Submission of contact on pharmacovigilance issues at national level using the SMUH-ALTER Portal
30 oct 2025
Para: Marketing authorisation holders
Contactos
- Centro de Informação do Medicamento e dos Produtos de Saúde (CIMI); Tel. 21 798 7373; E-mail: cimi@infarmed.pt; Linha do Medicamento: 800 222 444
Contact person for pharmacovigilance issues on a national level
With the transposition of the Directive 2010/84/EU of the European Parliament and of the Council, of 15 of December, into national law (through Decree-Law nº 176/2006, of 30th of August, as amended), it became mandatory to appoint a contact person for pharmacovigilance questions at national level who reports to the qualified person responsible for pharmacovigilance in the European Union (Qualified Person Responsible for Pharmacovigilance – EU QPPV).
The contact person for pharmacovigilance issues at national level must meet the following conditions:
- Be nominated by the MAH
- Be resident in Portugal
- Perform duties on a permanent and continuous basis
- Have adequate training and experience in pharmacovigilance, knowledge of the pharmacovigilance system in force and of the Portuguese language
It is the responsibility of the person responsible for pharmacovigilance (EU QPPV) to define the appropriate training and experience that the national contact person must have.
The indication of the contact person for pharmacovigilance issues at national level must be included in the submission of MA applications.
To indicate the contact person for pharmacovigilance issues at national level for medicines authorised by centralised procedure, the request must be sent by email to centralizados@infarmed.pt including the request for the allocation of registration numbers.
This information must be updated whenever there is a change in that contact person. The procedure for submitting updates of the contact person for pharmacovigilance issues at national level is carried out through the SMUH_ALTER portal, accessible at: https://app.infarmed.pt/smuh_alter/frmlogin.aspx, selecionando o separador PV National Contact Submission. After completion, the Application form must be dated, signed and attached on the SMUH-ALTER portal.
To update the contact person for pharmacovigilance issues at national level, for medicines authorised by centralised procedure, the request must be sent by email to dgrm@infarmed.pt, with the subject: Request to update the contact person for pharmacovigilance issues at national level, attaching the Application form duly completed and signed.
