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Royal Decree 1275 / 2011, From September 16, Whereby The State Agency "spanish Agency Of Medicines And Products Health" Creates And Approves Its Statute.

Original Language Title: Real Decreto 1275/2011, de 16 de septiembre, por el que se crea la Agencia estatal "Agencia Española de Medicamentos y Productos Sanitarios" y se aprueba su Estatuto.

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TEXT

I

Medicines and medical devices have made a decisive contribution to the prevention, treatment and diagnosis of human disease, promoting the improvement of hope and the quality of life of the population.

In the field of animal health, medicinal products and the regulation of their use have also made important advances in the fight against animal diseases, the prevention of zoonoses and the protection of the population against animal diseases. food consumption and use of products of animal origin.

The management and regulation of medicinal products and medical devices in general has been and is a universally perceived need for society, which has been progressively advancing at its level of demand from the very beginning. quality, initially, to be extended to aspects of efficacy, safety or information on these products. The need to ensure access to medicines and medical devices, their rational use, as well as respect for the environment, are others of the current needs in the field of medicinal products for human and veterinary use and products. health.

Hence the principle of public intervention on these products, which includes the submission to prior authorisation and registration of the production and marketing of medicinal products for human and veterinary use, to which the public intervention grants its legal recognition as such, compared to the rest it considers illegal, the Spanish Agency for Medicines and Health Products being the body that, on behalf of the General Administration of the State, takes care of exercise of such competence.

The Spanish Agency for Medicines and Health Products develops a wide range of actions in defence of public health, responding to the demand of citizens on the guarantees of medicines and products. (a) health and safety at work, and ensuring that they respond to an appropriate risk-benefit profile, so that their risks or adverse reactions are justified by the benefit or efficacy obtained in their use for the diagnosis, prevention or treatment of diseases. These activities also include the required guarantees of quality and safety in the field of cosmetics and personal hygiene products. Finally, and in the face of society's demand for rapid access to new medicines and medical devices, the Agency is committed to supporting research and innovation, as well as collaboration with the sectors and institutions of the European Union. public and private sector, in order to ensure that the availability of new diagnostic treatments and tools is produced in an agile manner and with the highest possible level of safety for citizens.

Access to new and expensive products, the increase in population and their aging or the chronification of numerous pathologies are, among others, factors of high impact in the determination of health needs, and they have to take into account the need to ensure the sustainability of health provision at a high level of quality through a rigorous framework for the safety and efficiency of medicinal products. In this regard, Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices entrusts the Agency to carry out the reports of therapeutic use of medicinal products.

In its actions, the Agency is based on the most advanced and rigorous scientific knowledge and follows principles of objectivity, independence and transparency, so that the data and criteria on which the Agency bases its decisions can be made known by citizens, healthcare professionals, researchers and the industrial sector, acting with complete independence from the pharmaceutical industry.

Spain participates through the Agency in the Network of European Medicines Agencies, in a model in which evaluations, inspections and other technical or scientific actions are carried out by the teams of the agencies in a framework of cooperation managed by the European Medicines Agency (EMA), a body of the European Union, which combines the resources of all European national agencies. Therefore, irrespective of the existence of various procedures for the authorisation and supervision of medicinal products in the European Union, all of them respond to the same technical and scientific criteria which have been adopted within the EEA and the Network of European Agencies.

In the field of quality control of medicinal products, the Agency's Official Control Laboratories are part of the European Network of Official Control Laboratories, which means that their technical competence is accredited to ensure that the results obtained are recognised by the other European health authorities and agencies. Under the coordination of the European Department of Quality of Medicinal Products (EDQM), the Agency's Official Control Laboratories participate in the quality control of medicinal products authorised by the European Commission under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and control of medicinal products for human and veterinary use and establishing a European Agency for the Medicines, and they are also involved in the process of establishing European reference materials.

Also in the field of medical and cosmetic products the Agency acts in accordance with the European Union's technical regulations and guidelines.

The specialized and complex task of the Agency, and the immediacy with which it must take European decisions, overflows the framework of the Agency as an autonomous body and needs a much more flexible management formula. Agile to solve problems of a technical-budgetary, economic-financial and personnel management, formula that only offers the organizational technique of the State Agency, and that regulates the Law 28/2006, of July 18, of Agencies state for the improvement of public services.

II

The transformation is available in the state agency, according to the typology mentioned above, of the autonomous agency previously called the Spanish Agency for Medicines and Health Products.

This is justified by the idea that the administrative activity is linked, in addition to the principle of legality, to the effectiveness, and that the management by objective and quality is adapted as an ordinary form. the provision of public services. This is an old aspiration of the Spanish administration which in a synthetic form is pointed out in the explanatory memorandum of Law 6/1997, of April 14, of the Organization and the Functioning of the General Administration of the State (LOFAGE), and that finds its definitive lace ten years later with the promulgation of Law 28/2006, of July 18, which contains, in addition to a clear exposition of principles and purposes in this respect, the organizational formula to which they will have to adapt in the future both existing public bodies, and those that need to be established in the future.

In the interval of the ten years between one and another legislative rule, and in particular in April 1999, the Medicines Agency is set up as an autonomous body as provided for in Article 43.1.a of the Treaty. LOFAGE, created by Law 66/1997, of December 30, of Fiscal, Administrative and Social Order Measures, with Statute approved by Royal Decree 520/1999, of March 26, which is entrusted with the management of the state intervention around the medication. Subsequently, Law 16/2003, of 28 May, of cohesion and quality of the national health system, added to it the competences in the field of sanitary products, cosmetics, hygiene products and products of clinical and personal use as well as competences waste in the field of medicinal products.

The Spanish Agency for Medicines and Health Products was born with a clear vocation to incorporate the principles of quality and efficacy into this management and, due to its proximity in time, came to be a precursor to the development dynamics generated by the current Law 28/2006 of 18 July, under which and with the budgetary authorisation contained in paragraph two of the additional twenty-sixth provision of Law 39/2010, of 23 December, of the General Budget of the State for the year 2011, is transformed by the present real State Agency decree, to understand that in this type of public body it is best to fit its objectives and activities, as well as the way to achieve its effective realization.

III

This royal decree consists of a preamble, a single article, five additional provisions, four transitional provisions, one derogating provision and two final provisions.

The Statute of the Spanish Agency for Medicines and Health Products incorporated below this royal decree is structured in fifty-three articles grouped into eight chapters.

The first of the chapters deals with the nature and legal regime, principles of action and range and effectiveness of the Agency's acts.

The second chapter sets out the Agency's object and powers as well as the exercise of sanctioning power.

The third chapter, divided into six sections, describes and regulates the bodies and structure of the Agency, distinguishing between the governing bodies: President, Vice-President and Council Rector and their respective powers and, the Executive Directorate, which on a one-person basis, assumes the legal representation of the Agency, and whose acts and resolutions put an end to the administrative route. The third section of this chapter is set out in the constitution and regime of the new control committee, as well as its functions, to move to the fourth section of the advisory and coordination bodies, with great importance and weight. in the resolutions of the Agency, given the high degree of specialisation achieved in the matters on which the Agency is dealing and decides, Section 5, for its part, lists and describes the administrative structure at the head of the Secretariat General and Department Headquarters, to close the chapter with a section sixth relative to the Network Experts.

The fourth chapter contains the Agency's staff arrangements, the management of jobs, with particular reference to management staff and the remuneration scheme, linking the complement of productivity to the labour market. a system of assessment of the performance of the job and the achievement of results or collective objectives or of the Unit.

Chapter 5 deals with the Management Contract and the Annual Action Plan, Activity Report and Annual Accounts.

The sixth chapter deals with the patrimonial and contracting arrangements of the Agency, which will be the general public sector of the entire public sector, making it possible to participate in commercial companies or foundations. management in terms of the existing legislation.

The seventh chapter refers to the legal assistance of the Agency and the eighth chapter covers the economic and financial, budgetary and accounting and control arrangements, which are also very close to and similar to the generic the entire public sector.

IV

This royal decree provides for the abolition of the autonomous agency Agencia Española de Medicaciones y Productos Sanitarios, succeeding in all its assets, rights and obligations, the new state agency that is created with the same denomination. Specifically and in this sense, the integration of the staff statutory, labor and official of the extinct autonomous agency is previewed in the new State Agency, without alteration of their working conditions and respect of the rights consolidated.

The functioning of the Agency and its holders until the establishment of the new bodies, and the appointment of the holders of the new bodies, are maintained.

On the other hand, and in the event that the approval of this royal decree does not coincide with the beginning or end of the financial year, the new Agency is expected to maintain the year of its creation and on a transitional basis, the the previous budgetary regime, with the corresponding credit modifications.

