Latest update: 25/05/2023

Guidance for the safe management of hazardous medicinal products at work

This non-binding guidance, published by the European Commission in 2023, provides an overview of existing good practices and advice on reducing workers' exposure to hazardous medicinal products.

Hazardous medicinal products (HMPs) are medicinal products that can cause carcinogenic, mutagenic or reprotoxic (CMR) and other adverse effects in exposed workers. All HMPs containing one or more substances classified as carcinogenic, mutagenic or reprotoxic fall within the scope of Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work.

The aim of the guide is to increase awareness of the risks of hazardous medicinal products and increase the uptake of good practices for the handling of HMPs across the EU. It also serves as a useful reference point and support for training activities. 
The guide is intended for all types of organisations, regardless of size, in both the public and private sectors, and provides practical information for workers, employers, public authorities, safety experts and occupational physicians.

It is divided into sections covering both general and specific topics. The general topics apply to all life cycle stages and include information on:

  • the identification of hazardous medicinal products;
  • creating a safe working environment;
  • risk assessment;
  • exposure assessment;
  • education and training;
  • health surveillance; and
  • incident management. 

The sections on specific topics cover each stage of the life cycle of HMPs: production, transport and storage, preparation, administration to human and animal patients, as well as waste management. 
Finally, there are also annexes featuring a glossary, additional information and examples of risk assessment templates and summary sheets.

Publication details
Published by: EU Commission
Publication date: 2023
Number of pages: 220 pp.

Available in languages

English