Primary source: EMA - What's new RSS
MAHs are now required to develop and maintain an up-to-date Shortage Prevention Plan (SPP) for any prescription medicinal products, and must submit this plan within two days upon request from authorities during crisis situations.
The implementation of SPPs is critical for ensuring the continuous availability of medicines in the EU, addressing potential shortages, and reinforcing supply chain resilience, which directly impacts patient care and public health.
MAHs must allocate resources to develop and maintain SPPs, ensuring they meet the new regulatory requirements and are ready for submission within two days upon request in crisis situations.
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MAHs must allocate resources to develop and maintain SPPs, ensuring they meet the new regulatory requirements and are ready for submission within two days upon request in crisis situations.
The European Medicines Agency (EMA) has published a new guidance document detailing the requirements for industry on implementing Shortage Prevention Plans (SPP). This guidance outlines that all Marketing Authorisation Holders (MAHs) must develop and maintain an up-to-date SPP for any medicinal products subject to prescription in the EU. The document provides information on the minimum set of data required for the SPP and a submission timeline following requests during crisis situations.
What changed: MAHs are now required to develop and maintain an up-to-date Shortage Prevention Plan (SPP) for any prescription medicinal products, and must submit this plan within two days upon request from authorities during crisis situations.
Why it matters: The implementation of SPPs is critical for ensuring the continuous availability of medicines in the EU, addressing potential shortages, and reinforcing supply chain resilience, which directly impacts patient care and public health.
Practical implication: MAHs must allocate resources to develop and maintain SPPs, ensuring they meet the new regulatory requirements and are ready for submission within two days upon request in crisis situations.
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