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RoseA Sep 16, 2019 03:47 PM
Hi everyone,

I am interested in why an environmental risk assessment is not taken into account in the risk-benefit analysis when it comes to pharmaceuticals getting its license.

In an EEA report from 2018 called "Chemicals in the European waters" is says (like in most places i have found) that the ERA is not taken into account, as is the ERA for veterinary medicines. However, I am looking for the question WHY.

Please help me out.
Replies (1)
EEA Sep 18, 2019 09:54 AM
Dear Ms. 'RoseA',

Thank you for contacting the European Environment Agency (EEA).

We would suggest you to contact DG SANTE - DG for Health and Food Safety via the online request form available at https://ec.europa.eu/health/location_en, since your request is policy-related and thus falls outside the core remit of the EEA.

You might also find useful the following draft guidelines on ERA of medicinal products for human use, which were produced by the European Medicines Agency: https://www.ema.europa.eu/e[…]edicinal-products-human-use .

We wish you all the best in your research.

With kind regards,
EEA Enquiry Service