Good Manufacturing Practice: Pharmacovigilance FAQs

Raised hand1. Does the MHRA perform searches to determine the number of companies for which a QP is acting as a Pharmacovigilance Qualified Person (QPPV)?
2. QPs named on Manufacturer’s/Importer’s Licences (MIAs) have rigorous suitability criteria which are assessed; are there similar criteria for Pharmacovigilance QPs?
3. Is it not too late if a QPPV is deemed unsuitable during an inspection. He/she may have been doing the job for some time?
4. Pharmacovigilance training is currently outside the scope of the current QP study guide. Should it be included?
5. Does the Pharmacovigilance Guideline cover safety data exchange agreements and product technical complaints?


1. Does the MHRA perform searches to determine the number of companies for which a QP is acting as a Pharmacovigilance qualified person (QPPV)?

This is not performed currently. Generally only one QPPV should be named per marketing authorisation holder (MAH). Sometimes one QPPV can perform pharmacovigilance duties for several MAHs, if a contractor. Sometimes one MAH can have 2 QPPVs if completely different pharmacovigilance systems are in place within the company. Further guidance is available in the Good Pharmacovigilance Practice Guide available from the Pharmaceutical Press.


2. QPs named on Manufacturer’s/Importer’s Licences (MIAs) have rigorous suitability criteria which are assessed; are there similar criteria for Pharmacovigilance QPs?

There is not the same assessment process for pharmacovigilance QPs, but the requirements for QPPVs are detailed in Volume 9A of the Rules Governing Medicinal Products in the European Union. As part of a marketing authorisation application (MAA) a company is required to provide proof that they have the services of a QPPV (a signed statement from the MAH and the QPPV) and to submit a summary CV and job description for the QPPV within the Detailed Description of the Pharmacovigilance System (DDPS). The DDPS is assessed during the licensing process, but the suitability of a QPPV is primarily assessed during on-site inspections.


3. Is it not too late if a QPPV is deemed unsuitable during an inspection. He/she may have been doing the job for some time?

Yes this can be an issue and findings have frequently been made in relation to failure of the MAH and/or QPPV to fulfil the roles and responsibilities of the QPPV. Questions can be raised at the time of assessment of the DDPS if the nominated QPPV is not deemed suitable.
4. Pharmacovigilance training is currently outside the scope of the current QP study guide. Should it be included?

Knowledge of pharmacovigilance systems and procedure is a good idea for new QPs and there should be a link with the QPPV on common areas such as customer complaints. QPs should be looking at basic pharmacovigilance training in their company, especially around complaints and adverse side effects. All personnel of the MAH should have an appropriate level of pharmacovigilance training such that any adverse events reported to the MAH are appropriately handled, as required by the pharmacovigilance legislation.


5. Does the Pharmacovigilance Guideline cover safety data exchange agreements and product technical complaints?

Yes both these topics are covered in the Good Pharmacovigilance Practice Guide.


Page last modified: 19 March 2010