Pharmaceutical compliance support in Italy
Local rules, connected to your global model.
Local compliance support for pharmaceutical and biotech companies working in Italy, connecting Italian medicines law, AIFA procedures and the Farmindustria Code to your global governance, with a named business partner for Italy.
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Who this support is for
For international pharmaceutical and biotech companies with Italian activities, European teams adding Italy to a regional model, and companies preparing an Italian launch. Start from the events, materials and HCP engagements you plan in Italy.
The practical challenge in Italy
Italy has several procedural steps with fixed lead times: HCP advertising material is filed with AIFA before use, and company-supported congresses and meetings are notified to AIFA in advance, with express authorisation needed in some cases. Global event and material processes often do not allow for these timelines.
How Eunomia can help
With local input from our Italy business partner, we can map your Italian activities against D.Lgs. 219/2006 and the Farmindustria Code, build AIFA filing and notification timelines into your approval workflow, and prepare transparency data. Where relevant, we can connect this to your organisational model under D.Lgs. 231/2001. Where Italian legal advice is required, we identify that need before delivery.
Your first working priorities
- List planned Italian congresses and meetings and build the AIFA notification lead time into your event calendar.
- Add AIFA filing of HCP advertising material to your review workflow before first use.
- Review gifts and hospitality against Articles 123 and 124 of D.Lgs. 219/2006 and the Farmindustria Code.
- Prepare transfers-of-value data for individual publication by 30 June, and track the status of the Sanità trasparente register.
Programme design and implementation · Operational shared services · Compliance automation
What we can take on
Pharmaceutical compliance in Italy: scope of support
HCP and patient organisation engagement review
Local transparency and disclosure requirements
Promotional and non-promotional material review
Market-entry compliance assessment
Responsible person and local representative support
What this gives you
Italy requirements built into your global processes
A named local partner for questions and escalation
Local support without unnecessary fixed headcount
The rules in Italy
What shapes compliance in Italy…
A short guide to the main legal and self-regulatory frameworks. Each summary links to its official source below.
Gifts and advantages: Article 123 of D.Lgs. 219/2006
In promoting medicines to doctors and pharmacists, companies may not grant, offer or promise prizes or pecuniary or in-kind advantages unless they are of negligible value and relevant to the professional’s practice. Healthcare professionals may not solicit or accept any prohibited incentive.
Congresses and meetings: Article 124
A company supporting a congress or meeting notifies AIFA at least 60 days beforehand; the event may go ahead if AIFA gives a favourable opinion within 45 days. Events abroad, or costing the company more than €25,822.85, need express AIFA authorisation. Hospitality is limited to qualified professionals, cannot extend to companions, and runs from 12 hours before to 12 hours after the event.
Supervision of advertising
Advertising material aimed at healthcare professionals must be filed with AIFA and may be used ten days after filing (Article 120). Advertising to the public requires authorisation from the Ministry of Health (Article 118).
The Farmindustria Codice Deontologico
Farmindustria’s code of conduct binds its member companies and is updated regularly. Its control bodies include the Comitato di controllo and the Giurì, which hears appeals. Its transparency section requires member companies to publish transfers of value to HCPs, HCOs, patient associations and expert patients each year, individually and on the company website, by 30 June of the following year.
The Italian Sunshine Act: Legge 62/2022
Law 62 of 31 May 2022 requires publication of transfers of value above set thresholds (for individual healthcare professionals, more than €100 per item or €1,000 a year) in a public register, Sanità trasparente, on the Ministry of Health website. The register’s start date is to be announced in the Gazzetta Ufficiale. We have not found an official notice that the register is operational, so check its status when planning reporting.
Corporate liability: D.Lgs. 231/2001
A company can be liable for specified offences, including bribery, committed in its interest or to its benefit. It can avoid liability if it proves it adopted and effectively applied a suitable organisational and management model, overseen by a body with autonomous powers.
Primary references
Your local partner
Ilaria is Eunomia’s Global Compliance Business Partner for Italy, providing local context for Italian compliance questions within your global operating model.
This overview is informational and does not constitute legal advice. Scope and application should be confirmed for the organisation, market, activity and counterparty in question. Sources checked September 2026.
Questions, answered
Pharmaceutical compliance in Italy FAQs
How far ahead must Italian congresses be notified to AIFA?
Under Article 124 of D.Lgs. 219/2006, at least 60 days before the event. Events abroad, or costing the company more than €25,822.85, need express AIFA authorisation.
Is the Sanità trasparente register live?
Law 62/2022 provides for the register and says its start date will be announced in the Gazzetta Ufficiale. We have not found an official notice that it is operational, so we check its status at the start of each engagement. Farmindustria’s code-based disclosure continues to apply to member companies.
Does a D.Lgs. 231/2001 model cover pharma compliance?
A 231 model addresses the specified offences, including bribery. It should connect to your commercial compliance controls, such as HCP engagement approval and gift and hospitality rules, so the model is applied in practice.
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We will listen, ask a few questions and recommend the right scope—without obligation or pressure.
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