When Your Team Goes on Holiday, Your Regulatory Obligations Don’t
It is mid-December. The warehouse closes on Christmas Eve. Half the team takes leave until January 8. The QPPV is away, and the safety database vendor operates with minimal staff during the Christmas and New Year period.
A serious adverse event report might arrive in the pharmacovigilance inbox on Boxing Day. Quality defects could surface, requiring immediate coordination of a recall. The TGA may contact the sponsor after hours with questions about safety signals.
Regulatory obligations continue during public holidays.
Serious adverse reactions must be reported within 15 days, and significant safety issues must be reported within 72 hours. Recall decisions cannot be delayed until after the holidays.
Sponsors often become unprepared during this period, scramble to find staff with system access, are unable to reach responsible personnel, and discover they have not documented critical emergency procedures. Reduced staffing causes oversight gaps when risks are highest.
This guide outlines 12 key areas to address before the holiday shutdown. These are practical steps, based on proven methods, to maintain inspection readiness while staff are on leave.
Why Holiday Preparedness Matters for TGA Compliance
Australian sponsors must meet regulatory obligations at all times. The TGA requires functional pharmacovigilance systems, continuous quality oversight, and recall capability throughout the year.
The December–January period creates specific risks:
- Reduced staffing when key decision-makers take leave
- Supply chain disruptions as manufacturers, wholesalers, and logistics providers shut down
- Temperature stress on the cold chain during the Australian summer
- Delayed communication when stakeholders aren’t monitoring systems
- System access issues for remote or skeleton staff
During TGA pharmacovigilance inspections, auditors review business continuity plans and assess whether sponsors can maintain safety obligations during disruptions. The Christmas period serves as an annual test of whether documented procedures are effective under pressure.
The 12 Critical Readiness Checks
1. QPPV and Deputy Coverage Documented and Tested
Your Qualified Person for Pharmacovigilance in Australia (QPPV/A-PVCP) oversees the pharmacovigilance system for regulatory purposes. The TGA expects a named individual who can be contacted and can make safety decisions.
Before shutdown, complete these verification steps:
- Confirm who serves as QPPV for each date between December 24 and January 8
- Document the deputy or alternate with clear handover dates.
- Verify that both individuals can access safety systems remotely.
- Update TGA records if contact details have changed.
- Test mobile numbers and ensure 24/7 availability.
- Brief deputies on any ongoing safety concerns or pending decisions
What auditors check: Whether you can show uninterrupted QPPV oversight and accountability, even during leave. Documentation of handovers and deputy authorities is critical for inspections.
2. All Safety Reporting Channels Monitored Daily
Adverse events don’t arrive only during business hours. Reports can come through pharmacovigilance mailboxes, medical information lines, customer service, social media, distributor complaints, or directly from healthcare professionals.
Before shutdown:
- List every channel where safety information might arrive.
- Assign specific individuals to monitor each channel on each day (including weekends)
- Test that all email forwarding, phone routing, and web form notifications work correctly.
- Ensure after-hours answering services know how to escalate “side effects” or “product defect” calls.
- Verify remote access credentials for all monitoring staff.
- Confirm distributors and third-party providers know their reporting obligations continue over holidays.
What auditors check: Evidence that all intake channels remain functional and are monitored. Documentation should show how Day 0 reporting timelines are met with reduced operations.
3. Recall Procedures Aligned to TGA’s PRAC Framework
As of March 2025, the TGA’s PRAC (Procedure for Recalls, Product Alerts and Corrections) replaced the URPTG guidance. Recall SOPs must reflect these current requirements.
Before shutdown:
- Verify recall procedures reference PRAC, not outdated URPTG.
- Confirm all relevant staff are trained on the current recall processes.
- Test access to distribution records remotely
- Document who serves as the Recall Coordinator and deputy during holidays
- Ensure senior management approval authorities are clear and contactable.
- Pre-approve communication templates where possible (customer letters, HCP notifications)
- Verify the TGA’s after-hours recalls mobile number is in all relevant procedures.
What auditors check: whether your recall system works with reduced staff, whether you can urgently contact the TGA outside business hours, and whether PRAC requirements are integrated into your procedures.
4. Medical Officer and Quality Decision-Makers On Call
Safety and quality decisions often require medical or technical judgment and cannot be delegated to administrative staff.
Before shutdown:
- Establish on-call rosters for medical advisors covering benefit-risk assessments.
- Confirm who can approve label changes, product corrections, or urgent safety communications.
