MEDICINES

Law 27.113

Declare of national and strategic interest the activity of the public production laboratories. National Agency of Public Laboratories. Creation. Sanctioned: December 17, 2014 Enacted in Fact: January 20, 2015

The Senate and Chamber of Deputies of the Argentine Nation, meeting in Congress, etc., are sanctioned by law:

Article 1-State and strategic interest the activity of public production laboratories engaged in the research and public production of medicines, raw materials for the production of medicines, vaccines, inputs and medical products.

Article 2 °-This law aims to promote the activity of public production laboratories, understanding for those belonging to the national, provincial, municipal and Autonomous City of Buenos Aires, of the The armed forces and the state management university institutions.

ARTICLE 3-This law has among its objectives the following: a) Promote scientific, technological and industrial research and development of public production laboratories; b) Strengthen the role of public production laboratories in the health system; c) Promote programs and policies (d) to encourage the accessibility of medicinal products, raw materials for the production of medicinal products, vaccines, inputs and medical products, considered as social goods; d) Orientate the production and supply of medicines, vaccines, inputs and medical products to the public health sub-sector and to bodies or institutions without (e) Promote exchange and cooperation between public production laboratories at regional and international level.

ARTICLE 4 °-Create the National Agency of Public Laboratories (ANLAP), a decentralized agency in the orbit of the Ministry of Health of the Nation, with economic, financial, own legal personality and capacity to act in the field of public and private law. Its patrimony is constituted by the goods transferred to it and by those it acquires in the future by any title.

ARTICLE 5-The ANLAP has the following functions and powers:

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(a) ensure compliance with the objectives set out in Law 26,688 and its rules; b) Design public policies for research and public production of medicinal products, raw materials for the production of medicinal products, vaccines, (c) Define priorities in strategic production lines, in accordance with the provisions of Law 26,688 and its regulations; (d) Provide technical assistance, propose actions, and to conclude agreements to ensure the training and training of human resources In the framework of the Federal Health Council (COFESA), national and provincial public policies aimed at public production laboratories are to be coordinated in the framework of the Federal Health Council; agreements between public production laboratories and universities or other relevant State entities to carry out quality control of medicinal products, vaccines, inputs and medical products and their distribution in the health system; public-private partnerships of mutual convenience in the area of the Research and development; (h) Articulate actions between the National Administration of Medicines, Food and Technologies (ANMAT-) and public production laboratories to ensure compliance with the current regulatory framework; (i) Promote actions in the framework of the COFESA to seek the best conditions in the provision and centralized purchase of inputs and in the development of the components of the distribution logistics, as well as to facilitate the access to sources of financing for the (j) Promote investments aimed at extending the installed capacity; the infrastructure and equipment of the public production laboratories which adhere to this law; (k) Carry out the registration of public production laboratories in accordance with the provisions of Law 26,688 and its regulations.

ARTICLE 6-The ANLAP is directed and administered by an integrated directory, by three (3) members, one (1) president, one (1) vice president and one (1) secretary. The board members must be selected from persons with technical and professional background in the field and appointed by the national executive branch, one of them on a proposal from the COFESA. Its term of office will last five (5) years and may be renewed for one time. The directory must dictate the rules of procedure. The board members must have exclusive dedication in their role, reaching them the incompatibilities set by law for the civil servants and can only be removed from their posts by the founded act of the national executive branch. The members of the Board shall receive the remuneration to be paid to them by the national executive branch.

ARTICLE 7 °-The directory is responsible for the management and supervision of the activities and functions of the ANLAP, and they are faculties of the same: a) Develop the ANLAP's operational plan for the coordination of production, research and development of medicines, raw materials for the production of medicines, vaccines, inputs and medical products; b) Promote relations ANLAP, national and international institutions and, where appropriate, propose agreements between public production laboratories, universities or other relevant state entities to promote public research and medicines, vaccines, inputs and medical products; c) Develop and approve plans, programmes and plans Investment by the ANLAP;

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(d) Propose the annual budget of expenditure, calculation of resources and investment accounts; (e) Approve the memory and balance sheet at the end of each financial year; (f) Require the various bodies of the national public administration (g) Appoint the members of the Advisory Committee and the Executive Committee, as appropriate, as appropriate for the operation of the agency.

