Key Benefits:
Bs. As., 20/8/92
Having regard to Decree No. 1269/92 and Record No. 2020-16,628/92-1 of the SECRETARIAT for HEALTH of the MINISTERY OF HEALTH and SOCIAL ACTION, and
CONSIDERING:
That the National Government is committed to the revision and adequacy of the basic functions to be provided by the National State and that in the same sense the provisions of Decree No. 1269/92 are framed.
That, through the sanction of that Decree, the NATIONAL EXECUTIVE POWER has explicitly established national health policy objectives and priorities.
That the Decree establishes as a priority objective of the SECRETARIAT OF HEALTH of the MINISTERY OF HEALTH and SOCIAL ACTION the exercise of a leading and leading role, efficiently fulfilling its responsibilities (Decree No. 1269/92, Substantive Policy 4.-).
That, through the reference decree, it is determined that it is appropriate to adapt the structure of the SECRETARIA DE SALUD in order to enable the agency to develop the proposed strategic lines of transformation, thus favoring the formation of a technical entity with the ability to lead health in development with equity, to implement strategic planning in standardization, in control and higher leadership, and to guarantee effective health action in the whole national field, by placing the emphasis on development of the measures 126.
It also provides that appropriate mechanisms for authorization, registration, standardization, epidemiological control and monitoring and control of drugs, drugs and food should be implemented to protect the health of the population (Decree No. 1269/92, item 4.1.6).
That Decree emphasizes the desirability of promoting the development and administration of technical scientific knowledge and research (Decree No. 1269/92, item 4.1.7).
That, as an instrumental support of the proposed objectives, the said Decree establishes the need to design alternative models of organization and administration of the National Institutes of Research, Teaching and Production under the SECRETARIA DE SALUD, in order to improve the technical-administrative process of management, efficiency in the use of resources and the level of institutional quality (Decree 1269/92, item 1.1.5).
It is of the interest of the National Government to promote and guarantee the actions of the public sector aimed at the prevention, safeguarding and health care of the population.
That in view of the above and in terms of strengthening the leading role of the National Public Sector, it is necessary to arbitrate the provisions leading to enable SECRETARIAT DE SALUD exercise in the most appropriate conditions the functions of counter-lor and surveillance on important subjects that are subject to the orbit of its competence.
That they acquire singular relevance for the proposed objectives of actions related to the control and control of the quality and health of the products, substances, elements, processes, technologies and materials that are consumed or used in human medicine, food and cosmetics.
That such actions set up a very specific field of action, characterized by a high level of complexity and diversity, both technical and scientific.
That such matters and competences are also subject to an important set of rules, regulations and provisions.
That these circumstances determine as an indispensable condition for carrying out their conduct and operation, have adequate institutional tools and mechanisms to respond to the demands that arise in the exercise of the functions to be performed by the HEALTH SECRETARIAT.
As it arises from the above requirements, it is appropriate to create within the scope of the SECRETARIA DE SALUD an organism that meets the control and control competences on the products, substances, elements, technologies and materials that are consumed or used in human medicine, food and cosmetics, and the pain of the activities and processes that mediate or are covered in these matters.
Given the functions to be performed by the agency and the characteristics and modalities of the activities to be carried out, the agency must have the appropriate institutional capacity to enable it to act efficiently and effectively against such requirements, and it is therefore necessary and appropriate to attribute to it the character of a decentralized agency.
That this level of autonomy, and without prejudice to the powers that the SECRETARY OF HEALTH will maintain on its management, will favor the speed in decision-making, the adequacy in time and form of its responses to the demands to satisfy and a more agile and practical functioning, determining factors for the efficiency of actions.
That the relocation and concentration in a decentralized agency of the current units of the SECRETARIA DE SALUD, DIRECCION DE DROGAS, MEDICAMENTS AND ALIMENTOS, the National Institutes of MEDICAMENTOS and ALIMENTOS and other areas, will promote the management of the levels of driving, technical, operational and administration, starting from having a more efficient management and management process,
It is also expected that, through the operation of this agency, institutional and social articulations can be facilitated, capable of enhancing and taking advantage of the participation of different depublic, private and non-governmental social actors, ,, in order to broaden the basis for interaction and cooperation that any health process requires to be effective.
Given the type of activities to be carried out by this agency, there are adequate conditions for generating its own income, without prejudice to the resources appropriate to it by the National Treasury.
The SECRETARIAT OF HEALTH will be responsible for the determination of the health policies and scientific criteria to be subject to, and the desirability and opportunity, on the basis of the above reasons, to establish their creation and to establish their decentralized nature.
That the General Directorate of Humanitarian Affairs of the Ministry of Health and SOCIAL has taken the intervention of its competence.
