BAKGRUNN (fra kommisjonsforordningen)

(1) Regulation (EU) 2019/6 aims at harmonising the internal market and increasing the availability of veterinary medicinal products, while guaranteeing the highest level of public and animal health and environmental protection. In particular, it aims at containing the spread of antimicrobial resistance with concrete measures to promote a prudent and responsible use of antimicrobials in animals, in line with the ‘One Health’ approach. 

(2) Certain veterinary medicinal products authorised for oral administration via routes other than medicated feed may be associated with risks to public and animal health and to the environment. Their inappropriate administration or dosing can lead to possible reduction of the effectiveness of the treatments, development of antimicrobial or antiparasitic resistance, unintended administration to non-target animals and risks for the target animals, environment and for consumers. 

(3) Veterinary medicinal products intended for incorporation into medicated feed in accordance with Regulation (EU) 2019/4 of the European Parliament and of the Council do not fall under the scope of this Regulation. 

(4) Pursuant to Article 106(6) of Regulation (EU) 2019/6, the Commission considered the scientific advice on the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed given by the European Medicines Agency on 28 August 2020.

 (5) Veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed and administered by the animal keeper to foodproducing animals cover a wide range of products and formulation types. While some veterinary medicinal products, such as tablets or oral solutions via drench application, are directly and individually administered to animals, others require their mixing in drinking water or into feed and may involve the use of equipment. Since the risks associated with the use of veterinary medicinal products administered orally by means of mixing in drinking water or into feed may be higher than those associated with other pharmaceutical forms of veterinary medicinal products, measures aiming at ensuring an effective and safe use are necessary.

(6) Therefore, this Regulation should apply to veterinary medicinal products administered orally by means of mixing into or addition onto feed and to the mixing of veterinary medicinal products in drinking water or in liquid feed by the animal keeper. It should not apply to the mixing of a veterinary medicinal product into feed by feed business operators irrespectively of whether they operate in a feed mill, with a mobile mixer or an on-farm mixer, which is covered by Regulation (EU) 2019/4. 

(7) Most veterinary medicinal products authorised for food-producing animals are subject to veterinary prescription. Veterinarians should prescribe the most appropriate route of administration. When considering an oral route of administration, the veterinarians should take into account, on a case-by-case basis, the individual circumstances of the animals to be treated, the facilities, equipment and expertise of the person responsible for the administration of the veterinary medicinal product that are relevant to ensuring the safe and effective use of veterinary medicinal products for each treatment. 

(8) Inappropriate administration or disposal of veterinary medicinal products and feed or drinking water containing veterinary medicinal products could pose risks to the environment and may contribute to the development, selection and spread of antimicrobial or antiparasitic resistance. Therefore, veterinarians should provide animal keepers with information and instructions in accordance with the product information of the veterinary medicinal product aiming at minimising those risks. 

(9) The oral administration of veterinary medicinal products by applying them onto the surface or by mixing them into solid feed immediately prior to feeding groups of animals competing for the same feed raises a risk of both underdosage and overdosage. In particular, for veterinary medicinal products containing antimicrobials and antiparasitics, this may contribute to the development and spread of antimicrobial and antiparasitic resistance. Therefore, the prescription and oral administration of an antimicrobial or antiparasitic veterinary medicinal product by means of mixing into solid feed or administration on the surface of solid feed immediately prior to feeding should only be allowed when the animals are fed individually or when the intake of the veterinary medicinal product by individual animals can be effectively controlled in a small group of animals.

(10) The availability of veterinary medicinal products, the access to medicated feed produced in accordance with Regulation (EU) 2019/4, the need for small group treatments due to local husbandry and farming practices as well as the national policy on prudent use of veterinary medicinal products may vary across the Union. Therefore, Member States should be allowed to further restrict within their territory the prescription and oral administration of antimicrobial or antiparasitic veterinary medicinal products that are mixed into solid feed or administered on the surface of solid feed immediately prior to feeding, to individually fed animals only. Such restriction should not have a negative impact on animal health or welfare. 

(11) As indicated in the scientific advice given by the European Medicines Agency, individual treatments via solid feed in aquaculture are not possible. Oral treatment via drinking water, which is an alternative oral treatment option for other animal species, is not suitable for treatments in aquaculture either. The aquaculture sector is very diverse across the Union, with large differences in terms of animal species, farming practices and size of the farms. In some Member States, there is a limited number of compound feed producers for aquaculture and immediate access to medicated feed produced in accordance with Regulation (EU) 2019/4 for group treatment may not be feasible. 

(12) Where medicated feed produced in accordance with Regulation (EU) 2019/4 is not available or where animal treatment should be started before the delivery of the medicated feed, a prohibition to prescribe antimicrobial and antiparasitic veterinary medicinal products to be mixed into solid feed for group treatment in food producing aquatic species would create animal health and welfare issues. Therefore, in those situations such group treatments should be allowed. 

(13) Since the combined use of several antimicrobial veterinary medicinal products may represent a particular risk with respect to the development of antimicrobial resistance, oral administration of several antimicrobial veterinary medicinal products at the same time, via routes other than via medicated feed should be restricted. 

(14) In order to ensure the effective and safe use of veterinary medicinal products prescribed for oral administration via routes other than medicated feed, animal keepers should use the veterinary medicinal products only in accordance with the veterinary prescription, which is based specifically on a diagnosis, the target species and the number of animals to be treated. 

(15) Animal keepers should have the relevant expertise and skills to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration by means of mixing in drinking water or into different types of feed. 

(16) The equipment used for the oral administration of veterinary medicinal products and its maintenance should be such as to ensure the effective and safe use of the prescribed veterinary medicinal products in the target animals and reduce the risks of contamination of the animals surrounding and the exposure of the environment. 

(17) The characteristics of the drinking water used to administer veterinary medicinal products via drinking water can impact the solubility and stability of those veterinary medicinal products. Therefore, the animal keeper should take appropriate measures to ensure that the drinking water used is appropriate for the oral administration of the veterinary medicinal product. 

(18) Biocidal products, feed additives or other substances used simultaneously with veterinary medicinal products administered via drinking water or liquid feed might interact with the veterinary medicinal products or impact their uptake or their efficacy and safety. Those products should not be used simultaneously with veterinary medicinal products if interactions or incompatibilities have been documented in the marketing authorisation of the veterinary medicinal products. Where no data or information on those interactions or incompatibilities is available, it should be reflected in the product information. 

(19) Article 106(1) of Regulation (EU) 2019/6 requires that veterinary medicinal products are used in accordance with the terms of the marketing authorisation. Therefore, existing marketing authorisations should be amended, where relevant, to ensure consistency with the requirements of this Regulation. That should ensure the proper prescription by veterinarians and administration and dosing of the veterinary medicinal products by the animal keeper. 

(20) Local husbandry and farming practices might be divergent among Member States. Therefore, Members States should have the possibility to provide further guidance at national level adapted to the animal species and production systems in their territory. Such guidance should contribute to the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration by means of mixing in drinking water, mixing into different types of feed or adding onto the surface of feed. 

(21) In order not to compromise the availability of the veterinary medicinal products concerned, it is necessary to provide for transitional measures to allow marketing authorisation holders, the competent authorities or, where the veterinary medicinal product is authorised under the centralised marketing authorisation procedure, the Commission, sufficient time to amend existing marketing authorisations with a view to ensuring consistency with the provisions of this Regulation. 

(22) The entry into application of this Regulation should be deferred in order to provide veterinarians and in particular animal keepers with sufficient time to adapt to the new requirements laid down by this Regulation,