By Royal Decree 495/2010 of 30 April approving the basic organic structure of the ministerial departments, compliance with the Agreement of the Council of Ministers of 30 April 2010, for which the Council of Ministers of the European approves the Plan for the rationalization of structures in the General Administration of the State, the reduction of senior positions and the reordering of the business public sector.

This agreement is in line with the government's objective of restoring budgetary stability and the resulting reduction of the deficit and has been implemented in a number of measures taken under the austerity plan. General Administration of the State.

As a result, a significant number of management bodies have been removed from the aforementioned Royal Decree 495/2010 of 30 April 2010, the holders of which have the status of a senior official.

The modifications operated in relation to the basic organic structure of the Ministry of Health and Social Policy are concretized in the suppression of two organs with the rank of Directorate General: the Directorate General of Human Resources and Economic and Budgetary Services and the Advanced and Transplant Therapies.

It is therefore necessary to adapt the organic structure of the department in order to reallocate the competencies that were being carried out by the suppressed organs adapting the existing organic structure to compliance with the these objectives.

Thus, the powers of the defunct General Directorate of Human Resources and Budgetary Services and the General Secretariat of Health are to be dependent on the Subsecretariat. Advanced Therapies and Transplants.

Likewise, in the context of austerity and rationalization of the department structure, other modifications are included, which respond to the need to adapt the functions to each organ and thus achieve an improvement in the management that will allow greater efficiency in the delivery of the public service to the ministry. It is therefore necessary to delete sub-directorates-general, in order to deepen simplification, all without further undermining the quality of the essential public service, the users of which are the citizens.

In any case, the modifications introduced aim to improve the adequacy of the organs to the functions attributed, a rationalization of the structure and a greater efficiency in the performance of the competences than the Ministry Health and Social Policy are entrusted to you.

In its virtue, on the initiative of the Minister of Health and Social Policy, on the proposal of the First Vice-President of the Government and Minister of the Presidency and after deliberation by the Council of Ministers at its meeting on 8 March October 2010,

DISPONGO:

Article 1. General organization of the department.

1. The Ministry of Health and Social Policy is responsible for the Government's policy on health, planning and health care and consumption, as well as the exercise of the powers of the General Administration of the State to ensure the citizens the right to health protection. It also corresponds to the proposal and implementation of the Government's policy on cohesion and social inclusion, families, child protection and care for dependent or disabled persons.

2. The powers conferred on this Royal Decree shall be understood in coordination and without prejudice to those corresponding to other ministerial departments.

3. Under the Minister's top management, the Ministry of Health and Social Policy develops the functions that are legally and regulations for the Ministry through the following management bodies:

a) The Deputy Secretary for Health and Social Policy.

b) The General Secretariat for Health.

c) The General Secretariat for Social Policy and Consumption.

4. The Health Advisory Board is the advisory and assistance body to the Minister in the formulation of health policy. Its composition and operating system is governed by its specific rules.

5. It is attached to the Ministry of Health and Social Policy, through its holder, the Spanish Agency for Food Safety and Nutrition with the structure and functions attributed to it by its specific provisions.

6. The Ministry of Health and Social Policy is assigned to the Ministry of Health and Social Policy, which will be its President, the Royal Board on Disability, which will exercise the powers conferred on it by Royal Decree 946/2001 of 3 August, which is approved by the Spanish Ministry of Health and Social Policy. their Staff Regulations.

7. As an immediate support to the Minister, there is a Cabinet, with an organic level of general direction, with the structure provided for in Article 18 of Royal Decree 495/2010, of April 30.

Article 2. Health and Social Policy Undersecretary.

1. The Secretariat for Health and Social Policy is the body to which the functions listed in Article 15 of Law 6/1997 of 14 April of the Organization and the Functioning of the General Administration of the State are responsible. the management, promotion and supervision of its dependent management bodies and of the public bodies assigned to it. It is also up to the department to coordinate the actions of the department in relation to the cases to be submitted to the government's collegiate bodies.

2. In addition, it corresponds to, in particular, the development of the following functions:

(a) The management of the official, statutory and employment staff of the department, the development of the employment relations, the preliminary draft public employment offer and the employment plans, and the handling of the calls for the selection and provision of jobs of the department and its self-employed bodies; training and promotion of staff, social assistance and relations with the staff board and the business committee, as well as security and The Commission has been in a position to make a statement on the situation in the Member States. enabling them.

b) The elaboration and processing of the preliminary draft budget of the department and its autonomous agencies, of the budgetary modifications of the department and those corresponding to the autonomous agencies assigned to it, as well as as the report and technical assistance in budgetary matters and the tasks entrusted to the budget offices.

(c) The implementation of the economic and administrative management of the department's budgetary appropriations and its previous accounting; to process the files on the firm and to justify, and the system of fixed-box advances; to justify accounts, credit rating, coordination of payment boxes and control of health fees, as well as the economic and financial management of the Ministry.

d) The development of the management of the internal system, heritage, works and technical maintenance services.

e) The design, development and implementation of the IT applications of the Ministry and its autonomous organizations, guaranteeing their integration and homogeneity; the provision and management of equipment, computer resources, and communications, both voice and data, including the administration of the domain and the server of the Ministry; the study, preparation and proposal of supplies of material and equipment and services and technical assistance necessary for the exercise of the tasks entrusted to it.

f) The impetus in the use of new technologies by the organs of the Ministry of Health and Social Policy and its autonomous organizations, as well as in the relations of these with the citizens, that allows the processing telematics and the establishment of a single electronic window in the health and social environment.

g) The impetus for the use of new technologies in cooperation with other public administrations and international and supranational bodies; the development, development and implementation of the action plan on information and communications technologies of the Ministry of Health and Social Policy and its autonomous bodies, as well as the management of the resources allocated to its implementation.

(h) The coordination and supervision of actions in the field of information technologies to be developed by the department's governing bodies and autonomous bodies, including processing before the Commission Ministry of Informatics of the proposals corresponding to this field.

i) The development of the communications network of the National Health System and the mechanisms of electronic exchange of clinical and health information.

j) The establishment and management of information systems of the Ministry of Health and Social Policy aimed at citizens.

(k) The attention to the public on the way in which the services, procedures, aids and subsidies of the Ministry of Health and Social Policy are accessible and the carrying out of information and information actions in subjects of the Department.

(l) The implementation of the inspection programmes of the personnel and departmental departments, the evaluation of the functioning of the independent centres and bodies dependent or assigned to the department.

m) The proposal for simplification and streamlining of procedures, the carrying out of studies and proposals on the improvement of the organization, as well as the disciplinary regime.

3. It is up to the Secretariat, the Technical General Secretariat, to exercise the powers provided for in Article 17 of Law 6/1997 of 14 April of the Organization and the Functioning of the General Administration of the State, as well as those provided for in the Article 3.

4. The following units with organic level of general subdirection are also dependent on the Subsecretariat:

(a) The Technical Cabinet, which will have as functions the development of tasks of technical support and direct advice to the Undersecretary, as well as the coordination of the units with organic level of general sub-direction directly dependent on the Secretariat.

(b) The Subdirectorate-General for Human Resources, to which the function referred to in paragraph 2 (a) corresponds.

(c) The budgetary office, to which the function referred to in paragraph 2 (b) corresponds.

(d) The General Financial Management Subdirectorate, to which the function referred to in paragraph 2 (c) corresponds.

(e) The General Staff, which corresponds to the tasks referred to in paragraph 2 (d), as well as the monitoring of the performance of contracts relating to these matters.

(f) The General Information Technology Subdirectorate, which shall exercise the functions referred to in paragraphs (e) to (i) of paragraph 2.

g) The General Subdirectorate for the Attention to the Citizen, which shall exercise the functions referred to in paragraphs (j) and (k) of paragraph 2.

(h) The Department's General Inspection of Services, which shall exercise the functions referred to in paragraph 2 (l) and (m).

5. They are attached to the Secretariat, with the functions assigned to them by the provisions in force, and without prejudice to their dependence on the Ministries of Justice and Economy and Finance, respectively, the following organs with organic level of General sub-direction:

(a) State Advocate in the department, organically and functionally dependent on the General Counsel of the State-Directorate of the State Legal Service, in which they are integrated organically.

b) The Delegated Intervention of the General Intervention of the State Administration.

