Agreement 082-2019 ARSA Recovery Timelines and Quotas

Allocate a budgetary allocation in the amount of TWO MILLION LEMPIRAS (L.2,000,000.00) for the purchase of an Ambulance, for use in the health model and Maternal-Child Clinic of the municipality of Atima, department of Santa Bárbara.

The purchase of this vehicle shall be made following all legal procedures established in the laws of our country.

This Decree shall enter into force as of the day of its publication in the Official Gazette "La Gaceta". Given in the city of Tegucigalpa, municipality of the Central District, in the Hall of Sessions of the National Congress, on the fourth day of the month of December of two thousand nineteen. ANTONIO CÉSAR RIVERA CALLEJAS PRESIDENT JOSE TOMÁS ZAMBRANO MOLINA SECRETARY SALVADOR VALERIANO PINEDA SECRETARY Therefore: Be Published. Health Regulatory Agency AGREEMENT No. 082-2019 Comayagüela, M.D.C., December 10, 2019 THE PRESIDENT COMMISSIONER OF THE HEALTH REGULATORY AGENCY (ARSA) WHEREAS: The Constitution of the Republic establishes that Article 145 establishes that: "The right to protection of Health is recognized" ... In the same manner, the same fundamental law in its Article 146 institutes that: "It is the responsibility of the State through its departments and entities constituted in accordance with Law, the regulation, supervision and control of food products, chemical, pharmaceutical and biological products. WHEREAS: By Presidential mandate through Decree PCM-032-2017, dated April 28, 2017, published in the Official Gazette "La Gaceta" on May 19, 2017, the Health Regulatory Agency (ARSA) is created as a Decentralized Entity of the Ministry of State in the Department of Health (SESAL) attached to the Sectoral Cabinet for Development and Social Inclusion, with functional, technical, financial and administrative independence, with legal personality, responsible for the supervision, review, verification, control, surveillance and oversight of compliance with the legal, technical and administrative regulations of establishments, suppliers, products and services of health interest and those that carry out activities or practice conduct that may affect or could 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... WHEREAS: The Health Code in its Article 78 establishes that: "Foods sold under trademark and determined name and those that before being placed in commerce undergo some process of elaboration, transformation and division must be registered in THE MINISTRY (now according to PCM-032-2017, It corresponds to the Health Regulatory Agency (ARSA)). WHEREAS: The Regulation for the Health Control of Products, Services and Establishments of Health Interest, in its Article 3, institutes that: "Health Registration is the authorization for a product of health interest to be manufactured, imported, packaged or sold once all technical and legal requirements are met. WHEREAS: That in Chapter X of the Regulation for the Health Control of Products, Services and Establishments of Health Interest, in its Article 241 institutes that: "The granting of health registrations, certificates, authorizations, renewals and other services... shall incur rights in accordance with the values contemplated in the Cost Recovery Regulation for Provision of Services..., and also, the aforementioned Regulation does not establish the time to resolve such requests nor does it establish the costs to be charged per request submitted and knowing that it is the competence of the Health Regulatory Agency (ARSA), to develop, update the regulatory framework that governs establishments, services and products of health interest, as well as also, it is an attribute, to establish mechanisms to guarantee the quality of services and products in the market that may affect the health of the population, in the same way it is the competence of ARSA, to approve the recovery fees for services rendered. WHEREAS: The performance of the function of regulation and surveillance of the regulatory framework is a very specific field of action, characterized by a high level of complexity and diversity both technical and scientific that requires having specialized institutions that improve the management of health regulation, oversight, control and surveillance, therefore, in order to respond efficiently to the demands previously raised it is necessary to design and implement a new model of organization and administration. For this reason, the Full Board of Commissioners of the Health Regulatory Agency (ARSA), in Extraordinary Session dated November twenty-third of this year, in Minutes No. SE-003-2019, specifically in its item No. One (1), approve: ESTABLISH THE RESOLUTION TIMEFRAMES AND THE RECOVERY FEES FOR THE FOLLOWING SERVICES PROVIDED:

• 1)

  NEW REGISTRATION, RENEWAL, MODIFICATION AND HEALTH REGISTRATION;

• 2)

