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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)

article  134

CELEX:  02019R0006-20220128

Prohibiting the supply of veterinary medicinal products
1. In the event of a risk to public or animal health or to the environment, the competent authority or, in the case of centrally authorised veterinary medicinal products, the Commission, shall prohibit the supply of a veterinary medicinal product and require the marketing authorisation holder or suppliers to cease the supply or recall of the veterinary medicinal product from the market if any of the following conditions apply:
(a) the benefit-risk balance of the veterinary medicinal product is no longer positive;
(b) the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the summary of the product characteristics referred to in Article 35;
(c) the recommended withdrawal period is insufficient to ensure food safety;
(d) the control tests referred to in Article 127(1) have not been carried out; or (e) the incorrect labelling might lead to a serious risk to animal or public health.
2. The competent authorities or the Commission may confine the prohibition on supply and recall from the market solely to the contested production batches of the veterinary medicinal product concerned.