The royal decree tries to respond to the aspirations of modernity and rationalization of public organizations, with the conversion of the Spanish Agency of Medicines and Health Products into the state agency, providing it with a new organizational structure that will allow the increase of public health guarantees to society through more effective management, higher quality and transparency, with better internal functioning and an increase in the capacity to generate revenue.

This new scheme is based on the one set out in Law 28/2006, Article 7 of which distinguishes between governing bodies, executive bodies and control bodies. With regard to the latter category, the Committee on Control, which will be set up within the Rector Council and which will have to inform you about the implementation of the management contract and all those aspects relating to the the economic-financial management to be known by the Rector Council itself and detailed in the Staff Regulations. Other notable developments worthy of mention are the recognition of the Agency for greater autonomy in the management of human resources, the introduction of a system of permanent financial control and through public audits, of an analytical accounting and the establishment of commitments required under a Management Contract for which the monitoring shall be carried out through the relevant management accounting systems.

In the processing of this royal decree, among others, the Autonomous Communities and the cities of Ceuta and Melilla have been consulted, and the report of the Council of Consumers and Users, regulated by the Royal Decree, has been obtained. 894/2005, dated July 22.

Therefore, in its virtue, at the initiative of the Ministries of Health, Social Policy and Equality, and the Environment, and the Rural and Marine Environment, and on a joint proposal of the Minister of Economy and Finance, and the Minister of Politics Territorial and Public Administration, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 16 September 2011,

DISPONGO:

Single item. Creation of the Spanish Agency for Medicines and Health Products as a state agency.

This royal decree aims at the creation of the state agency called the Spanish Agency for Medicines and Health Products for the purpose of approving its new Statute, the text of which is incorporated below.

Additional disposition first. Abolition of the autonomous agency Agencia Española de Medicines y Productos Sanitarios.

1. The autonomous agency Agencia Española de Medicines y Productos Sanitarios is hereby deleted.

2. As from the entry into force of this royal decree, the State Agency which is hereby established shall be subrogated to the entire assets, rights and obligations of the self-contained body, and shall take place in all its powers and functions.

3. The references to the autonomous agency Agencia Española de Medicaciones y Productos Sanitarios (Spanish Agency for Medicines and Health Products) shall be construed as references to the new State Agency that is created.

Additional provision second. Integration of personnel into the new State Agency.

The official staff providing their services in the autonomous body that is being deleted will be integrated into the new state agency which is created in active service in the body or scale of provenance, while retaining the seniority and degree to which it was consolidated and with the same rights and obligations as they had at the time of integration.

The statutory staff providing their services in the autonomous body that is being deleted will continue to provide services in the new State Agency under the same conditions as they were at the time of their integration.

Likewise, the new state agency will be subrogated in the contracts of work concluded with the personnel subject to labor law, which will be integrated into the template of that in the same groups, categories and areas of work to be attached, with the same rights and obligations as they had at the time of integration.

Additional provision third. Effective Constitution of the State Agency.

The constitution of the Spanish Agency for Medicines and Health Products, will be produced by holding the constituent meeting of its Rector Council, which will take place within four months from the date of the meeting. entry into force of this royal decree.

Additional provision fourth. Cities with Autonomy Statute.

The references in the Statute are made to the Autonomous Communities, they will be read also to the cities of Ceuta and Melilla, with the scope provided for in their respective Statutes of Autonomy and Royal Decrees of transfer of functions and services.

Additional provision fifth. Real Pharmacopoeia Española.

The statements made in the article of Royal Decree 294/1995 of 24 February, governing the Spanish Royal Pharmacopoeia, the national form and the advisory bodies of the Ministry of Health and Consumer Affairs matter, to the National Commission of the Spanish Royal Pharmacopoeia, they are understood to the Committee of the Pharmacopoeia and the National Form created by the Statute that approves the present royal decree.

First transient disposition. Transitional arrangements for the Governing Council, the Directorate, the management staff and the Technical Committees.

1. Until such time as the Governing Council has been established, the Advisory Board of the autonomous agency of the Spanish Agency for Medicines and Health Products will continue in the exercise of its duties.

2. By way of derogation from the second additional provision, pending the appointment of the head of the Directorate of the Agency in accordance with the provisions of Article 14 of the Staff Regulations, the head of the Directorate-General of the Agency This will be transformed into the functions that Law 28/2006, of July 18, of State agencies for the improvement of the Public Services and the Statute itself entrusts to the executive organ of the State Agency that is constituted.

3. Also, the owners of the organs and administrative units of the autonomous agency Agencia Española de Medicines y Productos Sanitarios, will continue to be temporarily in the performance of their functions until the appointment of the Management of the new State Agency.

4. The Technical Committees already established within the framework of the autonomous agency EAgencia Española de Medicaciones y Productos Sanitarios subsertiran transiently until they are replaced by those created in the framework of the new State Agency. No later than six months after the date of the constitution of the Governing Council, the new Technical Committees shall be operational.

Second transient disposition. Budgetary regime applicable to the State Agency for the Spanish Agency for Medicinal Products and Sanitary Products during the financial year 2011.

For the financial year 2011, the budgetary and credit adjustment arrangements for the deleted autonomous body shall be maintained.

The Spanish Agency for Medicinal Products and Sanitary Products shall pay the annual accounts for the financial year 2011 by integrating the management developed by the autonomous body deleted during that financial year.

Transitional provision third. Management Contract.

1. Pending the adoption of the management contract by joint ministerial order of the ministries of finance, the ministries of finance, and the Territorial Policy and Public Administration, the Agency's work will be carried out in accordance with the criteria and guidelines set out in the initial action plan which is incorporated into the memory referred to in Article 3 of Law 28/2006 of 18 July.

2. Within three months from the date of the constitution of the Rector Council of the Spanish Agency for Medicines and Health Products, and once the Board of Directors of the Agency has been appointed, the Board of Directors will approve the proposal for a management.

3. Without prejudice to Article 42.2 of the Staff Regulations, concerning the duration of the management contract, the validity of the first to be concluded shall start from the date of entry into force of the joint ministerial order.

4. As long as the Management Contract is approved, the current system of determination and approval by the Ministry of Economy and Finance of the productivity of the official personnel will apply.

Transitional disposition fourth. Remuneration scheme for statutory staff.

For the purposes of Article 39 (3) and 41 of this Statute, and as long as the provisions of the third provision of Law 55/2003 of 16 December 2003 of the Staff Framework Staff Regulations are developed. (a) the statutory staff of the State Agency for medicinal products and medical devices shall receive the remuneration corresponding to that job, as well as the rest of the health services provided for in Article 1 (1). basic and supplementary remuneration of the remuneration scheme applicable to staff Official of the Agency.

Single repeal provision. Regulatory repeal.

1. Repealed:

(a) Royal Decree 520/1999, of 26 March, approving the Statute of the autonomous agency of the Spanish Medicines Agency.

b) Articles 7 to 23 of Royal Decree 294/1995 of 24 February, governing the Spanish Royal Pharmacopoeia, the national form and the advisory bodies of the Ministry of Health and Consumer Affairs in this field.

(c) Article 10 of Royal Decree 1087/2003 of 29 August establishing the organic structure of the Ministry of Health and Consumer Affairs.

(d) Order PRE/962/2010, of 15 April, for which the Committee for the Availability of Veterinary Medicinal Products is regulated.

e) Order PRE/162/2011 of 28 January for the development of the composition, functions and functioning of the Technical Committee of the Spanish Pharmacovigilance System for Veterinary Medicinal Products.

2. Similarly, the provisions of equal or lower rank are repealed as set out in this royal decree.

Final disposition first. Enabling regulatory development.

The head of the Ministry of Health, Social Policy and Equality is authorized to dictate how many provisions are necessary for the development and execution of the provisions of this royal decree, with the exception of those relating to veterinary medicinal products, which shall be given jointly by the persons holding the Ministry of Health, Social Policy and Equality and the Ministry of the Environment, and the Rural and Marine Environment.

Final disposition second. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, 16 September 2011.

JOHN CARLOS R.

The Minister of the Presidency,

RAMON JAUREGUI STUNNED

STATUTE OF THE SPANISH AGENCY FOR MEDICINES AND MEDICAL DEVICES

CHAPTER I

General provisions

Article 1. Legal nature and organic membership.

1. The Spanish Agency for Medicines and Health Products is a Public Body of those provided for in Article 43.1.c) of Law 6/1997, of 14 April, of the Organization and the Functioning of the General Administration of the State, and regulated by the Law 28/2006, of July 18, of State agencies for the improvement of public services.

2. The Agency has a distinct legal personality with respect to that of the State, its own assets and treasury and its functional and management autonomy, within the limits laid down by Law 28/2006 of 18 July, and by this Statute.

