ERA

Environmental Risk Assessment (ERA) involves the comprehensive evaluation of potential ecological risks associated with medicinal products, as mandated by Article 8(3) of Directive 2001/83/EC and its amendments. This evaluation necessitates the submission of information detailing the environmental hazards posed by these products, their potential impact on the environment, and tailored strategies for mitigating these impacts on a case-by-case basis. Notably, the environmental impact of medicinal products should not serve as grounds for refusing a marketing authorization.

ERA is a mandatory component for new marketing authorization applications, whether processed through centralized, mutual recognition, decentralized, or national procedures. For type II variations, an assessment of environmental impact is crucial in instances of increased environmental exposure, such as expanded indications leading to substantial usage growth. In extension applications, an ERA is essential if there’s potential for elevated environmental exposure, like extending a product from oral to dermal administration.

ERA operates as a systematic approach aimed at appraising the likelihood of adverse ecological consequences stemming from the exposure of organisms and ecosystems to various chemical compounds. It encompasses the multifaceted process of evaluating the potential harm that substances, activities, or natural phenomena might inflict upon the environment. This encompassing assessment mechanism underscores the commitment to safeguarding environmental integrity in tandem with advancing medicinal progress.