Home » Regulatory areas » Environmental Risk Assessment / Pharmaceuticals

Environmental Risk Assessment / Pharmaceuticals

Assessing the environmental impact of your pharmaceuticals is in good regulatory hands with us

GAB Consulting has more than 15 years experience in the fields of environmental fate and ecotoxicology of crop protection and biocidal products. Its dedicated, environmental expert group, can assist with scientific and regulatory support for the Environmental Risk Assessment of pharmaceuticals (human or veterinary drugs) and to generate data or – if applicable – waiver which will successfully meet European regulatory requirements

Regulatory Aspects

In 2006, the guidelines on the environmental risk assessment of medicinal products for human use came into force. Since then, the assessment of the environmental impact of medicinal products is a legal obligation and must be performed to evaluate and limit potential adverse effects of medicines on the environment. In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by pharmaceutical products should be submitted and their environmental impact assessed.

Such Environmental Risk Assessment (ERA) is required for all new marketing authorization applications for a medicinal product through a centralized, mutual recognition, decentralized or national procedure.

Based on its broad experience in the field of environmental sciences of agrochemicals and biocides, GAB Consulting can offer services to assess the potential risk of pharmaceutical products to the environment including the full range of environmental fate and ecotoxicity testing required in Phase II of the tiered approach.

Preparing Environmental Risk Assessments

GAB Consulting’s expertise in the preparation of Environmental Risk Assessments for the separate categories of industrial chemicals and biocides, as well as our other business areas, offers you the best service to comply with the requirements for an Environmental Risk Assessment. Our experts can assist in the preparation of environmental evaluations and negotiations with the relevant authorities. In addition, we constantly monitor developments in regulatory affairs ensuring an exhausting fulfilment of your obligations.

GAB Consulting is part of the SynTech Research Group. For more information visit www.syntechresearch.com