Every marketing authorization holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products. When setting up a pharmacovigilance system in Europe, the Qualified Person for Pharmacovigilance (QPPV) is central to this system. However, many European countries also require a Local Person for Pharmacovigilance (LPPV) to report to the QPPV.
While the requirements and responsibilities of a QPPV are laid down in EU legislation (article 23 of regulation (EC) No 726/2004), LPPVs are subject to their own national legislation. In practice, this means that there are plenty of differences between requirements for LPPVs of different countries. Not only in Europe, but also in the rest of the world, where other legislations may apply. In this blog, I will, however, focus on Europe.
Guidance from Legislation
EU legislation is not entirely silent about LPPVs. In Directive 2010/84/EU amending Directive 2001/83/EC, Article 104 says:
“4. Notwithstanding the provisions of paragraph 3, national competent authorities may request the nomination of a contact person for pharmacovigilance issues at national level reporting to the qualified person responsible for pharmacovigilance activities.”
GVP (Guideline on Good Pharmacovigilance Practices) Module I says something similar in section I.C.1.1.:
“In addition to the QPPV, competent authorities in Member States are legally provided with the option to request the nomination of a pharmacovigilance contact person at national level reporting to the QPPV. Reporting in this context relates to pharmacovigilance tasks and responsibilities and not necessarily to line management. A contact person at national level may also be nominated as the QPPV.”
So, the detailed requirements for different LPPVs for different countries must be found in their national legislation. Of course, it may be challenging for an MAH to examine all local laws. I would like to give you a rough idea of some of the differences.
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.
For all marketing authorization holders, it is essential to have a functional PV system in place, which is also organized by having the right LPPVs in the right place at the right time.
Unfortunately, due to the national differences, this is not as straightforward as it seems. So it is essential to gain knowledge well before your products actually enter the market. If you need support, contact the team at ProPharma today.