On 30 October 2025, INFARMED published the Informative Circular No. 125/CD/550.20.001, introducing a new procedure for Marketing Authorization Holders (MAHs) in Portugal to submit and update national pharmacovigilance contact details. 

What has changed? 

• From the date of this circular, all MAHs must submit their national pharmacovigilance contacts exclusively through the SMUHALTER portal, under the “PV National Contact Submission” section. 

• The deadline for compliance with this requirement is January 31, 2026. 

• At the time of submission, a cover letter must be uploaded using the template provided by INFARMED. The cover letter must be correctly completed, dated, and signed. 

• Submission of contacts through previously used channels is no longer valid. 

• The portal facilitates the electronic management of operational pharmacovigilance contacts, ensuring record-keeping, traceability, and compliance with regulatory requirements. 

• This obligation does not apply to: 

• Medicinal products authorized through the centralized procedure, for which the specific update procedure indicated by INFARMED (via email) remains in effect. 

• New marketing authorization applications, which continue to follow the standard MA dossier process. 

Purpose of the measure 

The implementation of submission through the SMUHALTER portal aims to modernize and increase the efficiency of the national pharmacovigilance system by centralizing contact management and facilitating communication between INFARMED and MAHs. This will contribute to strengthening the safety of medicines in Portugal. 

For more information, please see Circular Informativa nº 125/CD/550.20.001 and comunicado do INFARMED.