Commission Implementing Regulation (EU) No 520/2012 Article 17

Audit

Article 17

1. Risk-based audits of the quality system shall be performed at regular intervals according to a common methodology to ensure that the quality system complies with the requirements set out in Articles 8, 14, 15 and 16 and to ensure its effectiveness. 2. Corrective action, including a follow-up audit of deficiencies, shall be taken where necessary. The audit report shall be sent to the management responsible for the matters audited. The dates and results of audits and follow-up audits shall be documented.

Read the full instrument → · Read this in context: Section 3 — Minimum requirements for the quality systems for the performance of pharmacovigilance activities by national competent authorities and the Agency →

Other provisions in Section 3 — Minimum requirements for the quality systems for the performance of pharmacovigilance activities by national competent authorities and the Agency

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 17 of Commission Implementing Regulation (EU) No 520/2012 (LawPlayer, data as of 2026-07-04)

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