On 17th of May 2023, EMA published recommendations for industry on the good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.
Medicine shortages are recognised as a global problem by the European Medicines Regulatory Network (EMRN) and other international organisations such as the World Health Organization. Shortages have been a global issue for some time, increasingly affecting European countries with a significant impact on patient care. Improving the availability of medicines authorised in the European Union (EU) is a key priority for the EMRN. Since 2016, a task force set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use, has been looking at availability issues, including medicines that are authorised but not marketed and supply chain disruptions, to improve the continuity of supply of human and veterinary medicines across Europe.
Guidance document recommends good practices to marketing authorisation holders, wholesalers, distributors and manufacturers on shortage prevention for human medicines, i.e. to reduce the likelihood of shortages occurring in the first instance. Recommendations on how to mitigate a shortage event are also included. Document describes some of the most common reasons for shortages and is not intended to be exhaustive. In addition, the document is not intended to provide any conclusive interpretation of the obligations imposed on stakeholders by the relevant EU legislation and is without prejudice to the application of such provisions. The guidance describes the various stakeholders involved in the medicine supply chain and their responsibilities and roles in the prevention and management of medicine shortages. It provides ten recommendations for marketing authorisation holders, wholesalers, distributors, and manufacturers to minimise the occurrence of medicine shortages and their impact.
Recommendations are based on the analysis of the causes of shortages and regulators’ first-hand experience in coordinating the management of shortages and include:
- informing national competent authorities of potential or actual shortages as early as possible and providing detailed information to better predict the possible impact and implement preventive measures;
- establishing robust shortage prevention and shortage management plans;
- optimising pharmaceutical quality systems and increasing the resilience of complex, multinational supply chains;
- timely communication between the various stakeholders in the medicine supply chain;
- general principles to promote fair and equitable distribution of medicines to meet the needs of patients.