That the NATIONAL EXECUTIVE POWER is entitled to the dictation of the present by art. 86 (1) and (2) of the NATIONAL CONSTITUTION.
Therefore,
THE PRESIDENT OF THE ARGENTINA NATION
RIGHT:
CHAPTER I: DECLARATION OF NATIONAL INTERES
Article 1 . The actions aimed at the prevention, safeguarding and health care of the population that are developed through the control and control of the quality and health of the products, substances, elements and materials that are consumed or used in human medicine, food and cosmetics, and the pain of the activities, processes and technologies that mediate or are covered in such matters, should be described in national interest.
CHAPTER II: NATIONAL ADMINISTRATION OF MEASURES, FOLLOW-UP AND TECHNOLOGY
Art. 2o ). Trust in the area of the HEALTH SECRETARIAT of the MINISTERY OF HEALTH and SOCIAL ACTION, the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT).
The NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT) will act as a decentralized agency of the National Civil Service, depending technically and scientifically on the rules and directives provided by the SECRETARIA DE SALUD, with a regime of economic and financial autarchy, with jurisdiction throughout the territory of the Nation.
Art. 3o ) Note that NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT) will have competence in all matters concerning:
(a) Control and control of the health and quality of drugs, chemicals, reactants, pharmaceutical forms, medicines, diagnostics, biomedical materials and technology and all other products of use and application in human medicine;
(b) Control and control of the health and quality of food conditioned, including specific, additive, colouring, sweeteners and ingredients used in human food, as well as household products and materials in contact with food;
(c) Control and control of the health and quality of the products of hygiene, toilet and cosmetics and of the drugs and raw materials that make up them;
(d) Monitoring of the effectiveness and detection of adverse effects resulting from the consumption and use of products, elements and materials covered by subparagraphs (a), (b) and (c) of this article, as well as the presence in these products of any kind of substance or waste, organic and inorganic, that may affect the health of the population;
(e) Controlling the activities, processes and technologies that are carried out according to the supply, production, processing, fractionation, import and/or export, deposit and marketing of the products, substances, elements and materials consumed or used in human medicine, food and cosmetics;
(f) The implementation of actions to prevent and protect the health of the population, which are covered in matters falling within their competence;
(g) any other action that contributes to the attainment of the objectives set out in article 1 of the present decree.
Art. 4o s Please note that the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UPS AND TECHNOLOGY MEDICA (ANMAT) will be the organ of application of the legal norms governing the subjects subject to its competence, those that in the future are sanctioned and those that in use of its powers dictate the MINISTERY OF HEALTH and SOCIAL ACTION and SECRETARIA DE SALUD, in reference to the scope of action of the Administration.
Art. 5o NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEASURES (ANMAT) THE DIRECTION OF DROGS, MEDICAMENTS AND FOLLOW-UPS under the SECRETARIAT OF HEALTH OF HEALTH AND SOCIAL ACTION, and the areas under the authority of the Directorate
Art. 6th . Please note that the NATIONAL INSTITUTE OF MEDICAMENTS (INAME) of the SECRETARIAT OF HEALTH OF THE MINISTERY OF HEALTH and SOCIAL ACTION, shall operate in such character within the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOWS AND TECHNOLOGY MEDICA (ANMAT), maintaining all the powers and functions established in the present by different
Art. 7o . Please note that the NATIONAL INSTITUTE OF FOODS (INAL) of the SECRETARIAT OF HEALTH of the MINISTERY OF HEALTH and SOCIAL ACTION shall operate in such character within the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOWS AND TECHNOLOGY MEDICA (ANMAT), maintaining all the powers, competences and functions established in the present by different provisions.
Art. 8o : Please note that the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT) will have the following powers and obligations:
(a) Develop and propose to the HEALTH SECRETARIAT the technical standards that may be applied in accordance with the adequacy, health and quality of the supply, production, processing, fractionation, import and/or export, marketing and deposit of the products, substances, elements, materials and technologies and processes referred to in Article 3 of the present.
(b) Design and propose to the SECRETARIAT OF HEALTH the implementation of Systems and/or Programs that favor the development of their actions, observing national regulations and international agreements concluded or to be held. Such proposals should contain the operative rules that will be applicable, the forecasts for the coordination of actions with the public and private agencies involved and the mechanisms and instruments that enable the organization, implementation and control of activities.
(c) Develop and propose to the HEALTH SECRETARIAT the Scientific, Technical and Operational Regulations that are relevant to the performance of its functions.
(d) Develop and upgrade the annual budget and resource calculation for its operation to the HEALTH SECRETARY, as well as the Annual Programme of Activities and Work.
(e) Analyze and propose to the SECRETARIAT OF HEALTH the conclusion of agreements and agreements with national, provincial and municipal public bodies, private entities and non-governmental organizations in our country, as well as with international agencies, governmental agencies, non-governmental organizations and foreign private entities.
