The European Medicines Agency defines “off-label” the use of a medicine for an unapproved indication or in an unapproved age group, dosage, or route of administration. The majority of marketed medicines world‐wide, including those commonly used or which could potentially be used in the paediatric population, have not been studied in the relevant paediatric age groups and are not approved by regulatory authorities for use in children. This topic is of particular interest for TEDDY Network, because the off-label medicines use in paediatrics is widespread in Europe and often there is no alternative than off-label treatments. For this reason, ad hoc TEDDY Working Group (WG) has been created to discuss and promote initiatives in this framework. One of the main activities undertaken within the WG is the development of a first draft of the paediatric guide, using a consensus approach. Starting from recent literature data and documents from paediatric experts, networks, public bodies/institutions, a comprehensive overview of the existing documents and recommendations on the issue of paediatric off-label medicines use will be prepared. On these bases, a first draft of relevant aspects to consider will be prepared followed by 1-2 rounds of consultation using a consensus approach (Delphi or similar). At the end of this process, a consensus /policy statement will be prepared, formalised within the TEDDY Network and shared with the European and National Agencies, scientific societies and other stakeholders, to receive support for its dissemination.