Article 3. Technical General Secretariat.

1. The Technical General Secretariat is the body to which it is responsible to carry out the duties referred to in Article 17 of Law 6/1997 of 14 April, and the others which attribute the current regulations to it.

In particular, it is up to you to develop the following functions:

(a) The issuance of the precept report of the bills and the draft general provisions emanating from the Ministry, in accordance with the provisions of Law 50/1997 of 27 November of the Government.

b) Participation in procedures for the preparation of bills or draft general provisions initiated by the department's management centers.

(c) Collaboration in the transposition of the rules of European Community law for the incorporation of the Ministry of Health and Social Policy into the internal legal order, as well as, in the the scope of the Department's powers, the monitoring and reporting of the European Commission's infringement proceedings against Spain and the cases before the Court of Justice of the European Union.

d) The coordination of the Ministry with other departments and agencies of the General Administration of the State and advisory bodies, in the elaboration, processing and reporting of normative projects.

e) The study, processing and formulation of the proposals for resolution in the administrative resources brought against the acts and provisions of the department and its agencies attached and procedures for review The Court of Justice also held that the Court of Justice held that the Court of Justice held that the Court of Justice held that the Court of Justice held that the Court of Justice held that the Court of Justice held that corresponding relations with the organs of the Administration of Justice.

f) The elaboration of the editorial program of the department and the management, in coordination with the agencies attached to the Ministry, of the edition, distribution and sale, if any, of the official publications, as well as the functions which, in connection with the editorial process, attributes to it the specific regulations on the subject, in particular in relation to the Advisory Commission of Publications of the department; the management of the general library and the management of the central archive of the department.

(g) monitoring of the provisions and acts of the autonomous communities, without prejudice to competition which in the same field and in relation to health, is the responsibility of the Directorate-General for Vocational Management, National Health and High Inspection System.

(h) The management and coordination of international relations, in collaboration with the Ministry of Foreign Affairs and Cooperation, and participation in international bodies and in the institutions of the European Union.

i) The preparation and negotiation of the projects of agreements, agreements and international instruments in the areas that are the responsibility of the department.

j) The coordination of matters related to development cooperation in the Ministry's own matters, in accordance with the criteria laid down in Law 23/1998 of 7 July of International Cooperation for the Development.

k) Coordination with the Secretariat of the Interterritorial Council of the National Health System, the Consumer Sectoral Conference and the other sectoral conferences of the department in the field of international relations, as well as as the legalisation of documents that may have an effect abroad.

(l) The management of the Ministry of Health and Social Policy's competence in respect of foundations whose protectorate corresponds to this department.

2. The following sub-directions are directly dependent on the Technical General Secretariat:

(a) The General Subdirectorate of Regulations which shall exercise the functions referred to in paragraphs (a) to (d) of the preceding paragraph.

(b) The Subdirectorate-General for Resources and Publications, which shall exercise the functions referred to in paragraphs (e) to (g) of the previous paragraph.

(c) The Subdirectorate General for International Relations, which shall exercise the functions referred to in paragraphs (h) to (k) of the previous paragraph.

3. It also depends on the Technical General Secretariat, with the organic level to be determined in the employment relationship, the Government's Collegiate Bodies Unit, which will carry out preparatory work on the documentation of the issues have to submit to the deliberations of the Council of Ministers, the Government's Delegation Committees and the General Commission of Secretaries of State and Undersecretaries.

4. The Technical General Secretariat is the Chair of the Committee of the Qualifier of Administrative Documents of the Ministry of Health and Social Policy.

5. The Technical General Secretariat, as responsible for development cooperation in matters of the department, will act as a coordinating and liaison body of the Ministry of Health and Social Policy, with the Foundation for Cooperation and Health International of the Spanish National Health System.

Article 4. General Secretary for Health.

1. The General Secretariat of Health is the executive body of the department to which the functions listed in Article 16 of Law 6/1997 of 14 April, in relation to the functions concerning public health, coordination, are to be performed. interterritorial, high inspection, health planning, management of the health professions and development and implementation of the pharmaceutical policy, as well as the functions of the State relating to public financing and fixing of the price of medicines and medical devices, the carrying out of activities intended for translation the innovation and advances of research in particular in the field of advanced therapies, to the National Health System, without prejudice to the competencies attributed to the Ministry of Science and Innovation and the development of the Ministry's policy in the field of coordination of the policy of transplantation. It is also responsible for the development of information systems and the promotion of health strategies and quality programs in the National Health System.

It also exercises the direction, impetus and supervision of the management centers that are dependent on it, as well as the public bodies attached to the Ministry through the General Secretariat of Health.

2. It also corresponds to the coordination with the "Carlos III" Health Institute, in accordance with the provisions of the additional seventh provision of this Royal Decree.

3. The General Secretariat of Health will act as the coordinating and liaison body of the Ministry of Health and Social Policy, with the Foundation for the Development of Research in Genomics and Proteomics.

4. The following management bodies are responsible for the General Secretariat of Health:

a) The Directorate General of Public Health and Foreign Health.

b) The Directorate-General for Vocational Management, Cohesion of the National Health and High Inspection System.

c) The General Directorate of Pharmacy and Healthcare Products.

d) The Quality Agency of the National Health System, with the rank of general direction.

5. It also depends on the General Secretariat of Health the Division of the Technical Cabinet as an organ of support and immediate assistance to the Secretary General, especially in the coordination of the institutional relations of the units and agencies dependent on the General Secretariat, with the organic level to be determined in the employment relationship.

6. The Ministry of Health and Social Policy, through the General Secretariat of Health, the autonomous agencies Agencia Española de Medicines y Productos Sanitarios y Organización Nacional de Transplantas, as well as the managing body, are assigned to the Ministry of Health and Social Policy. of the Social Security National Institute of Health Management.

7. The General Secretariat of Health is also attached to the National Commission of Assisted Human Reproduction.

Article 5. Directorate-General for Public Health and Foreign Health.

1. The Directorate General of Public Health and Foreign Health is the body that assumes the functions related to epidemiological information, health promotion and prevention of diseases, external health, occupational health, environmental health and sanitary and sanitary requirements for the products of human consumption and use, as well as the elaboration of the regulations in these matters. It is also for the determination of the criteria for establishing the Spanish position vis-à-vis the European Union and in international fora in public health matters, without prejudice to the powers of other departments. ministerial.

2. The Directorate-General for Public Health and Foreign Health shall also exercise the following functions:

(a) Carry out the declaration of coordinated actions in public health, in accordance with the provisions of Article 65 of Law 16/2003 of 28 May.

b) Those corresponding to the Ministry of Health and Social Policy in the establishment of the plan of cooperation and harmonization of actions in the field of public health referred to in Article 66 of Law 16/2003, of 28 of May.

(c) Those in the field of external health are derived from the provisions of international law, in Law 14/1986 of 25 April, General of Health, and in Royal Decree 1418/1986 of 13 June, including, in any case, the health authorisation and control for the import and export of human samples for diagnostic or diagnostic analytical studies and without prejudice to the powers of the Spanish Agency for Medicinal Products and Sanitary Products on medicines, medical devices, cosmetics, and personal hygiene products.

d) The development and monitoring of national and international programmes to combat non-food anthropozoonoses.

e) Those that in the field of veterinary public health are entrusted to the department, except those assigned to the Spanish Agency of Food Safety and Nutrition, with whom it will act in coordination in the field of safety food.

f) Regulatory production in the field of public health and veterinary health, as well as the monitoring of its implementation, without prejudice to the competences of other departments and the autonomous communities.

g) Plan, coordinate and develop strategies for action by the National Epidemiological Surveillance Network and other public health surveillance actions, in coordination with the organs of the General Administration of the State with competencies in the field and the services of the autonomous communities, through the working groups established within the Interterritorial Council of the National Health System.

(h) Analyze, propose and, where appropriate, manage public health policies, disease prevention and health promotion programs, especially those that involve the development of initiatives adopted by the European Union, in coordination with the autonomous communities, and develop recommendations to the National Health System for the improvement of the actions carried out in these areas.

i) The Register of Voluntary Pregnancy Disruption.

j) Promote the development of initiatives, programs and activities for the prevention of smoking, in coordination with the Autonomous Communities and promote and coordinate the activities of the Observatory for the Prevention of Smoking.

k) Exercise actions related to the National System for Transfusion Security.

