Pharmacovigilance Services Australia

Yes, you legally need a local contact person.

If you are a sponsor of a medicine listed or registered on the Australian Register of Therapeutic Goods (ARTG), the Therapeutic Goods Act 1989 requires you to nominate a Pharmacovigilance Contact Person who resides in Australia. This is not optional. You must notify the TGA of this appointment within 15 calendar days of your product’s first entry on the ARTG.

While the global industry often refers to this role as the “QPPV” (Qualified Person for Pharmacovigilance), the TGA specifically mandates an “Australian Pharmacovigilance Contact Person.” This individual serves as the single point of contact for the TGA regarding safety issues, and they cannot manage this role remotely from overseas.

More Than Just a Name on a Form

Many international sponsors assume they can simply list a local administrative staff member or a “mailbox” service to tick the regulatory box. This is a risky misconception.

The TGA expects your Australian Pharmacovigilance Contact Person to have a “sound understanding” of Australian pharmacovigilance reporting requirements. When a safety signal arises or a serious adverse event occurs, this person is responsible for notifying the TGA within strict legal timeframes.

If your nominated contact person misses a notification deadline because they lacked the technical training to recognise a Significant Safety Issue (SSI), your company is directly liable.

Key Responsibilities: What Does the Contact Person Actually Do?

Beyond serving as the primary liaison, your local contact ensures your pharmacovigilance system complies with the TGA Pharmacovigilance Guidelines (2023). Their core duties include:

1. Ensure there is a system in place to to Manage Adverse Event Reporting

The TGA has distinct reporting timelines that differ from those of the EMA or the FDA. Your contact person must ensure that:

Serious Australian Adverse Reactions are reported within 15 calendar days.
Significant Safety Issues (SSIs)—such as urgent safety measures taken overseas—are reported within 72 hours.

2. Being Present for the Australian PV System

Even if your global safety database is managed in Europe or the US, the Australian contact person must have oversight of the local data. They need access to your global safety team to answer TGA queries immediately.

3. Signal Detection & Validation

The contact person ensures that safety data specific to the Australian population is reviewed and determines whether safety information should be reported in collaboration with key personnel. They validate reports to ensure they meet the minimum criteria, supported by well-documented procedures, before submission.

Pharmacovigilance Reporting Requirements

The Sponsor’s pharmacovigilance regulatory reporting obligations — including what must be reported, how to submit, and required timeframes — are summarised in the table below, with all timelines calculated from Day 0.

Report type	How to report	Reporting timeframe
Australian pharmacovigilance contact person	Submit via TGA Business Services	≤15 calendar days of the first ARTG entry or of any updates to details
Significant safety issues	Submit a notification using the online Medicine Safety Issues – Electronic notification form	≤72 hours of Australian sponsor awareness and of any follow-up information
Other safety issues		≤30 calendar days of Australian sponsor awareness and of any follow-up information
Serious adverse reaction reports that occurred in Australia	Submit a CIOMS form via email to: adr.reports@health.gov.au, or Submit report online using the Adverse Event Management System (AEMS): TGA Business Services, or Submit via E2B reporting	≤15 calendar days of Australian sponsor awareness and of any follow-up information
Quality defect issues, including adulterated and counterfeit products	Report as per above, depending on report type, and also refer to the Uniform Recall Procedure for Therapeutic Goods to determine the appropriate recall or non-recall action	In accordance with the timeframe for safety issues or serious adverse reactions, as applicable
Non-serious adverse reaction reports and overseas adverse reaction reports	These are not required to be routinely reported. However, they MUST be presented as a cumulative table in a Periodic Safety Update Report (PSUR) where one is required or supplied to the TGA upon request in the requested format.	As specified by the TGA PSUR reporting requirements or a specific request

QPPV vs. Australian Contact Person: What’s the Difference?

This is the most common point of confusion for our clients.

Australian Pharmacovigilance Contact Person: The mandatory legal role defined in the legislation. They must reside in Australia.
QPPVA (Qualified Person for Pharmacovigilance in Australia): An industry-standard title often used to describe the person who holds the scientific and medical oversight of the system, the ‘Pharmacovigilance System’.

In practice, the TGA recommends that these be the same person. However, if your Contact Person is an administrator, you must have a qualified QPPVA (or access to a medically qualified person) to support them.

At GxPVigilance, we typically fulfil both roles for our clients to ensure seamless compliance and medical oversight.

How GxPVigilance Brings You Control & Confidence

Appointing an internal employee who lacks PV training creates a single point of failure. Conversely, hiring a full-time QPPV in Australia is often cost-prohibitive for small-to mid-sized sponsors.

GxPVigilance offers a “third way”—a partnership model built on clarity, control, and integrity.

We Don’t Just “File and Forget”

A dedicated Australian Pharmacovigilance Contact Person integrates with your global team. Instead of forwarding emails, we operate as your local safety intelligence unit.
Compliance shouldn’t create anxiety— it should create confidence. A smooth, inspection-ready system keeps you capable—not dependent.

Ready to Secure Your Australian Safety System?

You don’t need to navigate TGA requirements alone. Contact GxPVigilance today to appoint your Australian Pharmacovigilance Contact Person and move from uncertainty to assurance.

FAQ: Common Questions on Australian Pharmacovigilance (PV)

1) Can my Regulatory Affairs (RA) consultant be my PV Contact Person?