(f) To convene through the HEALTH SECRETARIAT to the different public and private sectors, to establish modalities of interaction and cooperation, as well as to establish committees or committees or working groups for specific activities.
(g) Develop the planning, organization implementation, evaluation and communication of your plans, programs and actions.
(h) Implement research, technical assistance, teaching, training, promotion, communication, dissemination and all other activities aimed at preventing and safeguarding the health of the population.
(i) Apply and ensure compliance with the legal, scientific, technical and administrative provisions within the scope of their competences.
(j) Propose to the HEALTH SECRETARIAT, in accordance with the applicable regulations, the creation of records and other devices and procedures that are deemed necessary, regulating and implementing its operation.
(k) Authorize, certify, register and register in compliance with the relevant provisions, products, substances, elements and materials covered by Article 3 of the present.
(l) Properly and reasonably ensure compliance with the health and quality standards established for products, substances, materials, technologies and processes referred to in Article 3 of the present.
(ll) Proceed to the registration and/or authorization and/or authorization .conforme to the applicable provisions de of the natural or legal persons involved in the actions of supply, production, processing, fractionation, import and/or export, deposit and marketing of the products, substances, elements and materials referred to in Article 3 of the present, controlling or supervising the execution of such activities.
(m) Determining and accruing the tariffs and retributive rates for the procedures and registries performed, as well as for the services provided.
(n) To have, on the basis of its competence, the conduct of all types of controls, checks and inspections that are deemed appropriate, where necessary, the assistance of the public force and/or the cooperation of any other public agency.
(in) To adopt, in the light of the detection of any risk factor related to the quality and health of products, substances, elements or materials covered by Article 3 of this Decree, the most timely and appropriate measures to protect the health of the population, in accordance with the current regulations.
(o) To establish in all cases, the notices, sanctions and penalties provided for by the applicable regulations.
(p) Develop, within the framework of its competence, any other action that contributes to the achievement of the objectives set out in article 1 of the present decree.
CHAPTER III: DIRECTION, ADMINISTRATION AND REPRESENTATION
Art. 9th La The direction, administration and representation of the NATIONAL ADMINISTRATION OF MEASURES, FOLLOW-UP AND TECHNOLOGY MEDICA will be in charge of a National Administrator, who will have rank and hierarchy of Secretary and will be appointed by the NATIONAL EXECUTIVE POWER.
The National Administrator will be assisted by a National Assistant Minister, who will have rank and rank as Assistant Secretary and will be appointed by the NATIONAL EXECUTIVE PODER.
(Article replaced by art. 1 Decree No. 1886/2014 B.O. 22/10/2014)
Art. 10. El The National Director of NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UPS AND TECHNOLOGY MEDICA (ANMAT) will, for the purpose of developing the actions provided for in article 8 of this Decree, have the following powers and obligations:
(a) To legally represent the Administration.
(b) Complying and enforcing existing rules in the areas of competence of the Administration.
(c) To advise the HEALTH SECRETARIAT on matters that are subject to the competence of the Administration.
(d) To direct the actions that the administration implements, and may require the Health Secretary, where he deems it necessary, to refresh his actions.
(e) To establish, with the agreement of the Secretary of Health, appropriate delegations of functions, in accordance with the competencies and responsibilities assigned to the areas and officials that make up the Organic Structure of the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOODS and TECHNOLOGY MEDICA (ANMAT).
(f) Develop and propose to the HEALTH SECRETARIAT the annual budget for erogations and calculation of resources and their modifications, as well as the Annual Programme of Activities and Work.
(g) To celebrate, through the HEALTH SECRETARY, technical and scientific cooperation agreements with public and private agencies and entities of our country and abroad.
(h) To have the implementation of the Systems, Programs and Projects approved by the SECRETARIAT OF HEALTH.
(i) Dictate resolutions that enable the development of the Agency ' s actions.
(j) To direct, coordinate and monitor actions, promoting the articulation and participation of other public and private agencies, national or external.
(k) Programme and implement teaching, research, training and technical assistance activities in matters subject to the competence of the Agency, as well as grant scholarships for studies, research and specializations, as approved by the National Executive Branch.
(l) To convene, with the agreement of the Secretary of Health, public agencies and private entities, for the formation of Advisory Committees or Ad Hoc Working Groups or other forms of work and cooperation deemed appropriate.
(ll) Conduct the administration and dictate the regulations, internal rules and administrative arrangements necessary for the operation of the Agency, establishing the delegations of functions in the relevant areas and officials.
(m) To conclude contracts and agreements of different types and purposes, in accordance with the existing rules.
(n) To keep the text ordained and compiled of the legal rules that apply to the Agency updated and systematized.
