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.