| CHAPTER I – National Pharmacovigilance System (SNFV)
Art. 4: Defines the SNFV as the official program that coordinates health surveillance activities to ensure the safe use of medicines, integrating public and private institutions, healthcare professionals, industry, and academia.
The main stakeholders are:
- Sanitary Regulation Agency (ARSA), through the National Pharmacovigilance Center (CNFV).
- Ministry of Health (SESAL): through the Department of Pharmacovigilance and the Expanded Program on Immunization (PAI).
- Public and private healthcare service providers.
- Honduran Social Security Institute (IHSS).
- Healthcare professionals.
- Pharmaceutical industry.
- Patient associations and organizations.
- Healthcare professional associations and societies.
- Professional colleges in the health sector.
- Academia.
The main attributions of the National Pharmacovigilance System include:
- Coordinating the regulatory pharmacovigilance function and ensuring compliance with the regulation through ARSA and its CNFV.
- Implementing active and passive surveillance mechanisms, including the reporting of suspected adverse reactions and intensive monitoring of patients or specific groups.
- Managing and analyzing pharmacovigilance data, feeding the national database and assessing causality for decision-making.
- Supporting the assessment of the risk/benefit balance of pharmaceutical products, especially in situations of clinical or regulatory uncertainty.
- Developing continuous training programs in pharmacovigilance for different system actors.
- Promoting the rational and safe use of medicines through education and health communication strategies.
- Promoting regulatory trust by using information and decisions from other national or international regulatory authorities and communicating adopted provisions in a timely manner.
Art. 5: The National Pharmacovigilance Center (CNFV) leads and coordinates the regulatory function, issuing guidelines, promoting continuous training, and ensuring safety feedback.
CHAPTER II – Responsibilities of SNFV Members
Art. 6: SESAL must report adverse events, coordinate with the CNFV, and promote active and passive surveillance mechanisms.
Art. 7: Healthcare service providers, public and private, must report adverse events and follow CNFV guidelines.
Art. 8: IHSS has similar duties to SESAL, in addition to taking preventive measures when risks are identified.
Art. 9: Healthcare professionals must report adverse reactions and actively participate in disseminating safety information.
Art. 10: Patient associations may report adverse events and collaborate in promoting pharmacovigilance.
Art. 11: Professional associations must encourage reporting and dissemination of safety information.
Art. 12: Professional colleges must promote surveillance and collaborate with the CNFV.
Art. 13: Academia must include pharmacovigilance in educational programs and support awareness campaigns.
CHAPTER III – Pharmaceutical Industry
Art. 14: Manufacturers and importers must comply with the following responsibilities:
- Reporting serious or unexpected adverse reactions:
Report to the National Pharmacovigilance Center (CNFV) within a maximum of 72 hours from the time the information becomes known, including the minimum required data (patient, suspected medicine, and reporter information), through the Noti-FACEDRA portal or other ARSA-authorized means.
- Reporting non-serious adverse reactions:
Inform within a maximum of 90 calendar days any suspicions of non-serious adverse reactions related to medicines or vaccines under their responsibility.
- Pharmacovigilance database:
Create or maintain an internal pharmacovigilance database according to the official format established by ARSA.
- Pharmacovigilance system and technical officer:
Have a pharmacovigilance system (internal or outsourced) aligned with WHO and PAHO Good Practices, directed by a healthcare professional responsible for pharmacovigilance, duly registered with ARSA.
- Zero Notification Report:
Submit to the National Pharmacovigilance Center (CNFV), semiannually, a report declaring the absence of suspected adverse reactions or medicine-related problems (SRAM, ESAVI, or other PRM).
- Periods: January–June and July–December.
- Deadline: within 15 business days after the end of each semester.
- Submission method: farmacovigilancia@arsa.gob.hn.
- Collaboration in investigations:
Support the CNFV promptly when additional information is required regarding a suspected adverse reaction or special investigation.
- Updating safety information:
Keep periodic safety reports (PSUR/IPS) and risk management plans (RMP/PGR) up to date as required by the regulation.
