📜 In May 2024, the European Medicines Agency (EMA) updated the requirements for the appointment of national pharmacovigilance contact persons in the EU: 4.a H Survey – pharmacovigilance contact person at national level_H
In short: every EU country has its own peculiarities when it comes to qualifications, nominations and responsibilities.
But let’s be honest: who is supposed to be able to see through this? 🤯
For many Marketing Authorization Holders (MAH), the question also arises:
Do I need a local contact person in every EU country? How do I implement this efficiently and compliantly?
💡 Don’t worry – we won’t leave you alone with this! Our DREHM solutions shed light on the regulatory jungle:
✅ We help you understand the regulatory requirements per country and find suitable solutions – from partner selection to qualification.
✅ Local literature search in every EU country? We do it – with a magnifying glass and passion.
✅ And in the Czech Republic and Slovakia, our experts Lucie Otahalova and Erika Vykouk are available to you as local PV contacts – directly via our branch office in Prague.
Feel free to contact us for an initial consultation or a non-binding offer at contact@drehm.at