On March 11, 2025, Information Circular No. 022/CD/100.20.200 was published, bringing important updates on the export of medicines. Check out the main points:
Updating the Lists annexed to the Regulation:
The lists that form part of the Regulation on the prior notification of drug transactions abroad have been updated. These changes have an impact on the export and distribution of medicines to other EU member states.
Medicines with Compulsory Prior Notification:
The first list presents the medicines whose export, or distribution to other European Union countries, and respective quantities, depend on prior notification to INFARMED, I.P. This measure was regulated by Deliberation no. 027/CD/2025.
Medicines with Temporary Suspension of Export:
The second list features medicines whose export is temporarily suspended. It covers all the critical medicines that were in short supply in February and also includes medicines that are being supplied by means of an authorization for exceptional use. This decision was regulated by Resolution 028/CD/2025.
Effective Date of Amendments:
The updates take effect on the business day following the publication of the circular, i.e. as of March 12, 2025.
SiExp Platform update:
In line with the updates to the lists, the SiExp platform will also be adjusted to reflect these changes, facilitating the notification process.
Access to Lists in Electronic Format:
The updated lists are available in electronic format in the “Management of drug availability” section of the INFARMED, I.P. website.
These changes aim to ensure better control and monitoring of drug transactions outside the country, ensuring the continuous and adequate supply of essential products to the national and international markets.
Stay tuned for updates and check the INFARMED website regularly for more details on the changes to the regulations.
