Judgment of the Court (First Chamber) of 17 March 2021

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2021:207
• Date: 17 March 2021
• Celex Number: 62020CJ0064
• Court: Court of Justice (European Union)

JUDGMENT OF THE COURT (First Chamber)

17 March 2021 (*)

(Reference for a preliminary ruling – Article 288 TFEU – Directive 2001/82/EC – Community code relating to veterinary medicinal products – Articles 58, 59 and 61 – Information to be provided on outer packaging, immediate packaging and the package leaflet for veterinary medicinal products – Obligation to provide information in all the official languages of the Member State in which the product is marketed – National legislation providing that the information may be provided in one or other of the official languages of the Member State – National court hearing an action for a declaration that the Member State had failed correctly to transpose Directive 2001/82/EC and that the competent national authorities must amend the national legislation)

In Case C‑64/20,

REQUEST for a preliminary ruling under Article 267 TFEU from the Ard-Chúirt (High Court, Ireland), made by decision of 20 January 2020, received at the Court on 6 February 2020, in the proceedings

UH

v

An tAire Talmhaíochta, Bia agus Mara,

Éire,

An tArd-Aighne,

THE COURT (First Chamber),

composed of J.-C. Bonichot, President of the Chamber, L. Bay Larsen, C. Toader, M. Safjan (Rapporteur) and N. Jääskinen, Judges,

Advocate General: M. Bobek,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

– UH, by D. Mac Cárthaigh, abhcóide, and S. Ó Tuathail, abhcóide sinsir,

– Ireland, by M. Browne, M. Teahan and A. Joyce, acting as Agents, assisted by C. Ó hOisín, abhcóide sinsir, and T. O’Malley, abhcóide,

– the Polish Government, by B. Majczyna, acting as Agent,

– the European Commission, by C. Cunniffe, L. Haasbeek and F. Erlbacher, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 14 January 2021,

gives the following

Judgment

1 This request for a preliminary ruling concerns the interpretation of Article 288 TFEU, and of Article 58(4), Article 59(3) and Article 61(1) of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1), as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p. 58) (‘Directive 2001/82’).

2 The request has been made in proceedings between UH and the Aire Talmhaíochta, Bia agus Mara, Éire (Minister for Agriculture, Food and Marine Affairs, Ireland), Éire (Ireland) and the Ard-Aighne (Attorney General, Ireland), concerning the compatibility with the language requirements laid down by Directive 2001/82 of the Irish legislation on the labelling and package leaflet of veterinary medicinal products.

Legal context

European Union law

Directive 2001/82

3 Title V of Directive 2001/82, entitled ‘Labelling and package insert’, includes, inter alia, Articles 58, 59 and 61 thereof.

4 Article 58(1) and (4) of that directive provides:

‘1. Except in the case of the medicinal products referred to in Article 17(1), the competent authority shall approve the immediate packaging and outer packaging of veterinary medicinal products. Packaging shall bear the following information, which shall conform with the particulars and documents provided pursuant to Articles 12 to 13d and the summary of product characteristics, and shall appear in legible characters:

(a) the name of the medicinal product, followed by its strength and pharmaceutical form; The common name shall appear if the product contains only one active substance and its name is an invented name.

(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 the common names;

(c) Manufacturer’s batch number;

(d) Marketing authorisation number;

(e) Name or corporate name and permanent address or registered place of business of the marketing authorisation holder and, where appropriate, of the representative designated by the marketing authorisation holder;

(f) The species of animal for which the veterinary medicinal product is intended; the method and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;

(g) The withdrawal period for veterinary medicinal products to be administered to food-producing species, for all the species concerned and for the various foodstuffs concerned (meat and offal, eggs, milk, honey), including those for which the withdrawal period is zero;

(h) Expiry date, in plain language;

(i) Special storage precautions, if any;

(j) Specific precautions relating to the disposal of unused medicinal products or waste derived from veterinary medicinal products, where appropriate, as well as a reference to any appropriate collection system in place;

(k) Particulars required to be indicated pursuant to Article 26(1), if any;

(l) The words ‘For animal treatment only’ or, in the case of the medicinal products referred to in Article 67, the words ‘For animal treatment only – to be supplied only on veterinary prescription’.

[…]

4. ‘The particulars mentioned in paragraph 1(f) to (l) shall appear on the outer package and on the container of the medicinal products in the language or languages of the country in which they are placed on the market.’

5 Article 59 of Directive 2001/82 provides:

‘1. As regards ampoules, the particulars listed in the first paragraph of Article 58(1) shall be given on the outer package. On the immediate packaging, however, only the following particulars shall be necessary:

– name of veterinary medicinal product,

– quantity of the active substances,

– route of administration,

– manufacturer’s batch number,

– date of expiry,

– the words ‘For animal treatment only’.

2. As regards small immediate packaging containing a single dose, other than ampoules, on which it is impossible to give the particulars mentioned in paragraph 1, the requirements of Article 58(1), (2) and (3) shall apply only to the outer package.

3. The particulars mentioned in the third and sixth indents of paragraph 1 shall appear on the outer package and on the immediate packaging of the medicinal products in the language or languages of the country in which they are placed on the market.’

6 Article 61(1) of that directive provides:

‘The inclusion of a package leaflet in the packaging of veterinary medicinal products shall be obligatory unless all the information required by this Article can be conveyed on the immediate packaging and the outer packaging...