Law of the Health Regulatory Agency ARSA

To ratify the creation of the SANITARY REGULATION AGENCY (ARSA), created by Executive Decree Number PCM-032-2017, published in the Official Gazette "La Gaceta" on May 19, 2017, reformed by Executive Decree Number PCM-013-2020, published in the Official Gazette "La Gaceta" on September 3, 2020, as a Deconcentrated Entity of the Secretariat of State in the Office of Health (SESAL), with functional, technical, financial, administrative and national security independence, with its own legal personality, which is the entity responsible for supervision, review, verification, control, vigilance and oversight of compliance with legal, technical and administrative norms of establishments, suppliers, products and services of sanitary interest and of those that carry out activities or practice conduct that affects or may affect the health of the population; and for the regulation, granting, renewal, modification, suspension or cancellation of registrations, permits, licenses, certifications and other sanitary authorizations. The Sanitary Regulation Agency (ARSA) has competence at the national level and is domiciled in the Municipality of the Central District.

The Sanitary Regulation Agency (ARSA) is under the charge of a President Commissioner, who is the highest authority and the legal representative of the institution, responsible for defining and executing policies, strategies, administrative and operational plans and programs, in accordance with the economic, fiscal and tax policy of the State, for complying with the institutional goals and results established by Law and by the Presidency of the Republic. The Sanitary Regulation Agency (ARSA) also has two Deputy Commissioners. The President Commissioner and the Deputy Commissioners shall be appointed by the President of the Republic for a period of five (5) years and may only be removed from their positions for legal or natural impossibility, when their actions conflict with the nature of the functions of the Sanitary Regulation Agency (ARSA).

To be President Commissioner or Deputy Commissioner of the Sanitary Regulation Agency (ARSA) the following is required:

• 1)

  To be Honduran, over thirty (30) years of age;

• 2)

  To be in enjoyment of civil and political rights;

• 3)

  To be a university professional of recognized capacity and ethical suitability;

• 4)

  To have no debts or pending accounts with the State; and,

• 5)

  Proven experience of at least five (5) years in the field of sanitary regulation.

The relationships between the Sanitary Regulation Agency and its respective personnel are governed by labor regulations that shall be approved for this purpose by the highest authority of the institution. Such regulations must contain as minimum norms the subsystems for adequate human talent administration. The personnel of the Sanitary Regulation Agency (ARSA) must be technical and highly qualified, subject also to certification of their suitability through the performance of trust tests. The remuneration of the personnel of the Sanitary Regulation Agency (ARSA) must respond to the responsibility of the positions and the positional structure within the institution, for which reason it is authorized to approve its own salary scale.

The President Commissioner holds all the faculties that correspond to Administrators and Superior Decision Bodies, specifically with respect to their functioning, development and operation, exercising therefore all the powers of administration and direction related to the competencies of the Sanitary Regulation Agency (ARSA), as well as the exercise of the other faculties that are conferred by applicable Laws and International Agreements.

The Organizational Structure of the Sanitary Regulation Agency (ARSA) shall be established in the Regulation that the Agency shall issue within ninety (90) calendar days from the publication of this Decree in the Official Gazette of the Republic "La Gaceta".

The Sanitary Regulation Agency (ARSA) has the following attributions and competencies:

• 1)

  To regulate, supervise, review, verify, control, monitor and oversee compliance with the normative framework of products, services and establishments of sanitary interest, including what is related to pharmacovigilance and technovigilance, with the exception of what corresponds to establishments providing health services, as well as what corresponds to the areas of environmental health, occupational health and health personnel;

• 2)

  To prepare, update and approve the normative framework that regulates establishments, services and products of sanitary interest;

• 3)

  To grant, renew, modify, suspend or cancel sanitary licenses of establishments, circumscribing hospitality and recreation services, as well as other sanitary certifications and authorizations that it extends. This attribution may be delegated to other official authorities with territorial competence, always exercising oversight and control;

• 4)

  To grant, renew, modify, suspend or cancel registrations and other sanitary authorizations of products of sanitary interest, including oversight of Clinical Trials, the products to be used in the same and its scientific ethics committee;

