Common PV Mistakes Made by Supplement Companies with Products Listed on the ARTG
For many supplement companies, pharmacovigilance is not the first regulatory priority that comes to mind.
The focus is often on getting a product listed on the Australian Register of Therapeutic Goods (ARTG), maintaining manufacturing compliance, managing claims, and ensuring that labels meet regulatory requirements. Once the product is on the market, however, sponsors continue to have important responsibilities for monitoring and managing product safety.
This is where smaller supplement companies can sometimes find themselves exposed.
A product being a listed medicine does not mean that pharmacovigilance can be treated as a formality. Sponsors remain responsible for having appropriate systems in place to identify, assess, document, and report adverse events associated with their products.
Below are some of the most common PV mistakes made by supplement companies with products listed on the ARTG.
1. Assuming "Listed Medicine" Means "Low Risk"
This is perhaps the most fundamental misconception.
Listed medicines are generally considered lower-risk products within Australia's regulatory framework, but lower regulatory risk does not mean that the product has no safety risks.
Supplements can still be associated with:
Adverse reactions
Drug interactions
Allergic reactions
Contraindications
Incorrect use
Overdose or excessive consumption
Product quality issues
Unexpected effects in particular populations
The safety profile of a product can also change as real-world exposure increases.
A product used by thousands of consumers may generate very little safety information during development but produce important patterns once it is widely marketed.
How to avoid it:
Treat pharmacovigilance as an ongoing post-market responsibility rather than something that ends when the product is listed on the ARTG.
2. Treating Consumer Complaints as Separate from Pharmacovigilance
For supplement companies, customer complaints are often handled by customer service or quality teams.
A consumer may report:
"This product made me feel dizzy."
If the complaint is simply recorded as a customer service issue and closed, the sponsor may have missed an adverse event.
The same applies to complaints involving:
Nausea
Headache
Rash
Palpitations
Gastrointestinal symptoms
Changes in blood pressure
Allergic reactions
Not every complaint will be an adverse event, but every potentially safety-related complaint should be assessed appropriately.
How to avoid it:
Ensure customer service, complaints, quality, and regulatory teams understand how to recognise and escalate potential adverse events.
3. Relying on the Manufacturer to Handle Safety
Many supplement companies use contract manufacturers and assume that the manufacturer will manage safety issues.
This can create a significant gap.
The manufacturer may be responsible for manufacturing quality, but the sponsor remains responsible for its pharmacovigilance obligations.
A manufacturing agreement does not automatically establish an effective PV system.
How to avoid it:
Clearly define pharmacovigilance responsibilities between the sponsor and manufacturer, including:
Adverse event escalation
Reporting timelines
Information sharing
Complaint handling
Quality issue escalation
Record retention
Regulatory communication
4. Having a PV SOP That Nobody Actually Uses
Another common problem is having a pharmacovigilance SOP because "we need one", without integrating it into the company's actual operations.
A procedure may state that adverse events are assessed within a particular timeframe, while employees have no practical understanding of what constitutes an adverse event or who is responsible for assessment.
This creates a gap between documented procedures and actual practice.
During an inspection or regulatory review, that gap can become very apparent.
How to avoid it:
PV procedures should be practical, proportionate to the organisation, and aligned with actual workflows. Relevant employees should also receive appropriate training.
5. Not Training Employees and Relevant Third Parties
Customer service teams are often the first people to receive safety information, but they are not the only ones who may encounter it.
For a supplement company, an adverse event could be received by almost anyone in the organisation, including employees working in:
Customer service
Sales and marketing
Medical or regulatory affairs
Quality
Complaints
Warehouse or distribution
Social media and digital teams
For this reason, pharmacovigilance should not be treated as the responsibility of the PV or regulatory team alone.
Sponsors should ensure that employees across the organisation receive appropriate training on pharmacovigilance and adverse event handling, with the level of training proportionate to their role and likelihood of receiving safety information.
Training should help employees understand:
What may constitute an adverse event
How to recognise safety information
What information should be captured
Who the information should be escalated to
The importance of escalating information promptly rather than deciding themselves whether an event is "important enough"
The same consideration applies to contractors and vendors.
A sponsor may have a well-designed PV procedure, but a third-party customer service provider, distributor, call centre, digital agency, or vendor may operate under different procedures and terminology. If these organisations receive consumer complaints or other safety information on the sponsor's behalf, they form an important part of the sponsor's PV information flow.
Sponsors should therefore consider whether relevant contractors and vendors require PV and adverse event training, particularly when they:
Interact directly with consumers or healthcare professionals
Receive product complaints
Handle customer enquiries
Manage social media or online channels
Process product returns or complaints
Perform activities that may generate or receive safety information
A refresher training should be held annually for relevant employees/vendors.
How to avoid it:
Establish a documented PV training programme covering employees and relevant contractors and vendors. Training should be tailored to the individual's role and should clearly explain how safety information must be recognised, documented and escalated.
Sponsors should also periodically confirm that outsourced parties understand the sponsor's PV requirements, particularly where the vendor's own procedures differ from the sponsor's internal processes.
A vendor should never become a blind spot in the sponsor's pharmacovigilance system.
6. Failing to Have a Clear Australian PV Contact
A common issue for smaller or overseas-owned supplement companies is unclear ownership of Australian pharmacovigilance activities.
The company may have a global regulatory or safety team overseas, but employees in Australia may not know who is responsible for PV matters locally.
This becomes particularly problematic when the TGA requests information or clarification.
