Law Of Vaccines.

Original Language Title: LEY DE VACUNAS.

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
1 index Legislative Decree No. 1013 the Legislative Assembly of the Republic of EL SALVADOR, considering: I.-that according to the Constitution, the health of the inhabitants of the Republic constitutes a public good; the State and the people are obliged to ensure their conservation and restoration;
II. in addition, the Constitution established State to give free care to patients who lack resources, and the inhabitants in general, where prevention and treatment is an effective means to prevent the spread of a communicable disease; in this case, every person is obliged to undergo treatments aimed at reducing risks;
III.-that is vitally important to establish legal mechanisms that guarantee the supply, availability, distribution, conservation, application and prescription of vaccines, to protect the population from diseases that are prevented by the same.
Therefore, in use of his constitutional powers and at the initiative of the members Zoila Beatriz jaw Solís, Irma Lourdes palaces Vasquez and the Deputy Guillermo Francisco Mata Bennett; the members of the 2003-2006 legislative period Hector Ricardo Silva Arguello, Miguel Francisco Bennett Escobar, Norman Noel Quijano González, and Elvia Violeta Menjivar Escalante; and with the support of members and deputies Miguel Elías Ahues Karra, Ana Vilma Castro de Cabrera, Guillermo Antonio Gallegos Navarrete, César Humberto Garcia Aguilera, José Rinaldo Garzona Villeda, José Nelson saved Menjivar, Juan Carlos Mendoza Portillo, Erick Mira Bonilla, Rafael Ricardo Morán Tobar, Rafael Eduardo Paz Veliz, Dolores Alberto Rivas Echeverría, Mauricio Ernesto Rodríguez, Rodrigo Samayoa Rivas, Mario Alberto Tenorio Guerrero Francisco Jose Zablah Safie and Melvin Gonzalez Bonilla.
DECREES the following: law of VACCINES chapter I object and scope of application object article 1.-the present law aims to ensure the population an adequate immunization from preventable infectious diseases, through the regulation and promotion of mechanisms that guarantee in the national health system, the acquisition of vaccines, its supply, availability, distribution, conservation, application and prescription.

2 index legislative scope of application article 2.-are subject to compliance with the present law, the institutions of the State forming part of the national health system, the municipalities, the Salvadoran Social Security Institute and support staff working in them; as well as owners and legal representatives of private health establishments and the personnel that work in these.
Chapter II rectory, gratuity and obtaining of vaccine rectory of the program article 3.-the Ministry of health, hereinafter "The Ministry", as the highest authority in the field of health, shall be the governing body for the implementation of this Act; It will carry out the control, monitoring, supervision and evaluation, in relation to vaccines and immunization of persons, which will feature a program of vaccinations and immunizations. The Ministry of agriculture and livestock, in coordination with the Ministry of health should be vaccination of domestic animals for the fulfilment of the objectives set out in the previous paragraph, will count with the collaboration of the El Salvador's Social Security Institute, military health, from the municipalities, the National Civil Police and other public entities, and autonomous institutions, even though their names are not detailed in this law.
Article 4.-the compulsory vaccination against vaccine-preventable diseases are mandatory, when the Ministry deems it necessary.
The supply and application of vaccines included in the program of vaccinations and immunizations, will be continuously and without discrimination of any kind.
In the case of vaccines for special schemes targeting specific risk groups, the same shall be established by the program of vaccinations and immunizations.
The Ministry, must develop and knowledge of the institutions mentioned in article 2 of this law, an official list of vaccines. The list may be reviewed and updated periodically, addressing the frequent technological changes in this field.
Guarantee of free and access article 5.-all vaccine will be applied for free on the national health system, even in private establishments, provided it is supplied by the governing body and the doctor come voluntarily and jointly and severally with the provision of this service.

3 legislative index when it is requested the vaccine by a user of the Salvadoran Social Security Institute, military health, municipalities or Salvadoran Institute of Magisterial welfare, you should be applied regardless of the affiliation of the same type.
Health professionals will be attended jointly and severally with the provision of this service, when so requested by the governing body in case of emergency or national disasters establishments approved article 6.-all public health establishment or private, including the El Salvador's Social Security Institute, must be legally authorized to operate by the competent authority, for vaccines.
The Ministry shall issue the requirements and procedures essential to meet the cold chain and the conservation of vaccines.
Chapter III of the practices of immunization Committee Advisor article 7.-the Ministry, will have an advisory practices Committee of immunizations, which hereafter may be called "The Committee", and will be, made up of the following institutions: a. a representative of the Ministry of health;
b. a representative of the Ministry of agriculture and livestock;
c. a representative of the Salvadoran Association of obstetrics and Gynecology;
d. a representative of the Salvadoran Association of infectious diseases;
e a representative of the Paediatric Association of El Salvador;
f. a representative of the Association of Geriatrics of El Salvador;
(g). A representative of the Salvadoran Association of allergy, asthma and Clinical Immunology;
The Committee shall elect from among its members to the Coordinator.