3. The Agency is attached to the Ministry of Health, Social Policy and Equality through the General Secretariat of Health, without prejudice to the supervisory powers exercised by the Ministry of the Environment's General Secretariat for Rural Affairs, and Rural and Marine environment, as far as veterinary medicinal products are concerned.

Article 2. Legal framework.

1. The Agency shall be governed by the provisions of Law 28/2006 of 18 July, as laid down in this Statute and by the rules applicable to entities governed by public law attached to the General Administration of the State.

2. In the exercise of his public powers, Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, shall apply.

3. In the exercise of its powers in relation to medicinal products for human and veterinary use, medical devices, cosmetics and personal hygiene products, the Agency shall be governed by Law 14/1986 of 25 April of 25 April, General Health, the Law 8/2003, of 24 April, of Animal Health, Law 16/2003, of 28 May, of Cohesion and Quality of the National Health System, Law 29/2006, of 26 July, of Guarantees and the rational use of medicines and medical devices and the rules that develop, as well as the existing Community law in this field.

4. The Agency shall retain the tax regime of the autonomous agency Agencia Española de Medicines y Productos Sanitarios, so it shall be exempt from the Company Tax, in accordance with the provisions of the additional provision of the Law 28/2006, of July 18, and in article 9.1 of the Recast Text of the Corporate Tax Law, approved by Royal Decree-Law 4/2004 of 5 March 2004.

Article 3. Principles of action and confidentiality.

The Agency will act within the framework of the policy of the Ministry of Health, Social Policy and Equality, and in respect of veterinary medicinal products, together with the Ministry of the Environment, and the Rural and Marine Environment, decisions in technical and scientific knowledge, with guarantees of objectivity and transparency and, with complete independence from industry.

The Agency will set up a management model for the provision of the services of its competence with the utmost efficiency and quality, using information and communication technologies and aiming at obtaining clear and evaluable objectives to identify the responsibility of those who implement them.

The Agency shall maintain strict confidentiality of the data contained in the files relating to the regulated products and which are considered to be subject to industrial secrecy, without prejudice to their transmission to the network of agencies. European Medicines Agency or the European Medicines Agency, and the Community authorities, or health authorities of third States, with which Spain has signed agreements or agreements, provided that there is justified cause and the recipient ensure confidentiality.

Article 4. Effectiveness of its acts and resolutions.

1. For the exercise of its powers and the development of its powers, the Agency shall give the necessary acts and resolutions, which may take the following forms:

a) Resolutions of the Governing Council.

(b) Resolutions, instructions and procedures for action by the Director of the Agency.

2. These two types of acts in the exercise of their powers or by delegation or endorsement shall exhaust the administrative route, with the exception of tax matters, which may be used in an economic and administrative way, without prejudice, in both cases, of subsequent access to the administrative-administrative jurisdiction.

3. Complaints prior to the civil or employment judicial procedure shall be dealt with by the Director of the Agency, who shall also be responsible for the resolution of the liability procedures arising from the actions of the Agency. compliance with Article 142.2 of Law 30/1992 of 26 November.

4. The remainder of the acts and resolutions of the Agency shall be subject to the use of a certificate before the hierarchical superior.

Article 5. Institutional headquarters.

The Agency will be based in the Villa de Madrid.

CHAPTER II

Object and competencies

Article 6. The purpose of the Spanish Agency for Medicines and Health Products.

The purpose of the Agency is to ensure that both human and veterinary medicinal products and medical devices, cosmetics and personal hygiene products comply with strict quality criteria, security, effectiveness and correct information in accordance with the current rules on such matters at the State and the European Union level.

Article 7. Competence of the Spanish Agency for Medicines and Health Products.

The Agency shall be responsible for the following:

1. To evaluate, authorise, modify, renew, restrict, suspend or revoke the marketing authorisation of medicinal products for human and veterinary use manufactured industrially.

2. To resolve on the allocation of the status of medicinal product, medical device, cosmetic or other products within the scope of the Agency's competence.

3. Carry out the registration of authorizations and the maintenance and updating of the same in the Register of Medicines, as well as assign the National Code to the medicines for human and veterinary use. The European Commission shall also be responsible for the incorporation into the Register of Medicinal Products of the authorisations granted by the European Commission in accordance with Regulation (EC) No 726 /2004/EC of the European Parliament and of the Council of 31 March 2004 establishing Community procedures for the authorisation and control of medicinal products for human and veterinary use and establishing the European Medicines Agency, and for the legal implications arising from the use of medicinal products for human and veterinary use; same.

4. To promote the existence, survival or rehabilitation of medicinal products for human, veterinary and medical use for the purpose of health care or of high therapeutic interest.

5. Limit or subject to reservations the requirements for the prescription and supply of medicinal products for human and veterinary use, without prejudice to the powers which, in this field, correspond to the Directorate-General of Pharmacy and Health Products in respect of the pharmaceutical provision of the National Health System.

6. Authorise, amend, suspend or revoke clinical trials for medicinal products for human and veterinary use and for medical devices. Authorise the importation of medicinal products not authorised in Spain for use in the field of clinical trials.

7. To authorise the individual access to investigational medicinal products, temporary authorisations of use, importation of medicinal products for human and veterinary use not authorised in Spain, and to draw up recommendations for the use of medicinal products used under conditions other than those authorised, with the participation of the Directorate-General for Pharmacy and Health Products in the relevant processes.

8. Exercise the powers of the Ministry of Health, Social Policy and Equality on the import, export and intra-Community trade in medicinal products and their raw materials, medical devices, cosmetics, hygiene products personnel, and biocidal products for clinical and personal use, by issuing, where appropriate, the certificates required for the authorisation by the Customs of their import, export or any other customs destination.

9. Act, where appropriate, as the National Competent Authority in Spain, representing the Ministry of Health, Social Policy and Equality, for the purpose of Spanish participation in the network of European Medicines Agencies and the European Agency for Medicines as well as in the relevant European health and cosmetic product groups.

10. To promote information on medicinal products for human use intended for healthcare professionals and the general public as well as to authorise the development and distribution of free samples.

11. To develop reports of therapeutic use of medicinal products within the framework of Article 90.3 of Law 29/2006 of 26 July, or at the request of the Directorate-General for Pharmacy and Health Products.

12. Perform the duties for the Official Medicines Control Laboratories.

13. Subject to prior authorisation, where necessary in the interest of public health in the case of biological products, each batch of finished product manufacture and condition its placing on the market, or the materials of origin, intermediate and bulk products and condition their conformity with their use in the manufacture.

14. To participate in the evaluation and control of medicinal products for human and veterinary use and medical devices authorised by the European Union, as well as in the activities carried out in this field by the European Union, the Council of Europe and others. international organisations.

15. To identify, assess and manage the risks arising from authorised medicinal products, as well as to coordinate the Spanish Pharmacovigilance System for medicinal products for human and veterinary use, and to participate in the relevant European networks. Act as a national reference centre for pharmacovigilance.

16. To assess and manage the risks arising from quality problems of authorised medicinal products in Spain.

17. To promote the conduct of pharmacoepidemiological studies and pharmacoepizootiology, in accordance with the provisions of the pharmacovigilance regulations. Coordinate the assessment and management of post-authorisation studies linked to the authorisation of medicinal products included in the Risk Management Plan.

18. To establish and publish the technical guidelines for the quality of the medicinal products, in particular the Spanish Official Denominations (DOE) and the Spanish Royal Pharmacopoeia, as well as to participate in the preparation of the monographs of the European Pharmacopoeia in its Spanish version.

19. Develop and publish the National Form

20. To grant, modify, restrict, suspend and revoke the authorization of the activity of pharmaceutical laboratories for medicinal products for human and veterinary use and to keep the Registry of pharmaceutical laboratories duly updated.

21. To verify through inspections compliance with the standards of good manufacturing, the standards of good clinical practice, the standards of good practice of pharmacovigilance, the standards of good laboratory practice, and the good practice distribution practices in the field of the competencies of the General Administration of the State.

22. Maintain and publish the catalog of drug wholesale warehouses.

23. Establish, in coordination with the Autonomous Communities, programmes for the inspection and control of medicinal products for human and veterinary use, medical devices, cosmetics, personal hygiene products and biocidal products for clinical and personal use the activities that correspond to the General Administration of the State in this field.

24. The adoption of precautionary measures and the exercise of sanctioning powers in the field of the Agency's powers.

25. Carry out the expert and expert actions requested by the judicial authorities.

26. To develop the control functions for medicinal products and other products within the Agency's field of competence, including those relating to illegal or falsified.

27. To develop the state functions and responsibilities of inspection and control in the field of traffic and licit use of narcotic drugs and psychotropic substances.

