Authors

Ivis Alvarado
Senior Associate
Honduras
E-mail

Andres Elvir
Associate
Honduras
E-mail

Honduras Strengthens Oversight of Health Advertising: What Agreement 0142-ARSA-2025 Establishes

Agreement No. 0142-ARSA-2025, issued by the Honduran Health Regulatory Agency (Agencia de Regulación Sanitaria – ARSA), establishes the regulatory framework for the control, supervision, and regulation of advertising related to products, establishments, and services of sanitary interest in Honduras. Its primary objective is to protect public health and prevent misleading or inaccurate advertising practices.

Key Points

1. Scope of Application

The regulation applies to all individuals and legal entities involved in advertising products, establishments, or services of sanitary interest throughout Honduras. It covers all dissemination channels, including print, digital media, social networks, and electronic platforms.

2. Definitions and Scope

The regulation defines key concepts such as “products of sanitary interest,” “advertising,” “advertising authorization,” and “advertising notice.” As a general rule, all advertising must obtain prior authorization from ARSA, except for specific exempt cases.

3. General Advertising Requirements

Advertising must be truthful, clear, accurate, and supported by scientific evidence.

  • False, misleading, or exaggerated claims are prohibited
  • Promotion of products as therapeutic alternatives without scientific support is not allowed

Advertising must also target only the audience approved by ARSA.

4. Advertising Classification

Advertising is classified into three categories:

  • Category A: Directed to healthcare professionals (e.g., prescription products)
  • Category B: Directed to the general public:
    • B1: Requires warnings and precautionary statements
    • B2: Lower-risk products
  • Category C: Exempt from prior authorization but still regulated

5. Control Mechanisms

Advertising Authorization: Required for public-facing materials.

Advertising Notice: Required for materials directed to healthcare professionals.

ARSA may monitor, inspect, and order immediate withdrawal of non-compliant advertising.

6. Authorization Procedure

To publish advertising, prior authorization must be obtained through ARSA’s platform, including:

  • Application form
  • Legal documentation
  • Advertising content and scripts
  • Supporting evidence for claims
  • Proof of payment

Authorization:

  • Is granted per advertising piece
  • Is valid for two years
  • Includes a unique code that must be displayed

Once approved:

  • No modifications are allowed
  • Unauthorized changes may result in sanctions
  • Content may be reused if unchanged

If the product’s health registration expires or is revoked, advertising must be withdrawn.

7. Obligations and Sanctions

The authorization holder must ensure compliance. Non-compliance may result in:

  • Administrative sanctions
  • Withdrawal of advertising
  • Suspension or cancellation of authorization
  • Civil or criminal liability

8. Entry into Force

The regulation will enter into force 90 days after publication. ARSA has 180 days to issue complementary regulations.

Conclusion

The Agreement strengthens oversight of health-related advertising in Honduras by imposing strict requirements on truthfulness, prior authorization, and audience targeting, supported by enforcement mechanisms aimed at protecting public health.

For more information, please contact us at
[email protected].