On 30 October 2025, INFARMED, I.P., through Information Circular No. 125/CD/550.20.001, has outlined a new procedure for the appointment of the Contact Person for Pharmacovigilance Issues at National Level. The update aims to streamline the process for indicating/updating contacts while ensuring centralized and accurate information.

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According to Decree-Law No 176/2006, of 30th of August, as amended, Marketing Authorisation Holders (MAHs) are legally required to appoint a Contact Person for Pharmacovigilance Issues at National Level. To optimize this process, INFARMED has implemented a methodological update that mandates the use of the SMUH-ALTER Portal for all submissions and updates.

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As of 30 October 2025, communications related to the appointment or update of the national pharmacovigilance contact(s) must be performed exclusively through the SMUH-ALTER Portal, available at https://app.infarmed.pt/smuh_alter/frmlogin.aspx. All MAHs are required to submit or update their current contacts by 31 January 2026, using the PV National Contact Submission section of the portal. The corresponding Application Form must be duly dated, signed, and uploaded via the same platform. The official form is available here: Update of the contact person responsible for pharmacovigilance issues at national level.

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INFARMED also clarifies that this process does not apply to the following situations:

• New Marketing Authorisation applications, where the contact person is already identified within the MA dossier;

• Applications via the Centralised Procedure: the contact person must be indicated by email to centralizados@infarmed.pt with the request for the allocation of registration numbers. For any subsequent changes/updates, the request should be sent to dgrm@infarmed.pt with the subject: Request for update the Contact on pharmacovigilance issues at national level, attaching the Application Form (the form mentioned above).

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This update reinforces INFARMED’s commitment to improving regulatory processes and data integrity in pharmacovigilance communications at the national level.

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