Belgium Prepares to Implement Regulation (EU) 2019/6 on Veterinary Medicinal Products
Earlier this week, Belgian plans for implementing Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC (the Vet Reg) were made partially publicly available pursuant to the notification procedure governing possible technical barriers to trade provided for by Directive (EU) 2015/1535. This Technical Regulation Information System or “TRIS” procedure allows both the European Commission and the EU Member States to review before their adoption technical regulations which Member States intend to introduce for products and Information Society services. The TRIS procedure thus created a mechanism to increase the likelihood that the proposed texts are compatible with EU law, including the Internal Market principles.
The European Commission’s TRIS platform now displays the text of a draft Law governing veterinary medicinal products (“Voorontwerp van Wet betreffende diergeneesmiddelen”/“Avant-projet de loi sur les médicaments vétérinaires” – the Draft Vet Law – see, attached Dutch and French versions) which will be submitted to Parliament and is intended to apply on 28 January 2022, the date of application of the Vet Reg. As a Regulation the Vet Reg is directly applicable in EU Member States and, theoretically, does not require national implementation. However, as was the case for many Regulations across diverse fields of law, implementing measures also proved necessary for the Vet Reg. Accordingly, the Draft Vet Law contains an extensive set of detailed rules and provides for the prospect of even more elaborate implementing rules that will be enacted by Royal Decree.
The Draft Vet Law regulates a set of important issues, including clinical trials with veterinary medicinal products; marketing authorisations; post marketing authorisation measures; pharmacovigilance; the manufacturing, preparation, importation and exportation of veterinary medicinal products; wholesale and retail trade, including sales at a distance; parallel trade; publicity; inspection, supervision and criminal penalties; administrative settlements; and the processing of inspection data.
As a result of the Draft Vet Law, the Law of 25 March 1964 governing medicines will no longer apply to veterinary medicinal products and is for that reason made subject to a lot of modifications.