- Regulatory Affairs: MAHs need an up-to-date Shortage Prevention Plan ready for submission within just two days of an EMA or authority request.
- Quality Assurance: QA teams should ensure supply-chain risk assessments, prevention controls and supporting documentation are approved, current and inspection-ready.
- Supply Chain & Manufacturing: Teams need to identify critical dependencies and shortage risks early, then maintain mitigation measures before supply disruptions occur.
EMA Tightens Shortage Prevention Expectations Ahead of 2027
EMA says the updated guidance aligns with Article 117 of the new EU pharmaceutical legislation, which introduces an obligation for MAHs to maintain a shortage prevention plan, or SPP, for prescription medicines in the EU. The European Commission may later extend the scope.
The new version replaces guidance issued in December 2024 and reflects feedback from the EU Medicines Regulatory Network, the Medicine Shortages Single Point of Contact Working Party and industry associations.
Each plan must contain product information, shortage prevention measures, a supply-chain risk assessment and a risk classification. Therefore, MAHs need to understand where supply interruptions could occur and which measures could prevent, mitigate or manage those risks.
The Two-Day EMA Rule That Could Test Pharma Readiness
The most important operational point is the submission timeline. EMA states that MAHs do not need to routinely submit every SPP. However, national competent authorities, EMA or the European Commission may request one, and the MAH then has two days to provide a copy.
That requirement changes the practical decision for pharmaceutical companies. Waiting until an authority requests the document could create unnecessary pressure. Instead, companies need to keep the required information complete, current and easy to retrieve.
EMA also allows companies to group medicines that share a common supply chain. However, the minimum data required under Annex I must remain available for each relevant medicine within the same two-day period.
Here’s how the new EMA requirement could reshape responsibilities across key pharma teams.
| Role | Main risk | Required Response | Evidence to Maintain | Timing |
|---|---|---|---|---|
|
Regulatory Affairs |
Late response |
Maintain the SPP |
Current plan and product data |
Before any request |
|
QA / Quality Leadership |
Weak risk governance |
Review controls |
Approved risk assessment |
Ongoing |
|
Supply Chain |
Unidentified vulnerabilities |
Map dependencies |
Supply-chain risk information |
Ongoing |
|
MAH Governance |
Incomplete grouped plans |
Confirm minimum data |
Annex I data set |
Within two days |
Why Pharma Teams Should Prepare for EMA Shortage Plans Now
Companies should now review whether their shortage documentation matches the updated EMA structure, confirm ownership of each SPP, verify the supply-chain risk assessment, test document retrieval and ensure grouped plans contain the required minimum data.
The next development will be EMA’s revised guidance and template for shortage mitigation plans. The agency says it expects adoption in Q4 2026. That update will further shape how MAHs prepare for and manage medicine shortages before the new pharmaceutical legislation takes effect.
A two-day submission window leaves little room to build compliance evidence after a regulatory request arrives. If your team is reviewing its readiness for the new EMA shortage prevention requirements, explore how Zamann Pharma’s Quality Management System support can help strengthen risk management, documentation, and regulatory preparedness.
Source: Raps.Org