(l) Manage the processing, resolution and payment of the aid established by Law 14/2002 of 5 June establishing social aid for persons with haemophilia or other congenital coagulopathies which they have developed Hepatitis C as a consequence of having received treatment with concentrates of coagulation factors in the field of the public health system, and other tax rules, in accordance with the provisions of Royal Decree 377/2003 of 28 March.

(m) Evaluate, prevent and control the effects of environmental factors on human health; develop draft general provisions for the transposition of Community directives for health protection; In the face of environmental risks to human health, the management of environmental risk monitoring and health monitoring networks; the drafting of proposals for regulations on the health control of water, the health control of air quality, of radiation protection and non-ionising radiation and in general on any exposure to chemical, physical and radiological agents affecting human health.

n) Activities related to health protection arising from the application of Regulation (EC) 1907/2006 relating to the registration, assessment, authorisation and restriction of chemicals-REACH-, and Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures-CLP- and the exercise of the competent authority of those Regulations to the European Union in respect of human health aspects.

n) Register, authorise and assess the risk to human health of biocidal products.

o) Assess the health risks of plant protection products, in accordance with the provisions of Law 43/2002 of 20 November on Plant Health.

p) The actions related to the promotion and protection of occupational health that fall within the competence of the Ministry of Health and Social Policy, in accordance with Law 14/1986, of 25 April, General of Health, and the Law 31/1995, of 8 November, of Prevention of Occupational Risks, as well as those corresponding to the Ministry in the framework of the National Commission on Safety and Health at Work and the relations with the Autonomous Communities in the field of health public.

q) Coordinate the working groups that in the field of environmental health and radiation protection are established within the Interterritorial Council of the National Health System.

r) Coordination, with other public bodies, of health control in the area of communicable and non-communicable diseases, environmental and occupational health, biological products and those potentially dangerous for the public health, in particular as regards the issue of scientific and technical reports and opinions, surveillance work, the conservation of international standards and the preparation and conservation of national standards.

s) Develop in collaboration with other public agencies involved, preparedness and response plans for current or emerging threats to human health.

t) Ensure the maintenance of the databases of the National Network of Epidemiological Surveillance, the analysis and communication of the data of the network to the autonomous communities and the European institutions, in collaboration with the "Carlos III" Health Institute.

u) Ensure the development of a sufficient national capacity for the diagnosis, detection, identification and characterization of infectious agents that may pose a threat to public health, particularly emerging, imported and tropical infectious diseases, and in the field of HIV, encouraging cooperation between specialist and reference laboratories, in collaboration with the "Carlos III" Health Institute.

v) Coordination in the field of environmental health with the collaboration of the National Center for Environmental Health, in particular in the field of air pollution, and for the development of the National Health and Environmental Plan.

w) The coordination of activities related to the training of professionals in the field of public health linked to the National School of Health, with a special impact on health training public and preventive medicine and at the National School of Work Medicine.

3. From the Directorate-General for Public Health and External Health the following sub-directions are dependent:

(a) The Deputy Directorate-General for External Health, which shall carry out the functions detailed in paragraphs (c) to (f) of the preceding paragraph, as well as the inspection and instruction functions of sanctioning files derived from the infringements in the area of the sale, supply, consumption and advertising of tobacco products, which fall within the competence of the General Administration of the State in the terms of Law 28/2005 of 26 December.

(b) The Subdirectorate-General for Health Promotion and Epidemiology, which shall exercise the functions detailed in paragraphs (g) to (l) of the previous paragraph.

(c) The Subdirectorate-General for Environmental Health and Labour Health, which shall exercise the functions detailed in paragraphs (m) to (q) of the previous paragraph.

4. The General Directorate of Public Health and Foreign Health is attached to the Center for the Coordination of Health Alerts and Emergencies.

5. The following collegiate bodies are assigned to the Directorate-General for Public Health and External Health:

(a) The Secretariat of the National Plan on AIDS and the National Commission for the Coordination and Monitoring of AIDS Prevention Programs, as provided for in Royal Decree 592/1993 of 23 April, determining the composition of the and the functioning of the National Commission for the Coordination and Monitoring of AIDS Prevention Programmes.

b) The National Commission for Hemotherapy, integrated into the National System of Transfusion Security, regulated by Royal Decree 1088/2005 of 16 September.

(c) The Observatory for the Prevention of Smoking created by the Council of Ministers Agreement of 28 July 2006.

d) The Observatory on Health and Climate Change, established by the Council of Ministers Agreement of 24 April 2009.

e) The Commission on the Evaluation of Social Aid (CEVHC), regulated by Royal Decree 377/2003 of 28 March.

Article 6. Directorate-General for Vocational Management, Cohesion of the National Health and High Inspection System.

1. The Directorate General for Professional Management, Cohesion of the National Health System and High Inspection is the body responsible for ensuring the functional vertebrate of the National Health System. It will support both the plenary and the committees and working groups of the Interterritorial Council of the National Health System and the Human Resources Commission of the National Health System, in order to facilitate cooperation between the Ministry of Health and Social Policy and the Autonomous Communities. It is up to him to exercise the high inspection of the National Health System that Law 16/2003, of 28 May, assigns to the State and to assume the coordination of the relations of the organs of the department with the autonomous communities, the corporations local and other health organisations and organisations, as well as the monitoring of the acts and provisions of the autonomous communities in the field of health. It is also up to them to make proposals for the management of health professions, management and management of training in the field of health sciences and professional relations, and the development of the Health Cohesion Fund and the elaboration and evaluation of the service portfolio of the National Health System.

It is up to the Directorate-General for Professional Management, Cohesion of the National Health System and High Inspectorate to develop the following functions:

a) Develop proposals for basic human resources regulation of the National Health System, including the management of health professions; order and manage training in health sciences and the system of health (a) accreditation of continuing training of the health professions and the recognition of professional effects on foreign qualifications which enable the exercise of the health professions in which the Ministry of Health does not have competence; Education.

b) The definition of the training needs of healthcare professionals in matters related to health strategies and with advanced therapies and transplants.

c) Coordination of training activities in the field of health sciences.

d) Exercise the functions of high inspection as a guarantee and verification of compliance with the competencies of the Autonomous Communities and the General Administration of the State in the field of health.

e) To process and follow the agreements concluded in the field of the department with other public administrations and public or private entities, as well as to follow the implementation of the agreements adopted in the Interterritorial Council of the National Health System and in the Human Resources Commission of the National Health System and all other those not expressly mentioned in Chapter XI of Law 16/2003 of 28 May.

f) Track and analyze the acts and provisions of the Autonomous Communities, formulate requirements for incompetence and propose the exercise of corresponding judicial actions in the field of health.

g) Develop and update the service portfolio of the National Health System.

h) The momentum of platforms to optimize the reference centers of the National Health System in order to consolidate them as leading centers in clinical-translational research.

i) Define the policy of benefit management and coordinate related activities, as well as define the guarantees of health benefits.

j) Establish the criteria and procedures for the designation of centers, services and reference units of the National Health System.

k) Develop prospective studies on the health needs of citizens and report, study, and analyze the perspectives and resource needs of the National Health System.

l) Identify emerging technologies and organize tutored uses.

m) Analyzing and evaluating the financing systems of the National Health System and their economic needs, thus preparing the necessary economic prospects in the medium term.

n) The development and management of the Health Cohesion Fund.

n) To analyze the economic impact of health care management and to develop studies and reports on the impact of health care expenditure and to develop health expenditure statistics, in collaboration with the Institute for Health Information.

2. From the Directorate-General for Vocational Management, Cohesion of the National Health and High Inspection System, the following subdirectorates-general are dependent:

(a) The Subdirectorate General for Vocational Management, which shall perform the functions provided for in paragraphs (a) to (c) of the preceding paragraph.

(b) The Subdirectorate-General of High Inspection and Portfolio of Services, which shall exercise the functions provided for in paragraphs (d) to (l) of the previous paragraph.

(c) The Sub-Directorate-General for Economic Analysis and the Cohesion Fund, which shall exercise the functions set out in paragraphs (m) to (n) of the previous paragraph.