  CANCELLATION OF HEALTH AUTHORIZATIONS;

• 3)

  CERTIFICATES (LABEL EXHAUSTION OR COMPLEMENTARY LABEL AUTHORIZATION);

• 4)

  CORRECTIONS;

• 5)

  SPECIAL AUTHORIZATIONS. THEREFORE THE HEALTH REGULATORY AGENCY (ARSA), in the exercise of the powers conferred upon it and in application of Articles 145 and 146 of the Constitution of the Republic; 116, 118, 119 and 122 of the General Law of Public Administration; 1, 3, 19, 24, 26, 32, 33, 40, 41 and 150 of the Administrative Procedure Law; 1, 4, 73, 74, 75, 78, 225 of the Health Code; 3, 15, 134, 155, 166, 168 and 241 of the Regulation for Health Control; 1, 3 subsection b), e) i) and k) 5, 8, 9 and 10 of PCM No. 032-2017 of the Health Regulatory Agency. RESOLVES: FIRST: In Extraordinary Session dated November twenty-third of this year, in Minutes No. SE-003-2019, specifically in its item number One (1), approve: ESTABLISH THE RESOLUTION TIMEFRAMES AND THE RECOVERY FEES FOR THE FOLLOWING SERVICES PROVIDED:

  • 1)

    NEW REGISTRATION, RENEWAL, MODIFICATION AND HEALTH REGISTRATION;

  • 2)

    CANCELLATION OF HEALTH AUTHORIZATIONS;

  • 3)

    CERTIFICATES OF LABEL OR COMPLEMENTARY LABEL AUTHORIZATION;

  • 4)

    CORRECTIONS;

  • 5)

    SPECIAL AUTHORIZATIONS. SECOND: That said procedure regarding the resolution timeframes and the recovery fees for services provided for New Registration, Renewal, Modification and Health Registration shall be as follows: Services Provided Business Days Cost Recovery 60 L.200.00 New Registration, Renewal, Modification and Health Registration. 30 1/10 Average Minimum Salary 10 1/5 Average Minimum Salary 5 2/5 Average Minimum Salary THIRD: In the case of Certificates for (label exhaustion or Complementary label authorization), the resolution timeframes and the recovery fees for services provided shall be as follows: Services Provided Business Days Cost Recovery Certificates for (label exhaustion or Complementary label authorization). 20 1/20 Average Minimum Salary 10 1/10 Average Minimum Salary FOURTH: The resolution timeframes and the recovery fees for services provided for Special Authorizations shall be: Services Provided Business Days Cost Recovery Special Authorizations 20 1/20 Average Minimum Salary 5 1/8 Average Minimum Salary FIFTH: The resolution timeframes and the recovery fees for services provided for Corrections of Health Authorizations shall be: Services Provided Business Days Cost Recovery Correction of health authorizations after having been notified of the corresponding Resolution or, due to error of the petitioner at the time of submitting the request. 20 L.200.00 5 1/20 Average Minimum Salary The institutional corrections that the petitioner finds, prior to the notification of the corresponding resolution, ARSA shall resolve within five (5) business days and at no cost. SIXTH: The resolution timeframes and the recovery fees for services provided for Cancellation of Health Authorizations shall be as follows: Company Registration Business Days Cost Recovery Cancellation of Health Authorizations 30 1/20 Average Minimum Salary SEVENTH: In the event that the interested party submits their request and subsequently wishes it to be resolved in less time, they must request the modification in time and pay the difference according to the timeframes in which they wish their request to be resolved. EIGHTH: For the timeframe of business days, it shall begin to run once the request is submitted and it contains all the corresponding technical/legal requirements, which must be in accordance with what was requested; in case there is a requirement, the resolution timeframe shall begin from the remedying of what was required. This Agreement shall enter into force as of its date of publication in the Official Gazette "La Gaceta". BE PUBLISHED. - Given in the city of Comayagüela, municipality of the Central District, on the tenth day of the month of December of the year two thousand nineteen. DR. FRANCIS RAFAEL CONTRERAS PRESIDENT COMMISSIONER ATTORNEY DILCIA ANABEL MEDINA GENERAL SECRETARY