4 index legislative designation and requirements article 8.-the members who make up the Committee, shall be appointed in the following manner: in the case of associations, their representatives to designate, will be elected in the breast of every one of them, according to its statutes.
In any case the Committee representatives, must be specialists in areas related to the program's vaccines and immunizations, preferably recognized in the area of teaching or research.
Period of functions article 9.-the members of the Committee shall be appointed for a period of three years, and may be reelected only once and their functions will be exercised pro bono.
The members of the Committee may be removed when they lose their quality of active members of the Association, public servant or cease to provide services at the institution they represent.
Quorum article 10.-the quorum be established with half plus one, and decisions shall be taken by a simple majority. Each Member will have voice and vote.
Functions article 11.-the Committee Adviser of practices of immunizations, will have the following functions: 1. propose to the Ministry, the scheme of vaccination and immunization;
2. support to the Ministry as it relates to vaccines and immunizations;
3 collaborate with the Ministry in the development of training in the field of immunization;
4 propose to the Ministry the update of the immunization programme, in accordance with the analysis of epidemiological information;
5 propose actions for surveillance of diseases preventable by vaccination;
6. propose guidelines and standards for immunization practices;
7 propose the use of new vaccines, or removal or replacement of them, as well as their incorporation within the program;
8 collaborate in the elaboration of the operational technical guidelines prior to the 5 development index legislative vaccination campaigns;
9 suggest research that permit the strengthening of the programme;
10 collaborate in investigations that the Ministry which enable the strengthening of the programme;
11 working with the Ministry on the design of strategies of participation of the different sectors in implementing the permanent program of vaccination and immunization;
12 counsel to the Ministry regarding the selection of strains, preservatives and vaccines that apply;
13 recommended to the Ministry the determination of the priority sectors of the population age groups, should be vaccinated.
Chapter IV transportation, distribution, handling and use of the vaccine distribution article 12.-the Ministry is the institution authorized to purchase and free distribution of the vaccines included in the vaccination, for the entire network of health scheme.
You can also distribute free of charge such vaccines to the network of providers private after registration.
It is strictly forbidden to market vaccines provided free of charge by the Ministry.
Is prohibited in any case, import vaccines that are not certified by the world Organization of the health - who-, FDA or other agencies internationally recognized or registered by the competent authority; you are excluded from this prohibition:

