Every company holding a NAFDAC Certificate of Registration for a medicinal product must have a Qualified Person for Pharmacovigilance (QPPV) permanently and continuously at its disposal, and NAFDAC's guidelines state that the QPPV should reside and operate in Nigeria. The QPPV is responsible for establishing and maintaining the company's pharmacovigilance system, needs real authority over it, must have a documented deputy, and acts as NAFDAC's single pharmacovigilance contact point on a 24 hour basis. A regional or head office safety contact outside Nigeria does not meet the requirement.
What is a QPPV?
A Qualified Person for Pharmacovigilance is the named individual responsible for a company's pharmacovigilance system: the structures, procedures and people that collect, assess, report and act on safety information about its products. In Nigeria the requirement comes from NAFDAC's Good Pharmacovigilance Practice Regulations and is set out in detail in the NAFDAC Good Pharmacovigilance Practice Guidelines. MedNova's glossary entry on Good Pharmacovigilance Practice gives the wider context, and our complete guide to pharmacovigilance in Nigeria explains how the QPPV fits into the whole system.
The role is not a job title for whoever handles side effect emails. It is a position of accountability, and NAFDAC defines what the company must give the QPPV for that accountability to be real.
Registration is only the beginning
For many manufacturers, entering Nigeria starts with product registration: a dossier is prepared, documents are submitted, and the company works towards its Certificate of Registration. But registration is not the end of regulatory responsibility. Once a medicine is imported, distributed, prescribed and used by patients, the company's obligations expand into post marketing safety, and the QPPV is at the centre of them.
NAFDAC requires the Pharmacovigilance System Master File, which records the QPPV's details, to be submitted with the application for a Certificate of Registration. Our NAFDAC product registration guide and market entry and compliance overview cover the registration side.
What NAFDAC requires of the QPPV
Residency and availability
The Certificate of Registration Holder must have an appropriately qualified QPPV permanently and continuously at its disposal, and NAFDAC's guidelines state that the QPPV should reside and operate in Nigeria. Permanently and continuously means the role cannot lapse during leave, travel or a vacancy. The company must submit the QPPV's name and contact details to NAFDAC.
Deputy and back-up arrangements
Back-up procedures must be in place for the QPPV's absence and must be reachable through the QPPV's contact details. The QPPV must make sure the back-up person holds all the information needed to act.
Authority over the system
The company must give the QPPV sufficient authority to influence the performance of the quality system and the pharmacovigilance activities, and to promote, maintain and improve compliance. The QPPV must have access to, and authority over, the Pharmacovigilance System Master File, be notified of changes to it, and be able to implement changes to the system and give input into risk management plans and regulatory action on emerging safety concerns.
Access to information at any time
The company must have mechanisms so the QPPV receives all relevant safety information, including from contractual partners. It must also have a procedure that lets the QPPV obtain information from the safety database at any time, including outside normal working hours, to respond to urgent requests from NAFDAC.
The 24-hour contact point
The QPPV acts as the single pharmacovigilance contact point for NAFDAC on a 24 hour basis, and as the contact point for pharmacovigilance inspections. The QPPV is also responsible for full and prompt responses to Agency requests for information needed to evaluate a product's benefits and risks.
Documentation of the role
The QPPV's duties must be defined in a job description, and the QPPV's position must be shown on an organisational chart alongside other managerial and supervisory staff. The QPPV's details, summary curriculum vitae, contact details and back-up arrangements must be recorded in the master file, together with a list of any tasks the QPPV has delegated.
One QPPV per system
Each pharmacovigilance system can have only one QPPV. One QPPV may serve more than one company, or more than one system within a company, provided the QPPV can fulfil all obligations for each.
Qualifications and training
NAFDAC expects the QPPV to have skills in managing pharmacovigilance systems, plus expertise, or access to expertise, in relevant areas such as medicine, pharmaceutical sciences, epidemiology and biostatistics. The company must train the QPPV in its own pharmacovigilance system before the QPPV takes up the position, document that training, and consider further training on the products covered.
Competence matters in practice as well as on paper. A 2018 situational analysis of pharmacovigilance in Nigeria, prepared with NAFDAC, recorded the Agency's concern about the pharmacovigilance competence of some QPPVs appointed by marketing authorisation holders.
