Implementing Regulations on veterinary medicinal products

New Implementing Regulations on veterinary medicinal products

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 (VMP-Regulation) is in force in the EU since 28.01.2022. However, the provisions of this Regulation has to be further elaborated in tertiary legislative acts.

The two Implementing Regulations in question here reduce the administrative burden, improve the functioning of the internal market and increase the availability of veterinary medicinal products through various labelling aspects.

II. Implementing Regulation (EU) 2024/875

Implementing Regulation (EU) 2024/875 based on Art. 17 para. 2 VMP-Regulation serves to further specify Art. 10 para. 2 and Art. 11 para. 3 VMP-Regulation with regard to the labelling of immediate packaging of veterinary medicinal products. According to Art. 4 No. 25 VMP-Regulation, an immediate packaging is “the container or any other form of packaging that is in direct contact with the veterinary medicinal product”. While Art. 10 para. 1 VMP-Regulation specifies the contents permitted on the immediate packaging, Art. 10 para. 2 VMP-Regulation regulates the form of labelling. Labelling using abbreviations and pictograms is limited to those commonly used throughout the EU and contained in a list based on Art. 17 para. 2 VMP-Regulation in order to create transparency and avoid misunderstandings.

The same regulatory structure is also contained in Art. 11 Para. 2 VMP-Regulation for the outer packaging of veterinary medicinal products, i.e. “packaging in which the immediate packaging is placed” (Art. 4 No. 26 TAM Regulation). For example, a blister containing tablets is the immediate packaging and the cardboard box in which the blister is contained is the outer packaging.

The abbreviations and pictograms are only intended as an option to replace (complete) written information, but do not have to be used if corresponding written instructions are provided.

However, when using the abbreviations and pictograms from Annexes I and II of Implementing Regulation (EU) 2024/875, the following additional, formal requirements from Articles 1 and 2 of Implementing Regulation (EU) 2024/875 must be observed:

  • No abbreviations and pictograms other than those contained in the appendices may be used.
  • Abbreviations and pictograms must be used as in the annexes and may only replace the texts specifically mentioned there.
  • The meaning of abbreviations and pictograms used must be explained in full in the enclosed package leaflet.
  • The pictograms must be used in black colour without additional visual design elements (such as shading).
  • The pictograms must stand out clearly from the rest of the packaging but must not have a negative impact on the legibility of the other labelling.

The following abbreviations of the routes of administration are provided in Annex I: i.m. = intramuscular, i.v. = intravenous and s.c. = subcutaneous.

The permitted pictograms are divided into two sections in Annex II and enable the graphic representation of different target animal species on the one hand and a standardised symbol for the storage notice ‘Store in a refrigerator’ on the other.

Finally, the Implementing Regulation (EU) 2024/875 applies from 11.05.2024 with all the restrictions on the use of abbreviations and pictograms mentioned. However, since the packaging design is the subject of the authorisation of a veterinary medicinal product and veterinary medicinal products with other abbreviations and pictograms on the immediate packaging and outer packaging may also have been authorised in the past, a transitional period is provided for in Art. 3 of Implementing Regulation (EU) 2024/875. Accordingly, all veterinary medicinal products no longer labelled with legally compliant abbreviations and pictograms that were authorised before 11.05.2024 or are already in the authorisation process on this date may continue to be placed on the market until 11.04.2029. By then at the latest, however, all authorisation holders, including those with old authorisations, must make a corresponding change to the labelling and also apply for a change to the authorisation.

III. Implementing Regulation (EU) 2024/878

The second Implementing Regulation (EU) 2024/878 establishes standardised criteria under which primary packaging can be regarded as ‘small immediate packaging units’ within the meaning of Art. 12 VMP-Regulation, is based on Art. 17 Art. 3 VMP-Regulation. A clear definition of the relevant size criteria in this context is important because Art. 12 para. 1 VMP-Regulation significantly restricts the mandatory information required on small primary packaging units compared to the otherwise required mandatory information for primary packaging under Art. 10 VMP-Regulation. However, in accordance with Art. 12 para. 2 VMP-Regulation, an outer packaging with all mandatory information from Art. 11 VMP-Regulation must be present when using this privilege.

Art. 1 of Implementing Regulation (EU) 2024/878 defines the following types of immediate packaging as small immediate packaging units within the meaning of Art. 12 VMP-Regulation:

  • Blister packs and strips
  • Ampoules and other single-dose containers
  • Packaging with a nominal volume of up to 50 ml with a further exemption option for multilingual immediate packaging units for the authorities of the Member States and the EU Commission (as part of the authorisation procedure) up to a nominal volume of 100 ml for prescription-only veterinary medicinal products within the meaning of Art. 34 TAM Regulation.

In this context, Art. 2 of Implementing Regulation (EU) 2024/878 also provides for a transitional period for veterinary medicinal products already authorised or in the process of being authorised as of 11.05.2024. These may still be placed on the market until 11.04.2031 within the scope of the authorisation granted, even if their primary packaging was or is classified and handled as small primary packaging units contrary to the requirements of the new Implementing Regulation. The requirements of the Implementing Regulation (EU) 2024/878 apply without restriction to all new applications for authorisation from 11.05.2024.

Do you have any questions about this news or would you like to discuss it with the author? Please contact: Dr. Boris Handorn

6. May 2024 Dr. Boris Handorn