Regulatory & Market Services Italy

Quality & Pharmacovigilance

Compliant operations and continuous safety oversight across every product we handle.

Quality

Quality first

Temperature-controlled transport

All products are transported under controlled temperature conditions, with monitoring systems that ensure compliance with the applicable standards.

Packaging integrity

Products are packaged to match the reference brand product, with Italian texts aligned to the approved documentation.

GMP and GDP sites

Relabelling and repackaging are carried out directly by sites authorised by AIFA operating under Good Manufacturing Practice and Good Distribution Practice.

Regulatory compliance

Marketing authorisations, packaging sites and leaflet variations comply with Italian pharmaceutical legislation (Legislative Decree 219 of 24 April 2006) and are published in the Gazzetta Ufficiale.

Pharmacovigilance

What pharmacovigilance is


Pharmacovigilance is the set of activities aimed at continuously evaluating all information relating to the safety of medicinal products on the market, and at ensuring a favourable benefit/risk balance for the population. It relies on a database collecting reports of suspected adverse reactions, often submitted spontaneously by patients, doctors, healthcare professionals and pharmaceutical companies.

Any unexpected event and any undesirable effect occurring during treatment — whether or not it is described in the package leaflet — must be reported promptly to the treating physician or pharmacist, or directly to the pharmacovigilance officer of the relevant local health authority (ASL).

Reporting an adverse reaction

If you are unable to contact healthcare personnel directly, you can complete the citizen reporting form, in paper or electronic format, and send it to the pharmacovigilance officer of your local health authority.

Questions about quality or safety?

Our team is available for quality documentation and pharmacovigilance enquiries.