How to avoid it:
Ensure that pharmacovigilance responsibilities are clearly assigned and that the appropriate Australian contact arrangements are established and documented.
7. Underestimating the Importance of Serious Adverse Events
Some sponsors assume that adverse events associated with supplements are unlikely to be serious.
This is not a safe assumption.
A listed medicine may be associated with an event requiring hospitalisation, resulting in significant disability, or otherwise meeting the criteria for a serious adverse reaction.
Seriousness should be assessed according to the applicable criteria, rather than based on assumptions about the product category.
How to avoid it:
Ensure that staff know how potential serious adverse events are identified, escalated, assessed, and reported within the applicable regulatory timelines.
8. Not Following Up for Missing Information
Initial consumer reports are often incomplete.
For example, a sponsor may receive:
"I felt really sick after taking your supplement."
Important information may be missing, including:
Patient age
Relevant medical history
Dose taken
Duration of use
Concomitant medicines
Outcome
Whether medical attention was required
Simply recording the initial complaint without attempting appropriate follow-up can limit the sponsor's ability to assess the case.
How to avoid it:
Establish a proportionate follow-up process and document attempts to obtain additional information.
9. Ignoring Social Media
For consumer-facing supplement brands, social media can be an important source of safety information.
Consumers may post comments such as:
"Has anyone else experienced headaches after taking this?"
or:
"I started getting a rash after using this product."
If the company actively monitors social media, relevant safety information may come to its attention.
The mistake is not necessarily failing to monitor every social media platform. The problem is having no defined approach to safety information that comes to the company's attention through digital channels.
How to avoid it:
Define responsibilities for handling safety information received through company-controlled websites, social media channels, online reviews, and other relevant consumer-facing platforms.
10. Failing to Connect Pharmacovigilance with Quality
A supplement company may have separate teams handling product complaints and pharmacovigilance.
This can create problems when an adverse event may actually indicate a product quality issue.
For example, a cluster of similar gastrointestinal complaints could potentially indicate:
A manufacturing issue
Contamination
Incorrect formulation
Stability problems
Labelling or dosage issues
If PV and quality teams work in isolation, important signals may be missed.
How to avoid it:
Establish clear communication and escalation pathways between pharmacovigilance and quality functions.
11. Poor Vendor Oversight
Supplement companies frequently rely on third parties for manufacturing, distribution, customer service, complaint handling, literature monitoring, and pharmacovigilance.
The sponsor remains responsible for ensuring that these arrangements work effectively.
Having a contract in place is not necessarily sufficient.
How to avoid it:
Implement proportionate vendor qualification and ongoing oversight, including clear responsibilities, appropriate agreements, performance monitoring, and escalation procedures.
12. Not Keeping Adequate PV Records
A sponsor should be able to demonstrate what happened, when it happened, who assessed it, and what action was taken.
A spreadsheet containing a list of complaints may not provide sufficient evidence of an effective pharmacovigilance process if there is no documented assessment or rationale.
Good records should provide a clear audit trail.
How to avoid it:
Maintain appropriate records of adverse events, assessments, follow-up activities, reporting decisions, training, vendor oversight, and relevant PV activities.
13. Assuming There Is Not Enough Data to Identify a Signal
A small sponsor may think:
"We only have a few adverse events, so there is nothing to analyse."
This can be misleading.
Signal detection does not necessarily require a large database. Repeated reports involving the same product, ingredient, event, population, or circumstance may warrant investigation even when the absolute number of reports is small.
How to avoid it:
Periodically review accumulated safety information and document the rationale for conclusions reached.
14. Treating the TGA PV Questionnaire as an Administrative Exercise
The TGA periodically asks sponsors to provide information about their pharmacovigilance systems.
For smaller supplement companies, this may be the first time they are required to describe their PV arrangements in detail.
A common mistake is to complete the questionnaire based on what the company believes it should be doing rather than what it actually does.
This can expose inconsistencies between documented procedures and operational practice.
How to avoid it:
Treat the questionnaire as an opportunity to assess your own system before responding. Review relevant SOPs, records, training, vendor arrangements, and reporting processes and ensure that the response accurately reflects current practice.
15. Waiting Until There Is a Problem
Perhaps the most common mistake is waiting until an adverse event, regulatory request, or inspection forces the company to establish a pharmacovigilance system.
By that point, the sponsor may have to reconstruct historical information, identify missed reports, train employees urgently, and develop procedures under regulatory pressure.
A proportionate PV system does not have to be complicated.
For many smaller supplement companies, an effective system can be built around:
Clearly defined responsibilities
A practical adverse event management procedure
Appropriate staff training
Complaint and PV integration
Clear reporting and escalation processes
Vendor oversight
Appropriate record keeping
Periodic review of safety information
The important point is that the system needs to work in practice.
Conclusion
For supplement companies with products listed on the ARTG, pharmacovigilance can easily become an afterthought, particularly where the organisation is small and resources are limited.
But being a listed medicine sponsor does not remove the responsibility to monitor product safety after the product reaches consumers.
The most effective PV systems are not necessarily the most complicated. They are the ones where responsibilities are clear, employees and relevant third parties know what to do, safety information reaches the right people, and the sponsor can demonstrate that appropriate decisions have been made.
For supplement companies, good pharmacovigilance is ultimately about more than meeting a regulatory requirement. It is about understanding what happens to a product once it reaches real consumers and having the systems in place to recognise when something requires attention.
