In accordance with Article 8(3) of Directive 2001/83/EC, an application for a marketing authorisation for a medicinal product for human use must be accompanied by an Environmental Risk Assessment (ERA). This assessment should be performed according to the European Medicines Agency, following the procedure described in Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (Doc. Ref. EMEA/CHMP/SWP/4447/00 corr. 21*) (1)
The environmental risk assessment process for a medicinal product is complex. It is based on overall usage, destination and transport, its persistence, and its ecotoxicity in the environment. The information available to assess this risk is often insufficient.
In the assessment of environmental risk two concepts have to be defined:
- PEC (Predicted environmental concentration), which is the calculated concentration of a medicinal product in the environment. It depends on factors which increase or decrease the exposure of an organism to a substance (persistence, transport, destination and usage). According to EMA(1), for pharmaceuticals, PEC is calculated using a worst-case scenario, assuming no metabolism by the patient or removal/degradation of the substance and using the total sales volume in the corresponding country.
- PNEC (Predicted no-effect concentration), which is the concentration, based on available tests, below which no adverse effects on the ecosystem are expected to occur for a specific organism. It is estimated using ecotoxicity testing data, by division of the lowest value for toxicity with the relevant assessment factor, as outlined by the EMA (1)
The environmental risk of a particular pharmaceutical can be quantified by the ratio PEC/PNEC. Depending on the PEC/PNEC ratio, the risk is divided into four different categories, consistent with the system for Environmental classification of pharmaceuticals at Swedish Prescribing guide (www.fass.se).
The risk categories are as follows:
|Ratio||Environmental risk level|
|PEC/PNEC ≤ 0.1||Insignificant|
|0.1 < PEC/PNEC ≤ 1||Low|
|1 < PEC/PNEC ≤ 10||Moderate|
|PEC/PNEC > 10 l||High|
OUR SERVICES: We have accredited toxicologists and experts in the development of ERA REPORTS for any pharmaceutical product, always in accordance with the existing regulation.
(1). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (Doc. Ref. EMEA/CHMP/SWP/4447/00 corr. 21*)