Importance of Regulations for Advertising Medicines and Medical Devices

Healthcare regulations safeguard public health by ensuring accurate information and ethical marketing. They prevent misleading claims, promote responsible advertising, and require scientific evidence for product claims. This empowers patients with reliable information and protects them from misuse of medications. Regulations also ensure fair competition within the industry.

1. Applicable Laws Regarding Advertising of Medicines and Medical Devices in Italy

Advertising of Medicines

Legislative Decree no. 219/2006 (Code of Medicines)
Ministry of Health Guidelines

Advertising of Medical Devices

EU Regulation no. 745/2017 (Medical Device Regulation – MDR)
Legislative Decrees no. 46/1997, 137/2022, and 138/2022
Ministerial Decree no. 93/2006

Consumer Protection

Legislative Decree no. 206/2005 (Consumer Code)

2. Self-Regulatory Codes of Conduct

In addition to legal regulations, self-regulatory codes play a significant role in governing the advertising of medicines and medical devices:

Code of Self-Discipline of Commercial Communication: Managed by the Institute of Advertising Self-Regulation (IAP), applying to all types of advertising, including medicinal products and healing treatments.
Farmindustria Code of Conduct: Established by the Italian pharmaceutical industry association, setting ethical standards for promotion and marketing.
Confindustria Dispositivi Medici Code of Conduct: Issued by the association representing medical device manufacturers and distributors, providing ethical advertising guidelines.

3. Licenses, Approvals, and Fees

Advertising to the General Public

Prior authorization from the Ministry of Health is required for advertising medicines and medical devices.
Each individual advertisement must be approved, even if multiple media channels are used.
Authorization is deemed granted if no response is received within 45 days.
Authorization is valid for 24 months.
Fee: €380.10 per text, product, and media.

Exceptions

Institutional advertising not promoting specific product properties
Promotions involving multiple packs sold for the price of one

Advertising to Healthcare Professionals

No prior authorization from the Ministry of Health is required.
Promotional materials for medicines must be submitted to AIFA 10 days prior to use. If no objection is raised, materials may be used.

4. Prescription-Only vs. Over-the-Counter Medicines

Prescription-Only Medicines: Advertising to the general public is prohibited. Promotion is limited to authorized healthcare professionals.
Over-the-Counter Medicines: May be advertised to the general public if no doctor’s intervention is required for diagnosis or treatment.

5. Restrictions on Advertising to the General Public

Medicines

Only non-prescription medicines may be advertised.
Advertisements must not discourage medical consultation, guarantee effects, or imply health enhancement beyond normal conditions.
Promotion to children, endorsements by public figures, and presentation as food or cosmetics are prohibited.
Providing free samples or promotional offers to consumers is forbidden.
Misleading visuals or healing claims are not allowed.
Additional digital advertising rules apply under guidelines issued on July 20, 2023.

Medical Devices

Only non-prescription devices authorized by the Ministry of Health may be advertised.
Advertisements must not attribute false functions, omit risks, or propose uses beyond approved purposes.
Accessories selected for aesthetic reasons (e.g., eyeglass frames) are exempt from these rules.

6. Advertising to Healthcare Professionals

Medicines

Restricted to authorized healthcare professionals.
Promotional materials must be submitted to AIFA.
Includes verbal promotion, materials, limited free samples, scientific events, and professional engagements.
Exaggerated claims, unfounded comparisons, and unsolicited electronic communications without consent are prohibited.
Digital content must be restricted to secure, professional-only access areas.

Medical Devices

No prior authorization required.
Advertising must be truthful, fair, clearly promotional, and not misleading.
Additional digital rules are outlined in Ministry of Health guidelines dated December 20, 2017.

7. Information Required in Advertisements to Healthcare Professionals

Medicines

Information from the Summary of Product Characteristics (SmPC)
Supply category
Selling price and reimbursement conditions
Optional: drug name, active ingredient, license holder, and co-promoter

Medical Devices

Alignment with labeling and instructions for use
Clear promotional intent and rational use messaging
Mandatory statement: “E’ un dispositivo medico CE”, product name, class, and warnings
Online content must include professional-only access disclaimers

8. Advertising Requirements

Medicines

Must be clearly identifiable as medicinal advertising
Include drug name, active ingredient, and essential usage information
Invitation to read package leaflet
Authorization number and date must be displayed

Medical Devices

Mandatory CE medical device statement
Product name, class, and safety warnings
Online ads must indicate general public targeting
Content must be in Italian, with translations for foreign terms

9. Scientific Data Requirements

Promotional claims must align with the SmPC and be supported by verifiable evidence.
Scientific articles must be reproduced faithfully and completely.
A disclaimer is required if no scientific evidence supports the claim.

10. Comparative Advertising

Comparative advertising is governed by the Consumer Code. No additional sector-specific rules apply to medicines and medical devices.

11. Internet and Social Media Advertising

Medicines

Guidelines issued on July 25, 2017, May 7, 2018, and updated July 20, 2023 apply to SOP and OTC medicines.
Product listings without promotional intent are allowed; promotional content requires authorization.
Platform-specific rules apply to Facebook, YouTube, Instagram, and TikTok.
Professional content must be restricted to secure, password-protected areas.

Medical Devices

Guidelines dated December 20, 2017 apply, including disclaimer and access restrictions.

12. Enforcement and Legal Consequences

The Ministry of Health enforces advertising regulations.
Orders may be issued to cease non-compliant advertisements.
Corrective statements may be required at the company’s expense.
Fines range from €2,600 to €15,600.

13. Future Developments in Italy

Legislative Decrees No. 137 and 138 of 2022 align national rules with EU MDR and IVDR.
Updates include distributor registration, clinical investigation procedures, distance selling controls, and revised sanctions systems.