3. The Directorate General for Professional Management, Cohesion of the National Health System and the National Health System Unit of the National Health System, with the organic level to be determined in the corresponding relationship, is attached. of jobs. It is up to him to exercise the Secretariat of the Interterritorial Council of the National Health System and the Human Resources Commission of the National Health System. It is also responsible for providing technical and logistical support to the plenary, committees, commissions and working groups of both bodies.

4. The Directorate-General for Vocational Management, Cohesion of the National Health System and the Technical Advisory Committee for Orthoprosthetic Provision, which is governed by the orders of the Ministry of Health and Consumer Affairs, of 18 January 1998, is attached to the Directorate-General for Vocational Management. 1996 and 30 March 2000, as well as the Advisory Committee for Dietary Benefits, set up by the Order of the Ministry of Health and Consumer Affairs of 2 June 1998, and the National Council of Specialties in Health Sciences and the national commissions for specialisations and health specialisations. The Board of Directors of the Designation of Centres, Services and Reference Units, regulated by Royal Decree 1302/2006 of 10 November

is also attached to this Directorate-General.

Article 7. Directorate-General for Pharmacy and Health Products.

1. The Directorate-General for Pharmacy and Health Products is the body responsible for the management, development and implementation of the department's pharmaceutical policy, as well as the exercise of the functions that the State has in the field of public financing and the fixing of the price of the medicinal products as well as of the sanitary products dispensed through official prescription, and determination of the special conditions of their prescription and supply in the National Health System, in the establishment of visas prior to the dispensation. It is also up to him to exercise sanctioning powers when carrying out inspection duties.

2. In the framework of Law 16/2003 of 28 May, the Directorate General of Pharmacy and Health Products will establish the general and common criteria for the development of the collaboration of the pharmacy offices, through concerts that guarantee Citizens must be exempt under conditions of effective equality throughout the national territory, regardless of their Autonomous Community of residence.

3. In particular, it is up to you to develop the following functions:

(a) Solve on the financing or non-financing of each medicinal product as well as its indications, and determine, where appropriate, the incorporation of the seal coupon, with the characteristics that in general and for each case In particular, the conditions for prescribing and dispensing of medicinal products in the field of the National Health System, in particular the establishment of visas prior to dispensing.

b) to decide on the financing or non-financing of each medical device dispensed through an official prescription, and to determine, where appropriate, the incorporation of the seal coupon, with the characteristics generally and for each specific case corresponds, as well as the conditions of prescription and dispensing of such products in the field of the National Health System, in particular the establishment of visas prior to the dispensation. To assign the national code for medical devices included in the pharmaceutical supply, in accordance with the provisions of Royal Decree 9/1996 of 15 January.

c) Provide technical and administrative support to the Inter-Ministerial Committee for the Prices of Medicinal Products for the purposes of fixing maximum industrial prices for medicinal products and medical devices intended to be included in the pharmaceutical provision of the National Health System. In addition, it will support the aforementioned commission in relation to the price revisions of medicines and sanitary products dispensed through an official prescription which, included in the pharmaceutical provision of the National Health System, will be are already on the market and will be the secretary of the Interministerial Committee on Drug Prices. Similarly, the prices of generic medicinal products should be fixed in accordance with the criteria laid down by the Commission and pursuant to Article 90 of Law 29/2006 of 26 July on guarantees and the rational use of the medicines and medical devices.

d) Make proposals to the head of the department in relation to the financing conditions, in the field of the National Health System and from the public funding of already authorized medicines and medical devices dispensed through official prescription. Administratively process the offer to the National Health System of medicines, as well as of sanitary products dispensed through official prescription.

e) To make proposals regarding the free or participation in the payment, by the sick, of the medicines and medical devices provided by the National Health System.

(f) Develop and implement the generalised price revisions for medicinal products already on the market, and propose the fixing and review of the maximum prices for medical devices dispensed by prescription. official.

g) Issue reports and make proposals on prices or margins for distribution and dispensing of medicines; regular reports on developments in pharmaceutical public expenditure.

h) Propose the active principles to be included in the reference price system, as well as determine the maximum amount to be financed by such a system for each set of medicines. Also propose the criteria for the revision of the reference prices and identify the medicinal products that are automatically incorporated into the reference price system.

i) Develop the reports for the Government's Delegation for Economic Affairs on the price action of medicines and medical devices dispensed through official prescription, and for the Council Interterritorial of the National System of Health of the prices of the medicines and medical devices included in the pharmaceutical provision of the National Health System, as established in Article 92.4 and the additional provision tenth of Law 29/2006 of 26 July, respectively.

j) Formulate proposals in relation to the total or partial exclusions of the medicinal products of the pharmaceutical provision of the National Health System, as provided for in the fifth additional provision, of Law 29/2006, of July 26.

k) Manage the income of the sales by volume of sales to the National Health System as set out in the additional provision sixth of Law 29/2006, of July 26.

l) Coordinate with the health services of the autonomous communities the measures and actions related to the pharmaceutical delivery of the National Health System through its Interterritorial Council.

m) Coordinate with the health services of the autonomous communities the measures and actions in the field of pharmaceutical management. To propose the requirements and requirements to be applied in the prescriptions and hospital orders. To establish the general and common criteria for the development of the collaboration of pharmacy offices, through concerts that guarantee citizens the dispensation in conditions of effective equality throughout the national territory, regardless of your autonomous community of residence.

n) Manage the information regarding public funding and the price of medicines and medical devices dispensed through an official prescription as well as keeping the relevant databases up to date.

n) Manage aggregated information resulting from the processing of prescriptions from the National Health System and maintain the databases related to information systems in the field of their competence. Manage aggregated information resulting from information regarding purchases of medicines and healthcare products made through the corresponding pharmacy services by the hospitals of the National Health System.

o) Coordinate with the autonomous communities information on the use of medications and sanitary products dispensed through official prescription and adopt measures to ensure their rational use.

p) Authorize the advertising of medicinal products for human use in accordance with the requirements laid down in Article 78.2 of Law 29/2006 of 26 July. It is also appropriate to ensure compliance with the provisions of Article 78.5 of Law 29/2006 of 26 July concerning medical devices.

q) To ensure that information on medicinal products that is provided to healthcare professionals meets the appropriate quality criteria.

r) Coordinate the development of health education programs aimed at promoting the rational use of the drug as a guarantee of quality and safety for citizens.

s) Promote, promote and develop relations with other bodies of the Spanish public administrations, as well as with national private entities, in the areas mentioned in the preceding paragraphs, and participate in the forums They refer to these, pointing out how many sponsors and organize the autonomous communities, as well as the Interterritorial Council of the National Health System.

t) Participate in the elaboration of the regulations in the subjects mentioned in the preceding paragraphs, as well as in the management of the specialized pharmaceutical formation and in the promotion of the pharmaceutical attention and the formation continuous. It is also up to him to study, design and evaluate the management procedures relating to the subjects mentioned in the preceding paragraphs.

(u) to instruct and to resolve the procedures arising from infringements related to the functions and powers of this general management and to promote the adoption of appropriate precautionary and control measures. It is also up to you to report on the resources raised in pharmacy.

v) Promote the establishment of lines of collaboration, agreements and platforms with public administrations, organizations, foundations, private biotechnology and pharmaceutical industry that allow the translation of advances scientists to the National Health System.

4. From the Directorate General of Pharmacy and Healthcare products the General Subdirectorate of Quality of Medicines and Health Products, which will exercise the functions referred to in paragraphs a) to k) of the previous paragraph, is dependent.

5. In the management and maintenance of databases and the information resulting therefrom, as referred to in paragraph 3, the Directorate-General for Pharmacy and Health Products shall act in collaboration with the Spanish Medicines Agency and Sanitary Products.

6. The following collegiate bodies are assigned to the Directorate-General for Pharmacy and Health Products:

(a) The Inter-Ministerial Commission for the Prices of Medicinal Products provided for in Article 90 of Law 29/2006 of 26 July.

b) The growth hormone and related substances advisory committee.

7. The coordinating Centre for ethical committees of clinical research, regulated in Royal Decree 223/2004, of February 6 is attached to the Ministry of Health and Social Policy, through the Directorate General of Pharmacy and Health Products.

Article 8. Quality Agency of the National Health System.

