Adverse Reactions Policy

We are committed to your safety and well-being. We choose Australian complementary medicine manufacturers who adhere to pharmaceutical Good Manufacturing Practice (GMP) standards. GMP is a pharmaceutical manufacturing system that ensures products are consistently produced and controlled according to quality standards, minimising the risks involved in pharmaceutical and complementary medicine production. 

What is an Adverse Reaction

Adverse events are unintended and sometimes harmful occurrences associated with using a medicine, vaccine, or medical device (collectively known as therapeutic goods). Adverse events include side effects from medicines and vaccines and problems or incidents involving medical devices. 

All medicines and vaccines can cause side effects or other adverse events.

Medicines include:

• prescription medicines
• over-the-counter medicines that are purchased without a prescription
• complementary medicines, such as:
  • herbal medicines
  • naturopathic or homeopathic preparations
  • nutritional supplements, like vitamins and minerals.

Adverse reactions are otherwise referred to as idiosyncratic reactions. Idiosyncratic drug reactions may be defined as adverse effects that cannot be explained by the known mechanisms of action of the therapeutic agent; they do not occur at any dose in most patients and develop mostly unpredictably in individuals. The reaction occurs due to the individual's unique biochemistry, which may make them susceptible to an unexpected reaction. Adverse reactions can occur with any food, supplement, or pharmaceutical medication, including complementary medicines and others.

For any adverse reactions, we diligently follow the procedures to ensure reactions has been reported to the Therapeutic Goods Administration (TGA), Australia's governing agency for medications and therapeutic supplements.  The TGA plays a crucial role in ensuring the safety of therapeutic goods, providing a robust system for monitoring and reporting adverse events.

For more information, visit https://www.tga.gov.au/resources/resource/guidance/reporting-adverse-events

 When a therapeutic good is first registered and made available in Australia, information about its safety and effectiveness is usually only available from clinical trials.

Clinical trials provide information about many of the possible adverse events associated with a therapeutic good but do not detect all possible adverse events because they:

• usually do not continue for long enough to detect adverse events that take a long time to develop
• do not include enough patients to detect adverse events that occur rarely
• do not include all the different types of people who might eventually use the product and who might be more susceptible to some adverse events, such as older people, children, pregnant people or people with other medical conditions.

The TGA monitors the safety of therapeutic goods to contribute to a better understanding of their possible adverse events when used outside the controlled conditions of clinical trials.

Reports by consumers and health professionals provide essential information for the TGA's safety monitoring program.

Who Can Report An Adverse Reaction

Anyone can.

The TGA receives a certain number of adverse event reports each year, which can be found at Adverse Events: Australian Statistics on Medicines and Adverse Events: Australian Statistics on Medical Devices.

 Most adverse event reports are made by sponsors (e.g., pharmaceutical companies and medical device suppliers), but many are also made by state and territory health departments, hospitals, health professionals, and consumers.

 If you have concerns about an adverse event, speaking to your prescribing healthcare professional is important.

Due to the unforeseen nature of an adverse reaction/ idiosyncratic event, Floralia Wellness will not provide a refund on the product/s in question. If you seek a refund, you will need to contact the sponsor (e.g., a pharmaceutical manufacturing company) directly to discuss and follow their reporting system for adverse reactions.

We have a strict TGA reporting process for adverse reactions. Please contact us immediately to commence the reporting process with the TGA and the manufacturer.

https://www.tga.gov.au/resources/resource/guidance/aems-guidance-health-professionals

Our Process for Reporting Adverse Reactions 

Please contact us at hello@floraliawellness.com.au, and we will assist with the TGA adverse reactions reporting process and guidelines.