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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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PART 3
The provisions of Part 3 shall apply to the simplified registration of homeopathic veterinary medicinal products referred to in Article 17(1) of this Directive with the following specification, without prejudice to the provisions of Regulation (EEC) No 2377/90 for substances included in the homeopathic stocks intended for administration to food-producing animal species.
Any missing information must be justified, e.g. justification must be given why demonstration of an acceptable level of safety can be supported although some studies are lacking.
(1)
This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.
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