AnimalhealthEurope welcomes the Commission commitments to simplify reporting and
diminish administrative burden for companies operating in the European Union and applauds the initiative to rationalise and simplify reporting requirements for companies by 25%.

We have several proposals to support the competitiveness of our, understandably, highly regulated
sector, by optimising some of the reporting requirements. The Animal Health Sector wishes to
constructively contribute to the process of simplification of the reporting requirements, including
through the Omnibus Proposals. We call on the Commission to give our sector the means to focus on
our core business: better protecting Europe against animal diseases today, preventing the zoonoses of
tomorrow.

1. As regards legislation directly related to the animal health sector (Regulations 2019/6,
   2016/429, etc.) it is imperative to ensure that the European Medicines Agency is properly funded
   to ensure that all services and processes, such as the Union Product Database are fully and
   optimally functional. Double and unnecessary reporting in areas such as pharmacovigilance
   should be ceased and digital product submissions and information leaflets should be prioritised
   to reduce administrative burden both for the agency and the companies. Due consideration
   should also be given to the changing nature of animal diseases and how we prepare for and
   address them as a union.
2. When it comes to legislation on corporate, social and environmental reporting, it is
   important to ensure better alignment between all the different pieces of legislation carrying
   reporting elements, and it is of further importance to ensure alignment in reporting requirements
   between the EU and Member States. Implementation dates of such legislation should be
   extended at least until all necessary delegated and implementing acts are adopted to ensure
   clarity on reporting requirements.
3. In the area of horizontal, social, chemical and environmental legislations it is essential that
   the benefit-risk approach takes precedence over the risk only approach. As veterinary medicines
   are an essential public good, their supply chains should not be disrupted and the EU should
   provide the necessary support as companies seek alternative solutions. Companies also need to
   have simpler guidance and clear definitions on how to implement reporting obligations