In February 2025, INFARMED – the National Authority for Medicines and Health Products, I.P., introduced new rules for controlling the export of medicines in Portugal.
These measures aim to ensure that essential medicines remain available in Portuguese pharmacies—an issue highlighted in the new Regulation on Medicines Availability Management.
What Are the Main Changes?
To strengthen the control of medicines leaving the country, INFARMED has published two key documents: Circular Informativa No. 012/CD/100.20.200 and Deliberation No. 234/2025.
Now, there are two essential lists:
- The Prior Notification List (LNP) – Medicines that can be exported, provided INFARMED is notified in advance.
- The List of Temporarily Prohibited Medicines for Export – Medicines that cannot be exported due to a risk of shortages
To reduce unnecessary bureaucracy in reporting obligations, only wholesale distributors are now required to communicate exports.
Exceptions for Special Cases
It is important to note that, in exceptional circumstances, even medicines with suspended export status can be sent abroad. INFARMED may authorize exports in cases of:
- Natural disasters
- Conflicts
- Urgent humanitarian aid
Impact on the Pharmaceutical Market
The new rules place greater responsibility on wholesale distributors, requiring them to closely monitor the updated lists of restricted medicines and ensure compliance with regulations.
On the other hand, manufacturers and pharmacies benefit from a simplified process, as they are no longer required to submit reports on medicine exports or dispensing.
Continuous Market Monitoring by INFARMED
INFARMED continues to ensure ongoing monitoring of the pharmaceutical market through the Information System for Export Control (SIEXP). The lists of controlled medicines are regularly updated and published transparently, ensuring greater predictability and compliance within the sector.
These measures align with European Union regulations, which allow national controls to protect medicine supply, provided they are temporary and proportionate.
With these new rules, Portugal aims to balance participation in the international pharmaceutical market while ensuring that its population has access to essential treatments.
For more information, visit the official INFARMED website or consult the Diário da República.
If you have any questions, ELS Group is here to assist you!
Contact your local ELS consultant or email info@elssolutions.pt.
