INFARMED has reinstated new rules upon the Resolution No. 233/2025 on the Regulation for the Management of Medicine Availability that was published in the Diário da República, updating the previous 2019 regulation.
Why was this update made?
These new rules are based on the experience gained by INFARMED – the National Authority for Medicines and Health Products, I.P., and the entire pharmaceutical distribution and commercialization sector in Portugal over recent years.
This update, resulting from the assessment of medicine availability at both national and European levels, aims to improve access to medicines in Portugal, while also considering European initiatives to strengthen supply chains for critical medicines.
Strengthened Responsibilities for Sector Stakeholders
The regulation clarifies and expands the responsibilities of various sector agents, including:
- Marketing Authorization Holders (MAH)
- Wholesale Distributors
- Pharmacies
- Hospital Pharmacy Services
- Other legally authorized entities dispensing medicines to the public
Measures to Mitigate Shortages
To prevent and mitigate future medicine shortages, INFARMED, in coordination with sector entities, will implement measures such as:
- Controlled distribution of medicines
- Stock allocation under INFARMED’s guidance
- Stock and supply chain monitoring
- Guidelines for distribution, prescription, and dispensing
- Identification of therapeutic alternatives
Export of Medicines – Additional Regulation
The Regulation on the Control of Medicine Transactions for Export was also published in the Diário da República, alongside the Regulation for the Management of Medicine Availability. This document addresses the issues highlighted in INFARMED I.P.’s 2024 Annual Report, strengthening export controls to ensure national supply is not compromised.
This represents a significant step in mitigating shortages and ensuring the availability of medicines in Portugal. These stricter monitoring and distribution measures reinforce the collaboration between INFARMED and key sector players, contributing to greater supply chain stability and a more effective response to shortages.
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Please contact your local ELS consultant or email: info@elssolutions.pt
