2024/875

22.3.2024

COMMISSION IMPLEMENTING REGULATION (EU) 2024/875

of 21 March 2024

adopting a list of abbreviations and pictograms common throughout the Union to be used on the packaging of veterinary medicinal products for the purposes of Article 10(2) and Article 11(3) of Regulation (EU) 2019/6 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 17(2) thereof,

Whereas:

(1) Articles 10 and 11 of Regulation (EU) 2019/6 set out the information to be contained on the labelling of the immediate packaging or on the outer packaging of veterinary medicinal products. Article 10(2) and Article 11(3) of that Regulation require this information to be easily legible and clearly comprehensible or to appear in abbreviations or pictograms common throughout the Union. In accordance with Article 17(2) of that Regulation, a list of abbreviations and pictograms common throughout the Union is to be adopted.

(2) The packaging of veterinary medicinal products is often small and therefore the label space is limited. The use of abbreviations and pictograms contributes to having all essential information contained on the label in a clear and readable format. The use of common abbreviations and pictograms should reduce the text on the labelling of veterinary medicinal products and facilitate the use of multilingual packaging.

(3) Uniform rules on abbreviations and pictograms common throughout the Union for use on the labelling of the immediate and outer packaging of veterinary medicinal products should reduce administrative burden and improve both the functioning of the internal market and the availability of veterinary medicinal products in the Union.

(4) In order to ensure a common understanding of abbreviations, the format and font used should be harmonised throughout the Union.

(5) Simple and clear pictograms should make labels easier to understand. In order to avoid any potential misunderstanding, the meaning of each pictogram used on the labelling of a veterinary medicinal product should be explained in full text in the package leaflet accompanying the veterinary medicinal product concerned.

(6) The proliferation of multiple pictograms for the same information should be avoided, in order not to create confusion for animal owners, animal keepers, veterinarians and retailers. Therefore, no other pictograms than those included in the Annexes to this Regulation should be used to replace the corresponding text as set out in the Annexes. Moreover, the colour in which pictograms are presented on the labelling should be harmonised.

(7) Pictograms should be clearly distinguishable and readable for animal owners, animal keepers, veterinarians and retailers. Therefore, common rules on how pictograms are to be displayed on the labelling of a veterinary medicinal product should be set.

(8) Veterinary medicinal products authorised before the date of application of this Regulation or which are subject to an ongoing application for a marketing authorisation on the date of application of this Regulation might contain abbreviations or pictograms that do not comply with the requirements of this Regulation. Therefore, to ensure the continued availability of those products it is necessary to provide for a transitional period during which they should be allowed to be placed on the market even if the pictograms and abbreviations used in their labelling do not comply with this Regulation.

(9) Applicants intending to submit an application either for marketing authorisation or for a variation would need sufficient time to adapt their applications to make them compliant with the provisions set in this Regulation. Therefore, this Regulation should apply 30 days after the date of entry into force.

(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Article 1

The abbreviations and pictograms set out in the Annexes to this Regulation may be used to replace the written information required on the labelling of immediate packaging and on the outer packaging of veterinary medicinal products referred to in Article 10(1) and Article 11(1) of Regulation (EU) 2019/6. No other abbreviations and pictograms than those listed in the Annexes to this Regulation shall be used to replace that written information.

Article 2

1.   The abbreviations and pictograms set out in the Annexes to this Regulation shall only be used to replace the corresponding text as set out in the Annexes. They shall not be used to replace any other information concerning the veterinary medicinal product.

2.   Abbreviations and pictograms used on the labelling of a veterinary medicinal product must be explained in full text in the package leaflet of the veterinary medicinal product concerned.

3.   Abbreviations shall be displayed in the same format as laid down in Annex I.

4.   Pictograms shall:

(a) be proportionate to the overall size of the labelling of immediate packaging or outer packaging of veterinary medicinal products;

(b) be presented in a sufficiently readable format;

(c) have a black symbol and no additional visual aspects such as shading;

(d) stand out clearly on the colour and presentation of the labelling of immediate packaging or outer packaging;

(e) not negatively affect the readability of the rest of the information on the labelling of immediate or outer packaging due to their location.

Article 3

Veterinary medicinal products authorised before 11 May 2024, or which are subject to an ongoing application for a marketing authorisation on the 11 May 2024, once authorised, may be placed on the market until 11 April 2029 even if the pictograms and abbreviations used in their labelling do not comply with this Regulation.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union

.

It shall apply from 11 May 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 21 March 2024.

For the Commission

The President

Ursula VON DER LEYEN

(1)  

OJ L 4, 7.1.2019, p. 43

, ELI: http://data.europa.eu/eli/reg/2019/6/oj.

ANNEX I

ABBREVIATIONS

When using abbreviations in accordance with Article 1 of this Regulation, the following abbreviations shall be used to replace the following routes of administration on the labelling of immediate packaging or on the outer packaging of veterinary medicinal products:

ANNEX II

PICTOGRAMS

When using pictograms in accordance with Article 1 of this Regulation, the pictograms included in this annex shall be used to replace the following particulars on the labelling of immediate packaging or on the outer packaging of veterinary medicinal products:

SECTION 1

Target species

SECTION 2

Storage conditions

ELI: http://data.europa.eu/eli/reg_impl/2024/875/oj

ISSN 1977-0677 (electronic edition)