Pharmacovigilance at Bluemed

Pharmacovigilance at Bluemed

BLUEMED has implemented a Pharmacovigilance System, which ensures that all suspected adverse reactions resulting from the use of the medicines we are MAH are evaluated and validated and subsequently notified to the National and / or International Regulatory Authorities.

    • - Contribution to the improvement of the national and European Pharmacovigilance system.
    • - Development of a Proactive Pharmacovigilance attitude.
    • - Collection and evaluation of all suspected adverse reactions and notification to the Regulatory Authorities in accordance with the legislation in force.
    • - Contribution to the adequate monitoring of BLUEMED drug safety data, through the elaboration of Periodic Safety Update Reports.
    • -Improve the information available to doctors / pharmacists and contribute to the safe and rational prescription of medicines.
    If you are aware of any suspected adverse reaction to one of the BLUEMED drugs, contact us to:

    BLUEMED Unipessoal Lda
    Pharmacovigilance Department
    Rua Poeta Adriano Correia de Oliveira, 233
    4510-698 Fânzeres - Porto, Portugal
    Tel: + 351-223228495
    The ADRs can also be notified to the Health Authorities through the form available on the INFARMED website and sending the adverse reaction information to the following contacts:

    INFARMED - National Authority of Medicines and Health Products, IP
    Parque da Saúde de Lisboa - Avenida do Brasil, 53
    1749-004 Lisboa - Portugal
    Tel: 217987100
    Fax: 217987316
    Infarmed - Notification Portal Adverse Reactions

    European Medicines Agency (EMA)
    Domenico Scarlattilaan 6
    1083 HS
    The Netherlands
    Tel: +31(0)88 781 7108
    European database for reporting reactions adverse drug reactions

    Unidade Regional de Farmacovigilância do Norte
    Tel: 225 513 681 - Fax 225 513 682

    Unidade Regional de Farmacovigilância do Centro
    Tel: 239 480 100 - Fax 239 480 117

    Unidade de Farmacovigilância de Setúbal e Santarém
    Tel: 217 971 340

    Unidade Regional de Farmacovigilância do Sul
    Tel: 217 971 340 - Fax 217 971 339