Partner Pharmacovigilance Policy
1 PURPOSE
This Policy is for the purpose of complying with legal pharmacovigilance requirements in order to protect public health and safety. The safety and quality of Herbs of Gold products are a priority. This Policy sets out the minimum pharmacovigilance and safety reporting obligations that apply to customers, distributors, retailers, healthcare practitioners, promoters and any other parties who market, sell, distribute, handle or promote Herbs of Gold products (each a Partner).
2 DEFINITIONS
In this Policy:
(a) adverse event includes any untoward medical occurrence in a person who used a Product, whether or not related to the Product;
(b) adverse reaction means an adverse event for which there is at least a reasonable possibility of a causal relationship with the Product;
(c) Partner Personnel means the Partner’s employees, contractors, agents and representatives (including customer service staff);
(d) reportable information means any matter described in clause 6 (including special situations and safety issues);
(e) Day 0 has the meaning given in the TGA guidance for medicine sponsors (for sponsor reporting), noting the sponsor’s reporting clock can be triggered when information is received by delegated partners.
(f) serious adverse reaction has the meaning used by the TGA for sponsor reporting and includes those outcomes described in clause 8.
(g) significant safety issue (SSI) has the meaning used by the TGA for sponsor reporting.
(h) other safety issue (OSI) has the meaning used by the TGA for sponsor reporting.
(i) TGA means the Therapeutic Goods Administration.
3 APPLICATION AND SCOPE
(a) This Policy applies to all Herbs of Gold products for which Herbs of Gold is the sponsor on the Australian Register of Therapeutic Goods (ARTG) from time to time (Products).
(b) This Policy applies to safety information that comes to a Partner’s attention through any channel the Partner owns, manages, administers, controls or funds, including in-store, phone, email, websites, webforms, and social media (including direct messages), and online forums or other digital channels.
(c) This Policy is incorporated by reference into Herbs of Gold’s customer trading terms (including its credit terms and terms and conditions of sale) where those terms require Partners to comply with this Policy.
(d) For convenience, the Products covered by this Policy are the products for which Herbs of Gold is listed as sponsor on the ARTG from time to time. A current list may be viewed at: [ARTG sponsor link]. This list may change as ARTG entries are added, varied or cancelled and no re-execution of this Policy is required for such changes.
(e) This Policy is intended to support Herbs of Gold’s statutory pharmacovigilance and record-keeping obligations that apply as conditions of listing on the ARTG, and must be complied with accordingly.
(a) A Partner must report relevant safety information to Herbs of Gold as soon as possible and in any event within 24 hours of first becoming aware of it (including weekends and public holidays).
(b) The 24-hour period starts when the information is first received by any of the Partner’s personnel (including employees, contractors, agents, representatives and customer service staff) through any channel.
(c) Partners must report even if information is incomplete and must forward follow-up information promptly as it becomes available.
(d) Partners must not screen out, delay, edit, summarise, or ‘assess’ reports before forwarding them, except to the extent necessary to remove information the Partner is legally prohibited from disclosing.
5 WHAT MUST BE REPORTED
A Partner must report to Herbs of Gold any of the following in connection with a Product:
(a) any adverse event or suspected adverse reaction;
(b) any report of lack of efficacy;
(c) any product complaint, quality issue, or suspected defect that may have safety implications;
(d) any misuse, abuse, overdose, medication error, or off-label use associated with a safety concern;
(e) any cluster or pattern of similar reports suggesting an emerging risk; or
(f) any suspected safety issue that may change the risk-benefit profile of a Product.
6 MINIMUM INFORMATION TO INCLUDE
Where available, a Partner should include the following minimum information:
(a) reporter name and contact details;
(b) an identifiable person affected (for example initials, age, or other identifier);
(c) suspected Product (including batch number);
(d) description of the reaction/event (symptoms, outcome and treatment required);
(e) where available, the Partner should also provide:
(i) expiry date, dose, route of administration, dates of use and time-to-onset;
(ii) relevant medical history, concomitant medicines and other relevant risk factors (as reported);
(iv) where the report arose from a digital channel (eg social media post or direct message), a copy of the post/message (or screenshot) and the date/time it was received; and
(v) any documents the Partner holds that are relevant to assessment (eg complaint photos, correspondence, return details, invoices, delivery/batch traceability data).
If the minimum information is not available, the Partner must still report within 24 hours and provide whatever information it has. The minimum information in clause 6(a) to 6(d) reflects the four minimum data elements required for reporting. .
7 MISSING INFORMATION AND FOLLOW-UP
(a) If the minimum information in clause 6(a) to 6(d) is not available, the Partner must still report within 24 hours and clearly identify what information is missing.
(b) The Partner must use reasonable efforts to obtain missing information and provide it to Herbs of Gold promptly.
(c) Where lawful and appropriate, the Partner must assist Herbs of Gold to contact the identifiable person affected or follow-up (including by facilitating communications or providing updated contact details).