Yes — if they formally accept the responsibility and have enough PV competence to recognise and action reportable issues within Australian timeframes. The risk is operational: many RA consultants are strong on submissions, but may not be set up for 24/7 safety issue escalation, SSI/OSI judgement, or audit-traceable PV records. Also consider conflicts: if the same person is accountable for registration strategy and safety issue decisions, you want clear governance to prove decisions were made on patient safety grounds.

2) Does the Pharmacovigilance Contact Person need to be a doctor?

No. Australian requirements do not mandate medical qualification for the Contact Person. But the TGA expects sponsors to have appropriate access to medically qualified judgement when it matters (e.g., causality assessment, benefit–risk decisions, major label changes). Practically: the Contact Person should have a clear pathway to a safety physician (internal or contracted) and be able to evidence how medical input is obtained and documented.

3) What happens if the Contact Person goes on leave or is unavailable?

You must have documented backup arrangements. The key issue is timeframes: if a Significant Safety Issue (SSI) occurs and nobody is available to act, you risk missing the 72-hour reporting window from Australian awareness. Your system should specify who steps in, how handover works, and how after-hours notifications are managed — and you should be able to show this during inspection.

4) Can the Contact Person be based overseas (or “virtually” in Australia)?

In practice, the TGA expects the Contact Person to reside in Australia, and to be reachable and able to respond within Australian operational realities. “Mailbox” arrangements or nominal contacts who can’t actually operate the role are a common weakness in inspections. If global PV is offshore, the Australian Contact Person still needs real oversight access and authority to escalate and action.

5) What’s the difference between “QPPV” and the Australian PV Contact Person?

“QPPV” is a global term (especially EU) describing senior PV oversight. Australia’s requirement is framed around a local Contact Person who is the TGA’s point of contact for safety issues. In many sponsor models, one person may perform both functions locally — but what matters is not the title; it’s whether your system shows clear responsibility, authority, availability, and evidence of oversight.

6) When does the 72-hour SSI clock start (“Day 0”)?

Day 0 starts as soon as the Australian sponsor (including delegated vendors/partners) becomes aware of the SSI. This includes awareness by third parties performing PV activities on your behalf. The clock can also “restart” when new clinically relevant information is received for a previously reported SSI.

7) What counts as a Significant Safety Issue (SSI) in Australia?

SSIs are safety issues requiring urgent attention. A common trigger is a major safety-related regulatory action overseas, or a change likely to materially affect benefit–risk. The TGA notes that adding a contraindication is generally considered an SSI, but professional judgement applies — and if you decide it’s not an SSI, you should document why.

8) What is an “Other Safety Issue” (OSI) — and when is it due?

An OSI is a safety issue that doesn’t need urgent attention but still requires notification once assessment is complete. Day 0 for an OSI is the day the assessment is completed in the Australian context, and the OSI must then be notified within 30 calendar days.

9) Do overseas regulator (COR) label update requests need to be reported to the TGA?

Yes. A safety-related label update request by a Comparable Overseas Regulator (COR) is considered reportable. Even if you disagree with the overseas regulator’s conclusions, the TGA expects the issue to be submitted, with your justification for the Australian position included in the notification.

10) If the overseas regulator raises a safety signal (but no action yet), do we report it?

Not always. The TGA’s position is that safety issues identified by a COR become reportable when there is an associated safety-related action or outcome (e.g., request to update labelling) — not just discussion or early “signal noted” steps. The practical control: document your monitoring and decision trail so you can defend why something wasn’t reported earlier.

11) What if we don’t yet know whether we’ll update the Australian PI — can we still submit an OSI?

The TGA’s expectation is that an OSI notification includes your planned risk mitigation strategies. If you don’t yet know whether you’ll update the PI (or take other actions), your assessment isn’t considered complete — so you should not submit the OSI until you have a proposed approach (or documented justification for no action).

12) Do these safety issue reporting requirements apply to listed medicines?

Yes — the PV Guidelines apply to medicines registered or listed on the ARTG.

13) Do these requirements apply to products supplied under the Special Access Scheme (SAS)?

No — the PV Guidelines safety issue reporting (SSI/OSI framework) applies to medicines registered or listed on the ARTG. Unapproved medicines supplied under SAS follow SAS-specific sponsor guidance and requirements.

14) Do these safety issue reporting requirements apply to clinical trials?

Only in limited circumstances. The PV Guidelines safety issue reporting applies to clinical trials where the medicine is used in line with the Australian approved indications (PI). For other clinical trial situations, follow clinical trial safety reporting guidance.

15) What if the online TGA safety issue form is down or blocked by our systems?

If the electronic form isn’t available, the TGA advises sponsors to contact the Signal Investigation Coordinator by email to alert them to the problem and (if needed) notify via email to maintain the required timeframes. Also note: from 1 Feb 2024, use of the notification form became mandatory for reporting safety issues.

References

Pharmacovigilance responsibilities of medicine sponsors. Therapeutic Goods Administration (TGA)
Medicine safety issues – Electronic notification form (online form guidance; last updated 1 August 2023). Therapeutic Goods Administration (TGA)
Frequently asked questions: Identifying and reporting safety issues – PV Guidelines (version 3.0) (PDF). Therapeutic Goods Administration (TGA)
Uniform Recall Procedure for Therapeutic Goods (URPTG). Therapeutic Goods Administration (TGA)

Pharmacovigilance Services in Australia: How to Appoint Your Local Contact Person & Ensure TGA Compliance