WS 2017: Environmental Risk Ass. of Veterinary Medicinal Products
In this workshop different approaches are presented and discussed together with aspects of an effective procedural organisation and legal aspects. The workshop also addresses the possible benefits for the environment, eventual reduction in administrative burden by data sharing and any impact the system may have on applicants, agencies, national competent authorities, the European Medicines Agency (EMA) and other stakeholders. The workshop is a follow-up of the one held in November 2014 in Brussels. It is being hosted by the German Ministry for the Environment, Nature Conservation, Building and Nuclear Safety and the German Environment Agency (UBA).
On 10 September 2014 the European Commission (COM) adopted a proposal for a Regulation on Veterinary Medicinal Products (VMPs). During the ongoing review of the EU legislation the necessity to improve the environmental risk assessment (ERA) of VMPs with a special focus on so called legacy products has been identified. Many legacy VMPs entered the market before an environmental risk assessment was introduced into the VMP authorisation procedure by the relevant EC legislation. Therefore, substantial information on environmental effects is missing for such legacy VMPs or at least not available to all EU competent authorities. A need for better knowledge on environmental effects of VMPs has also been brought up within the context of water protection.
Within its decision on the proposal for a regulation on VMPs from 10 March 2016 the European Parliament (EP) has asked the COM to “…present a report to the European Parliament and the Council on a feasibility study of a substance-based review system (‘monographs’) and other potential alternatives for the environmental risk assessment of veterinary medicinal products…”.
One of the most promising approaches seems to be a compilation of quality checked data for the environmental risk assessment of active pharmaceutical substances in substance based data files. Applicants could refer to such a data file instead of generating environmental data on their own; a fair sharing of costs will have to be provided for. In 2015 the German Environment Agency (UBA) initiated a research project in order to considerer different scenarios in a kind of ’impact assessment’, e.g. the ‘ERA master file concept’ and an alternative approach, not based on substances but on products, as proposed by industry.
Who should attend?
Experts from EU institutions, national ministries/competent authorities, industry associations and other stakeholders are welcome to discuss the benefits and challenges of the different approaches and to contribute proposals for putting it into practice.