Hazardous medicinal products: Commission regulation to improve the protection of workers

The main purpose of the new list is to improve the quality of the risk assessment of hazardous medicinal products (HMPs). It aims at further strengthening the safety of workers due to the exposure to HMPs.

The Commission issued on 18 February 2025 a Communication establishing an Indicative list of hazardous medicinal products.

It completes the previous Guidance for the safe management of hazardous medicinal products at work issued by the European Commission in 2023. It does not aim to replace HMPs with medicines that are not hazardous or are less hazardous to workers’ health.

Through this list, the European Commission also aims at improving the quality of the risk assessment according to Directive 89/391/EEC on Carcinogens, Mutagens or Reprotoxic Substances Directive (CMRD) and to provide an EU level approach on this topic.

Background

The Communication follows on Article 18a of Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work.  

It was issued following the request of the co-legislators to develop a definition and establish an indicative list of HMPs or the substances contained therein no later than 5 April 2025.

HMPs are essential in the treatment of patients with a wide range of medical conditions, including cancer and rheumatology. HMPs include notably some antiviral, immunosuppressants and antineoplastics medicines. 

Due to their effect on the body, often HMPs fall under the category of carcinogens, mutagens and reprotoxic substances. While they contribute to saving patients’ lives, workers who are exposed to them at the workplace may be the subject of unintended effects. Some examples of exposed workers are oncology nurses, oncology pharmacists, radiotherapists and veterinarians in sectors such as healthcare and veterinary care.

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