- Technical information updates:
Update technical sheets, monographs, and inserts with relevant safety changes (warnings, contraindications, adverse reactions, etc.), ensuring the availability of this information for professionals and users through official channels.
- Bibliographic surveillance:
Continuously monitor international scientific literature to identify reports of adverse reactions associated with the active ingredients of their products.
- Communication of safety studies:
Notify the CNFV without delay about new studies or findings related to the safety or effectiveness of their products and cooperate with ARSA in any request.
- Reporting substandard or falsified products:
Report to the CNFV within no more than 5 calendar days any product identified as substandard, falsified, or fraudulent, indicating at least:
- Product name
- Place of identification
- Batch, holder, and manufacturer
- Reason for suspicion
Additionally, they must maintain pharmacovigilance systems, update safety information, and report substandard or falsified products.
Art. 15: Distributors must designate a technical officer, ensure traceability, report events, and support the dissemination of alerts.
Art. 16: Exporters must ensure product quality, designate a technical officer, and maintain detailed export records.
CHAPTER IV – Pharmacies and Pharmacists
Art. 17: Pharmacies are key centers for pharmacovigilance; they must designate a responsible officer, create databases, and promote the reporting of adverse events.
Art. 18: The pharmacist-in-charge must ensure good practices, supervise dispensing, and report anomalies to ARSA.
Art. 19: The pharmacovigilance officer in the pharmacy must manage and report adverse reactions within defined timelines (72 hours or 90 days depending on severity).
CHAPTER V – Periodic Safety Reports (IPS/PSUR)
Art. 20: The professional responsible for the industry’s pharmacovigilance system must collect, evaluate, and submit safety information in a standardized manner to the Sanitary Regulation Agency through the National Pharmacovigilance Center, as established in Notice A-ARSA-009-V1 or its current version.
- For Honduran national industry: The PSUR must be submitted fully in Spanish; for multinational industry: The PSUR must be submitted in English, with the executive summary in Spanish.
- PSURs must be prepared according to the format established under ICH E2C(R2) guidelines.
- The CNFV will establish a format for local Honduran industry to submit PSURs and will provide a guideline to orient the regulated sector in PSUR submission.
Art. 21: The submission deadlines for PSURs based on the International Birth Date (IBD) of the medicine are as follows:
- Every six (6) months during the first two (2) years.
- Annually during the next three (3) years.
- Every five (5) years after the first five (5) years.
- For products with well-known molecules, submission must follow international provisions, using the European Medicines Agency (EMA) calendar as reference.
- Upon ARSA request through the CNFV when risk situations warrant it.
Art. 22: Deadlines for submission of PSURs to the CNFV are counted from the Data Lock Point (DLP) date as follows:
Submission deadlines depending on the product lifecycle:
- 6 or 12 months: 70 calendar days
- More than 12 months: 90 calendar days
CHAPTER VI – Risk Management Plan (RMP)
Art. 23: An RMP must be submitted for new molecules, special conditions, or when identified risks arise.
Arts. 24–26: Define the structure of the RMP and conditions for its update according to international standards (ICH E2E).
CHAPTER VII – Citizen Reporting
Art. 27: Citizens may report suspected adverse reactions directly through the regional Noti-FACEDRA portal.
CHAPTER VIII – Safety Information
Art. 28: Marketing authorization holders must update inserts and monographs when ARSA issues safety regulatory provisions.
CHAPTER IX – Clinical Trials
Arts. 29–30: Establish deadlines and procedures for reporting adverse events in clinical trials (serious in 24h, non-serious in 30 days) and submitting Development Safety Update Reports (DSURs) according to ICH E2F.
FINAL PROVISIONS
Art. 31: ARSA will publish an updated catalogue of medicines and their technical sheets.
Art. 32: ARSA will ensure compliance and provide tools to regulated entities.
Art. 33: Non-compliance will be sanctioned according to current regulations.
Art. 34: Confidentiality of received information is guaranteed.
Art. 35: Matters not foreseen will be governed by applicable health regulations.
Art. 36: The regulation enters into force upon its publication in La Gaceta (AGREEMENT No. 194-ARSA-2025 / SEPTEMBER 27, 2025).
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