28. To assess health suitability and compliance with the current rules for medical devices, cosmetics, personal hygiene products and biocidal products for clinical and personal use, establishing such conformity or authorising their placing on the market, proceed, as well as update your national unified records.

29. Modify, restrict, suspend, renew and revoke certifications and authorizations, sanitary products, cosmetics, hygiene products and products for clinical and personal use, may limit, restrict, prohibit or subject to conditions special market, placing in service, distribution, use, dispensing or sale.

30. Act as a Notified Body, assessing the conformity of medical devices, carrying out audits of quality systems, certifying the specific rules of such systems and issuing EC certificates with a view to affixing of the CE marking on such products, in terms of the designation made by the Ministry of Health, Social Policy and Equality, and the approval of the collaborating entities in the certification of the products health.

31. To authorise, suspend or limit the exceptional use of medical devices for reasons of health concern.

32. Plan, develop and manage the Spanish systems for monitoring health products and cosmetics by acting as a national reference centre in the relevant European networks.

33. To develop the inspection and control of medical devices, cosmetics, personal hygiene products, and products for clinical and personal use in accordance with the General Administration of the State.

34. Grant, modify, restrict, renew or revoke the authorisations of activities of the manufacturers, importers, stitchers and sterilizers of medical devices, cosmetics, personal hygiene products and biocidal products for clinical use and personnel. All of this with the exception of the authorisations for the manufacture of tailor-made medical devices.

35. Adopt or propose the necessary measures to ensure adequate supply and supply of medicinal products in the field of the competencies of the General Administration of the State.

36. Maintain a strategic repository of medicines and medical devices for emergencies, catastrophes and international cooperation, coordinating the supply of vaccines, medicines and sanitary products for health campaigns, the acquisition of and Joint distribution is decided by the different Health Administrations.

37. Organize, coordinate and impart teaching, promote and carry out research projects and provide scientific and technical advice in all fields that are of its own.

38. Propose the development of draft general provisions, technical guidelines, circulars and instructions in the field of their competencies.

39. To receive and manage the fees and other income corresponding to the Agency's activity, in accordance with the General Tax Law and other applicable regulations.

40. To coordinate the operation of the Health and Social Policy Areas and Dependencies in the activities of external health to carry out the checks provided for in the European Union or national law concerning medicinal products and their raw materials, medical devices, cosmetics, personal hygiene products, and biocidal products for clinical and personal use, when imported or exported, irrespective of their customs use for all products and of the commercial or non-commercial character issue as well as in the pharmaceutical inspection activities. Also coordinate their activities in the field of illicit trafficking in narcotic and psychotropic substances, in their technical and analytical content.

41. Cooperate with third countries, in particular with Latin America in the field of scientific and regulatory knowledge in the field of medicines, medical devices and other products within the Agency's competence.

42. Any others assigned to you by the laws and regulations.

Article 8. The exercise of the powers of the Agency.

1. The Agency, within the scope of its powers, shall be responsible for the exercise of the necessary administrative powers for the fulfilment of its purposes, in accordance with the terms laid down in this Statute, and in accordance with the law applicable.

The exercise of sanctioning power shall always be initiated on its own initiative by a decision of the Director of the Agency, either on its own initiative or as a result of reasoned requests from the Governing Bodies, or other bodies or third-party complaint.

The Director of the Agency shall also be responsible for the imposition of sanctions arising from the infringement proceedings by the initiates.

2. In any case not provided for in the specific legislation implementing it, the provisions of Title IX of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure shall be as laid down in Title IX. develops Royal Decree 1398/1993 of 4 August, approving the Rules of Procedure for the exercise of sanctioning powers.

CHAPTER III

Organs and structure of the Agency

Section 1. Organ Organs

Article 9. Governing bodies.

The Agency's governing bodies are as follows:

a) The President.

b) The Vice President.

c) The Rector Board.

Article 10. The President.

1. The Presidency of the Agency shall be held by the person holding the General Secretariat of Health of the Ministry of Health, Social Policy and Equality.

2. Corresponds to the President:

a) Ostend the representation of the Governing Council and lead and preside over its sessions.

b) Call the sessions of the same and set the order of the day.

(c) Vellar for the achievement of the objectives assigned to the Agency.

d) To provide for the institutional representation of the Agency, without prejudice to the legal representation functions that correspond to the Director.

e) Elevate to the Governing Council the proposal for the appointment or termination of the Director of the Agency.

(f) Inform the Congress and the Senate on the management of the Agency where it is required to do so, in accordance with the provisions of the seventh additional provision of Law 28/2006 of July 18.

g) Report to the Ministries of Health, Social Policy and Equality, Environment and Rural and Marine Affairs, Territorial Policy and Public Administration, and the Economy and Finance on the implementation and enforcement of the objectives set out in the Management Contract.

(h) Give an account to the Ministry of Health, Social Policy and Equality, of the annual activity report approved by the Rector Council, for further referral to the General Courts.

i) Exercise the other powers and functions conferred upon it by this Statute, the Governing Council and the provisions in force.

(j) Vellar for the fulfilment of this Statute and its implementing rules, as well as to exercise the top management of the Agency.

3. In the event of absence, vacancy or illness, the President of the Agency shall be replaced in the performance of his duties by the Vice-President of the Agency.

Article 11. The Vice President.

The Vice-Presidency of the Agency shall be carried out by the titular person of the General Secretariat of the Rural Environment of the Ministry of the Environment, and the Rural and Marine Environment, who shall ensure the achievement of the Agency's objectives. and, in particular, with regard to veterinary medicinal products.

Article 12. The Governing Council.

1. The Governing Council of the Agency is the collegiate governing body of this State Agency.

2. The composition of the Rector Board is as follows:

a) President of the Agency.

b) Vice President of the Agency.

(c) Vocals of the General Administration of the State: The head of the General Secretariat of Health, Social Policy and Equality and the head of the Agency's Directorate, as well as a voice representing each of the Directorates General de Salud Pública y Sanidad Exterior, y de Farmacia y Productos Sanitarios; a member of the General Directorate of the Civil Service of the Ministry of Territorial Policy and Public Administration; a member of the Directorate-General of the Ministry of Economy and Finance; a member of the Directorate-General for Resources Agriculture and Livestock of the Ministry of the Environment, and Rural and Marine Environment; a member of the Directorate of the Health Institute Carlos III of the Ministry of Science and Innovation; and a member of the Directorate General of Industry of the Ministry of Health Industry, Tourism and Trade; all of them, with rank at least Deputy Director General.

(d) The Mutualities of officials shall be represented by a vowel, who shall be appointed for a period of two years and on a rotating basis, by the person holding the Ministry of Health, Social Policy and Equality, on a proposal from the Commission for the Coordination of the participation of the General Administration of the State in the Interterritorial Council of the National Health System.

e) The autonomous communities shall be represented by three vowels, who shall be appointed for a period of two years, and shall be rotated by the person holding the Ministry of Health, Social Policy and Equality, on a proposal from the Interterritorial Council of the National Health System.

f) Two experts of recognized prestige in the field of Health Sciences appointed by the Presidency of the Agency, which will be renewed every two years.

g) A representative of the workers designated by the most representative union headquarters in the field of the General Administration of the State.

h) A consumer and user representative designated by the Consumers and Users Council.

i) Acting as Secretary of the Governing Council, with a voice and without a vote, the Secretary-General of the Agency.

3. The designation of the members of the Governing Council shall be in accordance with the principle of the balanced presence of women and men.

Article 13. Powers and legal status of the Governing Council.

1. They are the remit of the Governing Council:

a) Approval of the Management Contract proposal.

b) The approval of the objectives and plans of annual and multi-annual actions and the criteria for measuring compliance with those objectives, as well as the degree of efficiency in management as set out in the Contract management.

(c) The approval of the Agency's annual preliminary draft budget and the contraction of obligations of a multi-annual nature, within the limits set out in the Management Contract.

d) Control of the management of the Director of the Agency, and the need for appropriate responsibilities.

e) The monitoring, monitoring and control of the Agency's performance.

f) The approval of the overall activity report, assessing the results obtained and reporting the deficiencies observed.

g) The approval of the annual accounts and, where appropriate, the distribution of the result of the financial year in accordance with budgetary legislation.

h) Establish, in terms of the existing legislation, the criteria for the selection of the workforce, and approve the draft public employment offer, to be included in the State Public Employment Offer.

i) the approval of the Agency's employment relationship, which shall include all the public employees of the Agency, within the framework of action to be established in the field of human resources in the management.

(j) The appointment and termination of the Director of the Agency, on a proposal from its President.

k) The appointment of the holders of the Control Commission and other Committees integrated into the Agency.

