Workshop "Monograph system for active pharmaceutical substances"
An effective tool to strengthen the environmental safety of VMPs
The establishment of a Monograph system for active pharmaceutical substances comprising environmental information required for the environmental risk assessment of an active substance is one of the most promising measures to ensure the environmental safety of Veterinary Medicinal Products in use. This also applies to ‘old’ products which were already on the market before the requirement for an environmental risk assessment was introduced into the legislation. This fact was also stated in the DG Sanco Report “Study of environmental risks of medicinal products”, which was recently published. However, this measure was not considered in the current proposal for a new Regulation of the European Parliament and of the Council on veterinary medicinal products, which was adopted on the 10th of September by the Commission.
The workshop aims to review the current state of the environmental risk assessment in the pre- and post-market control of VMPs and to discuss the opportunity for improvement by implementing a monograph system on active pharmaceutical substances. The concepts of a monograph system and research results will be presented and discussed.
The one-day workshop (ca. 9 am – 16 pm) will be hosted by the German Federal Environment Agency (UBA) and by the French Agency for Veterinary Medicinal Products / ANSES. The workshop consists of introductory presentations, followed by discussions in three working groups focused on more detailed aspects of the monograph system. The working groups will deal with the following questions:
- 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
Poster contributions from all participants are very welcome. To disseminate the obtained results the conclusions of the scientific discussion will be published in a workshop report.
Who should attend
The workshop is open to experts from science, industry and regulatory agencies, and to policy stakeholders. All are welcome to discuss the benefits and challenges of a monograph system on environmental information of active pharmaceutical substances.