The truth serum for PV systems in Germany

Latest update: Deadline postponed to end of April 2020

20.03.2020 Due to the obstacles caused by the COVID-19 pandemic, BfArM and PEI have postponed the deadline for submission of the PV Questionnaire to 30.04.2020. Originally it was planned that all pharmaceutical companies with marketing authorisations in Germany should have submitted the answers to the questionnaire by 5 April 2020 at the latest. The official notification of the extension can be found here.

Survey helps BfArM to plan PV inspection priorities

Monday, 20th January 2020 14:43 MET: EU-QPPVs and Stufenplanbeauftragte of pharmaceutical companies holding Marketing Authorisations in Germany receive an email. Sent from BfArM and PEI.

Subject: Questionnaire for risk-based PV inspections

What had happened? BfArM (Federal Institute for Drugs and Medical Devices) and PEI (Paul-Ehrlich-Institut) decided in late 2019 to send out a Questionnaire to all Marketing Authorisation Holders to enquire about risk-based pharmacovigilance inspections.

The aim of this survey – according to BfArM – is to plan pharmacovigilance (PV) inspections on a risk-based approach and to determine the extent of PV activities taking place at the Marketing Authorisation Holders. The survey consists of 20 questions to be filled into an online form. MA Holders are asked to complete the survey not later than 5^th April 2020.

And as with any new obligation communicated by the drug authorities, Marketing Authorisation Holders are asking themselves, “Do I really have to spend my time on this survey, and do I have any benefit from this PV Questionnaire?”

The short answer? Absolutely. The longer answer? Read on to find out how.

However, from the legal point of view this survey is not mandatory and no MAH is obliged to reply. That is why in their email the agencies politely ask for the companies´ cooperation. On the other hand, what does a non-reply tell about the QPPV´s oversight and the probable status of the PV system?

Why is this survey BfArM´s best gambit to improve Pharmacovigilance in Germany?

Marketing Authorisation Holders are obliged to run an effective pharmacovigilance system whenever they have registered drug licenses (marketing authorisations). They establish a quality system to guarantee the effectiveness of the PV system and notify a responsible person to the drug authorities. However, as long as the PV system has not been inspected by the authorities, companies might shun the procedural and financial challenges of a fully compliant pharmacovigilance system.

This widely applied approach now turns out to become even more risky, as BfArM´s PV questionnaire asks directly for the most critical processes for PV performance.

While in the past BfArM was only able to inspect a few MA Holders, now inspectors, by analysing these new survey data, will see immediately which companies might have systematic safety problems and should be inspected first.

The trickiest question in the PV questionnaire for small MA Holders

In my view the most crucial question – especially for small companies – is number 14, where BfArM asks for the number of full-time equivalents working in pharmacovigilance in reference to the EU PSMF. This question is the truth serum and BfArM can estimate easily if the company (and/or its PV service provider) is able to run a pharmacovigilance system appropriately.

BfArM expects MA Holders to provide enough personnel for pharmacovigilance, regardless of the size of the company or the profit which the MAH earned with his medicines.

What should Marketing Authorisation Holders do?

MAHs should take the BfArM survey seriously and go through their PV system as if they were facing a mini PV inspection. If necessary, update the formal requirements, e.g. Art. 57 database entries of the organisation, the master file location, QPPV and products.

Screen your PSMF for required updates: are there any changes in the procedures, in the responsibilities, in the products or in any other annexes? Update the PSMF.

If you are working with partner companies (e.g. distributors) or any PV-related service providers, make sure that these are mentioned in the relevant PSMF annexes. Are the lists complete?

What MAHs located outside of Germany need to know

MAHs are obliged to notify a commissioner for the graduated plan (also called Graduated Plan Officer, in German “Stufenplanbeauftragter”) to BfArM. In Germany the “Stufenplanbeauftragter” is not only responsible for Pharmacovigilance but is also involved in handling quality complaints and recalls. This requirement is established in the German Drug Law.

If an MAH from outside of Germany sells pharmaceutical products in Germany, the “Stufenplanbeauftragter” can be established with an affiliate in Germany or with a distributor. However, it is important that all PV processes are clearly described, the “Stufenplanbeauftragter” is well-informed and has adequate oversight and a Safety Data Exchange Agreement between the parties is in place .

At the end of the day BfArM will ask the “Stufenplanbeauftragter” to explain and defend the PV system of the MAH. BfArM inspectors are less interested to speak to the EU QPPV. Please don´t leave your “Stufenplanbeauftragter” out in the rain and give him all the information he needs to fulfill the requirement of oversight.

Which question of the survey is most challenging for you?

Have you already gotten through a BfArM Pharmacovigilance inspection?