Is Declared Of National Interest Research And Public Production Of Medicines, Raw Materials For The Production Of Drugs, Vaccines And Medical Products
Original Language Title: Se declara de interés nacional la investigación y producción pública de medicamentos, materias primas para la producción de medicamentos, vacunas y productos médicos
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PUBLIC health law 26.688 declared of national interest research and public production of medicines, raw materials for the production of drugs, vaccines and medical products. Adopted: 29 June 2011 fact promulgated: July 29, 2011 the Senate and Chamber of deputies of the Argentina nation gathered in Congress, etc. they attest to the force of law: article 1º - declared of national interest research and public production of medicines, raw materials for the production of drugs, vaccines and medical understanding to them as social goods.
Article 2º - is the subject of this Act promote the accessibility of medicines, vaccines and healthcare products and promote the scientific and technological development through public production laboratories.
Article 3º - it is authority for the application of this law the Ministry of health.
Article 4º - they are considered laboratories of public production for the purposes of this Act, the laboratories of the State national, provincial, municipal and of the city of Buenos Aires, the thoughtful forces and State-run institutions.
Article 5º - instituting a regime of public production of drugs, raw materials, vaccines and medical products by this law.
Article 6º - the regime established by this law will have among its objectives the following: to) set a record in the laboratories of public production, which must contain as a minimum status of installed capacity, operating and conditions registration data; b) set as a frame of reference for the production of medicines the proposal from the World Health Organization essential medicines; (c) define priorities in strategic lines of production, taking into account seasonal and epidemiological profiles of the regions of our country; (d) to promote the provision of medicines, vaccines and healthcare products that requires the first level of attention within the framework of the primary health care strategy; (e) promote the research, development and production of orphan medicinal products; f) promote their articulation with academic and scientific institutions and organizations of workers and https://www.boletinoficial.gob.ar/pdf/linkQR/RjZPa21INDRlN015VC9wRXlpb01lUT09 users; (g) promote a better use of the resources available at every institutional level, avoiding the overlap of production; (h) promote centralized purchases of inputs, to the extent that more favourable conditions for the acquisition; (i) promote research and teaching, as well as the formation and training of human resources; (j) promote the research, development and production of vegetal active principles and phytomedicines, giving priority to the country's native species.
Article 7º - the Ministry of health should promote agreements with other national ministries and within the framework of the Federal Health Council - Cofesa hardware store - with the competent authorities of the jurisdictions, in order to establish criteria and priorities in the allocation of budgetary resources and coordinate the implementation of the system provided for in this Act for the purpose of developing the following actions: to) delineate and develop operational bases; b) establish an operating procedure that allows an effective distribution of medicines, vaccines, and medical products enabled for inter-jurisdictional transit; (c) implement the registry of laboratories of public production; (d) establish guidelines to ensure the quality, accessibility and traceability of medicines, vaccines, and medical products; (e) promote mechanisms to grant preferences in the purchase of medicines, vaccines, and medical products laboratories of public national, provincial, municipal State production and of the city of Buenos Aires; f) develop in form annual report on the activities carried out and its evolution and post it for all the available media.
Article 8º - public production laboratories can celebrate agreements with universities or other relevant State entities to perform the quality control of medicines, vaccines, and medical products.
Article 9º - the national administration of drugs, foods and technologies - ANMAT-, decentralized entity in the field of the Ministry of health, in the role of controller and enabling authority, you must enforce public production laboratories practices of manufacturing and control.
ARTICLE 10. -This policy does not limit the production of medicines in hospital pharmacies under the control of the respective jurisdictions.
ARTICLE 11. -The Ministry of health should promote the necessary agreements with the State universities that have public production laboratories, to coordinate its activity with the aims pursued by the present law.
ARTICLE 12. -The regime established by this law must be solved with specific headings corresponding to the jurisdiction 80 - Ministry of health, according to the provisions of the General budget for the national public administration.
https://www.boletinoficial.gob.ar/pdf/linkQR/RjZPa21INDRlN015VC9wRXlpb01lUT09 article 13. -Invite the provinces and the autonomous city of Buenos Aires to adhere to this law.
ARTICLE 14. -Communicate to the national executive power. GIVEN IN THE CHAMBER OF THE CONGRESO ARGENTINO, BUENOS AIRES, TWENTY-NINE DAYS OF THE MONTH OF JUNE OF THE YEAR TWO THOUSAND ELEVEN. -REGISTERED UNDER NO. 26.688 - JULIO C. C. COBOS. -EDUARDO A. FELLNER. -Enrique Hidalgo. -John H. Estrada.
Date of publication: 02/08/2011 https://www.boletinoficial.gob.ar/pdf/linkQR/RjZPa21INDRlN015VC9wRXlpb01lUT09
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