• 5)

  To establish mechanisms to guarantee the quality of services and products on the market that may affect the health of the population;

• 6)

  To monitor, evaluate, supervise and provide technical follow-up to the authorization processes for establishments and services of sanitary interest;

• 7)

  To establish mechanisms of transparency and accountability in the exercise of its functions;

• 8)

  To approve and execute the Strategic Plan and Annual Operational Plans of the Agency in accordance with national regulations;

• 9)

  To design and propose strategies and instruments to execute policies, plans and projects within the framework of its functions;

• 10)

  To apply sanctions in accordance with the provisions of current legislation and the Regulation issued by the superior decision body of the Agency;

• 11)

  To approve recovery fees for the provision of services; and,

• 12)

  To exercise the other functions that are assigned to it within the scope of its competence.

It is ratified that the functions of the General Directorate of Standardization and the General Directorate of Vigilance of the Normative Framework that, at that time, were dependent on the Subsecretariat of Regulation of the Secretariat of State in the Office of Health (SESAL), created by Executive Decree Number PCM-061-2013 published in the Official Gazette of the Republic "La Gaceta" of January 29, 2014 which amends Articles 67, 68 and 69 of the Regulation of Organization, Functioning and Competencies of the Executive Power, in relation to formulating and updating the sanitary normative framework; as well as interpreting, applying, monitoring, overseeing and controlling compliance with legal, technical and administrative norms that guarantee compliance with the quality standards established for suppliers of goods and services of sanitary interest or for those that carry out activities or practice conduct that affects or may affect the health of the population, respectively, shall be assumed by the Sanitary Regulation Agency (ARSA).

It is ratified that the Sanitary Regulation Agency (ARSA) assumes the functions that, at that time, corresponded to the Unit for Verification of Sanitary Norms ascribed to the Department of Vigilance of the Normative Framework and the Regulation Area of the Unit of Laboratory Services, ascribed to the Department of Integrated Networks of Health Services of the Health Regions, in accordance with the provisions of the Manual of Organization and Functions of the Health Regions, numeral 7.2 with the exception of function 6 and numeral 8.3.2 respectively. Laboratory services shall continue operating in the facilities where they currently function, until the Sanitary Regulation Agency (ARSA) has its own infrastructure.

The Patrimony of the Sanitary Regulation Agency (ARSA) is constituted by: 1) One hundred percent (100%) of net income generated by services of the Sanitary Regulation Agency (ARSA) from the provision of services of any kind; and, 2) Inheritances, legacies and donations from other public or private sources, national or foreign.

Public servants who, as of the date of entry into force of this Decree, work for the Sanitary Regulation Agency (ARSA), shall retain their seniority and other acquired labor rights, in accordance with their contracting modality.

The Sanitary Regulation Agency (ARSA) is ordered to issue the pertinent regulatory provisions within a period of three (3) months counted from the date of entry into force of this Decree.

The actions provided for in this Law and others that emanate from it shall be conducted in the Court of Letters of Administrative Litigation.

For the resolution of matters not expressly provided for in this Law, the general principles of administrative procedure shall be applied as supplementary, International Agreements to which Honduras has subscribed, in the absence thereof, the provisions of the Civil Procedural Code and other branches of law that are applicable according to their nature and purposes.

This Decree enters into force as of the date of its publication in the Official Gazette "La Gaceta". Given in the city of Tegucigalpa, municipality of the Central District, in the Session held by the National Congress in a Virtual manner, on the tenth day of the month of February of two thousand twenty-one. MARIO ALONSO PÉREZ LÓPEZ PRESIDENT JOSÉ TOMÁS ZAMBRANO MOLINA SECRETARY ROSSEL RENÁN INESTROZA MARTÍNEZ SECRETARY To the Executive Power. Therefore: Let it be executed. Tegucigalpa, M.D.C., March 4, 2021 JUAN ORLANDO HERNÁNDEZ ALVARADO PRESIDENT OF THE REPUBLIC THE SECRETARY OF STATE IN THE OFFICE OF HEALTH ALBA CONSUELO FLORES