance with this Direction to the email address listed on the first page of this Direction within 45 days of the date of this Direction.

OTHER INFORMATION

The possible consequences of failing to comply with this Direction are explained in Attachment A.

This is an initial decision and is reviewable. Your review rights are set out in Attachment B.

Please note, as required under subsection 42DV(6) of the Act, this Direction will be published on the Department’s website as soon as practicable.

DATED: 20 August 2025

[REDACTED]

[REDACTED]
Delegate of the Secretary of the Department of Health, Disability and Ageing
Regulatory Compliance Branch
Therapeutic Goods Administration

Attachment A

Effect of not complying with this direction

If you contravene a direction or a condition of a direction made under subsections 42DV(1) or (2) of the Act, you may commit a criminal offence contained in section 42DW or contravene a civil penalty provision under section 42DX, which could lead to court action against you or the issuing of infringement notices to you.

In addition to pursuing civil or criminal sanctions, the Secretary may also seek an injunction from a Federal Court that you immediately cease your advertising.

If you contravene a direction, or a condition of a direction, made under subsection 42DV(1) of the Act, the Secretary may cancel the registration, listing or inclusion of goods in relation to which the direction was given. This may be done without first notifying you of the proposal to cancel if the Secretary is satisfied that the contravention is significant (paragraphs 30(1)(f), 30(1)(fa), 32GA(1)(i), 32GA(1)(j), 41GL(g) and 41GL(ga)) or otherwise after first informing you of the proposed cancellation and giving you a reasonable opportunity to make submissions in relation to the proposed action (paragraphs 30(2)(eaa), 30(2)(eab), 32GC(1)(fa), 32GC(1)(fb), 41GN(1)(i) and 41GN(1)(j)).

The TGA can also alert the public to its concerns about particular therapeutic goods advertising through the use of public warning notices (section 42DY).

Attachment B

Request for reconsideration of an initial decision

This decision is a reviewable initial decision under section 60 of the Act. Under section 60, a person whose interests are affected by a ‘reviewable’ initial decision, can seek reconsideration of the initial decision.

As this document constitutes written notice of the making of an initial decision being given by the Secretary, a request for reconsideration of this initial decision must be given to the Minister within 90 days and be accompanied by any information that you wish to have considered. A request for reconsideration given to the Minister outside the statutory 90 day reconsideration period cannot be accepted.

The Minister may either personally undertake a request for reconsideration of an initial decision or delegate to an officer of the Department with the appropriate delegation.

Under section 60(3A) of the Act, the Minister (or the Minister’s delegate) is not able to consider any information provided after the notification is made of a request for reconsideration of an initial decision unless the information is provided in response to a request from the Minister (or the Minister’s delegate), or it is information that indicates that the quality, safety or efficacy of the relevant therapeutic goods is unacceptable.

Guidelines for requesting reconsideration of an initial decision

A request for reconsideration should be made in writing, signed and dated by the person requesting reconsideration, should be titled "<insert person/company name> - Request for Reconsideration Under Section 60 of the Therapeutic Goods Act 1989" and should include the following:

• a copy of the initial decision notification letter (or other evidence of notification);
• identify, and describe with as much specificity as possible, which component(s) of the initial decision should be reconsidered and set out the reasons why reconsideration is requested;
• any information/documentation in support of the request, clearly labelled to correspond with (any or each of) the reasons why reconsideration is requested; and
• an email address nominated for the purposes of receiving correspondence in relation to the request for reconsideration.

All requests for reconsideration should be given to the Minister by email:

Email: 'Minister.Butler.DLO@health.gov.au' and copied to 'decision.review@health.gov.au'

Requests for reconsideration that include dossiers (or similar bulk material) that cannot easily be attached to the request given first by email, may then be submitted on a USB drive or CD sent by express post or registered mail to:

Mail:

Minister for Health, Disability and Ageing
Suite MG 50
c/- Parliament House
CANBERRA ACT 2600

If upon reconsideration by the Minister (or the Minister’s delegate), you are dissatisfied with that decision, you can apply to the Administrative Appeals Tribunal (AAT) for a review of that decision (see the Administrative Appeals Tribunal Act 1975 (AAT Act)).

NOTE: This initial decision remains in effect unless and until it is revoked or revoked and substituted by the Minister (or the Minister’s delegate) as a result of a request for reconsideration under section 60 of the Act OR is set aside, varied or remitted by the AAT or is otherwise overturned or stayed.