DRUGS drug law 27.113 declared of national and strategic interest the activity of public production laboratories. National Agency of public Labs. Creation. Adopted: 17 December 2014 fact promulgated: January 20, 2015 the Senate and Chamber of deputies of the Argentina nation gathered in Congress, etc. they attest to the force of law: article 1 - declared of national and strategic interest the activity of public production laboratories dedicated to research and public production of medicines, raw materials for the production of drugs, vaccines, supplies and medical products.
Article 2 ° - this law is to promote the activity of the public production laboratories, understanding as such those who belong to the national, provincial, municipal State and of the autonomous city of Buenos Aires, of the armed forces and State-run institutions.
(Article 3 ° - this law has among its objectives the following: to) promote research and scientific, technological and industrial development of the public production laboratories; b) strengthening the role of laboratories in public health system in production; (c) promote programmes and public policies that prioritize the accessibility of drugs, raw materials for the production of drugs, vaccines, supplies and medical products, considered social assets; (d) guide the production and the supply of drugs, vaccines, supplies and products medical to the sub-sector public of the health and to agencies or institutions without purposes of profit; (e) to promote the Exchange and cooperation between laboratories of public production at regional and international levels.
Article 4 °-create is the Agency national of laboratories public (ANLAP), organism decentralized in the orbit of the Ministry of health of the nation, with autarky economic, financial, status legal own and capacity of action in the field of the right public and of the private. Its heritage is constituted by them goods that is you transferred and by which to acquire in the future by any title.
(Article 5 ° - La ANLAP has the following functions and powers: https://www.boletinoficial.gob.ar/pdf/linkQR/MUVpZ2M0STBvMHRycmZ0RFhoUThyQT09 to) shall ensure the fulfilment of the goals envisaged in the 26.688 Act and its regulations; (b) design them political public of research and production public of medicines, materials raw for the production of drugs, vaccines, supplies and products medical and its distribution in the system of health; (c) define priorities in strategic production lines, in accordance with provisions 26.688 law and regulations; (d) provide assistance technical, propose actions and celebrate conventions to ensure the training and training of them resources human that is operate in the laboratories of production public; (e) to coordinate, in the framework of the Council Federal health - COFESA-, national and provincial public policies aimed at public production laboratories; (f) promoting the conclusion of agreements between laboratories of public production and universities or other relevant State entities to perform the quality control of medicines, vaccines, supplies and medical products and their distribution in the health system; (g) promote partnerships of mutual convenience of public-private type in the area of research and development; (h) joint actions between national administration of drugs, foods and technologies - ANMAT - and public production laboratories to ensure compliance with the existing regulatory framework; (i) promote actions within the framework of the Cofesa hardware store to ensure the best conditions in the provision and centralized purchasing of supplies and in the development of the components of the logistics of distribution, as well as to facilitate access to sources of financing for investment; j) promote investments aimed at expanding the installed capacity, infrastructure and equipment of laboratories of public production that adhere to this law; (k) keep the register of laboratories of public production according to the 26.688 law and its regulation.
Article 6 ° - La ANLAP is directed and managed by an integrated directory, by three (3) members, one (1) President, a (1) Vice-President and a Secretary (1). The members of the Board should be selected from among individuals with technical and professional background in the field and designated by the national executive power, one of them a proposal of the Cofesa hardware store. His term will last five (5) years and may be renewed only once. The directory should dictate the rules of procedure. The Board members must be full-time in his role, reaching them with the incompatibilities laid down by law for public officials and can only be removed from office by the national executive power founded Act. The members of the Board shall receive the remuneration that attach them to the national executive power.
(Article 7 ° - the directory is responsible for the direction and supervision of the activities and functions of the ANLAP, and faculties of the same are: to) the operating plan of the ANLAP for the coordination of production, research and development of medicines, raw materials for the production of drugs, vaccines, supplies and medical products; (b) promoting the institutional relationships of the ANLAP, national and international, in his case, propose agreements between laboratories of public production, universities or other relevant State bodies to promote research and public production of drugs, vaccines, supplies and medical products; (c) develop and adopt plans, programmes and investment plan of the ANLAP;
https://www.boletinoficial.gob.ar/pdf/linkQR/MUVpZ2M0STBvMHRycmZ0RFhoUThyQT09 d) proposing the annual budget for expenses, calculation of resources and investment accounts; (e) approve the memory and balance sheet at the end of each financial year; f) require different bodies of the national public administration the Transitional Committee on personnel which is necessary for the operation of the Agency; (g) appoint to them members of the Committee consultative and the Committee Executive.