What the QPPV is responsible for
NAFDAC's guidelines list the QPPV's responsibilities for the products covered by the system. In summary, the QPPV must:
- Have an overview of each product's safety profile and any emerging safety concerns
- Know the conditions and commitments attached to each Certificate of Registration
- Know the risk minimisation measures in place
- Be involved in reviewing and signing off post authorisation safety study protocols
- Provide input into risk management plans
- Ensure pharmacovigilance is conducted, and documents submitted, in line with legal requirements
- Ensure the quality, correctness and completeness of data submitted to NAFDAC
- Respond fully and promptly to Agency requests
- Provide input into regulatory action on emerging safety concerns, such as variations, urgent safety restrictions and safety communications
- Oversee the quality system, including procedures, contracts, database operations, reporting compliance, audits and training
The QPPV may delegate specific tasks to qualified, trained people under supervision, as long as the QPPV keeps oversight of the whole system and the delegation is documented.
Why foreign companies need local QPPV support
Foreign manufacturers often have strong global safety systems. Those systems still need local implementation. A global safety department may understand its internal reporting rules but not the practical realities of Nigerian distribution, local partner behaviour, documentation gaps or communication routes with NAFDAC.
Local QPPV support bridges global standards and Nigeria's operating environment. It meets the residency requirement, gives NAFDAC a reachable contact, captures safety information from Nigerian sources that a distant team would miss, and keeps the Nigerian master file accurate.
That last point matters more each year. After the Med Safety App was introduced, reports in Nigeria's national system rose:
NAFDAC increasingly sees cases first, and a company without a working local contact may learn about its own safety issues from the regulator.
In-house or outsourced QPPV
NAFDAC allows companies to subcontract pharmacovigilance activities, including the QPPV role. The QPPV's details aligned to a product may be those of a contract QPPV rather than an employee. Three rules apply:
A written contract
The arrangement must be governed by a detailed written contract describing each party's responsibilities.
Recorded in the master file
The delegated activities must be described in the master file, with the contract listed in its annex.
Responsibility stays with you
The company keeps full responsibility for the pharmacovigilance system, and the service provider may itself be inspected.
Outsourcing moves the work, never the accountability. Our QPPV Support Essentials guidance covers oversight of an outsourced QPPV, and our guide to choosing between an in-house and outsourced QPPV compares the two models side by side.
QPPV and regulatory affairs are one conversation
In many companies, pharmacovigilance and regulatory affairs sit in separate teams. In practice they are linked. A safety issue may require a variation and updated product information. A renewal may require evidence that post marketing obligations are being met. An acquisition brings products with their own safety history, and NAFDAC's guidelines say the QPPV should be told as early as possible in due diligence. When the QPPV and the regulatory team work from the same plan, changes move faster and fewer obligations fall between the two.
What NAFDAC looks for at inspection
NAFDAC may inspect a company's pharmacovigilance system at any time. On the QPPV, an inspector will typically expect to see:
QPPV inspection evidence
- The QPPV appointment and NAFDAC notification
- Evidence that the QPPV resides and operates in Nigeria
- A job description and an organisational chart showing the QPPV's position
- Deputy arrangements, and evidence the deputy is trained
- A tested procedure for out of hours access to safety data
- QPPV training records
- A log of delegated tasks
- Evidence the QPPV reviews audit findings and corrective action plans
- A current master file that reflects the system the QPPV actually oversees
Our PV Readiness Guide covers inspection preparation, and our breakdown of GVP compliance in Nigeria sets out the full system the QPPV oversees.
Who should consider local QPPV support
- Foreign manufacturers entering the Nigerian market
- Marketing Authorisation Holders with products already registered in Nigeria
- Importers and distributors managing several brands
- Companies preparing renewals or variations
- Companies whose QPPV is based outside Nigeria, has no deputy, or has left
- Companies expanding their portfolio through new products or acquisitions
The earlier the arrangement is in place, the better. Fixing a QPPV gap after a safety issue or an inspection notice is more expensive, more stressful and more damaging than preparing properly from the start.
