Notification of Adverse Reactions

Who can report an adverse reaction?

Anyone can report an adverse reaction, regardless being or not a healthcare professional. Patients/Consumers can report adverse reactions.

 

What to report?

All adverse reactions can be reported, regardless the seriousness and expectedness.

 

When and how to report?

1. Patients 

Patients shall report any suspicion of an adverse reaction to their healthcare professional. Additionally, they can report an adverse reaction to Tecnimede Group or to the Competent Authority in the country where the adverse reaction occurred.

 

2. Healthcare Professionals 

Adverse reactions can be reported directly to Tecnimede Group or to the Competent Authority in the country where the adverse reaction occurred.

 

What are the minimum criteria?

The notification of an adverse reaction is considered valid if the following minimum criteria are fulfilled:

  • Patient Identification (the initials, age and gender are enough),
  • Identification of the Reporter,
  • Description of the Adverse Reaction,
  • Identification of the suspicious Medicinal Product.

All the information collected regarding an adverse reaction is confidential.

Any other information that can be provided (e.g., concomitant medication, history of allergy, past adverse reactions, among others) is helpful in the evaluation of the report and consequently, in the benefit-risk evaluation of the medicinal product.