- Document quality escalation paths for manufacturing or sterility concerns
- Test communication chains between operations, medical, and regulatory functions
- Ensure decision-makers can access relevant product and safety documentation remotely.
Why this matters: Meeting safety timeframes requires qualified and available decision-makers.
5. Pharmacovigilance Database and Systems Accessible Remotely
Your safety staff must be able to access case management systems, document stores, and regulatory submission portals from anywhere during Christmas.
Before shutdown:
- Test VPN access for all on-call pharmacovigilance staff.
- Verify database logins and permissions are up to date.
- Confirm backup procedures if primary systems fail.
- Document manual workarounds for critical functions during system outages
- Ensure IT support contacts are available for urgent technical issues.
What auditors check: Whether you maintain data integrity, audit trails, and regulatory submission capability even when primary systems are stressed, or staff are working remotely.
6. Serious Adverse Reaction Reporting Timelines Can Be Met
Australian sponsors must report serious adverse reactions to the TGA within 15 calendar days. “Day 0” begins when anyone in your organisation becomes aware, not when staff return to the office in January.
Before shutdown:
- Confirm processes to identify, validate, and assess cases within required timeframes.
- Ensure that a minimum medical review is possible with the on-call staff.
- Test submission pathways to TGA (AEMS, B2B portal, or alternative routes)
- Document what constitutes a serious adverse reaction requiring immediate action.
- Establish clear escalation from case intake to medical assessment to submission.
Why this matters: Missing reporting deadlines results in regulatory non-compliance. Documented processes that function with minimal staff are essential for inspection readiness.
7. Significant Safety Issue Notification Within 72 Hours
Significant safety issues require TGA notification “as soon as possible and no later than 72 hours” from sponsor awareness. This includes unexpected serious adverse reactions, new safety concerns affecting the benefit-risk balance, or quality defects with patient impact.
Before shutdown:
- Define what triggers a significant safety issue notification.
- Establish who makes this determination (medical + regulatory + quality input)
- Document how to contact TGA urgently (standard channels plus after-hours if needed)
- Create template notifications to speed preparation.
- Ensure decision-makers understand they cannot delay urgent assessments until January.
What auditors check: Whether your risk assessment and decision processes can function under time pressure with reduced staff.
8. Supply Chain and Cold Chain Continuity Verified
Australian summer creates temperature stress on medicines requiring cold storage. Warehouse shutdowns can interrupt distribution. Supply delays can leave pharmacies without critical stock.
Before the shutdown, confirm trading hours and minimal staff schedules for manufacturers, third-party logistics providers (3PLs), wholesalers, and sellers.
- Verify temperature monitoring and alarm systems remain active in warehouses.
- Check who responds to cold-chain excursions during holidays.
- Assess whether stock levels can buffer supply disruptions.
- Document contingency plans if primary suppliers are unavailable
Why this matters: Quality defects and shortages often result from lapses in supply chain oversight during the holiday period. Prevention requires documented continuity plans.
9. Business Continuity Plans Tested and Validated
Storing a business continuity plan on a server does not suffice. You must demonstrate that the plan functions effectively during holiday conditions.
Before shutdown:
- Run a table-top exercise simulating a serious safety issue or recall on a public holiday.
- Test communication cascades (who calls whom, in what sequence)
- Verify remote access to critical documentation and systems.
- Document the exercise results and update procedures based on lessons learned.
- Ensure all participants know their roles and can execute under pressure.
What auditors check: Evidence that you tested your BCP. Documentation showing the plan is known, workable, and continuously improved—not just created for compliance purposes.
10. AI and IT Systems Have Manual Fallback Procedures
Many sponsors use AI-enabled tools for literature monitoring, case coding, or regulatory intelligence. Consider how you will respond if these systems fail during the holidays.
Before shutdown:
- Identify all AI-involving processes in pharmacovigilance and quality functions.
- Document manual procedures that can be activated during AI vendor outages
- Ensure data remains exportable and accessible locally.
- Verify that human oversight requirements are maintained.
- Confirm the contract’s address service availability, data access, and incident response.
Why this matters: Regulators expect core pharmacovigilance functions to be maintained regardless of technology dependencies. Manual fallback procedures demonstrate effective control.
11. TGA Contact Information Current and Accessible
The TGA operates limited hours between Christmas and New Year but maintains urgent contact lines for recalls and critical safety matters.
