Agreement ARSA No. 003-2021

This law sets the fees and timeframes that applicants must pay to ARSA for sanitary licenses to sell medications, food, cosmetics, or other health products. Costs vary depending on the type of business (pharmacy, laboratory, distributor, etc.) and whether processed in-person or online, aiming to fund health supervision that protects the population.

Whereas the Constitution of the Republic in its Article 145 establishes that: "The right to protection of Health is recognized" … In the same manner, the same constitutional charter in its article 146 institutes that: "It corresponds to the State, through its departments and organisms constituted in accordance with the Law, the regulation, supervision and control of food products, chemical, pharmaceutical and biological products".

Whereas the Administrative Simplification Law in its article 3 institutes that: "Every State Agency has the obligation to permanently conduct diagnoses and analyses of the different administrative procedures and proceedings that must be followed in its departments, in order to design simplification measures which shall be adopted in accordance with the objectives of the Administrative Simplification Law".

Whereas by Presidential mandate through Decree PCM-032-2017, dated April 28, 2017, published in the Official Gazette "La Gaceta" on May 19, 2017 and amended in Articles 1, 4, 6, 7 and 10 of PCM-032-2017, through Executive Decree No. PCM-013-2020, published in the Official Gazette "La Gaceta" on September 3, 2020, the Health Regulatory Agency (ARSA) is created as a Deconcentrated Entity of the State Secretariat of the Office of Health (SESAL) ascribed to the Sector Cabinet for Development and Social Inclusion, with functional, technical, financial, administrative and national security independence, with legal personality, responsible for the supervision, review, verification, control, vigilance and oversight of compliance with the legal, technical and administrative regulations of establishments, suppliers, products and services of health interest and those that conduct activities or engage in 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 health authorizations, with competence at the national level…

Whereas the Health Code in its article 1 establishes that: "Health, considered as a state of comprehensive well-being, biological, psychological, social and ecological, is an inalienable human right and corresponds to the State, as well as to all natural or legal persons, the promotion of its protection, recovery and rehabilitation".

Whereas the Health Regulatory Agency is the guarantor entity of strict compliance with the regulations, whose primary purpose is the protection of health in the field of health regulation of establishments and products of health interest for the Honduran population, regarding health-type authorizations in an efficient manner, always seeking to avail itself of the mechanisms permitted by current technical-legal regulations, as well as the simplification of procedures, making available to interested parties its services regarding the promotion, guidance and training of its technical-legal personnel, always seeking that these procedures be completed in an effective and precise manner.

Whereas the Regulation for the Health Control of Products, Services and Establishments of Health Interest in its Article 69 institutes that "Public or private establishments of health interest, with or without profit motive, are considered those related to the manufacture, import, export, transport and commercialization of products of health interest and their raw materials" …. In the same manner, the same legal provision in its article 70 establishes that: "Prior to its operation and installation every establishment of health interest requires a Health License. - For the expansion, modification and relocation of establishments, authorization is now required from the Health Regulatory Agency, as well as vehicles and means of transport of products of health interest. Consequently, the same legal provision in its article 145 establishes that: "The health authority in qualified cases may order the retention of food products, beverages, medications and related products and others that the authority determines, in the facilities of the importer or distributor and they shall remain there until the respective registration is obtained, for this purpose the necessary controls shall be established" … In the same manner, the health authority may conduct inspections in all premises and departments of establishments of health interest.

Whereas the Regulation for the Health Control of Products, Services and Establishments of Health Interest, in its Chapter X, article 241 establishes that: "The granting of health registrations, health licenses, analysis services, certificates, authorizations, renewals and other services contemplated… shall incur fees in accordance with the values contemplated in the Regulation of Recovery Fees for Integrated Services for Regulation of Products, Services and Establishments of Health Interest…, and in turn, the aforementioned regulation does not establish the time to resolve such requests nor does it establish the costs to be charged for the services provided and, knowing that it is the competence of the Health Regulatory Agency (ARSA) to elaborate and update the regulatory framework that regulates establishments, services and products of health interest, as well as it is also an attribution to establish the control mechanisms to guarantee the quality of services and products in the market that may affect the health of the population, in the same manner, ARSA may approve the recovery fees for services rendered.

Whereas the performance of the regulatory function and the guarantee of its compliance is a very specific field of action, characterized by a high level of complexity and diversity both technical and scientific that requires specialized institutions to improve the management of health regulation, oversight, control and vigilance, therefore, in order to respond efficiently to the requirements previously stated it is necessary the implementation of a new model of organization and administration. For which reason, the Commissioners of the Health Regulatory Agency (ARSA), in a meeting held on February seventeenth of the present year, through Minutes No. 001-21, specifically in its point Number one (1): agree to approve in all and each of its parts the RECOVERY FEES AND RESOLUTION PERIODS FOR PROCEDURES PRESENTED IN PERSON OR ONLINE FOR NEW HEALTH LICENSE, RENEWAL AND MODIFICATION FOR ESTABLISHMENTS OF HEALTH INTEREST, TRANSPORT OF HEALTH INTEREST, SPECIAL GOVERNMENTAL AUTHORIZATION, SPECIAL NON-GOVERNMENTAL AUTHORIZATION AND SPECIAL PERSONAL AUTHORIZATION, ISSUED BY THE PHARMACEUTICAL PRODUCTS DIRECTION AND OTHER PRODUCTS OF HEALTH INTEREST, FOOD AND BEVERAGES DIRECTION AND MEDICAL DEVICES DIRECTION AND OTHER DEVICES OF HEALTH INTEREST; AS WELL AS, THE RECOVERY FEES FOR SERVICES PROVIDED AND RESOLUTION PERIOD FOR THE AUTHORIZATION CONTROL BOOKS OF CONTROLLED SUBSTANCES, AUTHORIZATION OR SALE OF PRESCRIPTION BOOKS FOR NARCOTICS AND ADVERTISING FROM THE PHARMACEUTICAL PRODUCTS DIRECTION AND OTHER PRODUCTS OF HEALTH INTEREST; AND, THE RECOVERY FEES FOR VIGILANCE, OVERSIGHT, HEALTH INSPECTION AT CUSTOMS ENTRY POINTS OR OUTSIDE CUSTOMS ENTRY POINTS OF THE COUNTRY, AS WELL AS THE VERIFICATION OF DESTRUCTION OF PRODUCTS OF HEALTH INTEREST.