As of 28 January 2022, Regulation 2019/6 became effective. From that moment onwards, European Member States must comply with all rules from this regulation.
During the past few years, new European rules on medicinal products for veterinary use were worked on. The existing rules had to be adapted in order to eliminate the differences between the sectors involved in medicinal products for human use and veterinary use. Until 27 January 2022, the European framework concerning medicinal products for veterinary use was regulated by Directive 2001/82. A directive means that countries are free to set up national regulation in agreement with the goals of the European directive.
On 28 January 2022, the new European rules on medicinal products for veterinary use become effective with all regulatory aspects for veterinary medicinal products prepared industrially or by a method involving an industrial process and intended to be placed on the market. Furthermore, the regulation is partly applicable to other medicinal products for veterinary use.
In view of harmonisation, Europe chose a regulation, meaning that European rules will apply in each Member State. A regulation can be directly implemented in national legislation and will be the same in all countries of the European Union. Belgium thus has to comply with European rules concerning medicinal products for veterinary use.
Regulation 2019/6, the implementing decisions and delegated acts referred to, are considered to be the priority regulation in Belgium. Europe gives Member States the possibility to focus on certain topics at national level, taking into account the specific character or customs of the country.
This regulation aims to reduce the administrative burden and to enhance the European market. It also aims to increase the availability of medicinal products for veterinary use on the market, while guaranteeing the highest level of public and animal health and environmental protection.
Regulation 2019/6 also provides three European databases.
• European Union database on medicinal products for veterinary use (article 55)
Everyone shall have basic access to the European database containing all medicinal products for veterinary use authorised in Europe. For veterinarians, this database can be useful to get an overview of the available medicinal products and, on the basis of this information, to make a choice or to gain an insight into the availability of a veterinary medicinal product.
• European Union database on veterinary pharmacovigilance (article 74)
Suspected adverse events for medicinal products for veterinary use will be stored in a European veterinary pharmacovigilance database. This will allow these adverse events to be better detected and monitored at European level. The general public shall have access to general information on pharmacovigilance.
• Database on manufacturing and wholesale distribution (article 91)
The general public shall have access to a database containing the list of manufacturers and wholesale distributors who are concerned with the manufacturing, import and wholesale distribution of medicinal products for veterinary use and who have been found to comply with applicable European Union rules following an inspection by the competent authorities of a Member State.
For the time being, the law on medicinal products of 25 March 1964 and the Royal Decrees of 14 December 2006 and 21 July 2016 remain valid, to the extent that they are not inconsistent with Regulation 2019/6.
In order to provide stakeholders with better information on the implementation of the new rules and on the different procedures, the FAMHP services concerned update the information on the FAMHP website.