ARTICLE 8 °-The president of the ANLAP has the following duties and functions: (a) to exercise the administration of the ANLAP by subscribing to this end for the relevant administrative acts; (b) to convene and chair the sessions of the advisory committee and executive committee and to participate in them with a voice and vote; at least one (1) time for every six (6) months and subject to its consultation the planned policies and those that are being implemented; (d) Coordinate and conduct the whole of the agency's activities for the purpose of achieving the best performance of the objectives proposed in Article 3; (e) to conclude agreements with public or private organisations; national or foreign, for the achievement of the objectives of the ANLAP in coordination with the bodies with competence in the field; f) Approve the annual budget of expenditure, calculation of resources and investment accounts; g) Administer the funds of the ANLAP and carry the inventory of all its assets, in accordance with the rules established by the directory and the legislation in force in the field; h) Exercise the other functions and functions that the directory delegates or entrusts; i) regulatory standards necessary for the operational functioning of the ANLAP; (j) Exercise the representation and general direction of the ANLAP, acting in judgment as acting and defendant in matters of its exclusive competence.

ARTICLE 9 °-The Vice-President shall perform the duties that the President delegated or entrusts to him, and shall replace him in the event of absence, impairment or vacancy of the office.

ARTICLE 10. -The members of the Board may not be owners or have any direct or indirect interest in private sector companies in the pharmaceutical market or in medicines, private health providers, or in their controlled or controlling companies.

ARTICLE 11. -The ANLAP will be assisted by an advisory committee that will have as its function to collaborate and to advise on all matters concerning public policy of production, research and development of drugs, raw materials for the production of drugs, vaccines, inputs and medical products. The committee shall be composed of representatives of non-governmental human rights organizations of recognized trajectory, members of the multi-sector for the public production of medicinal products, with an ad honorem character, by a representative. of the ANMAT, by a representative of the INTI, by a representative of the Conicet, by a representative of the National Interuniversity Council, by a representative of the trade unions, by a representative of the Ministry of Science, Technology and Innovation Productive, a representative of the Argentine Confederation of Clinics, Sanatorios and Hospitals-Confeclisa-, a representative of the Council of Provincial Social Services and Works of the Argentine Republic -Cosspra-and a representative of the ANLIS. The advisory committee will function: 1. Propose public policies in the field of public production of medicines, raw materials for the production of medicines, vaccines, inputs and medical products, and express opinions on those that are carried out by ANLAP.

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2. To prepare and to raise semi-annually the directory of ANLAP proposals for public policies in the field of public production of medicines, raw materials for the production of medicines, vaccines, inputs and medical products, development and research.

ARTICLE 12. -The ANLAP will be assisted by an executive committee, which will have as a function to coordinate the implementation of national policies in the field of public production of medicines, raw materials for the production of medicines, vaccines, inputs and medical products; research and development and shall be integrated, with an ad honorem character, by the representatives of the national, provincial, municipal public production laboratories of the Autonomous City of Buenos Aires, of the The armed forces and the state management university institutions.

ARTICLE 13. -For the purposes of the formation of the executive committee of the ANLAP, the laboratories that decide to join as full members shall be subject to the rights and obligations that are established in the framework of this law, those that emanate from their regulations and those laid down in the rules of procedure.

ARTICLE 14. -The ANLAP's operational resources will come from: (a) the budget items allocated by the budget law to the Ministry of Health of the Nation or special laws; (b) All income not provided for in the previous item, from the administration (c) the movable and immovable property which is transferred to the ANLAP by other State bodies; (d) Any other income which is legally provided for.

ARTICLE 15. -The ANLAP is only obliged and may require commitments to the public laboratories that are part of its executive committee.

ARTICLE 16. -It is the enforcement authority of the Ministry of Health of the Nation.

ARTICLE 17. -Invite the provinces, the Autonomous City of Buenos Aires and the municipalities to adhere to this law.

ARTICLE 18. -Contact the national executive branch.

GIVEN IN THE SESSION HALL OF THE ARGENTINE CONGRESS, IN BUENOS AIRES, AT THE SEVENTEENTH DAY OF DECEMBER OF THE YEAR TWO THOUSAND FOURTEEN.

-REGISTERED UNDER NO. 27.113-

JULIAN A. DOMINGUEZ. -GERARDO ZAMORA. -Lucas Chedrese. -Juan H. Estrada.

Date of publication: 28/01/2015

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