ENVIRONMENTAL RISK ASSESSMENT (ERA)

Environmental protection has become clearly visible in society in recent years. Pharmaceutice industry has been aware of this issues for a long time. Regulatory Bodies not only focus on thi patient safety, but also consider the impact of medicinal product on the whole environment. Th Environmental Risk Assessment (ERA) aims to establish the potential environmental hazard arising from the use, storage and disposal of medicinal products.

WHEN ARE YOU OBLIGATED TO SUBMIT ENVIRONMENTAL RISK ASSESSMENT (ERA)?

In accordance with Article 8(3) of Directive 2001/83/C, every application for medicinal product for marketing authorisation in EU, through centralised, mutual recognition (MP), decentralised (DCP) or national procedure needs to be submitted with relevant ERA authorised by an Expert.
According to NTA, Vol. 2B-CTD, ERA should be presented at 1.6.1 module (for medicinal products which do not contain GMOs (Genetically Modified Organisms)), or 1.6.2 module (for products containing, or consisting of GMOs). ERA is also required for type II variations or extensions, if there is a potential impact on the environment (e.g. addition of new indication). Renewals, type IA/IB variations do not trigger the need to submit ERA unless it may result in a potential increase in active substance consumption.
Hub Net Scientific Pharma has great experience in evaluation whether a given ERA is sufficient for EU procedures on national and international level (DCP, MP, central). We can demonstrate what is missing, what can cause Expert questions, and finally we can comprehensively prepare the whole risk analysis. We can also advise on next steps depending on the outcome of ERA