1. The Quality Agency of the National Health System, with the rank of general management, is the organ responsible for the elaboration of the information systems, to promote health plans and quality programs in the National Health System and to analyze the functioning of the Spanish healthcare system compared to other healthcare systems.

2. The Quality Agency of the National Health System will have the following functions:

a) Develop the annual report on the state of the National Health System.

(b) Develop comparative studies of the health services of the Autonomous Communities in the field of the organization, provision of services, health management and results; disseminate studies on the services of health of the National Health System, as well as gathering information on health reforms in European countries.

c) Facilitating methodological information and tools for quality management in healthcare organizations and extending this information in order to facilitate decision making at clinical, management and of health authorities.

d) To encourage and facilitate research by the health services themselves, within the framework of the sectoral health research initiative.

e) Call on organizations involved in the development of quality management and technology assessment to address common information, training and research needs in these fields.

f) Coordination with other public bodies in the development of reports on health technologies and health services aimed at supporting decision-making at different levels of the National Health System.

g) Develop, maintain and disseminate the quality infrastructure of the National Health System: standards and standards, indicators, clinical and care guidelines, record of good practices, and record of adverse events.

h) Define the basic criteria for the authorization of health centers, services, and establishments; support the Interterritorial Council of the National Health System in the elaboration of the quality plan of the National Health System; in order to coordinate and promote communication and quality management; encourage the external and internal evaluation of health centres and services through strategies of support, facilitation and incentives for professionals and healthcare organisations, as well as developing the methodology and accrediting companies and competent institutions to carry out audits of health facilities and services that are valid for the National Health System.

i) Develop the methodology and accredit the National Health System reference centers.

j) The study, promotion and promotion of transversal actions that accelerate the transmission of knowledge to patients in the National Health System.

k) Develop the activities necessary for the functioning of the health information system set out in Article 53 of Law 16/2003 of 28 May, as well as the performance of statistics of general interest suprachomunitary, in accordance with the provisions of Article 55 of the same Law.

l) To collect, develop and disseminate objective, reliable and comparable information that allows the achievement of the objectives of the National Health System to be assessed, responds to the information needs of the entities that make it and serve as a support for the generation of knowledge in this field, in accordance with guidelines to be established by the Interterritorial Council of the National Health System.

m) Establish and ensure compliance with the standards of standardisation of information to be integrated into the information system of the National Health System, in line with the Union's standardisation framework European for such systems.

n) To collect data from other sources, both national and international, in order to complement the intrinsic information to the National Health System, to enable the establishment of correlations, as well as facilitate comparison with other areas.

n) Assign the unique personal identification code of the National Health System, as provided for in Law 16/2003 of 28 May, and in Royal Decree 183/2004 of January 30, which regulates the health card individual.

o) Develop and direct the national health survey and health barometer and manage the dissemination of data from the National Defunctions Index.

p) Coordinate the department's statistical operations and information systems.

q) To provide a structure for the dissemination and exchange of initiatives and experiences on health information systems in the different areas of competence.

r) Veloing for the integrity and security of the data committed, ensuring its confidentiality.

s) Develop and maintain the General Register of health centers, services and establishments, as well as recognize as valid for the National Health System records of existing health information in different areas professionals and scientists.

t) Maintain institutional relations with national and international bodies competent for statistics and health information systems, in coordination with the General Secretariat for Relations International.

u) Develop the functions referred to in Article 55 of Law 16/2003 of May 28.

v) Plan and monitor actions in the field of information systems, developed by the National Institute of Health Management.

w) Establish the technical standards and functional procedures necessary for the access and exchange of clinical and individual health information in the National Health System in the terms provided for in Article 56 of the Law 16/2003, May 28.

2. From the Quality Agency of the National Health System, the following organs with organic level of general subdirection depend:

(a) The Office of Health Planning and Quality, which shall exercise the functions detailed in paragraphs (g) to (j) of the previous paragraph.

(b) The Institute for Health Information, which shall exercise the functions detailed in paragraphs (k) to (w) of the previous paragraph.

3. The Observatory of the National Health System established by Law 16/2003 of 28 May, is assigned to the Agency, with the organic level to be determined in the corresponding relation of jobs.

4. The Health Observatory of Women is also assigned to the Quality Agency of the National Health System.

Article 9. General Secretary for Social Policy and Consumer Affairs.

1. The Secretary-General for Social Policy and Consumer Affairs, whose holder will serve as Secretary-General of the Royal Board on Disability, is the executive body of the department to which the functions listed in the Article 16 of Law 6/1997, of 14 April, in relation to the functions concerning social policy, to the articulation of the participation of the General Administration of the State in the System for Autonomy and Attention to Dependence, in the Terms provided for in Law 39/2006 of 14 December of the Promotion of Personal Autonomy and Attention to people in a situation of dependency, the promotion of social services and the promotion of cooperation with non-governmental organizations and the promotion of social volunteering, in the field of constitutionally reserved to the State, the protection and promotion of families and children and the prevention of situations of need in which these groups may incur, in the area of the constitutionally reserved powers to the State, the attention and support for people with disabilities, in the field of skills Constitutionally reserved to the State, the exercise of the protection of the State over the care entities outside the Administration, without prejudice to the functions of the Secretariat on the protection of foundations, the promotion of policies on equality, non-discrimination and universal accessibility in the field of their competences, as well as on drug dependency and consumer policy.

2. The following management bodies are dependent on the General Secretariat for Social Policy and Consumption, with a general direction:

a) The Directorate-General for Social, Family and Children's Policy.

b) The Directorate-General for the Coordination of Sectoral Policies on Disability.

c) The Government Delegation for the National Plan on Drugs, with an organic level of general direction.

d) The Consumer General Address.

3. The Ministry of Health and Social Policy, through the General Secretariat for Social Policy and Consumer Affairs, the managing body of Social Security, the Institute of Older and Social Services (IMSERSO), which will exercise the powers that They attribute the recast text of the General Law of Social Security, approved by the Royal Legislative Decree 1/1994, of 20 June, and Royal Decree 1226/2005, of 13 October, which regulates the organic structure and functions of the Institute of Seniors and Social Services.

4. They are consultative collegiate bodies attached to the Ministry of Health and Social Policy, through the General Secretariat for Social Policy and Consumer Affairs, the following:

(a) The State Council of Older Persons, which shall exercise the functions conferred on it by Royal Decree 117/2005 of 4 February, which regulates the State Council of Older Persons.

b) The National Disability Council, which will perform the duties attributed to it by Royal Decree 1865/2004 of 6 September, which regulates the National Disability Council.

c) The State Council of Non-Governmental Organizations of Social Action, which will exercise the functions conferred on it by Royal Decree 235/2005 of 4 March, which regulates the State Council of Non-Governmental Organizations Social Action.

(d) The State Council of the Gypsy People, which shall exercise the functions conferred on it by Royal Decree 891/2005 of 22 July, establishing and regulating the State Council of the Roma People.

e) The State Council of Families, which will exercise the functions attributed to it by Royal Decree 613/2007, of 11 May, for which the Council and the State Observatory of Families are created and regulated.

(f) The International Adoption Advisory Board, which shall perform the tasks assigned to it by Royal Decree 521/2005 of 13 May establishing the Advisory Council for International Adoption.

Article 10. Directorate-General for Social, Family and Children's Policy.

1. They correspond to the Directorate-General for Social, Family and Children's Policy, in the field of the constitutionally reserved powers to the State and in cooperation with the autonomous communities, the following functions:

(a) The impetus, analysis, elaboration, coordination and monitoring of the programmes of action in the field of social services of primary care, social inclusion, protection and promotion of families and the children and the prevention of situations of difficulty or social conflict.

b) The impetus, elaboration, coordination and follow-up of the National Action Plan for Social Inclusion, in accordance with the European Social Inclusion Strategy.

c) The promotion of public policies for the promotion and improvement of the living conditions of the Spanish gypsy population.

d) Managing the social services user information system

e) The management of studies, statistics and the training of social services professionals in primary care, social inclusion and protection and promotion of families and children.

