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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 82Scope of the Union interest referral
1.Where the interests of the Union are involved, and in particular the interests of public or animal health or of the environment related to the quality, safety or efficacy of veterinary medicinal products, the marketing authorisation holder, one or more of the competent authorities in one or more Member States or the Commission may refer its concern to the Agency for the application of the procedure laid down in Article 83. The matter of concern shall be clearly identified.
2.The marketing authorisation holder, the concerned competent authority or the Commission shall inform the other parties concerned accordingly.
3.The competent authorities in the Member States and marketing authorisation holders shall forward to the Agency on its request all available information relating to the Union interest referral.
4.The Agency may limit the Union interest referral to specific parts of the terms of the marketing authorisation.
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