Welcome to ERA-support.net, a platform for Environmental Risk Assessment on Drug Substances and Medicinal Products.
Since 1992, evaluation on environmental impact for medicinal products for human use has been required in Europe; since 1993 also for veterinary products.
Current regulatory background for marketing authorisation applications is given in directives 2001/83/EC, amended by 2004/27/EC (human use) and 2001/82/EC, amended by 2004/28/EC (veterinary use) and in regulation 726/27/EC.
Documentation provided in the application dossiers during the last years was quite variable. Very often, applicants for products containing known drug substances tried to avoid proper evaluation based on "generic statements". On the other hand, various drug substances have been fully tested and reported by several applicants, so redundant testing was followed by redundant assessment.
Throughout the discussions with colleagues from regulatory authority, industry, service providers and university, it was common understanding that exchange of knowledge and documentation would reduce workload and costs for each single applicant and also increase quality of application dossiers.
Based on these discussions, this ERA-support.net platform was implemented to facilitate communication, exchange and co-operation between all parties involved.
The platform shall facilitate direct communication and co-operation between parties involved without proprietary information being published.
Owners of documentation may offer to share their expertise.
Interested Parties may request support.
Please support this interactive platform by sending requests and offers.
urgent request: documentation on different NSAIDs