Before shutdown:
- Document TGA’s general contact numbers, product recalls unit details, and after-hours emergency mobile number.
- Verify safety reporting routes (AEMS portal, B2B system, email addresses)
- Ensure this contact sheet is stored centrally in your QMS and available offline.
- Test that the responsible staff know when to use routine versus urgent contact pathways.
- Confirm your sponsor details and A-PVCP contacts are current in the TGA systems.
What auditors check: Whether you know how to reach TGA urgently and whether TGA has the correct contact details for your responsible persons.
12. Training and Documentation Confirmed for Skeleton Staff
Your on-call team during holidays may include staff who do not normally handle adverse events or recalls. They require clear, accessible procedures and appropriate training.
Before shutdown:
- Deliver refresher training on recognising adverse events and product complaints.
- Provide escalation flowcharts and contact lists.
- Ensure SOPs are accessible remotely (with offline backups for critical procedures)
- Document training completion for all on-call personnel
- Confirm competency for anyone performing functions outside their usual role.
What auditors check: Evidence that staff responsible for regulated activities during disruptions are appropriately trained and competent.
Frequently Asked Questions
Q: What happens if we can’t meet a regulatory deadline because staff are on leave?
Regulatory deadlines are mandatory regardless of staffing. “Business closure” is not an acceptable reason for late reporting. Business continuity plans and deputy coverage are essential.
If you cannot meet a deadline due to circumstances beyond your control, document the situation thoroughly and contact the TGA proactively. However, plan to avoid this situation entirely.
Q: Does the TGA actually inspect business continuity and holiday preparedness?
Yes. Pharmacovigilance and quality system inspections include review of business continuity plans. Auditors assess whether your documented procedures function during disruptions and whether they have been tested. The Christmas period is the most predictable annual disruption. Failing to plan for it raises questions about the overall robustness of your system.
Q: How detailed should our holiday coverage roster be?
Document specific names, dates, and contact details. “Someone will be available” is not sufficient. Clearly indicate who is responsible for each function (QPPV duties, medical review, recall decisions, case intake monitoring) on each date. Include primary and backup contacts. Update this roster annually and file it in your QMS.
Technology and Vendor Management During Holidays
Q: What if our AI-enabled pharmacovigilance vendor has limited holiday support?
Your contract should address service levels and continuity. For critical functions, ensure you have documented manual procedures that can be activated. Regulators expect you to maintain pharmacovigilance obligations regardless of vendor availability. Dependency on external providers does not transfer your regulatory accountability.
Q: Can we use ChatGPT or public AI tools to help with case processing during staff shortages?
No. Do not place patient-identifiable or commercially confidential information into public AI tools, regardless of convenience. Use only contracted, validated systems with appropriate data handling agreements. Staff shortages do not justify shortcuts with patient privacy or data integrity.
Q: How do we prove to auditors that our holiday preparations are adequate?
Document everything: training records, competency assessments, BCP test results, contact rosters, system test evidence, and communication with vendors and distributors. When auditors review your pharmacovigilance or quality system, this documentation demonstrates you maintain control year-round—not just when the office is fully staffed.
Your Next Step: Run the Readiness Check
The checklist above works as an internal audit tool. Assign someone in your organisation to verify all 12 areas before December 20th. Document what you find. Fix gaps immediately or document mitigation plans if fixes take longer.
After the holiday period, conduct a short “lessons learned” review. What worked? What didn’t? What will you do differently next year? File this in your continuous improvement records.
If you need assistance in building inspection-ready business continuity plans or testing the readiness of your pharmacovigilance system, GxPVigilance can help. We align with TGA expectations and support sponsors in closing gaps before inspections.
References and Further Reading
- Therapeutic Goods Administration. Pharmacovigilance responsibilities of medicine sponsors. Australian regulatory guidelines.
- Therapeutic Goods Administration. Procedure for recalls, product alerts and product corrections.
- International Council for Harmonisation. ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
- Medsafe NZ Closure Time – Christmas
- Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers, Device Manufacturers, and Distributors. FDA
Content Disclosure
This content is provided for training and educational purposes to support Australian pharmaceutical sponsors and other staff in maintaining TGA compliance during holiday periods.
The content represents general guidance based on current regulatory requirements and industry best practices. It does not constitute specific advice for your organisation’s pharmacovigilance or quality systems.
For information pertaining to your specific system, regulatory obligations, or compliance requirements, contact the Therapeutic Goods Administration directly or reach out to GxPVigilance for tailored implementation support.