Pharmaceutical companies take note: the EU plans to refuse marketing authorizations for environmentally-unfriendly medicines.  

The EU has published a package of revisions to the bloc’s common pharmaceutical regime.  Many revisions aim to reduce the environmental impact of human medicinal products.  The key environmental measures include:

• Pre-authorization — Environment-related refusals:  The European authorities will be able to refuse a marketing authorization application where the accompanying Environmental Risk Assessment (“ERA”) is not adequate, or if the environmental risks have not been sufficiently addressed.  
• Post-authorization — Environment-related monitoring and conditions of use:  The European authorities will be able to impose environment‑related conditions of use on authorized medicines, including limiting the product to prescription-only or requiring additional post-authorization ERAs.  They will also be able to suspend, revoke or vary marketing authorizations where a medicine presents a serious risk to the environment.
• Awareness and knowledge building — Warnings and environmental risk databases:  Companies will be required to include additional information on environmental impact in a medicine’s EPAR, and additional awareness‑raising information in the product packaging of antimicrobials. 

In this post, we lay out what pharmaceutical companies need to know about the key environmental measures.