New regulation Environmental Risk Assessments

As of June 30^th 2019, the consultation period has been closed for the draft guideline on the environmental risk assessment of medicinal products for human use. With the update of this guideline, the execution of a two-tailored environmental risk assessment becomes mandatory for all new marketing authorization applications. In the past it was possible for manufacturers of generic medicines to provide a statement that their product was intended for substitution of the already marketed product from competitors and that hence the product did not contribute to an increased environmental risk. With the update of this guideline, this statement is no longer accepted.

The two-tailored risk assessment calculates a theoretical environmental burden in phase I of the assessment. If the risk is below a threshold of 0.01 µg/L and the product at issue not categorized as a hormone or anti-parasitic agent, the risk assessment can be stopped after phase I, although it might be accompanied by a Persistence, Bioaccumulation and Toxic assessment. If the risk is above 0.01 µg / L or the product at issue is categorized as a hormone or anti-parasitic agent, the assessment has to be continued to phase II, in which environmental fate studies need to be performed.

Interdos has in-house expertise regarding environmental risk assessments as our employees have carried out and coordinated these studies in the past. Therefore, we can provide you with an A-Z service package regarding the environmental risk assessment, but we can also take care of the coordination of environmental fate studies only. Please feel free to contact us in case this is of interest to you and your business or should you require more information about our services.