Now published in the EU Official Journal, the new EU Regulations on Veterinary Medicines and Medicated feed are set for application in all EU Member States in early 2022.
Trumpeted by many as legislation to restrict the use of certain antibiotics to address antibiotic resistance, the objectives of the new rules were essentially to simplify existing rules to boost innovation, to streamline procedures for granting marketing authorisations and monitoring of side effects, and to improve the functioning of the internal market. The collective goal was to encourage development of medicines for all animal species and improve their availability across all EU countries.
A number of important processes have been streamlined to meet the objective of reducing administrative burden. The foremost is in the pharmacovigilance system for reporting adverse side effects of medicine use. The new rules put an end to the current periodic safety update reports when there was nothing to report. Now, side effects must be signalled only when they occur, using a signal-management system, and centrally stored in the EU Pharmacovigilance Database.
Regarding availability, the EU centralised procedure which offers a pan-EU authorisation to market a product, will now be open to all types of products, in a bid to support a single market in animal medicines. Pictograms and standardised abbreviations are also approved for packaging and labelling to help reduce translation and country-specific production costs.
To further encourage innovation, maximum periods of protection of technical documentation have increased from 13 to 18 years. An extra 4 years has been added to make products available for minor species like goats, and products for bee health have the longest protection period at 18 years. New antimicrobial products are extended to a total of 14 years and a new protection period of 4 years is added for improvements on existing products.
Much of the revision discussions focused on addressing antibiotic resistance and the impact of medicines use on the environment. As is the case today, all antibiotics for animals remain prescription only throughout the EU, the ban of routine use of antibiotics to compensate poor farm management is reinforced, and the ban on using antibiotics for growth promotion or increased yielding is upheld. The current procedure of carrying out an environmental risk assessment within the licensing process is also upheld and reconfirmed in the new regulation.
But there are a number of changes. When it comes to prescribing antibiotics for preventive use (prophylaxis), this will only be allowed for a single animal and prescriptions for group preventive use (metaphylaxis) must be limited in time only to cover the period of risk of infection and limited to small groups, only after diagnosis of the infectious disease by the vet. A list of antibiotics deemed ‘Critically Important’ for human health will also be elaborated on the basis of scientific advice from the European Medicines Agency and European agencies.
A large number of implementing measures – 29 in total - mean that there is still a lot of work to be done, so the full impact of the new regulation, and whether it has achieved its objectives, cannot really be judged until the content of these measures are known. AnimalhealthEurope will continue dialogue with the European Commission on a balanced and science-based approach so that we can improve the availability of animal health solutions for more animals, in more countries in Europe.