(f) The promotion of cooperation with non-governmental organisations in the fields of social action programmes, social inclusion, Roma, families and children.

g) The call for and management of grants from the tax allocation for social purposes of the Income Tax of the Physical Persons, and of the general regime of social services, families and children.

h) The drive and development of social volunteering.

i) Cooperation with public and private entities, national and international, in the field of international adoption, without prejudice to the functions of management and coordination of the Secretariat of the Department in the field of international cooperation.

j) The impetus and management, of collegiate bodies for analysis, debate and proposals in the field of families, children, the Roma population and social action.

k) The analysis of the regulations on the protection and promotion of families and children, non-governmental organisations, volunteering and the fight against poverty and social exclusion and, where appropriate, the formulation of corresponding proposals.

l) Relations with the European Union and foreign and international organizations and technical cooperation in international cooperation programmes for families and children, non-governmental organisations, voluntary organisations and the fight against poverty and social exclusion, without prejudice to the functions of management and coordination of the Secretariat of the department.

m) To exercise the secretariat of the Commission on social aid to those affected by HIV.

2. From the Directorate-General, the following bodies depend, with organic level of general subdirection:

(a) The Subdirectorate-General for Social Programmes, which corresponds to the exercise of the functions listed in paragraphs (a) in the field of social services of primary care and social inclusion, (b) and (j) in social services of primary care, social inclusion and Roma population of the previous section.

(b) The Subdirectorate-General of Non-Governmental and Voluntary Organisations, which corresponds to the exercise of the functions listed in paragraphs (f) in respect of the social action programmes, (g) and (h) and (k) and (l) in the field of non-governmental organisations and voluntary organisations in the previous section.

(c) The General Subdirectorate of Families which corresponds to the exercise of the functions listed in paragraphs (a), (f), (j) (k) and (l) of the previous paragraph in respect of families.

(d) The General Children's Subdirectorate to which the exercise of the functions listed in paragraph (i) and paragraphs (a), (f), (j) (k) and (l) of the previous paragraph in the field of childhood is appropriate.

3. The Commission is attached to the Directorate-General for Social, Family and Children's Policy, the Commission on Social Aid to those affected by the acquired human immunodeficiency virus, as provided for in Royal Decree-Law 9/1993 of 28 May 1993. regulated by the Order of 18 November 1996.

Article 11. Directorate-General for the Coordination of Sectoral Policies on Disability.

1. They correspond to the Directorate-General for the Coordination of Sectoral Policies on Disability, the holder of which will also perform the duties of Director of the Royal Board on Disability in the field of the Constitutionality. reserved for the State and in cooperation with the Autonomous Communities, the following functions:

a) The impetus of sectoral policies on disability and their inter-ministerial coordination, as well as between the General Administration of the State and that of the Autonomous Communities and local corporations.

b) The planning, design and management of state-wide programmes and plans in the field of disability and their coordination with the autonomous communities.

c) The management and evaluation of state-wide plans and programs in cooperation with other ministries, autonomous communities, and local corporations.

(d) The proposal for legislation in matters of its competence, without prejudice to the competences of the Technical General Secretariat.

e) The promotion of cooperation with organisations and entities that bring together people with disabilities and their families, and the coordination and monitoring of the performance of the disability advisory bodies.

f) The promotion of collaboration and support for the Spanish Red Cross, the National Organization of the Blind Spaniards and the welfare and disability foundations, for the fulfillment of their social ends.

g) The exercise of the protection of the State in respect of the care and disability entities outside the Administration, without prejudice to the functions of the Subsecretariat on the protectorate of foundations.

h) Relations with foreign and international bodies and the technical coordination of international cooperation programmes relating to disability, without prejudice to the functions of management and coordination which correspond to the Assistant Secretary of the department.

2. From the Directorate-General, the following bodies depend, with organic level of general subdirection:

(a) The General Coordination and Management Subdirectorate, which corresponds to the exercise of the functions listed in paragraphs (a), (d) and (e) of the previous paragraph.

(b) The General Subdirectorate for Participation and Tutelated Entities, which corresponds to the exercise of the functions listed in paragraphs (b), (c), (f) (g) and (h) of the previous paragraph.

Article 12. Government Delegation for the National Drug Plan.

1. The Government Delegation for the National Plan on Drugs corresponds to the functions of direction, impulse, general coordination and supervision of the services responsible for the updating and implementation of the National Plan on Drugs. In the field of the competences of the Ministry of Health and Social Policy, under the top management of the Secretary General of Social Policy and Consumption, it assumes the impetus of policies to reduce the demand for the consumption of drugs and prevention, treatment, rehabilitation and harm reduction programs.

2. In particular, the following functions correspond to:

(a) Exercise the Secretariat of the Inter-Ministerial Group and the Sectoral Conference of the National Plan on Drugs, preparing and coordinating all the issues that need to be submitted to these collegiate bodies, to ensure that the of all its agreements, as well as to exercise coordination in this area between organs and units of the various ministerial departments, in accordance with the political declaration adopted by the United Nations General Assembly in June 1998 and with the European Drugs Strategy 2005-2012 and the action plans that develop it.

b) To promote and coordinate relations with the different administrations and institutions, both public and private, including non-governmental organizations, which develop activities in the field of the National Plan on Drugs, providing them with the necessary technical support.

(c) Develop and propose National Strategies on Drugs and Action Plans to develop them, coordinating with public administrations and social actors the implementation of actions and measures aimed at achievement of the measures identified in them.

(d) to encourage, analyse, propose and manage, in the field of their competences, programmes for prevention, assistance and reintegration in the field of drug dependency, in coordination with the various institutions involved in the the National Plan on Drugs.

e) Promoting the participation of companies and social entities in the activities of the National Plan on Drugs, promoting the incorporation of drug and drug programs into the development of social responsibility corporate.

(f) Promoting and encouraging training for health professionals and other professionals in the various aspects of drugs and drug dependency, without prejudice to the powers of the European Communities. Stand-alone.

g) To carry out and coordinate activities in the Spanish territory for the collection and analysis of data and the dissemination of information, both statistical and epidemiological, on the use of drugs and drug addiction, defining, to these effects, indicators and criteria, acting as the Spanish Observatory of Drugs and Drug Addiction, without prejudice to the competences that the autonomous communities can exercise in their respective territorial areas, agreement with its Autonomy Statutes.

(h) To promote research activity in the field of drugs and drug dependency at the State level and to propose priority research lines that are considered to be of interest to the objectives of the National Plan on Drugs and Drug Addiction. drugs.

i) Promote systems for the evaluation of prevention, treatment and social integration programs and apply these systems to programs and activities funded from the National Drug Plan.

j) Develop and direct the state survey on the use of drugs in secondary education and the home survey on alcohol and drugs in Spain, as well as collect and elaborate the information of the indicators that make up the The State System of Information on Drug Dependencies.

k) To direct the Documentation Center of the National Plan on Drugs that serves as a documentary and informative reference in the field of additions and drug dependencies.

(l) In collaboration with the General Secretariat for International Relations, coordinate the national position, participate in the meetings of the relevant international organizations, and intervene in the implementation of the (i) agreements resulting from those agreements and, in particular, those which are developed within the framework of cooperation within the European Union, in the field of drugs, by exercising general coordination between the units of the various departments; (a) ministerial, carrying out actions in such fields, without prejudice to the powers conferred on them have been recognised and of the State's external representation and performance unit, attributed to the Ministry of Foreign Affairs and Cooperation.

(m) Serve as a state body of communication with the European Monitoring Centre for Drugs and Drug Addiction in the exercise of its powers recognised in Community legislation.

n) Manage and manage all aspects related to the human, economic and technical resources of the Government Delegation, without prejudice to the powers conferred on other higher bodies or governing bodies of the department.

n) Manage, manage and dispose of, under the direction and supervision of the adjudications coordination bureau, the assets integrated into the Fund of goods seized by illicit drug trafficking and other related crimes, regulated by Law 17/2003 of 29 May, and to provide technical and material support to that table.

or) to collaborate with the competent judicial bodies in the early disposal of the goods of lawful trade apprehended or seized by the commission of any of the crimes referred to in article 1 of Law 17/2003, May 29.

3. The following general sub-directions will be directly dependent on the Government Delegate for the National Drug Plan:

(a) The Subdirectorate-General for Information, Studies and Coordination of Prevention, Assistance and Reinsertion Programs, which will develop the functions detailed in paragraphs (d) to (k) of the previous paragraph.

