Responsibility for authorities and payers
- At: 2009 FIP Congress in Istanbul (Turkey)
- Type: Presentation
- By: RECHENBERG, Bettina (German Federal Environmental Agency Umweltbundesamt, Dessau, Germany)
European legislation requires an environmental risk assessment within the pharmaceutical authorization procedure. Authorisation of a human medicinal product, however, can explicitly not be denied if an environmental risk is identified. For veterinary pharmaceuticals the legal situation is different - authorisation may be denied, or may be limited.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.