2013/0222(COD)COM(2013)472

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Stage: No longer in force
Procedure: Regulation · Ordinary legislative procedure
Last activity: 17 Jul 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 Delegated Regulation (EU) 2022/1520	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.

8 documents

Documents

Newest first. Each opens at its source.

Report · A7-0476/2013Parliament
Proposal · COM(2019)0439Commission
Text adopted · OJ L 189 27.06.2014, p. 0112Commission
Report · PE519.514Parliament
Amendments · PE523.004Parliament
Text adopted · Regulation 2014/0658Commission
Text adopted · SP(2014)471Parliament
Text adopted · T7-0438/2014Parliament

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.

What the workspace adds on this file

Everything above is the public record. In the workspace, subscribers see this file with their own layer on top.

Why it matters to you

What this file means for your organization, assessed against your own priorities.

What moved

When this file moves, it reaches your own briefing, with a link to its source.

Your contacts on it

Your team's contacts logged against this file: who you met, what was said and the next step.

A first draft

A statement, a member update or a meeting brief on this file, in your organization's voice, with its sources.

Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 30 Sept 2026. Something wrong on this page? Report an error.

Request access

See this file with your own layer on top: why it matters to you, your contacts on it and a first draft. We’ll schedule a 20-minute walkthrough.

Hosted in the EU · Security →

By submitting, you agree to our privacy policy.