1. ADHERING TO REGULATORY ASSESSMENT
- All medicines undergo thorough review by the EMA including proof of efficacy and assessment of resistance risk.
- Risk management of any potential human health or environmental impact.
- Application of good manufacturing practice ensuring medicines comply with quality requirements.
2. COMMUNICATING RESPONSIBLE USE
- Promoting our core message that antibiotics should always be handled responsibly and only used under prescription: “as little as possible, as much as necessary”.
- Contributing to awareness-raising through active involvement in events organised at both EU – e.g. European Antibiotics Awareness Day – and national level.
3. ENGAGING WITH STAKEHOLDERS
- Established a stakeholder platform with vets and farmers in 2005 to promote responsible use of medicines in animals
- Growing engagement with stakeholders as EPRUMA membership now includes: vets; farmers and agri-cooperatives; manufacturers of animal medicines and diagnostics; feed manufacturers; professionals working in animal health, sanitary security and sustainable agriculture; and pharmacists.
4. PROMOTING DISEASE PREVENTION PRACTICES
- Promoting a “Prevention is better than cure” approach in the context of good hygiene; nutrition; prevention through vaccination; health management; etc.
5. HELPING DEVELOP RESPONSIBLE USE STANDARDS
- Contributed proactively to the development of guidelines at EU level as well as internationally via Codex and the OIE, and in many European countries.
- Contributed in time, commitment and funding to standards developed by numerous responsible use platforms.
7. IMPROVING LABELLING AND PRACTICES
- Adhering to requirements in terms of marketing and distribution of all medicines, including antibiotics.
- Including responsible use guidelines on the labelling of medicines.
8. MONITORING, SURVEILLANCE AND USAGE STUDIES
- Advocating more harmonised data collection and regulalrly contribute to usage studies, including the EMA’s ESVAC report, OIE usage reports, etc.
- Backing the CEESA programme – a unique pan-European programme of monitoring resistance in foodborne and veterinary pathogens.
9. INVESTING IN R&D
- Investing on average 8% of annual turnover in R&D to continuously provide new and improved solutions for managing infectious diseases.
- Researching and developing innovative prevention options including vaccines, immunostimulants, or novel anti-infectives.
10. ADVOCATING LEGISLATION CONDUCIVE TO INNOVATION
- All medicines undergo thorough review by the EMA including proof of efficacy and assessment of resistance risk
- Supporting proposals for EU decision-making on the categorisation of critically important antibiotics to be entirely science-based, following the recommendations of EU scientific experts within the EMA.
- Supporting the implentation of the new EU Veterinary Medicines Regulation and its rules on antibiotic use in Europe.