(b) The General Secretariat for Institutional Relations, which shall develop the functions detailed in paragraphs (l) and (m) of the previous paragraph.

c) The General Management Subdirectorate that will develop the functions detailed in paragraphs (n) to (o) of the previous paragraph.

4. The following collegiate bodies are attached to the Ministry of Health and Social Policy, through the Government Delegation for the National Plan on Drugs:

(a) The Advisory Board of the Spanish Observatory on Drugs and Drug Addiction, which will have the organization and functions to be determined.

b) The Adjudications Coordination Bureau, with the powers laid down in the specific regulations of the Fund for goods seized by illicit drug trafficking and other related crimes.

(c) The Technical Commission for the Evaluation of Drug Action, regulated by Order SCO/2036/2007 of 3 July.

Article 13. General Direction of Consumption.

1. The Directorate-General for Consumer Affairs is the body to which the proposal for a regulation falls within the scope of state competences, which have an impact on the protection and promotion of the rights of consumers and users; the establishment and promoting effective procedures for the protection of the same; inter-territorial institutional cooperation in the field; the promotion of consumer and user associations and support for the Consumer and Users ' Council.

2. The following functions are the responsibility of the Consumer General Directorate:

a) Provide citizens with information about their rights as consumers.

b) Carry out analysis, testing and testing on the quality and safety of consumer goods and services, promoting analytical and technological quality in the area of control of goods and services, as well as training and advising to technical personnel.

c) Encourage the strengthening of consumer and user associations in the area of the Autonomous Community and promote the operation of the Consumer and Users ' Council.

d) Manage and boost the Consumer Umpire System.

e) To promote institutional cooperation in consumer affairs.

f) Promote, in the field of state competences, the rights of consumers and users.

3. It is attached to the Ministry of Health and Social Policy through the Directorate-General for Consumption, the autonomous body Instituto Nacional del Consumo.

4. The Research and Quality Control Centre shall be assigned to the Directorate of the National Consumer Institute, with the organic level to be determined in the list of posts, and shall carry out the functions referred to in the paragraph (b) in paragraph 2.

Additional disposition first. Inter-Ministerial Committee on the Prices of Medicinal Products.

1. It is for the Interministerial Committee on Drug Prices to establish the maximum industrial price on a national basis for each pharmaceutical specialty financed by public funds.

2. The Commission shall be composed of:

a) President: The Secretary General of Health.

b) Vice President: The Director General of Pharmacy and Healthcare Products.

c) Vocals:

1. Two representatives of the Ministry of Economy and Finance, with the rank of director-general.

2. A representative of the Ministry of Industry, Tourism and Trade, with the rank of Director General.

3. The Subdirector General of Quality of Medicines and Healthcare products.

d) Act as the Secretary of the Commission, with a voice but no vote, an official of the General Administration of Quality of Medicines and Sanitary Products of the Directorate General of Pharmacy and Health Products.

3. The operation of the Inter-Ministerial Committee for the Prices of Medicinal Products shall be in accordance with the provisions of Chapter II of Title II of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Rules of Procedure Common Administrative.

4. The members of the Interministerial Committee for the Prices of Medicinal Products shall not be entitled to any remuneration or economic compensation for their membership, unless they are entitled to travel or subsistence allowances, according to the applicable rules.

Additional provision second. Interministerial Committee on Food Management.

The Chair of the Spanish Food Safety Agency is the Chair of the Inter-Ministerial Committee on Food and Food Management, which is regulated by Royal Decree 1456/1982 of 18 June.

Additional provision third. Ministerial Committee on Statistics.

The Ministerial Committee on Statistics, regulated by the Order of 6 September 2001, will be composed of the following members:

a) President: The Director General of the Quality Agency of the National Health System.

b) Vice President 1. º: The Director General of Social, Family and Childhood Policy.

c) Vice President 2. º: The Director General of Public Health and Foreign Health.

d) Vocals: The Deputy Director-General for Health Promotion and Epidemiology, the Deputy Director-General of Information Technologies, the Deputy Director-General for Economic Analysis and Cohesion Fund, the Deputy Director-General for Programmes Social, and a representative of the Health Advisory Board.

e) Secretary: The Deputy Director General of the Institute for Health Information.

Additional provision fourth. Board of Coordination of Adjudications.

The Board of Coordination of Adjudications, as regulated in Article 6 of Law 17/2003 of May 29, will be composed of the following members:

a) President: The Government Delegate for the National Drug Plan.

b) Vice President: The Deputy Director General of Government Delegation Management for the National Drug Plan.

c) Vocals, with Deputy Director General level or equivalent:

1. A representative of the Ministry of the Interior.

2. Three representatives of the Ministry of Economy and Finance.

3. A representative of the Ministry of Justice.

4. The Advocate of the Head State, State Advocate of the Ministry of Health and Social Policy, with a voice but without a vote.

d) Act as Secretary, with a voice but no vote, an official from the Government Delegation for the National Drug Plan.

Additional provision fifth. Supply of the heads of the management bodies.

In the cases of vacancy, absence or illness of the holder of a management body, and in default of appointment of an alternate as provided for in Article 17 of Law 30/1992, of 26 November, of the Legal Regime of the Public Administrations and the Common Administrative Procedure, shall be responsible for the supply to the Deputy Directors-General for the same order in which they appear in the respective structure established in this royal decree.

Additional provision sixth. Removal of organs.

1. The following management bodies are deleted:

(a) From the Directorate-General for Vocational Management, Cohesion of the National Health and High Inspection System, the High Inspection and the Portfolio of Services and New Technologies.

b) From the Food Safety and Nutrition Agency, the General Secretariat for Scientific Coordination.

c) The Royal Disability Patronate, the Technical Directorate, with an organic level of general sub-direction.

Additional provision seventh. Joint Committee on Coordination between the Ministry of Science and Innovation and the Ministry of Health and Social Policy, in relation to the "Carlos III" Health Institute.

The Ministry of Science and Innovation and the Ministry of Health and Social Policy participate in the decision-making on the functions of the Health Institute "Carlos III" related to the subjects referred to in the Royal Decree 785/2009, of April 30, through the Joint Commission constituted in that royal decree.

Additional disposition octave. Exception in the appointment of Directors-General.

The heads of the Directorate-General who are currently excluded from the general rule of appointment provided for in Article 18.2 of Law 6/1997 of 14 April, Organization and the Functioning of the General Administration of the State, shall maintain in force the characteristics and reasons justifying the application of that derogation.

Additional provision ninth. Delegation of powers.

The delegations of privileges granted by the various organs of the Ministry of Health and Social Policy and not revoked until the date of entry into force of this royal decree, will continue to be valid and will be able to make use of they are the competent bodies by reason of the matter that come to replace the delegates, until they are expressly revoked or again granted to the different organs resulting from the application of this royal decree.

Additional provision 10th. Collegiate bodies.

It is for the head of the department to chair the collegiate bodies whose presidency corresponds to the extinct Ministers of Health and Consumer Affairs and Education, Social Policy and Sport in the field of competition. of the department or any other organ in which it is assigned to it.

Additional provision eleventh. Reference to deleted organs.

The references that are made in the legal order to the organs that are deleted by this royal decree will be understood to be those that are created, replaced or assume their competences in this same norm.

Single transient arrangement. Units and jobs with lower organic level than general sub-direction.

1. The units and posts with a lower organic level than the general sub-directorate shall remain subsist and shall be paid from the same budgetary appropriations until the relations of the posts adapted to it are approved. organic structure of this Royal Decree, which under no circumstances will be likely to increase public expenditure.

2. The posts in the organs deleted in this Royal Decree, or which are affected by the changes in the powers laid down therein, shall be provisionally attached by resolution of the Deputy Secretary for Health and Policy Social to the relevant governing bodies, according to the functions assigned to each one in this Royal Decree and until the new relations of jobs are approved.

Single repeal provision. Regulatory repeal.

1. Royal Decree 1041/2009 of 29 June 2009, for which the basic organic structure of the Ministry of Health and Social Policy is developed and amended by Royal Decree 438/2008 of 14 April, is hereby repealed. basic organic of the ministerial departments.

