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Commission Implementing Regulation (EU) 2025/2091 Article 7

Commission Implementing Regulation (EU) 2025/2091 Article 7

Self-inspection

Article 7

1.   Self-inspections shall be conducted to monitor the implementation of the arrangements regarding personnel, premises, equipment, documentation, production, quality control, batch release and arrangements to deal with quality-related complaints and recalls with the aim of verifying the suitability thereof to ensure that the veterinary medicinal products meet the required quality standards, and comply with the terms of the marketing authorisation and with good manufacturing practice. 2.   Self-inspections shall be conducted at pre-defined intervals by individuals not involved in the audited activities. 3.   Self-inspections shall be recorded. Reports shall include the observations made and, where applicable, proposals for corrective measures. The actions subsequently taken shall also be recorded.

Read the full instrument → · Read this in context: CHAPTER II — PHARMACEUTICAL QUALITY SYSTEM →

Other provisions in CHAPTER II — PHARMACEUTICAL QUALITY SYSTEM

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 7 of Commission Implementing Regulation (EU) 2025/2091 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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