(in) Propose to the authorities of the SECRETARIAT OF HEALTH the tariffs and fees for the procedures and records that are performed, as well as for the services provided.
(o) Designate, move, promote and remove the staff, in accordance with the relevant regulations, and propose to the SECRETARIAT OF HEALTH the modifications to the organizational structure of the body.
(p) To require the Secretary of Health, in extreme cases that justify the statement of the state of emergency. Established such an emergency, it may hire works, personnel and equipment locations and make all other expenses necessary to meet the urgent needs and to which they may associate or derive from that state.
(q) To have all types of controls, checks and inspections that are deemed appropriate, depending on the competences assigned to the Agency, where necessary the assistance of the Public Force, as well as the cooperation of any other public agency.
(r) Establish the perceived, sanctioned and penalized under applicable rules.
(s) To dispose of the destruction, transfer or sale of property confiscated for breaches of the regulations of rigor or for lack of conditions of aptitude to be consumed by the population or, if they were of imported origin, to order their re-export by the importer.
(t) Delegate due to illness or prolonged absence, the exercise of its functions in the Assistant Director.
CHAPTER IV: RESOURCES
Art. 11. de Please note that for the development of its actions the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT) will have the following resources, which will be deposited to your order in the accounts to be opened to that effect:
(a) Contributions from the National Public Administration Budget and extraordinary contributions made by the National Treasury;
(b) those from the rates and tariffs applicable in accordance with the provisions adopted;
(c) funds from conventions and/or agreements with national and/or international, public and private agencies and institutions;
(d) donations and legacies;
(e) those resulting from the fines and sanctions applied and the sale of confiscated property;
(f) the arrears established by the arrears in the payment of the fees, fines and tariffs it receives;
(g) Interests and incomes deriving from investments in resources obtained; and
(h) any other type of resources to be determined through the laws and provisions established for that purpose.
CHAPTER V: GENERAL PROVISIONS
Art. 12. . Please note that the professional staff of the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT) will be included in the career of the professional staff of the Institutes of Research and Production dependent on the SECRETARIAN HEALTH OF HEALTH MINISTERY AND SOCIAL ACTION, which is provided for by Decree No. 277/91.
Art. 13. de Please note that the personnel of the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT) will be reached by a special regime of incompatibility, which states that it reaches those in the circumstances:
(a) To maintain dependency, permanent or eventual;
(b) To provide direct or indirect professional or other services; and
c) to own, shareholder, partner or director of companies or companies; provided that such activity or character is presented with companies, companies or establishments that act in the supply, production, processing, fractionation, import and/or export, deposit and marketing of products, substances, elements and materials consumed or used in human medicine, food and cosmetics.
Art. 14. . Determine that the National Director and, in cases where he or she is replacing, the Deputy Director shall be entitled to authorize and approve the expenses in accordance with Article 60 of the Accounting Act and with the scope established for the Ministers by Article 57 of the said Law.
The National Director shall issue such resolutions as may be determined by officials authorized to authorize recruitment, irrespective of their amount, and to approve those which do not exceed the amount set out in article 58 of the Accounting Act, giving reason to the NATIONAL TRIBUNAL.
In terms of direct payments, the Treasury of the NATIONAL ADMINISTRATION OF MEASURES, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT) may make them up to the amount set as the approval limit for the directors of decentralized agencies.
CHAPTER VI: TRANSITORY PROVISIONS
Art. 15. ). The SECRETARIAT OF HEALTH will have the driving measures to propose to the NATIONAL EXECUTIVE PODER, within the OCHENTA (180) days of the present, the Organigram, Objectives, Primary Responsibilities and Actions, Permanent and Cabinet Plant, Budget and the realization of the accounting administrative transfers in order to put into operation the NATIONAL ADMINATION OF MEDICALY.
Art. 16. . Until the operationalization of the Organic Structure of the NATIONAL ADMINISTRATION OF MEDICAMENTS, FOLLOW-UP AND TECHNOLOGY MEDICA (ANMAT), the organisms and areas referred to in Article 5 of the present will continue to develop their actions with their current structures, responsibilities and functions.
Art. 17. . Provide the Secretary of Health, for the only time, for the appointment of professionals who will fill the charges referred to in Article 9 of the present, those who will be considered to be positions with Executive Functions for weighting rates I and II, in the terms of the National System approved by Decree No. 993/91 and its complementary standards.
Within the time limit of CIENTO OCHENTA (180) days counted from the entry into force of the present, such charges must be covered strictly subject to the selection procedures provided for in the National System mentioned in the preceding paragraph.
Art. 18. . Communicate, publish, give to the National Directorate of the Official Register and archvese. . MENEM. . Julio C. Aráoz.
- Article 9 replaced by art. 1 Decree No. 1271/2013 B.O. 9/9/2013.
