The recent Regulation for Sanitary Surveillance and Oversight in Honduras, established by the Sanitary Regulation Agency (ARSA), came into effect on October 28, 2024. This regulation aims to strengthen the control and supervision of products and services of sanitary interest in the country, with the goal of protecting public health.
The Responsibilities of the Directorate of Sanitary Surveillance and Oversight (DVFS) is in charge of nationwide supervision of all products and services of sanitary interest. Its main functions include ensuring that all establishments and products comply with current sanitary regulations, conducting regular inspections, following up on prior inspection recommendations, and carrying out sanitary surveillance operations at the country’s entry and exit points.
Sanitary and oversight inspection
Sanitary and oversight inspection activities include:
- Regular inspections of all establishments of sanitary interest to ensure regulatory compliance.
- ARSA may access any establishment, review facilities, verify documentation, and take product samples.
- Products failing to meet regulations may be retained or seized until their safety and efficacy are verified.
Corrective action plans
Businesses must submit corrective action plans to address non-conformities identified during inspections. These plans should outline measures to correct deficiencies and prevent recurrence. ARSA will review and approve these plans and conduct follow-up inspections to ensure their implementation.
Product and establishment safety, quality, and efficacy
The regulation sets strict measures to ensure the quality, safety, and efficacy of sanitary products, such as:
- Products under sanitary alert must undergo analysis in accredited laboratories to verify their safety and compliance.
- Establishments must implement Good Manufacturing Practices (GMP), as well as proper storage, distribution, and laboratory practices to ensure product quality.
Products unfit for consumption
Products deemed unfit for consumption will be removed from the market and destroyed safely. ARSA will establish procedures for retaining and destroying these products to ensure they pose no risk to public health.
Requests for inspection and oversight
Companies can proactively request inspections to ensure regulatory compliance:
- Requests must include detailed information about the establishment or product and the justification for the inspection.
- Relevant documentation must be submitted, and corresponding fees paid for the inspection to be carried out.
Infractions, penalties, and procedures
The regulation also defines a clear framework for penalties in cases of non-compliance:
- Infractions are classified as minor, serious, or very serious, depending on the risk to public health.
- Penalties may include fines, temporary suspension of licenses (up to 180 days), or, in severe cases, permanent cancellation of sanitary permits.
- A statute of limitations is set for the accumulation of infractions, ensuring penalties are applied fairly and promptly.
- A detailed procedure for imposing penalties is outlined, guaranteeing due process and the right to appeal.
graciela.cruz@garciabodan.com
Partner
García & Bodán
Honduras