(l) The appointment and termination of management staff, on a proposal from the Director of the Agency.

m) Other than that attributed to it by Law 28/2006, of July 18, in this Statute or in other provisions.

2. The Governing Council may make specific delegations for action in the Director of the Agency, in relation to the tasks assigned to it in the previous paragraph, which, by their nature, content and importance, may be delegated. In these cases, the Director shall report to the Governing Council of the actions carried out under such delegations, after the conclusion of the proceedings. The preparation of the annual employment offer and the approval of the employment relationship are excluded from the possibility of delegation.

3. The Governing Council shall meet at least once every six months in ordinary session, and in an extraordinary manner when determined by its President or requested by half more than one of its members.

4. As provided for in Law 28/2006 of 18 July, and in this Statute, the Rector Board shall be governed by the provisions of Chapter II of Title II of Law No 30/1992 of 26 November 1992 on the functioning of the bodies of the Administration.

Section 2. First Executive Body

Article 14. The Director.

1. The Director of the Agency is the executive body with the executive status of the Agency, responsible for its management, management and coordination of actions.

It shall be appointed by the Governing Council, on a proposal from its President, on the basis of criteria of professional competence and experience among official or statutory staff of group A, subgroup A1 of any of the Administrations Public. The Governing Council shall also be responsible for its termination, on a proposal from its President.

The Director will have the consideration of Alto Cargo, in accordance with the provisions of article 3.2.e) of Law 5/2006, of April 10, of regulating the conflicts of interest of the members of the Government of the Nation and of the Senior positions of the General Administration of the State and its development provisions.

2. As the Executive Body of the Agency, the Agency's Director is responsible for the following tasks:

a) Ostend the legal representation of the Agency.

b) Schedule, direct and coordinate activities that are necessary for the development of the Agency's functions.

c) To exercise the direction of the Agency's services and its personnel, as provided for in the current legal provisions.

d) Develop and propose to the Governing Council the proposal for a management contract for approval and subsequent referral to the Ministries of Health, Social Policy and Equality, Territorial Policy and Public Administration and Economy and Finance.

e) Develop and propose to the Governing Council the Agency's preliminary draft budget.

(f) Subscribe to all types of acts, conventions, contracts and packages on behalf of the Agency.

g) Coordinate the development of draft general provisions, technical guidelines, circulars and instructions.

h) Approve expenses and order payments.

i) Approve the disposal of movable property and securities, or the purchase of any of the Agency's own assets. In the event of the acquisition of real estate or of rights on the same, it will be required prior agreement of the Governing Council and favorable report of the Ministry of Economy and Finance.

j) Exercise the initiative for the authorisation of budgetary changes and determine the fate of the remaining credit balances resulting from the liquidation of the financial year, as set out in paragraph 3.b) and 4, respectively, of Article 27 of Law 28/2006, of July 18.

k) Approve the expenditure increases financed with credit balances from the previous financial year, in the terms set out in Article 27.4 of Law 28/2006, of July 18.

l) Form and render the Agency's accounts to the Court of Auditors, through the General Intervention of the State Administration, once approved by the Governing Council.

m) Develop and submit to the Governing Council the Agency's overall activity report on an annual basis.

n) Propose to the Governing Council, for its approval, the appointment and termination of the Agency's management staff, the employment relationship of the Agency, as well as to resolve the calls for the provision of the Agency's official staff and contract staff.

or) Propose to the Governing Council the number and amount of fees to be applied by the Agency in relation to the services provided by the Agency, as a project for further processing in accordance with the current regulations.

p) Coordinate relations with the European Medicines Agency and other European institutions, with the other similar entities and bodies of the Member States of the European Union, third countries and bodies in collaboration with the competent international relations body of the Ministry of Health, Social Policy and Equality, and in accordance with the guidelines established by the Ministry of Health.

q) Define the Agency's quality policy and lead the implementation of quality management systems through commitment and active involvement in the achievement of the Agency's objectives.

r) To ensure the Agency's transparency policy and to coordinate its communication activities, acting as the Agency's top spokesman. Propose the Agency's External Communication Plan to the full Board of the Governing Council.

s) To direct relations with the main authorities, bodies and collectives of citizens interested in the Agency's activities.

t) Coordinate and mentor the Health and Social Policy Areas and Dependencies of the Government Delegations in the field of medicines, medical devices, cosmetics and personal hygiene products, without prejudice to the protection of Each Department's own technical functional function,

u) To perform as many other functions as legal or regulatory rule, how many powers and powers is delegated to you by the Governing Council.

3. The Director of the Agency may formalize the management arrangements which are necessary for the performance of activities of a material, technical or service nature within the meaning of Article 15 of Law No 30/1992 of 26 November.

4. In the event of vacancy, absence or illness, the Director of the Agency shall be replaced by the Secretary-General of the Agency, and in his absence by one of the Heads of Department, according to order of seniority in the performance of the office.

Section 3. Control Commission

Article 15. Composition and operation.

1. The Governing Council, acting on a proposal from its President, shall appoint three of its members, who have no management responsibilities at the Agency and with knowledge and experience in management, budgeting, internal control or activity economic-financial, to form the Control Commission.

The financial controller delegated to the Agency and the legal adviser of the Agency may attend the meetings of the Control Committee with a voice and without a vote.

2. At the constituent meeting of the Control Committee, the latter shall elect one of its members, acting as the Secretary-General of the Agency with a voice and without a vote, the Secretary-General of the Agency.

3. The Control Board shall meet at least once a quarter.

Article 16. Functions of the Control Board.

Corresponds to the Control Commission:

1. Report to the Governing Council on the implementation of the Management Contract.

2. Report to the Governing Council on the implementation of the budget and on the budgetary changes which, if necessary, are approved by the Director.

3. To know and report to the Governing Council on reports of financial-economic management control issued by the Court of Auditors and the General Intervention of the State Administration.

4. To know the economic and budgetary information that the State Agency, because of its membership in the state public sector, must prepare, and to send to the competent bodies, in compliance with the obligations contained in the current regulations, both for the completion of those obligations.

5. Report to the Governing Council on how many issues or issues it requests.

Section 4. Complementary Organs

Article 17. Advisory and coordination bodies.

1. As advisory and coordinating bodies, the Agency and its Governing Council will have a group of Technical Committees, as well as an External Expert Network.

2. To this end, the Technical Committees attached to the Agency are related and developed normatively:

a) The Committee for Medicinal Products for Human Use.

b) The Committee on the Safety of Medicinal Products for Human Use.

(c) The Committee for Veterinary Medicinal Products.

(d) The Committee on the Safety of Veterinary Medicinal Products.

e) The Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use.

f) The Committee for the Coordination of Possession Studies.

g) The Technical Committee of the Spanish Pharmacovigilance System for Veterinary Medicinal Products.

h) The Committee for the Availability of Veterinary Medicinal Products.

i) The Pharmacopoeia Committee and the National Form.

j) The Technical Inspection Committee.

k) The Peripheral Pharmaceutical Services Coordination Committee.

Article 18. The Committee for Medicinal Products for Human Use.

1. The Committee for Medicinal Products for Human Use (CMH) is the collegiate body of the Agency which represents the interests of society and ensures the transparency, objectivity and scientific rigour of the Agency's decisions on the marketing of medicines.

2. They are functions of the Committee for Medicinal Products for Human Use:

a) Velar for efficiency and transparency in human drug authorization procedures

b) Inform precept the procedures for authorization, relevant modification, suspension or revocation of medicinal products for human use carried out from the Agency, for any of the procedures in force.

c) On an optional basis, at the request of the Director of the Agency, reports on the procedures related to human medicinal products

d) Coordinate committees and working groups in the procedures for the evaluation and therapeutic utility of medicinal products for human use.

3. Reports issued by the Committee for Medicinal Products for Human Use shall be required in the cases in which it is established, but shall in no case be binding.

4. The Committee for Medicinal Products for Human Use shall be composed of the following members:

a) Ten vowels on the basis of their position:

1. The Director of the Agency.

2. The Head of the Agency's Department of Medicinal Products for Human Use.

3. The Head of the Department of Procedures Management of the Department of Medicinal Products for Human Use.

4. The Head of the Division of Pharmacology and Clinical Evaluation of the Department of Medicinal Products for Human Use.

5. The Head of the Division of Pharmaceutical Chemistry and Technology of the Department of Medicinal Products for Human Use.

6. The Head of the Division of Biological Products and Biotechnology in the Department of Medicinal Products for Human Use.

7. The Head of the Division of Pharmacoepidemiology and Pharmacovigilance of the Department of Medicinal Products for Human Use.

8. The representative of the Agency in the Committee for Human Medicinal Products of the European Medicines Agency (EMA).

