TGA & Regulatory Statement.

Power to Practice operates as a distributor of medical aesthetic devices, skin-needling serums and consumables in Australia. Our distribution and advertising activities are conducted in accordance with:

• Therapeutic Goods Act 1989 (Cth) and Therapeutic Goods Regulations 1990.
• Therapeutic Goods Advertising Code (the current Code in force from time to time).
• Health Practitioner Regulation National Law and AHPRA's professional advertising framework.
• Industrial Chemicals Act 2019 and Australian Industrial Chemicals Introduction Scheme (AICIS) where applicable to cosmetic-classified ingredients.
• Western Australian Medicines and Poisons Act 2014 and Medicines and Poisons Regulations 2016 in respect of any state-level supply requirements.

Pages of the Site that are accessible to the general public describe our brand, the device platforms we distribute, and treatment indications addressed by those platforms. Public-facing content is intentionally limited to:

• Devices listed on the Australian Register of Therapeutic Goods (ARTG) where direct-to-consumer description is permitted under the Advertising Code.
• Cosmetic-classified topical serums for which manufacturer information may be communicated to the general public.
• Treatment indications expressed in device-class language (for example, "hair reduction", "skin rejuvenation") consistent with the Code.

Public pages do not name, depict, or solicit demand for any prescription-only therapeutic goods (Schedule 4 medicines), in line with section 42DL of the Therapeutic Goods Act 1989 (Cth).

Information about therapeutic goods that may only be advertised to healthcare practitioners under the Therapeutic Goods Advertising Code is held behind a verified login (the "Practitioner Portal"). Access requires:

• A current AHPRA registration number.
• An attestation that you are a registered Australian healthcare practitioner authorised to receive practitioner-only product information under the Code.
• Acceptance of the access conditions notified at login.

Information accessed through the Practitioner Portal must not be shared with the general public, used in patient-facing advertising, or otherwise distributed beyond the registered practitioner accessing it. We reserve the right to revoke access for misuse.

Information about therapeutic goods provided on the Site (including in the Practitioner Portal) is drawn from manufacturer-supplied documentation, including Instructions for Use (IFU), product monographs and clinical handling guides. Healthcare practitioners must read the manufacturer's full IFU before administering any product, and rely on their own clinical judgement and the patient's individual circumstances when planning treatment.

Where summary product information appears on the Site, it does not replace, override or modify the manufacturer's IFU. If there is any discrepancy between Site content and the IFU, the IFU prevails.

Treatment information on the Site is presented in a manner intended to comply with AHPRA's professional advertising framework, including the obligations on registered health practitioners not to use testimonials, before-and-after imagery in respect of regulated health services, or claims that may create unrealistic expectations.

Healthcare practitioners using the Site to inform their own clinic marketing remain responsible for ensuring their advertising complies with AHPRA's framework as applied to their profession and treatment scope.

If you experience or observe an adverse event, side effect or product quality issue in relation to a therapeutic good supplied by Power to Practice, please contact us as soon as possible:

• Email: info@powertopractice.com.au with subject line "Adverse Event Report".

We will assist with documentation and, where required by law, escalate the report to the Therapeutic Goods Administration in accordance with our pharmacovigilance obligations.

You may also report adverse events directly to the Therapeutic Goods Administration via the Database of Adverse Event Notifications (DAEN) at tga.gov.au, or by calling the TGA on 1800 020 653.

Where Power to Practice acts as the sponsor or importer of a device on the Australian Register of Therapeutic Goods, we accept the regulatory obligations attaching to that role, including post-market surveillance, complaint handling, mandatory problem reporting, and recall obligations under the Therapeutic Goods Act 1989 (Cth) and the Uniform Recall Procedure for Therapeutic Goods.

We do not promote off-label use of any device or therapeutic good. Information on the Site, in the Practitioner Portal and in materials we distribute reflects the indications cleared or notified for the relevant Australian regulatory pathway. Any decision to use a product outside its approved indications is the sole clinical responsibility of the treating practitioner.

In addition to Commonwealth obligations, supply within Western Australia is subject to the Medicines and Poisons Act 2014 (WA) and the Medicines and Poisons Regulations 2016 (WA). Practitioners in WA are responsible for holding any authorisation or approval required to obtain, store and administer the product in their practice, including (where relevant) authorisations applicable to specific Schedule 4 medicines.

Australian regulatory frameworks evolve. We update this Statement to reflect material changes in the Therapeutic Goods Act, the Advertising Code, AHPRA guidelines, or our own product portfolio. The Effective date at the top of this page indicates when the Statement was last updated.

Regulatory questions, requests for further information, or notifications under this Statement should be directed to:

• Email: info@powertopractice.com.au