- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
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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This legislation may since have been updated - see the latest available (revised) version
1.The immediate packaging of a veterinary medicinal product shall contain the following information and shall, subject to Article 11(4), contain no information other than:
(a)the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;
(b)a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;
(c)the batch number, preceded by the word ‘Lot’;
(d)the name or company name or logo name of the marketing authorisation holder;
(e)the target species;
(f)the expiry date, in the format: ‘mm/yyyy’, preceded by the abbreviation ‘Exp.’;
(g)special storage precautions, if any;
(h)route of administration; and
(i)if applicable, the withdrawal period, even if such period is zero.
2.The information referred to in paragraph 1 of this Article shall appear in easily legible and clearly comprehensible characters, or in abbreviations or pictograms common throughout the Union as listed in accordance with Article 17(2).
3.Notwithstanding paragraph 1, a Member State may decide that, on the immediate packaging of a veterinary medicinal product made available in its territory, an identification code shall be added to the information required under paragraph 1.
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