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Pharmacovigilance

Pharmacovigilance is a key factor in the development and use of a drug. It includes all those activities whose objective is to collect and evaluate information on the safety of drugs on an ongoing basis, including their suspected adverse reactions. Through an ongoing review of the safety profile of medicines, Pharmacovigilance establishes the implementation of appropriate precautionary measures, ensuring that the drugs available on the market have (in their authorised terms of use) a benefit-risk ratio that is favourable for the population. In this sense, Pharmacovigilance is an essential activity to learn more about the drugs, to properly inform the doctors who prescribe them and to protect patients who take them, ensuring their safe use over time through the close cooperation between all industry professionals involved, national and international health authorities, local healthcare authorities and pharmaceutical companies.

 

The ultimate goal of Pharmacovigilance for the Dompé Groupis to constantly evaluate the tolerability profile of the drug throughout its period of use, from the first clinical trials up to and through post-marketing.

What is an adverse reaction?

An adverse reaction is a noxious and unwanted effect resulting from:

  • use of a medicinal product in accordance with the provisions contained in the marketing authorisation;
  • therapeutic errors;
  • use of the drug not according to the instructions contained in the marketing authorisation (off label), including overdose, misuse, and abuse of the medicinal product;
  • exposure due to occupational reasons.

“Effect” in this context means that there is at least a reasonable possibility of a causal relationship between the drug and the event.

What to do in case of a suspected adverse reaction to a drug

Suspected adverse reactions can be reported spontaneously both by citizens and healthcare professionals in one of the following ways:

  • by filling out the suspected adverse drug reaction reporting form (electronic or printed) and sending it to the Pharmacovigilance Manager of one’s facility by email or fax sent to the addresses listed on the following page;
  • or directly online at www.vigifarmaco.it by following the wizard.

The Pharmacovigilance Manager will proceed with the registration and/or validation of reports in the Rete Nazionale di Farmacovigilanza [National Pharmacovigilance Network] of the AIFA (Agenzia Italiana del Farmaco [Italian Medicines Agency]) connected to EudraVigilance, the European database for collecting ADRs managed by the European Medicines Agency (EMA).

Alternatively, suspected adverse drug reactions can be reported to the Marketing Authorisation Holder (MAH) of the medicinal product that is suspected to have caused the adverse reaction. The company will notify every report in the manner within the deadlines provided for by laws and regulations in force.

Like other Member States, Italy too, is part of a European pharmacovigilance system and operates in accordance with the procedures agreed at a Community level and defined by the European Medicines Agency (EMA).

The Citizen should consult a Doctor (providing all the available details about the event and His/Her medical history) before taking any other initiatives, in particular with regard to the clinical treatment of a suspected adverse reaction.

For further information about pharmacovigilance

http://www.agenziafarmaco.gov.it/
http://www.ema.europa.eu/ema

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