During EMA veterinary medicines info day 2023, Access VetMed presented the industry view and experiences with the new veterinary medicines regulation. During the first year of implementation, the companies have reported many challenges and have not yet experienced the overall objectives and benefits.
“We appreciate the amount of work, resources and efforts EMA has put into supporting the marketing authorisation holders in the transition”, our representative Aafke Huizenga from Dechra highlighted.
Still, the lack of harmonisation, different interpretations and national requirements have consumed resources and added considerable workload in companies.
The industry called for increased harmonisation among the member states and for more clarity on interpretation, especially on processes related to variations, labelling and packaging. This would give the companies a more predictable and transparent environment to operate in.
“This past year with all its challenges has brought the industry and the regulators closer together and helped us understand each other. There is still a long way to go, but we remain hopeful that we are on the right track”, Aafke concluded.