Environmental risk assessment of medicinal products for human use
In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by the use of medicinal products shall be submitted, their environmental impact shall be assessed and, on a case-by-case basis, specific arrangements to limit this impact shall be considered.
An 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 ERA dossier should be updated if there is an anticipated increase in the environmental exposure, e.g. a new indication which results in an increase in the extent of the use.
For extension applications according to Annex II of Commission Regulation (EC) No 1085/2003, ERA is also required if there is an anticipated increase in the environmental exposure, e.g. an extension application of an oral medicinal product to include a dermal patch.
Environmental Risk Assessment requirements basics
Who should attend
Anyone with a responsibility for and/or interest in placing medicinal products on EU market.
Dr. Martina Kubáňová, PhD., ERA expert
PaedDr. Martin Murin, REACH expert