9. A representative of the Directorate General of Pharmacy and Health Products of the Ministry of Health, Social Policy, and Equality.

10. A representative appointed by the Directorate-General for Industry of the Ministry of Industry, Tourism and Trade.

(b) Twelve vowels appointed by the Rector Council for a period of four years, one representing the consumer and user organisations and eleven of the members of recognised prestige and dedication to the field of sciences and techniques related to the medicinal product and therapy, designated on a proposal from:

1. º One by the Pharmaceutical Industry Business Association.

2. º One by the General Council of Medical Colleges.

3. º One by the General Council of Pharmaceutical Officers.

4. º Eight by the Agency's Directorate.

5. The President and Vice-Chair of the Committee for Medicinal Products for Human Use shall be appointed by the Agency of the Agency from among the eight members appointed on a proposal from the Director of the Agency. He shall act as Secretary of the Committee for Medicinal Products for Human Use, the Head of the Agency's Department of Human Use Medicines.

Article 19. The Committee for the Safety of Medicinal Products for Human Use.

1. The Committee for the Safety of Medicinal Products for Human Use is the collegiate body for technical and scientific advice on the safety of medicinal products for human use.

2. In case the Committee on Safety of Medicinal Products for Human Use reports on a modification, suspension or revocation, it shall give the interested party a hearing.

3. They are the functions of the Committee on Medicinal Products for Human Use:

(a) Propose to the Agency the conduct of studies and research that it considers necessary for the best practice of pharmacovigilance for medicinal products for human use.

(b) To advise the Agency in the exercise of the coordination function which it is responsible for, with regard to the planning, evaluation and development of the Spanish Pharmacovigilance System in respect of medicinal products for use human.

c) Inform precept in the procedure for the suspension or revocation of a marketing authorisation for medicinal products for human use, in the cases provided for in Law 29/2006 of 26 July.

(d) Provide technical advice to the Spanish representatives in the pharmacovigilance working groups and meetings on medicinal products for human use to be held in the European Union.

e) On an optional basis, at the request of the Director of the Agency, report on post-authorisation studies, periodic safety reports and risk management plans, as well as on medicinal products to be subject to to special medical control for safety reasons.

4. Reports issued by the Committee on the Safety of Medicinal Products for Human Use shall be required in the cases in which it is established, but in no case shall they be binding.

5. The Committee shall be composed of the following members:

a) Five vowels due to their position:

1. The head of the Agency's Directorate.

2. The Head of the Agency's Department of Human Use Medicines.

3. The Head of Pharmacoepidemiology and Pharmacovigilance Division of the Agency's Department of Human Use Medicines.

4. A representative of the Directorate General of Pharmacy and Health Products of the Ministry of Health, Social Policy and Equality.

5. The Chair of the Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use.

b) Five vowels of the Sanitary Administrations of Autonomous Communities, chosen among professionals of recognized prestige in the field of medicine and pharmacy on the proposal of the Interterritorial Council of the System National of Health, and appointed by the Minister of Health, Social Policy and Equality for a period of four years.

c) Six free-designation vowels selected from professionals and experts with widely recognised expertise in pharmacovigilance, pharmacoepidemiology, evaluation and control of medicines and various areas of the medicine, on a proposal from the Director of the Agency and appointed by the Governing Board of the Agency, for a period of four years.

6. The President and the Vice-President of the Committee for the Safety of Medicinal Products for Human Use shall be appointed by the Agency's Governing Board from among the six members appointed on a proposal from the Director of the Agency. He shall act as Secretary of the Committee on the Safety of Medicinal Products for Human Use, the Head of the Agency's Department of Medicinal Products for Human Use.

Article 20. The Committee for Veterinary Medicinal Products.

1. The Committee for Veterinary Medicinal Products is the collegiate body responsible for technical and scientific advice on the activities of the evaluation and authorisation of veterinary medicinal products, ensuring objectivity and impartiality in administrative action.

2. These are functions of the Committee for Veterinary Medicinal Products:

(a) Issue a mandatory report in the procedures for the authorisation, revocation or suspension of veterinary medicinal products containing new chemical, biological or radiopharmaceutical entities.

(b) On an optional basis, at the request of the Director of the Agency, he shall issue a report on the procedures for the authorisation of abbreviated files, on the modification of the marketing authorisation, and on any another related to the authorisation of veterinary medicinal products.

(c) Provide technical advice to the Spanish representatives on the Committee for Veterinary Medicinal Products and on working groups and meetings related to the evaluation of veterinary medicinal products to be carried out in the European Union.

d) Inform precept in the procedure of suspension or revocation of a marketing authorization, in the cases provided for in Law 29/2006, of July 26.

e) Provide technical advice to the Spanish representatives in the working groups to be held in the European Union.

3. The reports issued by the Committee for Veterinary Medicinal Products shall be required in cases where it is established and shall not be binding, except for those issued for reasons of public health and animal health.

4. The Committee for Veterinary Medicinal Products shall be composed of the following members:

a) Five vowels due to their position:

1. º The person holding the Agency's address.

2. The Head of the Agency's Department of Veterinary Medicinal Products.

3. A representative of the Spanish Agency for Food Security and Nutrition, Ministry of Health, Social Policy and Equality.

4. The Deputy Director General of Health in the primary production of the Ministry of the Environment, and the Rural and Marine Environment.

5. A representative appointed by the Directorate-General of Industry of the Ministry of Industry, Tourism and Trade.

(b) Twelve members appointed by the Minister for Health, Social Policy and Equality for a period of four years, on a proposal from the Rector Council; one representing consumer and user organisations and the other 11 between experts of recognised prestige and dedication to the field of science and techniques related to the veterinary medicinal product, on a proposal from:

1. º One by the Business Association of the Veterinary Pharmaceutical Industry.

2. º One by the General Council of Veterinary Officers.

3. º One by the General Council of Pharmaceutical Officers.

4th. Eight by the Director of the Agency following the agreement of the head of the General Secretariat for Rural Affairs of the Ministry of the Environment, and the Rural and Marine Environment.

5. The President and the Vice-President of the Committee for Veterinary Medicinal Products shall be appointed by the Governing Council from among the eight members referred to in the preceding paragraph. He shall act as the Secretary of the Veterinary Medicines Evaluation Committee, the Head of the Department of Veterinary Medicinal Products.

Article 21. The Committee for the Safety of Veterinary Medicinal Products.

1. The Committee on Veterinary Medicinal Products is the collegiate body of the Agency for the technical and scientific advice on the safety of veterinary medicinal products.

2. If the Committee on Veterinary Medicinal Products reports on a modification, suspension or revocation, it shall give the person concerned a hearing.

3. These are the functions of the Committee on Veterinary Medicinal Products:

(a) Propose to the Agency the conduct of the studies and investigations it deems necessary for the best practice of pharmacovigilance for veterinary medicinal products.

(b) to advise the Agency in the exercise of the coordination function which it is responsible for, with regard to the planning and development of the Spanish Pharmacovigilance System as regards the veterinary medicinal product.

(c) Inform precept in the procedure for the suspension or revocation of a marketing authorisation for veterinary medicinal products, in the cases provided for in Law 29/2006 of 26 July, with the aim of appropriate information from the competent authority in the field of veterinary health.

d) Provide technical advice to the Spanish representatives in the veterinary pharmacovigilance working groups and meetings to be held in the European Union.

e) On an optional basis, at the request of the Director of the Agency, to assist in the evaluation of the Periodic Safety Studies and Reports.

4. The reports issued by the Committee on Safety of Veterinary Medicinal Products shall be required in the cases in which it is established, but shall in no case be binding.

5. The Committee on Veterinary Medicinal Products shall be composed of the following members:

a) Three vowels due to their position:

1. The Director of the Agency.

2. The Head of the Agency's Department of Veterinary Medicinal Products.

3. The Deputy Director General of Health in the primary production of the Ministry of the Environment, and the Rural and Marine Environment.

(b) Six members representing the autonomous communities, appointed by the head of the Department of Health, Social Policy and Equality, for a period of four years, on a proposal from the Sectoral Conference on Agriculture and Rural Development.

(c) Six free-designation vowels selected from professionals and experts with widely recognised knowledge in the field of pharmacovigilance, veterinary medicine, evaluation and control of medicinal products Veterinarians, appointed by the Governing Board of the Agency, for a period of four years, on a proposal from the Director of the Agency, following the agreement of the holder of the General Secretariat of the Rural Environment of the Ministry of the Environment, and Marine.

6. The President and the Vice-President of the Committee on Veterinary Medicinal Products shall be appointed by the Agency's Governing Board from among the six members appointed on a proposal from the Director of the Agency. He shall act as the Secretary of the Committee on Veterinary Medicinal Products, the Head of Veterinary Medicines of the Agency.

