Environmental Risk Assessment (ERA)

In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by medicinal products should be submitted, their environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit the impact should be considered. In any event this impact should not constitute a criterion for refusal of a marketing authorisation.

An environmental risk assessment (ERA) is required for all new marketing authorisation applications for a medicinal product through a centralised, mutual recognition, decentralised or national procedure.

For type II variations, the evaluation of the environmental impact should be made if there is an increase in the environmental exposure, e.g. a new indication may result in a significant increase in the extent of the use. For extension applications according to Annex II of Commission Regulation (EC) No 1085/2003, an environmental risk assessment is also required if there is a potential increase in the environmental exposure, e.g. an extension application of an oral medicinal product to include a dermal patch. An ERA is not required for renewals or Type IA/IB variations.