EMA Pharmacovigilance Fees Regulation

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use

Stage: In force
Procedure: Regulation
Last activity: 15 May 2014

5 acts

Delegated and implementing acts beneath it

By status: 5 published.

Act	Kind	Status	Adoption
Commission Delegated Regulation (EU) 2023/1766	Delegated · Regulation	Published	Q3 2023
Commission Implementing Regulation (EU) 2021/966	Delegated · Regulation	Published	Q3 2022
Commission Delegated Regulation (EU) 2020/1431	Delegated · Regulation	Published	Q3 2020
Commission Delegated Regulation (EU) 2018/1298	Delegated · Regulation	Published	Q2 2018
Commission Delegated Regulation (EU) 2018/92	Delegated · Regulation	Published	18/10/2017

Titles link to EUR-Lex where the act has been published.

Summary

Generated

Regulation (EU) 658/2014 sets EMA fees for pharmacovigilance activities on human medicines, covering PSUR assessments, post-authorisation safety studies, referral procedures, and an annual fee for IT systems and literature monitoring. It applies to marketing authorisation holders, with micro enterprises exempt and SMEs eligible for reductions.

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Sources: EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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