Health and food safety

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Veterinary medicines

Overall state of play:

Commission proposal adopted on 10 September 2014, COM(2014) 558
Legal act adopted on 11 December 2018, Regulation (EU) 2019/6;
Application on 28 January 2022

State of play, main conclusions, outlook

The implementation of the following measures should significantly reduce the administrative burdens on the industry and bring savings for the competent national authorities:

• measures to simplify the requirements regarding packaging and labelling;

• variations procedures;

• pharmacovigilance;

• streamlining of the mutual recognition procedure;

• changes to the system of use where there are no veterinary medicines authorised or available for an animal species or for an indication;

• harmonisation of "legacy" products (products that are already on the market in the EU).

Extending the period of data protection for veterinary medicines should stimulate innovation and consequently improve the availability of novel veterinary medicines, including antimicrobials and medicines for limited markets.

It is also expected that overall these measures would free resources from the pharmaceutical industry for re-investment in new product development, therefore indirectly having a positive effect on the availability of novel medicines for companion and farmed animals.

Estimated savings and benefits

The impact assessment showed that the main savings will originate from the activities with the highest administrative burden i.e. packaging and labelling; authorisations, renewals and variations to existing marketing authorisations and pharmacovigilance reporting. The existing administrative burden of EUR 537 mio should be substantially reduced. In line with the impact assessment, the total estimated savings would amount to at least EUR 145 mio a year.

The savings estimated at the time of the impact assessment have not been updated after the adoption of the Regulation. However no major changes in these estimates are anticipated.

State of Play:

COM(2014) 558, adopted by the Commission on 10 September 2014

Which objective(s) does the Commission pursue?

The revision of the legislative framework on veterinary medicines aimed at:

• reducing administrative burdens to business for placing and maintaining on the market of veterinary medicines,

• providing better rewards for innovative products,

• improving the functioning of the internal market and increasing the availability of veterinary medicines for animals,

• facilitating internet retail of veterinary medicines across the Union,

• responding to the problem of antimicrobial resistance by allowing to restrict or refuse marketing authorisations and reserve certain critical antimicrobials for use in human medicine only.

SMEs would benefit from the overall simplification measures and in particular from the harmonisation of clinical trials for veterinary medicines.

Estimated savings and benefits

The value of the existing annual administrative burden in million Euros by activity (baseline: 2009) is the following: Packaging and labelling (184); New Marketing authorisation (MA) (91); Variations (134); Renewing a MA (70) and Pharmacovigilance (59).

The new provisions should reduce significantly these amounts: A risk-based pharmacovigilance system would allow a reduction of administrative burdens of around EUR 47 mio per year. The deletion of the requirement for renewal would allow savings of EUR 68 mio per year and the review of the procedures for variations savings of EUR 11 mio per year.

State of Play:

Legal act adopted on 11 December 2018, Regulation (EU) 2019/6
Application on 28 January 2022

Outcome of Legislative Procedure

The simplification provisions proposed for packaging and labelling, clinical trials, pharmacovigilance system, variation requirements, application requirements for limited markets were maintained. The proposal for deletion of the requirement for renewal of marketing authorisations and the sunset clause were as well retained by the co-legislators.

As regards SMEs, it is still foreseen that Member States should take appropriate measures to advise small and medium-sized enterprises.

However, the proposals to simplify the marketing authorisation procedures and the harmonisation of summary product characteristics (SPCs) were retained only to some extent.

The legal tools to address the risks of antimicrobial resistance were strengthened by the co-legislators, including for example specific rules on the use of antimicrobials in animals, limited validity of the prescription for an antimicrobial, and rules for off-label use of antimicrobials.

Estimated savings and benefits

The savings estimated at the time of the impact assessment have not been updated after the adoption of the Regulation.

State of Play:

Some 25 delegated and implementing acts are to be adopted.

Noteworthy ones expected to contribute to simplification and reduction of administrative burden:

• Implementing act on the Union product database: enhance the single market by providing the widest possible access to information on veterinary medicinal products available in Member States; allowing health professionals to obtain information on veterinary medicinal products which might be considered for elaboration of potential treatment alternatives where no suitable veterinary medicinal product is authorised or available in their Member State; ensure support for the processing of variations that do not require assessment. (Commission Implementing Regulation (EU) 2021/16 of 8 January 2021).

• Implementing act on variations that do not require assessment: provide a list of variations that will not need scientific assessment and thus reduce administrative burden for both national competent authorities and marketing authorisation holders during their processing which in turn is to be supported by the Union product database. (Commission Implementing Regulation (EU) 2021/17 of 8 January 2021)

• Implementing acts on the design of the common logo for retail of veterinary medicinal products at a distance: facilitate and enhance online retail of veterinary medicinal products while building and maintaining trust of consumers. (Commission Implementing Regulation (EU) 2021/1904 of 29 October 2021)

• Implementing acts on good pharmacovigilance practice and on the format and content of the pharmacovigilance system master file: ensure that the veterinary pharmacovigilance systems for all authorised veterinary medicinal products are consistent; support the overhauled system of pharmacovigilance; enhance and ensure the efficiency of the system of pharmacovigilance. (Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021)

• Implementing act on the list of abbreviations and pictograms: support the simplification of rules оn packaging and labelling of veterinary medicinal products by ensuring common pictograms and abbreviations as an alternative to textual information (not yet adopted).