Seminars 2024

IUCLID Seminar for REACH, 2-day seminar: 4th/5th of June 24 in Dresden  

Avoid accidents: HAZOP/ LOPA/ Human Factors/ Functional Safety Seminar;

Environmental safety assessment of Medicinal Products for Human use

The guideline for the environmental risk assessment of medicinal products for human use came into effect on 1 December 2006 (EMEA/CHMP/SWP/4447/00).

An Environmental Risk Assessment (ERA) shall accompany an application for a marketing authorisation for a medicinal product for human use and is required for all new marketing authorisation applications.

REACh ChemConsult GmbH gives support in the evaluation of the potential risks of the medicinal product to the environment and offer expertise to support the Environmental Risk Assessment Report according to guideline EMEA/CHMP/SWP/4447/00.

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.

We would be pleased to work for you. 

Please contact  us for further information and a non-binding offer.