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  • Writer's pictureAvv Aldo Lucarelli

Pharmaceutical Law in Italy.

Pharmaceutical Law is a complicated section of Italian Legal System, with many different applications in different fields. The core section is represented by the NHS and its offices and structures.

The Italian National Health System, NHS, was established under Law no. 833/1978.

The NHS is structured according to the Constitution, which defines its national and regional powers. The NHS consists of the:

Ministry of Health (the central body).National Institute of Health and IIZZSS (Institute of Experimental Zooprophylaxis), Regions, Local health authorities, such as mayors.

Regions, has many important power to organize, plan, direct, authorize health's system procedure. They are also responsable in the pharmacies' organization.

More over, in Italy there is AIFA, Italian Pharmaceutical Agency, is the national public body that regulates medicines for human use in Italy. AIFA governs pharmaceutical expenditure and follows the life cycle of the medicine to ensure its effectiveness, safety and appropriateness as well as access to the national territory.

AIFA can revoke, suspend or modify a marketing authorisation based on a medicine being unsafe.

A good Lawyer will help you as single entity or pharmaceutical company in Italian health care system. A good advisor help to focus on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Aldo Lucarelli


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