QPPV Office
Appointing an experienced Qualified Person for Pharmacovigilance (QPPV), Local Person for Pharmacovigilance (LPPV), and deputy QPPV/LPPV can require considerable time and resources.
Although the requirements and responsibilities of a QPPV are specified in EU and UK legislation, LPPVs are subject to their own national legislation (e.g., the Graduated Plan Officer "Stufenplanbeauftragter" for Germany), which can also be daunting. As a global pharmacovigilance provider, ProPharma can advise you on the varied requirements for QPPVs and LPPVs to determine the services that will accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location.
Once you’ve identified your requirements, ProPharma can provide appropriately qualified and experienced QPPVs, LPPVs, and deputies globally. We have a world-wide network of QPPVs and LPPVs to serve you with their expertise from Europe to Australia and in more than 50 countries.
Role of the EU QPPV
Every Marketing Authorization Holder (MAH) in Europe has an obligation to establish a pharmacovigilance (PV) system for the fulfillment of PV tasks for its products. When setting up a PV system in Europe, the MAH must appoint an EU QPPV to establish and maintain the MAH’s PV system. In addition to the establishment and oversight of the PV system, the QPPV also has several legislative responsibilities.
Responsibilities of the EU QPPV include:
- Establish and maintain the MAH’s PV system
- Monitor the safety of the MAH’s drug products
- Coordinate actions to stay compliant with local legislation
- Serve as the 24/7 point of contact for Competent Authorities
- Conduct audits and inspections to ensure compliance with EU regulations
Role of an LPPV
In addition, many European and other countries legally require a Local Person for Pharmacovigilance (LPPV) at a country level who may report to the EU QPPV (e.g., for Germany a Stufenplanbeauftragter is required). Although the requirements and responsibilities of an EU QPPV are specified in EU legislation, LPPVs are subject to their own national legislation.
Some QPPVs may have their own network of LPPVs to help fulfill local requirements. As a global pharmacovigilance provider, ProPharma can advise you about the various important requirements for EU QPPVs and LPPVs, to ensure you have the right resources in place to fully comply with the regulations for your PV system in Europe.
Understanding Regional Requirements
There are many differences between national legislations, so when you market a product in multiple European countries, you need several LPPVs, all with their own requirements. Some examples are:
- Required: As you can see in the legislation, an LPPV seems optional (“may request…”, “provided with the option to…”). So, when setting up a pharmacovigilance system, the first question is: for which countries do we need an LPPV? Not all European countries actually require an LPPV. Some do require an LPPV, and others only recommend having one.
- Name: The LPPV may also go by different names. While most of them are more or less a translation of ‘local person for pharmacovigilance’ in the local language, for example German “Stufenplanbeauftragter” (“graduated plan officer”) is clearly not.
- Timing: It is also very important from what point in the process an LPPV is required. This may be either from marketing application, from marketing authorisation, or from first marketing, as often is the case. However, please make sure you know beforehand, so your LPPVs are appointed in time.
- Language and country: All countries require their LPPV to speak the local language(s), and many require that the LPPV resides in the country. If the EU QPPV resides in the country, he or she may also act as an LPPV, provided that he or she speaks the local language, but there may be exceptions to this, so you cannot always assume you do not need an LPPV if you already have a QPPV in that country.
- Education: Another difference is the requirements with regard to education. These range from none or not specified, to trained in PV, to medically qualified (basic medical training at academic level), to actually being a medical doctor or pharmacist.
- Availability: Some countries require their LPPVs to have 24/7 availability for authorities, and some do not, but may require a 24/7 availability for patients and health care professionals.
- Deputy: Finally, many countries also require a deputy LPPV, who acts as a backup when the LPPV is not available.
Through simple and scalable solutions, we provide tiered options and customized services to fit your needs. Contact us to learn more about our QPPV and LPPV services.
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