Guidance is available for marketing authorisation holders for human and veterinary medicines on detecting and reporting medicine shortages, based on a harmonised definition of a shortage agreed upon by all national competent authorities and EMA.

When a shortage occurs, or is expected to occur, in one or more EU Member States, the marketing authorisation holder should report it to the national competent authorities concerned. If the shortage concerns a centrally authorised product, the marketing authorisation holder should also notify EMA. 

The guidance contains a reporting template for use if none is provided by the country in question.

It aims to facilitate the early notification of shortages to national competent authorities, allowing them sufficient time to make contingency arrangements where necessary. It covers:

• what constitutes a shortage;
• what issues marketing authorisation holders should report;
• who is responsible for monitoring supply and reporting shortages;
• when and whom to notify;
• what information to include in notifications.

It does not cover issues such as withdrawals of marketing authorisations, which can also affect a medicine's availability.