A serious adverse reaction includes any suspected adverse reaction that results in, or is associated with:
(a) death;
(b) hospitalisation (admission; emergency presentations should be assessed for seriousness);
(c) life-threatening circumstances;
(d) significant disability or persistent impairment;
(e) congenital anomaly or birth defect (including relevant pregnancy exposure); or
(f) other medically important events requiring medical intervention to prevent serious outcomes (for example anaphylaxis).
Partners must report all adverse events and adverse reactions within 24 hours regardless of seriousness.
9 SAFETY ISSUES (SIGNIFICANT AND OTHER)
A safety issue is any factor that may change the risk-benefit balance of a Product and may require assessment or action. Safety issues include (without limitation):
(a) changes in frequency or severity of known serious reactions;
(b) new serious risks or risk factors;
(c) clusters suggesting a quality defect;
(d) significant lack of efficacy patterns;
(e) suspected teratogenic effects or significant public health hazards;
Partners must report suspected safety issues within 24 hours. This includes safety issues that may ultimately be assessed by Herbs of Gold as an SSI or an OSI.
Herbs of Gold, as sponsor, has statutory notification obligations to the TGA, including reporting serious adverse reactions no later than 15 calendar days from receipt and reporting significant safety issues no later than 72 hours from awareness. The relevant reporting clocks can start when the information (including the four minimum data elements) is received by sponsor personnel, including contractors, or when delegated partners become aware of a safety issue. The 24-hour escalation requirement in clause 4 is intended to give Herbs of Gold sufficient time to assess, investigate and comply with these obligations.
10 SPECIAL SITUATIONS
Special situations include (without limitation):
(a) pregnancy or breastfeeding exposure;
(b) reports involving infants, children or the elderly;
(c) misuse, abuse, overdose;
(d) quality defect issues; and
(e) lack of efficacy reports.
Partners must report special situations within 24 hours.
11 HOW TO REPORT
(a) Complete the “Herbs of Gold Adverse Reaction Report” form.
(b) Email the completed form and any supporting material to Herbs of Gold’s Pharmacovigilance Team at: pharmacovigilance@herbsofgold.com.au
(c) Reports should be provided in full and unredacted except to the extent the Partner is prohibited by law from providing particular information, in which case the Partner must explain the basis for the redaction and provide the remaining information promptly.
(e) The Partner must keep an internal record of the date/time the report was first received, the channel it was received through, and the date/time it was forwarded to Herbs of Gold.
(f) Where the report arises through a digital channel (including social media), the Partner must preserve the original content (including screenshots and timestamps) and must not delete or materially modify the content before capture, so far as it is within the Partner’s control.
12 TRAINING AND INTERNAL PROCESSES
Partners must ensure relevant staff are trained to:
(a) identify reportable safety information;
(b) escalate it within 24 hours;
(c) use the reporting form and email pathway; and
Partners must maintain internal processes so reports from all applicable channels (including social media direct messages) are captured and escalated.
13 RECALL AND CORRECTIVE ACTION COOPERATION
(a) Partners must cooperate with and implement any safety communications, corrective actions or recalls issued by Herbs of Gold, including identifying affected stock, quarantining it, ceasing supply/sale as directed, and maintaining distribution records sufficient to support traceability.
(b) On request, the Partner must promptly provide Herbs of Gold with distribution and traceability records in its possession or control that Herbs of Gold reasonably requires to expedite a recall or meet a TGA request, subject to applicable law.
(c) If the Partner receives any enquiry, complaint, notification or request from any regulator, marketplace operator, or other authority relating to the safety, quality, labelling, advertising, supply or recall of a Product, the Partner must notify Herbs of Gold within 24 hours and provide copies of relevant correspondence (subject to law).
Partners must retain records relating to this Policy, including reports received and forwarded, reconciliation confirmations (if requested), and training records, for the lifetime of the Product and for at least 5 years after cancellation from the ARTG, unless a longer period is required by law. Without limiting the above, distribution records must be retained for at least five years and provided to Herbs of Gold promptly on request to support sponsor obligations.
In particular, Partners must retain and be able to promptly provide distribution and traceability records sufficient to support product recall and batch tracing, including (where applicable) invoices, quantities supplied, dates of supply, batch/lot details, customer/store details, and stock movements.
15 PRIVACY
Partners must only disclose personal information to Herbs of Gold where permitted by law and reasonably necessary for pharmacovigilance and safety monitoring. Herbs of Gold handles personal information in accordance with its Privacy Policy.
16 NON-COMPLIANCE
A failure to comply with this Policy may constitute a material breach of the applicable trading terms incorporating it, and may result in suspension of supply, termination of trading terms, and other contractual or legal remedies (subject to the terms of the applicable agreement).
17 contacts
(a) Email: pharmacovigilance@herbsofgold.com.au
(b) Phone: [1800 852 222].
Our policy was last updated on 19 January 2026.
