It has been one year since the implementation of the new veterinary medicines legislation started. Companies were promised easier and lighter administrative processes but the opposite happened. Not all the systems and guidelines were ready at the time of implementation. During the past year industry and authorities have worked hard together to fix some of these issues. We asked our working group chairs, what the situation looks like now.
For pharmacovigilance, the new legislation has brought many changes but the chair of the working group, Andreas Werner from Bela-Pharm, sees light at the end of the tunnel.
“The companies are getting used to the new pharmacovigilance activities, partly thanks to EMA’s training. However, constant changes to the databases – which are appreciated as they provide new functionalities -require constant adaptation in our processes. I foresee that it will still be a long time until we can say with confidence that we trust the databases and that we have well established procedures to fulfill our legal obligations”.
The new data registry, the union product database (UPD) has been one of the big efforts for both, EMA and companies to set up. According to the chair of the telematics working group Jaka Petrič from Krka, the adaptation is still ongoing.
“Although EMA is putting a lot of effort, all the products expected to be in UPD are not uploaded yet and certain features are still missing. The existing products data is lacking quality. Companies are using a lot of time to check and communicate with national agencies to enhance it so that they could submit the necessary information, for example variations not requiring assessment, sales volumes and availabilities.”
The chair of the regulatory procedures working group, Inma Zorrilla from Livisto finds a positive angle amidst the challenges:
“It has brought us companies and authorities closer together and helped understand each other’s perspective. Some processes have changed completely, such as submitting variations, and this has been somewhat challenging. We have given feedback to the authorities to help them update and align guidelines and processes as we go along.”
Even though we are not quite there yet, our members give credit to the authorities for trying to solve the issues and for keeping an ongoing and open dialogue with the industry. Most companies have struggled with increased administrative burden, except in one area.
“The environmental risk assessment (ERA) requirements for generics were rationalised. We are no longer required to duplicate the assessments for same ecotoxicity scenarios of products, which is a welcome change,“ reports Pablo Tejero from Labiana, chair of the ERA working group.
The variation working group member Aafke Huizenga from Dechra summarises the sentiments: “There is still a long way to go, but we are getting on the right track.”
We also thank Anna Ballbé from Maymó (labelling working group), Sunčana Abramović from Dechra (Immunological working group), and Xavier Molins from Bimeda (Quality working group) for their input for this content.