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Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance)
- Recitals
CHAPTER I — Pharmacovigilance system master file- Article 1 — Structure of the pharmacovigilance system master file
- Article 2 — Content of the pharmacovigilance system master file
- Article 3 — Content of the Annex to the pharmacovigilance system master file
- Article 4 — Maintenance
- Article 5 — Form of the documents contained in the pharmacovigilance system master file
- Article 6 — Subcontracting
- Article 7 — Availability and location of the pharmacovigilance system master file
- CHAPTER II — Minimum requirements for the quality systems for the performance of pharmacovigilance activities
- Section 1 — General provisions
- Section 2 — Minimum requirements for the quality systems for the performance of pharmacovigilance activities by marketing authorisation holders
- Section 3 — Minimum requirements for the quality systems for the performance of pharmacovigilance activities by national competent authorities and the Agency
- CHAPTER III — Minimum requirements for the monitoring of data in the Eudravigilance database
- Article 18 — General requirements
- Article 19 — Identification of changed risks and new risks
- Article 20 — Methodology for determining the evidentiary value of a signal
- Article 21 — Signal management process
- Article 22 — Worksharing for signal management
- Article 23 — Signal detection support
- Article 24 — Signal detection audit trail
- CHAPTER IV — Use of terminology, formats and standards
- CHAPTER V — Transmission of reports of suspected adverse reactions
- CHAPTER VI — Risk management plans
- CHAPTER VII — Periodic safety update reports
- CHAPTER VIII — Post-authorisation safety studies
- CHAPTER IX — Final provisions
- Final
- ANNEX I — Risk management plans
- ANNEX II — Format of the electronic periodic safety update reports
- ANNEX III — Protocols, abstracts and final study reports for post-authorisation safety studies