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Commission Implementing Regulation (EU) 2021/1280 CHAPTER VIII — SELF-INSPECTIONS AND FINAL PROVISIONS

Article 23–Article 24 · 2 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Self-inspections

Article 23

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1.   The persons referred to in Article 1(2) shall conduct and record self-inspections in order to monitor the implementation of and compliance with good distribution practice for active substances used as starting materials in veterinary medicinal products laid down in this Regulation. 2.   Regular self-inspections shall be performed in accordance with a schedule set out in the quality system. 3.   Self-inspections shall be conducted in an impartial and detailed way by designated competent company personnel. 4.   The results of all self-inspections shall be recorded. Reports shall contain all observations made during the inspection and be presented to the relevant personnel as well as management. 5.   Necessary CAPA shall be taken and the effectiveness of the CAPA shall be reviewed.

Entry into force

Article 24

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

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Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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