Strengthened Environmental Risk Assessment requirements under the proposed new directive on medicinal products for human use

As part of the revision of the EU pharmaceutical legislative framework, a new directive on medicinal products for human use is proposed, which will repeal Directive 2001/83/EC. One of the objectives of this proposed directive is to reduce the environmental impact of medicinal products. This proposal strengthens the requirements for the environmental risk assessment (ERA) and extends the scope of the ERA to cover new protection goals, including antimicrobial resistance.

Currently, Article 8(3)(g) of Directive 2001/83/EC only requires an ERA to be submitted with the application for a marketing authorisation. The accompanying guidelines for the ERA describe how to assess the potential risks of the medicinal product to the environment and prescribe precautionary and safety measures to be considered if environmental risks cannot be excluded. However, under Directive 2001/83/EC, the result of the ERA cannot be a reason to refuse the marketing authorisation.

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