Project MONO4ERA

The European Commission asked for a feasibility study to be performed in the MONO4ERA project. In this study, Fraunhofer ITEM and partners identified, collected and analysed information to assess the feasibility of an active-substance-based approach (monograph system) and other potential alternatives. The monograph system as defined in the literature and two alternatives presented by Animal Health Europe and the European Group for Generic Veterinary Products were examined for their possible impacts, efficiency and effectiveness in achieving the objectives of Regulation (EU) 2019/06, i.e. reduce the administrative burden, enhance the internal market, increase the availability of veterinary medicinal products, while guaranteeing the highest level of public and animal health and protection of the environment.

The study concludes: In an initial phase, the monograph system would be more expensive and resource-intensive but in the long-term the benefits should overbalance the disadvantages. In addition, a number of suggestions were developed to improve the acceptability of the monograph system. The benefit would be enhanced by using existing tools and experiences from other regulatory frameworks (such as REACh, biocidal product regulation). Moreover, it would support current EU strategic approaches, such as the “one substance, one assessment“ approach of the European Green Deal (COM/2019/640). Especially in view of these EU goals, a monograph system is justified, proportionate and may be affordable in a long-time perspective.