Pharmacovigilance encompasses all activities that contribute to the protection of public health. These activities are aimed at identifying, assessing, understanding, and preventing adverse effects or any other issues related to the use of medicines, in order to ensure a favorable benefit/risk ratio for the population.

Pharmacovigilance is a mandatory activity by law, as required by Italian and international health authorities.

The objective of pharmacovigilance is therefore to continuously provide the best possible information on the safety of medicines, thereby enabling the adoption of appropriate measures.

Pharmacovigilance has four main objectives:

• To recognize, as quickly as possible, any adverse drug reaction (ADR).
• To improve and increase information about suspected or known ADRs.
• To assess the benefits of a drug in comparison with others or with different types of therapy.
• To communicate information to Health Authorities in order to improve therapeutic practice.

How to report an Adverse Reaction

Reporting a suspected adverse drug reaction (ADR) is a fundamental tool to ensure the safe use of medicines in everyday clinical practice. Reports can be made by healthcare professionals, patients, or anyone who becomes aware of an adverse event, thereby contributing to the continuous updating of the benefit/risk profile of medicines.

It is possible to report an adverse reaction directly to Mastelli S.r.l. using the following contacts:

• Phone: +39 0184 5111
• E-mail:
  farmacovigilanza@mastelli.it
  or: pharmacovigilance@virelpharma.it

Alternatively, one of the following official methods provided by AIFA (the Italian Medicines Agency) can be used:

A) Completion of the paper reporting form for suspected adverse reactions, available on the AIFA website. The form must be chosen based on the reporter (citizen or healthcare professional). Once completed, the form must be sent to the Pharmacovigilance Officer (RFV) of the relevant local healthcare facility.

B) Completion of the electronic reporting form online via the AIFA portal (https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse). In this case as well, the form can be completed digitally, saved, and sent via email to the RFV of the relevant facility. Alternatively, it can be printed and sent in the same way as the paper form.

Individuals who become aware of a potential problem or report of an accident or adverse effect involving a medical device, whether a site employee or agent/field representative, must report it immediately (either directly or through the company switchboard) to the internal Medical Director or Regulatory Affairs office who will immediately inform the Medical Devices Post-Sales Surveillance Manager. 

Cristina Cavalli

phone: +39 342 6312094

email: cristina.cavalli@mastelli.it 

Giulia Cattarini Mastelli

phone: +39 348 2717442

email: giulia.cattarini@mastelli.it

Mastelli

phone: +39 0184 5111

email: vigilanza@mastelli.it

It is advisable to note the name, surname and email or telephone number of the reporter, should it be necessary to retrieve further information.

Public and private healthcare professionals, based on what they discover in the course of their work, are obliged to immediately notify the competent authority, through the competent local health unit, of any alteration in the characteristics and performance of a device, as well as any inadequacy in the instructions for use that could be or have been the cause of death or worsening of a patient's health condition.

A specific section of the Ministry of Health's website at the following link is provided for this purpose: http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=26&area=dispositivi-medici&menu=vigilanza

Reports of events occurring in Italy should be sent to dgfdm@postacert.sanita.it.

Send a copy to Mastelli srl for information.

For reports of events occurring in other European countries see the contact list of the relevant Competent Authorities at the following link: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_vigilance_contact_points.pdf

As an alternative, it is possible to report directly to the company MASTELLI at the following addresses:

Mastelli

phone: +39 0184 5111

email: vigilanza@mastelli.it

It is good practice to note the reporter's first name, last name and email or phone number, should you need to retrieve further information.