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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 33Outcome of the assessment
1.The competent authority or the Agency, as applicable, examining the application in accordance with Article 28, shall prepare, respectively, an assessment report or an opinion. In case of a favourable assessment, that assessment report or opinion shall include the following:
(a)a summary of the product characteristics containing the information laid down in Article 35;
(b)details of any conditions or restrictions to be imposed as regards the supply or safe and effective use of the veterinary medicinal product concerned, including the classification of a veterinary medicinal product in accordance with Article 34;
(c)the text of the labelling and package leaflet referred to in Articles 10 to 14.
2.In the case of an unfavourable assessment, the assessment report or the opinion referred to in paragraph 1 shall contain the justification for its conclusions.
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