(Article 8 °-the President of the ANLAP has the following duties and functions: to) exercise the administration of the ANLAP subscribing to such end them acts administrative relevant; (b) convene and preside over the sessions of the Committee Advisory and Committee Executive and participate in them with voice and vote; (c) convene to the Committee Advisory at least a (1) time by every six (6) months and submit to your query them political planned and which is found in execution; (d) coordinate and lead the joint of the activities of the Agency for the purposes of achieve the best compliance of them goals proposed in the article 3 °; (e) sign agreements with public or private, national or foreign, organizations for the achievement of the objectives of the ANLAP in coordination with the bodies with competence in the matter; f) approve the annual budget of expenses, calculation of resources and investment accounts; (g) administer the finances of the ANLAP, and the inventory of all their goods, in accordance with the rules laid down by the directory and the existing legislation on the subject; (h) to exercise other powers and functions which the Board delegated or entrusted; (i) issue the necessary regulations for the operation of the ANLAP; (j) to exercise representation and general direction of the ANLAP, Act on trial as a plaintiff and defendant in matters of its exclusive competence.
Article 9 ° - the Vice President shall perform the functions that the President delegated or entrusted, and replace it in the event of absence, impediment or vacancy of the post.
ARTICLE 10. -The members of the Board may not be owners or have interest whatsoever, direct or indirect, in the private pharmaceutical market or drug companies, health providers private health, nor its subsidiaries or parent.
ARTICLE 11. -The ANLAP will be assisted by an Advisory Committee that will function help and advise on all matters concerning public policy of production, research and development of medicines, raw materials for the production of drugs, vaccines, supplies and medical products. The Committee shall be composed, on a pro bono basis, representatives of renowned human rights non-governmental organizations, members of the multisectoral public drug production, by a representative of the ANMAT, a representative of INTI, 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 productive innovation, a representative of the Argentina Confederation of clinics, sanatoriums and hospitals - Confeclisa-, a representative of the Board of works and services social provincials of the Republic Argentina - Cosspra - and by a representative of the ANLIS. Functions of the Advisory Committee will be: 1. propose public policies on public production of medicines, raw materials for the production of drugs, vaccines, supplies and medical products and express opinions on which are carried out by ANLAP.
2 develop and raise every six months to the directory of ANLAP public policy proposals in public production of medicines, raw materials for the production of drugs, vaccines, supplies 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 drugs, vaccines, supplies and medical products; research and development and will be integrated, with character ad honorem, by the representatives of the laboratories of production public national, provincial, municipal, of it city autonomous of Buenos Aires, of them forces armed and of them institutions University of management state.
ARTICLE 13. -To them late of the conformation of the Committee Executive of it ANLAP, them laboratories that decide incorporate is as members full will be subject to them rights and obligations that is established in the frame of the present law, which emanate of its regulation and which is established in the regulation internal.
ARTICLE 14. (-Of the ANLAP operational resources will come from: a) budget allocations allotted by the budget law to the Ministry of health or special laws; (b) all income not planned in the subsection above, coming of it management same of the organism; (c) the real and personal property that will be transferred to the ANLAP by other government agencies; (d) any other income that is expected to legally.
ARTICLE 15. -The ANLAP is only bound and may require commitments before the public laboratories that are part of its Executive Committee.
ARTICLE 16. -It is the Ministry of health implementing authority.
ARTICLE 17. -Invite to the provinces, the autonomous city of Buenos Aires and the municipalities to adhere to this law.
ARTICLE 18. -Communicate is to the power Executive national.
GIVEN IN THE CHAMBER OF THE CONGRESO ARGENTINO IN BUENOS AIRES, THE SEVENTEENTH DAY OF DECEMBER IN THE YEAR TWO THOUSAND FOURTEEN.
-REGISTERED UNDER NO. 27.113 - JULIAN A. DOMINGUEZ. -GERARDO ZAMORA. -Lucas Chedrese. -John H. Estrada.
Date of publication: 28/01/2015 https://www.boletinoficial.gob.ar/pdf/linkQR/MUVpZ2M0STBvMHRycmZ0RFhoUThyQT09