Chiesi Farmaceutici has a system of pharmacovigilance in order to assume liability for our products (whether marketed or under clinical development) and to take appropriate actions when necessary. We ensure that all information relevant to patient safety and the risk-benefit ratio of our products is continuously evaluated and implemented. When important safety issues arise, if applicable, we promptly notify healthcare professionals, patients and regulatory agencies concerned in accordance with current legislation.

What is Pharmacovigilance?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (Ref. World Health Organization, WHO. The importance of pharmacovigilance: safety monitoring of medicinal products, Genève, WHO, 2002).

In line with this general definition, the main objectives of pharmacovigilance in accordance with the applicable EU legislation are:

• preventing harm from adverse reactions in humans;
• promoting the safe and effective use of medicinal products, in particular by providing timely information about the safety of medicinal products for patients, healthcare professionals and the public.

Pharmacovigilance is therefore an activity contributing to the protection of patient and public health.

What is an Adverse Drug Reaction?

A response to a medicinal product which is harmful and unintended (response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility).

Adverse reactions may arise from use of the product within or outside the terms of the marketing authorization or from occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, abuse and medication errors.

What is Materiovigilance?

The Medical Device Vigilance (materiovigilance) is a system aimed at monitoring and evaluating incidents related to medical devices. The Medical Device Vigilance System aims to improve the protection of the health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.

What is an incident or an untoward event related to a medical device?

The term “incident” in the Medical Device Regulation (UE) 2017/745 means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.

Report adverse drug reactions, special situations and incidents directly to: pharmacovigilancenordic@chiesi.com