Suspected Adverse Event Reporting Procedure

Please note the requirements to complete the Adverse Event Reporting Form

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To lodge a product reaction, the information in the reporting form must be completed in full.

This information is necessary for our internal pharmacovigilance obligations and may be used for Therapeutic Goods Administration (TGA) reporting purposes.

You will need to complete ALL sections of this form to proceed with a product return.

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What you’ll need to complete this form:

1. Practitioner details – First name, surname, email, phone number & business name.

2. Patient details – First name, surname, email, phone number, gender, age & weight.

3. Suspected medicine – Product suspected of causing the reaction, dosage, date(s) of starting and stopping the medicine(s) / duration, reason for use, batch number, expiry date, AUST L number & any other dosage information.

4. Adverse event – Description of the event, including symptoms and signs experienced, timeline, and any other clinically relevant information; date of onset of the adverse event; duration of the event; & any other concomitant products taken at the time of the reaction.

5. Seriousness of event – Fatal, life‑threatening, hospitalised, required visit to a medical practitioner, & details of how the adverse event was treated (e.g. medications given, hospitalisation, supportive or follow‑up care).

6. Outcome of event – Recovered/resolved, recovering/resolving, not recovered/not resolved/ongoing, unknown, & date of outcome.

7. Relevant medical history – Details of any known allergies, medical conditions or diseases, past surgeries, risk factors, and any previous side effects or reactions to medicines or supplements that may help in understanding this case.

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Personal Information 

We are collecting your personal information, including your health information, as part of our obligation to report adverse reactions or product complaints.

Depending on the severity of the reaction, your personal information and details of your experience with our product may be shared with the Therapeutic Goods Administration (TGA).

Please note that all information provided to the TGA is de‑identified. Additionally, we will inform you if a submission is required.

We may also use this information for quality improvement purposes and to contact you if further clarification or follow‑up is required.

If you have any questions about how we handle your personal information, please refer to our Privacy Policy on the Designs for Health Australia website.

You can contact our Customer Care team at: [email protected]