After 12 years of preparatory work and three years of transition period, the new veterinary medicines legislation (Regulation (EU) 2019/6) became applicable today.
The regulation aims to reduce administrative burden for the industry and increase availability of products. It also takes steps towards a more digital regulatory system. A new European-level database brings medicines information available to all, while the changes in pharmacovigilance make the procedures more efficient and enhance monitoring of medicines safety.
Access VetMed, and its predecessor EGGVP, were involved in the legislative process since its beginning.
“It has been a long road to this day. Even though there is still adaptation work to be done in the companies, we can celebrate this milestone and the huge effort done by all the stakeholders. We also appreciate the collaboration and support of the Commission, EMA and CMDv during the past three years of preparations”, states Dolores Cainzos, chair of Access VetMed.
The big aim to reduce administrative burden seemed to get diluted during the legislative process.
“While there are improvements, for example through digitalisation, the final outcome did not go as far as we expected. Our members, most of which are SMEs, still foresee a lot of administrative work. In addition, their costs related to placing and keeping products on the market will increase. We do hope that when fully operational, the centralised database will help companies save time and by doing that, increase the availability of medicines,” Cainzos adds.