PGEU welcomes the adoption of the EU Regulation on veterinary medicinal products (Regulation (EU) 2019/6) which entered into force on 28th January 2019. The Regulation introduces new measures aimed at tackling antibiotic resistance, given the need to ensure rational use of antimicrobials in the veterinary sector under ONE Health approach. It also aims at modernizing the legal framework applying to veterinary medicines, including in connection with the retail and dispensing of such medicines. Finally, it also intends to give incentives to stimulate innovation and increase the availability of veterinary medicines within the European Union. The new rules apply as from 28 January 2022.

The Regulation develops further principles set out originally in the Patients’ Rights Directive¹ and the Falsified Medicines Directive², with respect to the recognition of veterinary prescriptions and the Common Logo for Internet sites selling veterinary medicines.

Indeed, the Regulation provides that internet sale of veterinary non-prescription medicines must be authorised in all Member States under conditions which mirror the provisions introduced by the Falsified Medicines Directive for the Internet sale of human non-prescription medicines (i.e. provide certain information, display a common logo, etc.). This makes the Veterinary Medicines Regulation consistent with the rules applying to human medicines which is welcome.

However, the Regulation confirms Member States’ discretion in deciding whether to allow or prohibit the sale at a distance of prescription veterinary drugs within their respective territory. This is again consistent with the current regime applicable to human medicines and is also in line with PGEU’s position.

The Regulation also updates the list of the minimum requirements veterinary prescriptions must comply with. Veterinary prescription compliant with the Regulation must be recognised throughout the Union. This means that veterinary prescriptions written by a veterinary established in one Member State can be recognised and dispensed in another Member State.

 

Generally, PGEU welcomes EU legislator efforts to achieve a well-balanced Regulation. However, we have raised specific concerns in respect to the recognition of prescriptions issued for human medicines prescribed for veterinarian purposes or the broad manufacturing authorisation exception, which exclude retailers of veterinary medicinal products from needing a manufacturing authorisation when preparing a veterinary medicinal product. Please find more information on PGEU position paper in the link below.

PGEU is currently monitoring the implementation of the Regulation and, in particular, matters regarding dispensation of veterinary medicines in pharmacies, obligations on collecting data on use and volume of sales of certain categories of veterinary medicines, cross-border recognitions of prescriptions and ethical and environmental matters.

 

¹ DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2011 on the application of patients’ rights in cross-border healthcare

² DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products