a. the vaccines that are part of clinical research in the country, provided that these studies are duly authorized by the Ministry of health. Vaccines used in situations of urgency or emergency declared or that is shown the need and the lack of availability in the domestic market.
b. for single use with proper medical justification.
c. public health situations which demonstrates the necessity and availability 6 legislative index of the product on the national market.
Supply art. 13-the Ministry may provide vaccine to public health institutions, autonomous or private through previously established agreements.
Transportation and mobilization article 14.-the Ministry will establish technical provisions, conservation, distribution and handling of vaccines, within the appropriate temperatures to ensure the immunizing power of them, from their manufacture, import, to managing users.
Transport for vaccine mobilization, shall be authorized by the Ministry.
Control and surveillance article 15.-the Ministry, have the responsibility to ensure that public and private entities authorized to practice vaccination practices, have adequate systems of storage, distribution, and control that guarantee the quality and stability of vaccines, so it should be a good control of the date of expiration or expiration, which ensures the population required prophylactic and immunological effects.
Chapter V of the information system and record meat of vaccination article 16.-to all vaccinated user, will extend you the respective vaccination card authorized by the Ministry.
The Ministry will provide free of charge forms of meat the medical professionals, that are registered in the program of vaccinations and immunizations.
In the case of patients immunized in private clinics, physician must extend the respective card; It must be registered and authorized by the competent authority.
Mandatory article 17.-any person who wishes to enter the educational system must submit the vaccination card, at all levels, at the time of enrollment in the educational center, unless this becomes a barrier to access to education.
Public and private educational institutions have a period of thirty days to inform the health unit of the corresponding geographical area, the number of students that they do not have 7 index legislative meat, to determine their vaccine status and apply vaccines appropriate to their age and be issued the respective meat.
Also, for the issuance of residence or citizenship, abroad should check their State vaccine, by means of certification issued by the competent authority of the country of origin; not be taken in the case, the person should be vaccinated to or is issued with the respective meat.
Notification of cases article 18.-the persons or public bodies and private providers of health services, must notify suspected cases of diseases preventable by vaccination, to facilitate research and the establishment of control measures.
Notification of dose vaccines applied article 19.-is compulsory notification to the Ministry, of the monthly doses of the vaccines applied by persons or public bodies and private providers of health services.
Article 20.-the adverse event notification to the Ministry of adverse events attributable to immunizations, required by persons or public bodies and private providers of health services.
Chapter VI financing Provision of funds article 21 – the Ministry within its budget annually, must have a special extra Fund which shall be used exclusively for the purchase of vaccines, equipment and specialized inputs to ensure the cold chain. Fund will not be reduced to one per cent of the General budget of the nation from the previous fiscal year, which shall establish the corresponding budget heading.
They will also be part of the Fund, donations involved international agencies, governmental, non-governmental agencies or bilateral cooperation for the strengthening of the programme.
The initial amount will be determined on the basis of the budget established by the Ministry within the same budget structure, in which the funds will be established to ensure the functioning of the program.
Acquisition of vaccines article 22.-the acquisition of vaccines to the national health system will be subject to the procedures established in the Revolving Fund of the Pan American Health Organization or 8 legislative index to those contained in the cooperation agreements signed and ratified by our country.
If the vaccine that is required can not be supplied by international agencies or may not provide any necessary vaccinations either within the official schema or within special schemes, the Ministry will buy the vaccines following the procedure for the acquisition of drugs.
Art. 23 donations-donations of vaccine or other supplies for use in vaccination, carried out by public or private national and international institutions, will be assessed and authorised by the Ministry Chapter VII of management preferentially the vaccine exemption tax article 24.-the vaccines and vaccination use inputs acquired by the Ministry and the Salvadoran Social Security Institute they will be exempt from taxes, customs duties or contributions special, State and municipal; to his retirement from the customs, just the written request of the holder of the Ministry.
Withdrawal article 25.-the vaccines purchased by the Ministry, shall be paid to the premises of the Ministry, in one period not more than twenty-four hours of arriving at any Customs Office, with the care of optimally maintain the cold chain.
Chapter VIII offences and penalties offences article 26.-are considered offences, as follows: a. in the case of official or public employee, refusal without just cause to provide the service;
b. hinder the proper functioning of the programme;
c. refuse to provide the information required by the program, or do so outside the time limits.
d. hinder the process of obtaining the meat of vaccination, in cases established by this law.

9 index legislative e. Not report persons who at the time of admission to one of the educational institutions do not have updated immunization card within the deadlines set at the Ministry.
f breaking, health officials and managers of public and private health facilities, standards and technical guidelines, designated by the Ministry of health, in relation to immunization and cold chain;
g sell or obtain any benefit by the transfer of vaccines and supplies of the program.
h. collect the population, in any installation of public health, inputs and the application of vaccines under the programme.
i. market by the private sector of health, in the application of vaccines purchased through the Ministry of health.
j renege on immunization in the event of a national emergency action, ordered by the Ministry of health.
k issue vaccination meat not approved by the Ministry of health.
l issue certificates that express the supply of vaccines not applied sanctions article 27.-without prejudice to the corresponding criminal proceedings, public servants and the health professionals who commits the offences referred to in the previous article, shall be punished in accordance to provisions of the respective regulations of the institution to which it belongs the alleged infringer or the Monitoring Board , as appropriate.
Chapter IX of the competent authority competent authority article 28.-the competent authority for the application of the penalties referred to in the previous article, it will be the head of the institution to which the offender pay services or respective monitoring boards, with respect to professionals of health and professions related to this matter, if any.
Chapter X procedure 10 index legislative procedure article 29.-the procedure to impose the sanctions set out in this law, shall be laid down in the respective regulations of the institution to which it belongs the alleged infringer or surveillance Board as appropriate.
Denunciation article 30.-everyone has the right to denounce any violation referred to in this law. The complaint will be made before the competent health authority.
Chapter XII provisions late Regulation Art. 31.-the President of the Republic in accordance to the ordinal 14 ° of article 168 of the Constitution, will have a term of 180 days after its entry into force, to issue the regulation of this law, but the lack of this not will make impossible their application.
Repeal article 32.-repeal articles 146 and 147 of the health code, issued by Legislative Decree. No. 955, date on April 28, 1988, published in the official journal. No. 86, volume no. 299, of 11 May of the same year.
Entry into force article 33.-the present law shall enter into force eight days after its publication in the official journal.

GIVEN in the blue room of the Legislative Palace: San Salvador, twenty-nine days of the month of February in the year two thousand twelve.

Presidential House: San Salvador, fourteen days after the month of March of the year two thousand twelve.
Publish, CARLOS MAURICIO FUNES CARTAGENA, President of the Republic.
Maria ISABEL RODRIGUEZ VDA. DE SUTTER, Minister of health.
D. o not. 58 vol. No. 394 date: March 23, 2012 JCH/geg 24 April 2012