Regulatory information – EMA provides advice notes on pharmacovigilance annual fees

20/04/2015

Marketing-authorisation holders are advised to liaise with their qualified persons for pharmacovigilance prior to invoicing in July 2015

The European Medicines Agency (EMA) has provided ‘advice notes’ on pharmacovigilance annual fees to the qualified persons for pharmacovigilance.

From 1 July 2015, EMA will charge and collect annual fees for pharmacovigilanceactivities for nationally authorised medicines.

These ‘advice notes’ contain the line listing of the chargeable units on which annual pharmacovigilance fees will be calculated. Their distribution today gives companies the opportunity to review and correct their product information held by EMA prior to invoicing in July 2015.

Marketing-authorisation holders are advised to check, together with their qualified persons for pharmacovigilance, that the line listing of the chargeable units contained in the advice notes is correct. Amendments and updates in the ‘Article 57 database’ should be made no later than 30 June 2015.

EMA has also published today a pharmacovigilance fees questions-and-answers (Q&A) page as well as a series of video tutorials on pharmacovigilance fees.

Any questions on the content of the advice note can be sent to EMA through a dedicated query form available on the Q&A webpage.