The European Medicines Agency (EMA) has published new guidelines on the development of Shortage Prevention Plans (SPP). These guidelines are linked to the new European Union pharmaceutical legislation (NPL) and are part of efforts to strengthen the security of medicine supply and reduce the risk of shortages.

Under the new pharmaceutical legislation, marketing authorization holders will be required to establish and maintain shortage prevention plans for prescription medicines and, where applicable, other medicines. This obligation is expected to come into force within the European Union around mid-2027.

Shortage prevention plans are based on risk assessments that consider, among other factors, vulnerabilities in production and supply chains, the potential impact of supply disruptions on patients, and measures to prevent medicine shortages. EMA’s guidelines adopt a risk-based approach, where the scope of the plans is tailored to the risk associated with each medicine.

Preparations for the Icelandic Pharmaceutical Market

The provisions of the new pharmaceutical legislation regarding shortage prevention plans have not yet come into effect in Iceland. Nevertheless, the Icelandic Medicines Agency would like to bring the upcoming changes to the attention of marketing authorization holders and other relevant stakeholders and encourages companies to familiarize themselves with EMA’s guidelines and prepare in advance.

Preventive measures and active risk management play a crucial role in ensuring the continuous supply of medicines, particularly in smaller markets like Iceland, where supply chains can be especially vulnerable to disruptions.

Further information regarding the implementation and execution of the new rules in Iceland will be published as preparations progress and the effective date of the relevant provisions approaches.

EMA SPP guidlines