These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which vulnerabilities in the supply chain have been identified.
Measures considered by the MSSG will be selected according to the risks posed to the supply chain and the type of medicine, and include:
- Possible recommendations to marketing authorisation holders (MAHs) to increase manufacturing capacity and diversify the suppliers in the supply chain (for example through the addition of alternative manufacturing sites), and to monitor forecasts of supply and demand of medicines and available stocks in the entire supply chain.
- Recommendations to certain actors in the supply chain, such as MAHs, and the European Commission to stockpile medicines to protect against fluctuations in demand or supply.
- The possibility to request a MAH to establish a shortage prevention plan for medicines in the Union list of critical medicines. EMA will publish guidance and templates for shortage prevention plans in June 2024.
- Provision of scientific and regulatory support to address vulnerabilities in the supply chain, including assistance to small and medium-sized enterprises…
