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Milan, 7 February 2019 - After four years from the first regulation proposal on veterinary medicinal products (“VMP”)[1], on 26th November 2018 the Council approved the new Regulation, which has been published on the Official Journal on 7th January 2019 (EU Regulation 2019/6, the “Regulation”). The Regulation repeals Directive 2001/82/EC and shall apply from 28 January 2022.

Since the first regulation proposal on this matter, the European Commission has called for an in-depth revision of the internal market of VMP. In particular, the Commission highlighted the need to harmonise the European legal framework, as well as to introduce provisions aimed not only at improving competitiveness and innovation, but also, and above all, at ensuring a greater safety of public health.

In this scenario, the Regulation directly addresses one of the main issues of the sector, namely the increasing spread of antimicrobial resistance (AMR) caused by the overuse (and misuse) of antibiotics, and it dedicates to this matter several provisions.

First of all, pursuant to Article 37, the granting of market authorisation (“MA”) from the competent authority of the Member State is subject to a balancing exercise of the interests involved, the protection of public health – in case of development of antimicrobial resistance or antiparasitic resistance – and the benefits of the VMP to animal health. Consequently, the MA shall be refused if the benefit will result lower than the risk[2] for public health. Furthermore, the Commission shall designate categories of antimicrobials to be reserved to human use, in order to preserve their efficacy (Article 37)[3].

The Regulation, moreover, bans the marketing of antimicrobials intended for the sole purpose of promoting the growth of animals or increasing their yields (Article 37, par. 2, point d). In this context, a central role is played by the veterinarian, who shall be able to justify the need of using antimicrobials in prescribing such medicines (Article 105, par. 2 and 10). In order to allow an evaluation about the use of antimicrobials used in food-producing animals, the Member States should monitor and send to EMA the data related to the volumes of sales and the use of such VMP (Article 57)[4].

In accordance with the initial proposal of the Commission, the Regulation also provides for rules concerning the harmonisation of the Community legal framework:

The main provisions in this regard are the following:

  • Harmonisation of Member States MA procedures (Article 6), introduction of a centralized procedure (Articles 42-45) and a decentralised procedure (Articles 48, 49). The national procedures will remain valid only throughout the Member State of the authority which granted it (Articles 46, 47);
  • Veterinary prescriptions, in respect of which the regulation identifies the minimum requirements enabling the cross-border recognition and the subsequent use of such prescriptions (Article 105, par. 5). Furthermore, Article 34 sets forth a detailed list of VMP subject to veterinarian prescription (different from the generic provisions set forth in Article 67 of the Directive 2001/82/EC), which includes also antimicrobials.
  • Introduction of specific provisions concerning the distance sales, which are expressly admitted, except for the VMP subject to veterinarian prescription (Article 104, par. 1).
  • Introduction of common rules concerning VMP advertisement (Articles 119-121): in this regard, with particular reference to online sales, the Commission shall define a common logo, which will enable to identify the Member State where the person offering VMP for distance sales is established (Recital 77, Article 104, par. 6). Thanks to this logo, the public could easily identify legal websites offering VMP.

In the context of the new regulatory framework Italy seems to be at the forefront, at least in relation to some of the provisions introduced by the Regulation.

Today the matter is regulated by legislative decree no. 193/2006, which implemented Directive 2001/82/EC.

Among the issues of particular interests with a view to the new Regulation, we would focus on Article 70 of the abovementioned decree, under which the sale of VMP shall always happen in the presence of individuals who are licensed pharmacists; therefore, the sale at a distance of VMP is forbidden, with limited exceptions[5]. Recently, furthermore, the so-called “Decreto Milleproroghe” (Thousand-Exceptions Decree) introduced the obligation of the electronic prescription as from 1 January 2019[6]. This practice allows the monitoring of the use of a significant part of VMP, in accordance with the provisions of Article 57 of the Regulation. Lastly, with regard to MA procedures, articles 36 and 37 of legislative decree no. 193/2006 already foresee the possibility to access to harmonised procedures, such as the mutual recognition procedure and the decentralised procedure, both aimed at promoting VMP trade throughout the Member States.

 

 

[1] Proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products, published on 17 September 2014.

[2] EU Regulation 2019/6, Article 37, par. 2: “A marketing authorisation shall be refused if any of the following conditions are met: […] f) the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health”.

[3] To this end, the Commission shall adopt delegated acts on this regard.

[4] EU Regulation 2019/6, Article 57, par. 1 and 2: “Member States shall collect relevant and comparable data on the volume of sales and on the use of antimicrobial medicinal products used in animals, to enable in particular the direct or indirect evaluation of the use of such products in food-producing animals at farm level, in accordance with this Article and within the time limits set out in paragraph 5. 2. Member States shall send collated data on the volume of sales and the use per animal species and per types of antimicrobial medicinal products used in animals to the Agency in accordance with paragraph 5 and within the time limits referred to therein. The Agency shall cooperate with Member States and with other Union agencies to analyse those data and shall publish an annual report. The Agency shall take into account those data when adopting any relevant guidelines and recommendations”.

[5] Notwithstanding that provision, pesticide and disinfectant VMP for external use, as well as VMP for small pets, laid down in Article 90 of the legislative decree no. 193/2006 could be sell at a distance as long as they are not subject to a veterinary prescription.

[6] Article 118, par. 1 bis, legislative decree no. 193/2006. The paragraph has been added by Article 3, par. 1, point b) of law no. 167/2017 (Legge europea 2017) and thereafter amended by Article 8, par. 1 of law decree 91/2018 (Decreto Milleproroghe), converted with amendments into law no. 108/2018.

 

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