New shortage prevention recommendations for pharmaceutical companies
Network of European medicines authorities has compiled recommendations for pharmaceutical companies for the prevention of medicine shortages. The recommendations describe the responsibilities and roles of different stakeholders in the pharmaceutical sector in the prevention of medicine shortages and in the management of shortages.
Ten recommendations have been issued to marketing authorisation holders and other actors in the distribution chain to prevent medicine shortages and to reduce their impact.
The recommendations given include the following:
- informing national competent authorities of shortages as early as possible and providing detailed information to better predict the possible impact and implement preventive measures,
- establishing shortage prevention and shortage management plans,
- optimising pharmaceutical quality systems and increasing 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.
The recommendations are based on an analysis of the causes of medicine shortages and the authorities' experiences of the coordination of shortages. European industry associations of pharmaceutical companies have also been consulted in the drafting of the recommendations.
European Medicines Agency EMA’s press release on 17 May 2023:
Guidance for industry to prevent and mitigate medicine shortages
Fimea online news 13 February 2023:
EU Joint Action project CHESSMEN has begun
- Johanna Linnolahti, Head of Division, tel. +358 29 522 3231
- Julia Lehtinen, Senior Inspector, tel. +358 29 522 3288
- Fimea e-mail addresses are in the format firstname.lastname@example.org