Article 22. The Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use.

1. The Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use is a coordinating body, whose objective is to promote the operability and quality of the work performed by the Spanish Pharmacovigilance System. Medicinal products for Human Use.

2. They are the functions of the Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use:

(a) Harmonize the procedures necessary to ensure homogeneity in the treatment and evaluation of data collected in the reports of suspected adverse drug reactions by the Autonomous Centers of Pharmacovigilance.

b) The scientific discussion and discussion of the signs of adverse reactions of the medicinal products for human use reported through the intended systems.

c) Ensure the application of the same working methods and the same criteria for coding, recording and evaluation of reports of suspected adverse drug reactions.

(d) Submit to the Secretariat of the Committee on the Safety of Medicinal Products for Human Use those signals which, due to their relevance and consistency, are considered to be transferred to the latter.

3. The Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use shall be composed of the following members:

a) Four vowels on the basis of their charge:

1. The Head of the Pharmacoepidemiology and Pharmacovigilance division of the Department of Medicinal Products for Human Use.

2. The Head of the Unit for the Coordination of the Spanish System of Pharmacovigilance for Medicinal Products for Human Use in the Division of Pharmacoepidemiology and Pharmacovigilance of the Department of Medicinal Products for Human Use.

3. A vocal from the General Inspection of Defence Health-Head of Support and Pharmaceutical Management.

4. The President, and in his absence the Secretary, of the Technical Inspection Committee.

b) Seventeen vowels representing each one to an Autonomous Pharmacovigilance Center and designated by the person responsible for it in each Autonomous Community.

4. The President and the Vice-President of the Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use shall be elected by their members from among the representatives of the Autonomous Communities. He shall act as Secretary of the Technical Committee of the Spanish Pharmacovigilance System for Medicinal Products for Human Use, responsible for the SEFV Coordination Unit of the Pharmacoepidemiology and Pharmacovigilance Division.

Article 23. The Committee for the Coordination of Possession Studies.

1. The Committee for the Coordination of Posauthorization Studies is a coordinating body whose aim is to harmonise and coordinate criteria and requirements for post-authorisation studies for the Agency and the Autonomous Communities.

2. These are the functions of the Possession Studies Coordination Committee:

(a) Establish guidelines and procedures for the harmonisation of actions in the field of post-authorisation of medicinal products.

b) Establish simplified procedures for studies promoted by health administrations or financed with public funds, in order to facilitate their implementation.

c) Advise different administrations on post-authorization studies when required.

3. The Committee for the Coordination of Posauthorization Studies shall be composed of the following members:

a) Two vowels due to their position:

1. The Head of the Agency's Department of Human Use Medicines.

2. The Head of the Division of Pharmacoepidemiology and Pharmacovigilance of the Department of Medicinal Products for Human Use.

3. The seventeen vowels each representing a competent body in the field of post-authorization studies of the autonomous communities, officially designated by that body.

4. The President and the Vice-Chair of the Committee for the Coordination of Posauthorization Studies shall be elected by their members from among the representatives of the Autonomous Communities. The Head of the Division of Pharmacoepidemiology and Pharmacovigilance of the Department of Medicinal Products for Human Use shall act as Secretary of the Coordination Committee for Studies.

Article 24. The Technical Committee of the Spanish Pharmacovigilance System for Veterinary Medicinal Products.

1. The Technical Committee of the Spanish Pharmacovigilance System for Veterinary Medicinal Products is the collegiate body of the Agency which aims to unify the performance criteria and to evaluate the signals to veterinary medicinal products detected by the Spanish Pharmacovigilance System for Veterinary Medicinal Products.

2. These are functions of the Technical Committee of the Spanish Pharmacovigilance System for Veterinary Medicinal Products:

(a) Evaluate the signs corresponding to veterinary medicinal products detected by the Spanish Pharmacovigilance System for Veterinary Medicinal Products, ensuring the maintenance of the same coding and assessment in accordance with the Pharmacovigilance Practice of the Spanish Pharmacovigilance System for Veterinary Medicinal Products, and those other regulations that the Committee itself is developing and approving.

b) Coordinate the activities of the different administrations involved in the Spanish Pharmacovigilance System for Veterinary Medicinal Products.

(c) Submit proposals relating to the adverse effects of the veterinary medicinal products to the Agency.

(d) Report to the Department of Veterinary Medicinal Products on the veterinary pharmacovigilance activities of the Autonomous Communities.

(e) Vellar for the intervening administrations in the Spanish Pharmacovigilance Pharmacovigilance System to adopt the national and international recommendations on pharmacovigilance veterinary.

f) Develop and approve the Good Pharmacovigilance Practice for Veterinary Medicinal Products and all actions deemed necessary for the operation of the Spanish Pharmacovigilance System for Medicinal Products Veterinarians.

g) Facilitating and promoting the dissemination of the programme for the spontaneous reporting of adverse reactions with veterinary medicinal products, in order to harmonise and increase the levels of participation of professionals health.

3. The reports issued by the Technical Committee of the Spanish Pharmacovigilance System for Veterinary Medicinal Products shall be required in cases where it is established, but shall in no case be binding.

4. The Technical Committee of the Spanish Veterinary Medicinal Pharmacovigilance System shall be composed of the following members:

1. The Head of the Agency's Department of Veterinary Medicinal Products.

2. The Deputy Director General of Primary Production Health at the Ministry of the Environment, and Rural and Marine Environment.

3. A responsible for Veterinary Pharmacovigilance for each Autonomous Community and the city of Ceuta and the city of Melilla.

4. The person holding the chair of the Committee on the Safety of Veterinary Medicinal Products

5. The Head of Veterinary Pharmacovigilance of the Agency's Department of Veterinary Medicinal Products.

6. The responsible for the coordination of the Veterinary Pharmacovigilance databases of the Agency's Department of Veterinary Medicinal Products.

5. The President and the Vice-President of the Technical Committee of the Spanish Pharmacovigilance System for Veterinary Medicinal Products shall be appointed by the Governing Board of the Agency from among the members. He shall act as the Secretary of the Committee on Veterinary Medicinal Products, the Head of Veterinary Medicines of the Agency.

Article 25. The Committee for the Availability of Veterinary Medicinal Products.

1. The Committee for the Availability of Veterinary Medicinal Products is the collegiate body attached to the Agency, which aims to promote and promote the availability of veterinary medicinal products for all livestock farming species. (a) food and pet animals where there is a therapeutic vacuum and/or because of reduced markets are not available for medicinal products to treat certain diseases, by means of actions aimed at encouraging, encouraging and supporting research, experimentation, development, registration and marketing of the same.

2. These are the functions of the Veterinary Medicines Availability Committee:

a) Identify the problems of the availability of Veterinary Medicines in the different species of livestock and therapeutic indications.

b) Rate the availability of Veterinary Medicinal Products by species and their specific problems.

c) Develop recommendations, proposals and initiatives related to the availability of Veterinary Medicines.

d) Inform and advise on the availability of Veterinary Medicines by target species, establishing for each of them the minimum essential needs for the maintenance of a sanitary state acceptable.

e) In the case of immunological medicinal products, delimit a list of indications or diseases that may be categorized as minor uses for certain species in Spain, depending on their specificity, character of emerging, low incidence in the livestock census by species or for which there is no economic interest in the development of veterinary medicinal products.

f) Value the existing therapeutic gaps in each species of destination, setting in turn a priority order for each species, prior to analysis of the causes of these voids.

g) Develop reports on the need to establish maximum residue limits in a species for certain pharmacologically active substances.

h) Conduct studies of possible therapeutic alternatives compatible with public health or food safety and the production periods of each species.

i) Carry out risk analysis and forecasts on the lack of availability of medicines.

j) Report on the consumption and administration of medicinal products by means of the exceptional prescription for therapeutic vacuum, by species.

k) Propose possible technical measures regarding the requirements of the records of medicinal products intended for these species in accordance with Community legislation.

l) Assessor and participate in the development of technical and administrative measures within the European Union.

m) Report on the case of therapeutic vacuum drug imports.

n) Perform an annual assessment and report of the existing situation.

n) Other functions or activities that may be derived from the availability of Veterinary Medicines.

3. The reports issued by the Committee on the Availability of Veterinary Medicinal Products shall be required in cases where it is established, but shall in no case be binding.

4. The Committee for the Availability of Veterinary Medicinal Products shall be composed of the following members:

a) Four vowels due to their position:

1. The Head of the Agency's Department of Veterinary Medicinal Products.

2. The Deputy Director General of Primary Production Health at the Ministry of the Environment, and Rural and Marine Environment.

