The updated guidance on the preparation of an application for authorisation is now published.

This version reflects the 2019 General Court judgments on interpreting the suitability of alternatives in the application process. It clarifies the need for applicants to include substitution plans in their applications if the analysis of alternatives shows that suitable alternatives are available in the EU – although these alternatives might not be technically or economically feasible for the applicant.

The document will be made available in 23 EU languages.