2. Similarly, any provisions of equal or lower rank shall be contrary to the provisions of this Royal Decree.

Final disposition first. Amendment of Royal Decree 709/2002 of 19 July 2002 approving the Statute of the Spanish Agency for Food Safety and Nutrition.

Article 26 of the Statute of the Spanish Agency for Food Safety and Nutrition, approved by Royal Decree 709/2002 of 19 July, is worded as follows:

" Article 26. General sub-addresses and basic units.

The Spanish Food Safety and Nutrition Agency is structured in the following units and centers, under the agency's Executive Director:

(a) General Secretariat, with an organic level of Subdirección General, which performs functions of support to the Executive Director in administrative, financial, legal and human resource management matters and, specifically, in the development of the functions set out in paragraphs (a), (d), (h) and (u) of Article 2.2 of Law 11/2001, as well as the Secretariat of the Inter-Ministerial Committee for Food Management (CIOA).

(b) General Food Risk Management Subdirectorate, which assumes the development of functions related to the management of food risk in the production, processing, processing, transport, distribution and sale or service to the final consumer and collectivities, as well as those of the same nature that were being assigned to the pre-existing units or services that are integrated in this Subdirectorate General. Specifically:

1. To formulate proposals on the regulation of sanitary control of food and products specified in the Spanish Food Code, and of the health risks of other products and services.

2. Manage the General Health Sanitary Register.

3. The elaboration and monitoring of national and international programmes to combat anthropozoonoses for food transmission.

4. The production of legislation in the field of veterinary public health in the areas of action of the Agency, as well as the monitoring of its implementation, without prejudice to the competences of the Autonomous Communities.

5. The functions described in paragraphs (c), (k), (p), (q), (s) and (t) of Article 2.2 of Law 11/2001.

6. The functions specified in paragraphs (a), (b), (c), (d) and (i) of Article 4 (2) of this Statute.

(c) General Secretariat for Coordination of Food Alerts and Programming of Official Control, which will perform the following functions:

1. The ones described in paragraph (n) of Article 2.2 of Law 11/2001 of 5 July and in paragraph 2 of Article 4 (2) of this Statute, exercising them in accordance with the provisions of Article 30 of the This Statute.

2. The functions listed in paragraphs (b), (g), (j), (o) and (r) of Article 2.2 of the Act cited in the preceding paragraph.

(d) to the Executive Directorate, which directly assumes the functions set out in paragraphs (e), (f) and (i) of Article 2.2 of Law 11/2001, as well as those set out in paragraphs (e), (f) and (g) of Article 4 (2) of this Regulation. Status is assigned to it, with the organic level to be established in the corresponding relation of jobs:

1. The Office of the Communication of Food Risks, which specifically performs the functions set out in paragraphs l) and m) of article 2.2 of Law 11/2001, and through which the relations of the Agency with broadcast media.

2. The National Food Center, which performs functions of scientific and technical support and laboratory analytical control, acting as a reference laboratory in those cases established in the corresponding.

3. The Community Laboratory of Marine Bioxins, which will perform functions of scientific-technical support and laboratory analytical control in the field of marine biotoxins, acting as a reference laboratory in the cases in the relevant provisions so establish.

4. The functions set out in paragraphs (e), (f) and (i) of Article 2.2 of Law 11/2001, as well as those set out in paragraphs (e), (f) and (g) of Article 4 (2) of this Statute.

e) Other technical units and functions shall be structured as established by the employment relationship of the Spanish Food Safety and Nutrition Agency and shall be attached to the unit or general sub-directorate corresponding. "

Final disposition second. Amendment of Royal Decree 1825/2009 of 27 November approving the Statute of the National Transplant Organisation.

A new paragraph is added to Article 5, and the existing text, of the Statute of the National Transplantation Organization, approved by Royal Decree 1825/2009, of 27 November, is added to the following wording:

" Article 5. Functions:

1. For the achievement of its purposes ... (rest, equal).

2. It is also appropriate to develop the Ministry's policy on advanced therapies and transplants, without prejudice to the powers conferred on the Ministry of Science and Innovation, in particular the application of research in advanced therapies and in regenerative medicine to the National Health System.

This will perform the following functions:

a) Promote the therapeutic application of regenerative medicine and advanced therapies, in particular by transferring them to the National Health System.

b) Promote the adoption of therapeutic protocols in the field of regenerative medicine and advanced therapies. "

Final disposition third. Amendment of Royal Decree 946/2001 of 3 August, approving the Statute of the Royal Patronate on Disability.

Article 1 (1) and (2), Article 4 (3), Article 5 (1) (a) (b) and (c), Article 8 (1) and (3) and Article 10 of the Statute of the Royal Patronate shall be amended as follows: Disability, approved by Royal Decree 946/2001 of 3 August, being drafted as follows:

One. Article 1 (1) and (2) are worded as follows:

" 1. The Royal Board on Disability is an autonomous body provided for in article 43.1.a) of Law 6/1997, of 14 April of the Organization and the Functioning of the General Administration of the State, attached to the Ministry of Health and Politics Social, through its headline.

2. It is up to the Minister for Health and Social Policy to carry out the strategic direction, evaluation and control of the results of his activities; it is also up to him to monitor effectiveness, without prejudice to the powers conferred on the General Intervention of the State Administration in the assessment and control of the results of public bodies in the state public sector. "

Two. Article 4 (3) is worded as follows:

" 3. They are technical bodies: the expert commissions and the management of the Royal Board. "

Three. Article 5 (1) (a), (b) and (c) shall be worded as follows:

" a) The President will be the Minister of Health and Social Policy.

b) They will be vocal: Ministers of Justice, Economy and Finance, Development, Education, Culture, Labour and Immigration, Science and Innovation, and the Secretary General for Social Policy and Consumption.

(c) The Secretary, who shall be the Director-General for the Coordination of Sectoral Policies on Disability, shall act with a voice but without a vote. "

Four. Paragraphs 1 and 3 of Article 8 are worded as follows:

" 1. The Secretary-General of the Royal Board will be appointed and separated by Royal Decree of the Council of Ministers, on the proposal of the Minister of Health and Social Policy. It shall have a status of under-secretary, for representation and protocol, so that its functions shall not be remunerated, without prejudice to the corresponding compensation.

The official designated as Secretary-General will continue in the administrative situation of provenance. "

" 3. The Secretary-General shall, in the case of vacancy, absence or sickness, be replaced by the Director. "

Five. Article 10 is worded as follows:

" Article 10. The Directorate of the Royal Board.

1. The Directorate of the Royal Board of Trustees, is the administrative management body of the same. The holder shall be the Director-General for the Coordination of Sectoral Policies on Disability.

2. It is up to the Royal Board of Trustees to perform, in accordance with the above guidelines, the following functions:

a) Prepare or report matters to be submitted to the Council.

b) Elaboration of the proposal for the preliminary draft annual budgets of expenditure and revenues of the Royal Board and the economic and financial management of the same.

c) Management of the Agency's human resources.

d) The coordination and management of the services related to the internal regime and general affairs of the Agency.

e) Maintaining technical relations with public and private bodies and with scientists, experts and promoters, both national and international. Preparation of proposals for the establishment of committees of experts and management of the same and of the support they need.

f) Coordinate the activities of studies, research and development and information on matters related to the functions of the Royal Board. "

Final disposition fourth. Amendment of Royal Decree 42/2010 of 15 January, which regulates the National Commission of Assisted Human Reproduction.

Article 8 of Royal Decree 42/2010 of 15 January, which regulates the National Commission on Assisted Human Reproduction, is worded as follows:

" Article 8. The Vice-Presidency.

The Vice-Presidency of the Commission shall be performed by the head of the General Directorate of the Quality Agency of the National Health System.

It is established that in cases of vacancy, absence, illness or other legal cause, the person holding the Presidency shall be replaced by the person who holds the Vice-Presidency. "

Final disposition fifth. Powers of development.

The Minister of Health and Social Policy is hereby authorised to take the necessary measures for the development and implementation of this Royal Decree.

Final disposition sixth. Entry into force.

This Royal Decree will enter into force on the day of its publication in the "Official Gazette of the State".

Given in Madrid, on October 8, 2010.

JOHN CARLOS R.

The First Vice President of the Government and Minister of the Presidency,

MARIA TERESA FERNANDEZ DE LA VEGA SANZ