Proposal major revision of EU pharmaceutical legislation
  Published on May 2, 2023
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End of April, the European Commission has released its proposal for major change in the human pharmaceutical legislation, undoubtedly making the system more sustainable. One of the key changes is the importance of the environmental risk assessment (ERA), in line with the European Green Deal. The ERA rightfully now becomes a possible reason for not granting a new marketing authorization or withdrawing an existing one, which was previously only the case for veterinary medicines. Moreover, the ERA will need to be more profoundly worked out, consistent with other EU regulations such as REACH, veterinary medicines, water framework directive, etc. requiring a novel dimension in the life cycle of a medicine.

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