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Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)
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Article 126Specific rules on pharmacovigilance inspections
1.The competent authorities and the Agency shall ensure that all pharmacovigilance system master files in the Union are regularly checked and that the pharmacovigilance systems are being correctly applied.
2.The Agency shall coordinate and the competent authorities shall carry out inspections on the pharmacovigilance systems of veterinary medicinal products authorised in accordance with Article 44.
3.The competent authorities shall carry out inspections on the pharmacovigilance systems of veterinary medicinal products authorised in accordance with Articles 47, 49, 52 and 53.
4.The competent authorities of the Member States in which the pharmacovigilance system master files are located shall carry out inspections of the pharmacovigilance systems master files.
5.Notwithstanding paragraph 4 of this Article and pursuant to Article 80, a competent authority may enter into any work-sharing initiatives and delegation of responsibilities with other competent authorities to avoid the duplication of inspections of pharmacovigilance systems.
6.The results of the pharmacovigilance inspections shall be recorded in the pharmacovigilance database as referred to in Article 74.
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