Ecologic Institute organised and moderated an international workshop on the monograph system, which was jointly convened by ANSES (French Agency for Food, Environmental and Occupational Health and Safety) and UBA (German Federal Environment Agency). The workshop, titled "An effective tool to strengthen the environmental safety of medicinal products: Monograph system for active pharmaceutical substances", took place in Brussels on November 26, 2014. Its aim was to discuss the benefits, design, and possible implementation of a monograph system with national authorities, EU Commission representatives, the veterinary pharmaceuticals industry, and further stakeholders. A further aim of the event was to heighten the awareness of such a monograph system, in view of the possibility of its being taken up in the current revision process of the Veterinary Medicinal Products Directive.
An "environmental monograph system" is considered one of the most promising options to address the information gaps for the environmental risk of medicinal products.
The workshop’s key questions, addressed by working groups in a breakout session, were:
- What are the benefits of a monograph system?
- How could a monograph system be designed?
- How could a monograph system on active pharmaceutical substances be implemented into the legislative framework?
Rodrigo Vidaurre and Lucas Porsch were responsible for moderating the plenary session, moderating two working groups in the breakout session, and the reporting back / final discussions in the plenary.
To download the workshop agenda, please click here. Four of the five introductory presentations can be downloaded below:
- Ariane van der Stappen (EU Commission, DG Health and Consumers): Current proposal for a regulation on veterinary medicinal products.
- Mathilde Harvey (ANSES): Relevant experiences in the authorisation of veterinary medicinal products from the perspective of national competent authorities (NCAs).
- Ines Rönnefahrt (UBA): Needs, challenges and perspectives of a monograph system for active pharmaceutical substances.
- Tom Hargreaves (Director, Blue Frog Scientific Limited): Legal, cultural and logistic considerations for the sharing of environmental data between companies.
Please find the powerpoint summaries of the 3 breakout working groups, and the preliminary workshop conclusions attached. A Workshop Report will be made available shortly.