To check where you stand, apply the NAFDAC QPPV Compliance Checklist (also available as a downloadable PDF), or take the free MedNova PV readiness assessment for an instant readiness score.
Take the PV Readiness AssessmentFrequently asked questions
Does every NAFDAC registered company need a QPPV?
A Certificate of Registration Holder for medicinal products must have an appropriately qualified QPPV permanently and continuously at its disposal. Companies should confirm how the requirement applies to their product categories against the current NAFDAC regulations.
Does the QPPV have to live in Nigeria?
Yes. NAFDAC's guidelines state that the QPPV should reside and operate in Nigeria. A safety contact based outside Nigeria does not meet the requirement.
Can a company outsource its QPPV in Nigeria?
Yes. NAFDAC allows subcontracting, including of the QPPV role, under a detailed written contract described in the master file. The company keeps full responsibility for its pharmacovigilance system.
Can one QPPV serve several companies?
Yes, provided the QPPV can fulfil all obligations for each system. Each pharmacovigilance system can have only one QPPV.
Does the QPPV need a deputy?
Yes. Back-up procedures for the QPPV's absence must be in place and reachable through the QPPV's contact details, and the back-up person must have the information needed to act.
What qualifications should a QPPV have?
Skills in managing pharmacovigilance systems, and expertise or access to expertise in areas such as medicine, pharmaceutical sciences, epidemiology and biostatistics. The company must also train the QPPV in its own system before the QPPV starts.
What does the QPPV do?
The QPPV establishes and maintains the pharmacovigilance system, oversees product safety profiles, ensures reporting quality and compliance, responds to NAFDAC, contributes to risk management and regulatory safety action, and acts as NAFDAC's 24 hour contact point.
Must NAFDAC be told who the QPPV is?
Yes. The company must submit the QPPV's name and contact details to NAFDAC, and the QPPV's details must be recorded in the Pharmacovigilance System Master File.
Does the QPPV need access to safety data outside office hours?
Yes. The company must have a procedure that lets the QPPV obtain information from the safety database at any time, including outside normal working hours.
What happens if the QPPV leaves?
The role must stay covered permanently and continuously, so deputy arrangements must take over while a replacement is appointed. A new QPPV should accept the transfer of responsibility in writing, and NAFDAC and the master file must be updated.
Is the QPPV involved in acquisitions and partnerships?
Yes. NAFDAC's guidelines say the QPPV should be notified as early as possible in due diligence and involved in preparing contracts that affect the pharmacovigilance system.
How MedNova supports QPPV and pharmacovigilance readiness
MedNova Lifesciences provides local QPPV representation in Nigeria as part of its pharmacovigilance services: QPPV and deputy cover, pharmacovigilance system setup and SOPs, case processing and reporting, signal detection and risk management, distributor and partner safety oversight, and inspection readiness. Because we also provide regulatory affairs support and training and consulting, safety and regulatory work run as one plan. See our capability statement.
Related reading: NAFDAC pharmacovigilance requirements, signal detection in pharmacovigilance, what happens after you report an adverse event to NAFDAC, ICH guidelines compared with NAFDAC requirements, what the African Medicines Agency means for NAFDAC registered companies, and the adverse drug reaction glossary entry. Browse the resources library.
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Contact our team to identify gaps, clarify responsibilities and strengthen your local safety operating model in Nigeria.
Contact our team Take the PV Readiness AssessmentRelated resources
References
- National Agency for Food and Drug Administration and Control. NAFDAC Good Pharmacovigilance Practice Guidelines (Doc. Ref. PV/PMS-GDL-017-01).
- National Agency for Food and Drug Administration and Control. Good Pharmacovigilance Practice Regulations, 2021.
- National Agency for Food and Drug Administration and Control. Pharmacovigilance and Post Market Surveillance Guidelines index. Use this page to confirm the current edition of any NAFDAC document referenced above.
- KNCV Tuberculosis Foundation, NAFDAC and partners. Pharmacovigilance in Nigeria: a situational analysis at the start of the PAVIA project, 2018.
- Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria. Pharmaceutical Medicine, 2024. PubMed record 38705932.