EMA pubblica la linea guida per prevenire le carenze di medicinali (Shortage Prevention Plans - SPP)
EMA has published a revised guidance and a standardized template to support industry implementation of Shortage Prevention Plans (SPPs). The guidance anticipates requirements under the forthcoming revised EU pharmaceutical legislation, which will require marketing authorization holders (MAHs) to establish and maintain an up-to-date SPP for prescription medicines. Although the legislation has not yet been published in the Official Journal of the European Union, EMA recommends that MAHs begin implementing SPPs for prescription-only medicines marketed in one or more EU/EEA countries.
SPPs should use a proportionate, risk-based approach to identify supply vulnerabilities, assess the potential public-health impact of a disruption, and document measures to prevent or mitigate shortages. Required information includes:
- Product, authorization, and market details
- API and finished-product manufacturing sites
- Key inputs, suppliers, and geographic dependencies
- Production-volume allocation across manufacturing sites
- Previous shortages, root causes, and mitigation measures
- Alternative manufacturing arrangements and appropriate stock strategies
- Processes for demand forecasting, disruption detection, regulatory notification, escalation, review, and plan maintenance
The final risk classification—low, medium, or high—combines the medicine’s public-health impact with its supply-chain vulnerability. Greater documentation and more detailed risk controls are expected for medium- and high-risk products. EMA also recommends senior-management oversight and application of the principles in ICH Q9 and ICH Q12.
SPPs generally will not require routine submission. However, MAHs must be prepared to provide a plan to EMA, a national competent authority, or the European Commission within two days of a request. Plans may be grouped for products sharing a common supply chain, provided product-specific minimum information remains readily available.
Document Source
Guidance: guidance-industry-implementing-shortage-prevention-plans-en.pdf