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Commission Implementing Regulation (EU) 2025/2091 Article 20

Commission Implementing Regulation (EU) 2025/2091 Article 20

Documentation system

Article 20

1.   A documentation system that is adequate to achieve the objectives of the pharmaceutical quality system shall be established and maintained. 2.   The documentation system shall cover in a comprehensive matter the instructions and specifications as well as other documentation relevant to the pharmaceutical quality system and shall ensure that records of the activities which may, directly or indirectly, affect the quality of the veterinary medicinal products are kept. 3.   The content of documents shall be unambiguous and be kept up to date. 4.   Documentation may be kept in a variety of forms and the requirements set out in this Chapter are applicable irrespective of the form. Where electronic, photographic media, video recording or other data processing systems are used, the relevant systems shall be validated first to ensure that such systems are adequate to appropriately store the data during the required period of storage.

Read the full instrument → · Read this in context: CHAPTER V — DOCUMENTATION →

Other provisions in CHAPTER V — DOCUMENTATION

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 20 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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