LSHC Horizons Brochure 2024 - Flipbook - Page 7
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | ESG and Supply Chain
7
Environmental risk assessment in the
new EU pharmaceutical law package
With its proposal for new pharmaceutical
legislation, the European Commission aims to
reduce the environmental impact of medicinal
products. To achieve this objective, the new
legislation will strengthen and extend the
current requirements for environmental
risk assessment (ERA) for marketing
authorization holders.
Under the proposed EU legislation, the ERA
shall include risk mitigation measures to limit
or even avoid emissions to air, water and soil
of pollutants. Non-compliance with the ERA
requirements or not proposing (sufficient)
precautionary and safety measures on the
environmental risks that were identified in
the ERA, should lead to refusal of the
marketing authorization.
Although not yet adopted, the new set of
legislation aims to impose a wider and stricter
set of requirements on manufacturers of
medicinal products with regard to their impact
on the environment.
These new requirements that would apply
specifically to marketing authorization holders
of medicinal products, come in addition to
extensive other new legislation in the area of
environment, the European Commission’s
“Green Deal” as well as broader evolving
ESG considerations.
Hein van den Bos
Partner
Amsterdam
Milan Tuijp
Junior Associate
Amsterdam
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