EMA has started to review the list of Chargeable Units

pv fees

EMA has started to review the list of Chargeable Units

As every year, European Medicines Agency (EMA) has started to review the list of Chargeable Units of the different holders in order to calculate the Pharmacovigilance Fee.

Holders should make a review of those lists to verify that the information held by EMA and the holders is the same, and therefore a correct fee is charged.

Many times, and due to the lack of review of the 3rd AcK by the holders, these lists are not correct, which means an investment of time and money to update EMA’s and the holder’s internal databases.

If you need support in reviewing the chargeable units lists, such as reviewing the 3rd AcK, please do not hesitate to contact our team at xevmpd@asphalion.com

Asphalion will be happy to help you!

COVID-19 impact on MDR | European Commission working to postpone MDR for 1-year
Exceptional measures applicable to clinical trials in Spain to manage problems arising from the COVID-19 emergency