3. The Deputy Director General for Agrarian and Food Research of the National Institute of Agricultural Research (INIA).

4. The Deputy Director General of Food Risk Management at the Spanish Food Safety and Nutrition Agency.

b) Five vocal representatives of the autonomous communities, appointed by the head of the Ministry of Health, Social Policy and Equality, on a proposal from the Sectoral Conference on Agriculture and Rural Development.

c) Two vowels by the Business Association of the Veterinary Pharmaceutical Industry.

d) A vowel by the General Council of Veterinary Officers.

e) A vocal by the General Council of Official Colleges. Pharmacists.

f) Six vowels by the livestock sector, sectors of minor species or minor uses, designated by the holder of the Ministry of Health, Social Policy and Equality, on a proposal from the holder of the General Secretariat of Rural environment of the Ministry of the Environment, and the Rural and Marine Environment: one in the aquaculture sector, one in beekeeping, one in the farming sector, one in the farming sector, one in the ovine and caprine sector and one in the field of animal company.

g) A vowel representing the Spanish Technological Platform for Animal Health (Vet + i), appointed by the head of the Ministry of Health, Social Policy and Equality, on a proposal from the Ministry of Health.

(h) Five free-designation vowels selected from professionals and experts with widely recognised knowledge in the field of medicinal products and animal health, designated by the Agency's Governing Council, on a proposal of the Director of the Agency, following the agreement of the holder of the General Secretariat of the Rural Environment of the Ministry of the Environment, and the Rural and Marine Environment.

5. The President and the Vice-President of the Committee for the Availability of Veterinary Medicinal Products shall be appointed by the Agency's Governing Board from among the five members appointed on a proposal from the Director of the Agency. He shall act as the Secretary of the Committee on Veterinary Medicinal Products, the Head of Veterinary Medicines of the Agency.

Article 26. The Pharmacopoeia Committee and the National Form.

1. The Pharmacopoeia Committee and the National Form is the collegiate body of the Agency, which aims to promote and supervise the work carried out by the Pharmacopoeia and the National Form.

2. They are functions of the Pharmacopoeia Committee and the National Form:

(a) Inform, with a mandatory and non-binding nature, the successive editions of the Spanish Royal Pharmacopoeia and of the National Form, as well as its additions and corrections, and propose the dates of its entry into force.

b) Approve the proposed listing of new monographs and other texts to include in the Spanish Royal Pharmacopoeia and the National Form.

c) Set priorities in the elaboration of new monographs or revision of old ones.

d) Advise the Spanish Delegation to the European Pharmacopoeia Commission.

e) To ensure that the compilation of the monographs of the Spanish Royal Pharmacopoeia and of the National Form responds to the criteria of information transparency, quality, objectivity and speed, as well as to take into account the established in other International Pharmacopeas or Forms with a view to international harmonisation.

f) Seek the eventual collaboration of advisors with outstanding knowledge in specific subjects.

g) Propose to the Director of the Agency the carrying out of studies and research that it considers necessary for the best accomplishment of the purpose of the Pharmacopoeia and of the National Form.

3. The reports issued by the Pharmacopoeia Committee and the National Form shall be required in the cases in which it is established, but in no case shall they be binding.

4. The Pharmacopoeia Committee and the National Form shall be composed of the following members:

a) Five vowels due to their position:

1. The Director of the Agency.

2. The Head of the Department of Medicinal Products for Human Use

3. The Head of the Department of Drug Inspection and Control

4. The Head of the Department of Veterinary Medicines.

5. The Director of the National Institute of Toxicology.

(b) Eight members appointed by the head of the Department of Health, Social Policy and Equality for a period of four years, on a proposal from the Governing Council representing the following groups or institutions:

1. A scholar of the Royal Academy of Pharmacy.

2. The President of the General Council of Pharmaceutical Officers or a person to whom you delegate.

3. The President of the General Council of Veterinary Officers or a person to whom you delegate.

4. The President of the General Council of Physicians or the person to whom you delegate.

5. A General Pharmaceutical Officer of the Ministry of Defense's General Inspection of Health.

6. A vocal from private organizations representing pharmaceutical laboratories.

7. A vocal from private organizations representing the processing industry of pharmaceutical raw materials.

8. A vocal representative of private organizations in the professional field of the veterinary medicinal product industry.

In the last three cases, the highest representative of the most representative private organization in each field will propose the appointment of the vowels in question.

(c) Six free-designation vowels selected from professionals and experts with widely recognised knowledge in the field of pharmacopoeia and quality control of medicinal products, designated by the Agency's Governing Council, for a period of four years, on a proposal from the Director of the Agency.

5. The President and the Vice-President of the Pharmacopoeia Committee and the National Form shall be appointed by the Agency's Governing Board from among the six members appointed on a proposal from the Director of the Agency. He shall act as the Secretary of the Commission and the Committees, with a voice, but without a vote, the Head of the Agency's Pharmacopoeia and National Form Unit.

Article 27. The Technical Inspection Committee.

1. The Technical Committee for Inspection is the coordinating body for the inspection and control of medicinal products, medical devices, cosmetics and personal hygiene products, and the task of ensuring the homogeneity of the criteria and actions of the Inspection and control services of the Agency and the competent bodies of the Autonomous Communities.

2. The Technical Inspection Committee forms an integral part of the Agency as a collegiate body for the development of the functions and activities necessary for the coordination and harmonization of criteria and requirements for inspection and control. between the Agency and the Autonomous Communities.

3. The Technical Committee for Inspection shall be composed of the holders of the Department of Inspection and Control of Medicinal Products and the Agency's Department of Health Products, as well as the technicians responsible for the inspection services of the Agency. Agency, and each of the Autonomous Communities, in addition to the specific technicians responsible for the control area for all activities specific to its scope.

4. The President and the Vice-President of the Technical Inspection Committee shall be elected from among the representatives of the Autonomous Communities and the Agency for a period of two years. For exceptional reasons and where no candidate is present, he may take this charge in a row for a maximum period of 4 years.

5. The following are functions of the Technical Inspection Committee:

(a) Promote the harmonisation of criteria for inspection and control measures on medicinal products, medical devices, cosmetics and personal hygiene products in the field of their competence.

b) Develop documents that collect the basic principles of quality assurance systems for inspection services for the development of inspection activities.

c) To analyse existing national and Community legislation in order to incorporate the relevant aspects into inspection procedures.

d) Collect, know and analyse documents and reports from the International Pharmaceutical Inspection and Control Agencies and promote the adoption of relevant guidelines for their general application.

e) Promote the study, analysis and proposal of guidelines of specific technical materials for the manufacture, conservation, distribution and supply of medicines, medical devices, cosmetics and hygiene products personnel.

f) Establish protocols for the coordinated management of alerts for medicines, medical devices and cosmetics.

g) Participate in the preparation of the drug proposal to be included in the Annual Drug Control Program and approve the distribution of sample sampling of the program.

h) Approve the Coordinated Plans of Inspection of Autonomous Communities and Spanish Agency of Medicines and Health Products proposed by the Technical Working Groups.

i) Develop coordinated health product inspection programs, cosmetics, and personal hygiene products and approve their application.

j) Promote and support the realization of Pharmaceutical Inspection Days.

k) Approve the Training Programs of the inspectors.

l) Approve the creation and dissolution of the Technical Working Groups, define their scope of action and approve their Operating Standards.

m) Choose the President and Vice President of the Technical Inspection Committee.

n) Approve the Committee's Rules of Procedure and its modifications.

o) Approve the annual summary of the Committee's activities.

p) Any other function assigned to you within your competence scope.

6. The operation of the Technical Inspection Committee shall be provided by the Agency's general appropriations.

Article 28. The Peripheral Pharmaceutical Services Coordination Committee.

1. The Committee for the Coordination of Peripheral Pharmaceutical Services is the coordinating body responsible for promoting homogeneous criteria and actions by the peripheral pharmaceutical services with functional dependence of the Spanish Agency of Medicines and Healthcare products.

2. The Committee for the Coordination of Peripheral Pharmaceutical Services forms an integral part of the Agency as a collegial body geared to the development of the functions and activities necessary for the coordination and harmonization of criteria and requirements in (a) foreign trade matters relating to medicinal products and their raw materials, medical devices, cosmetics and personal hygiene products, as well as pharmaceutical inspection activities and activities in the field of illicit trafficking in narcotic and psychotropic substances, in their technical-analytical content.

3. The Peripheral Pharmaceutical Services Coordination Committee shall be composed of the holders of the Departments of Medicinal Products for Human Use, and of the Agency's Inspection and Control of Medicines and Health Products, as well as The technical assistance of these peripheral pharmaceutical services and specific technicians of the departments mentioned with responsibility in the areas covered by the coordination.

4. The Chairman and the Vice-Chair of the Peripheral Pharmaceutical Services Coordination Committee shall be elected from among the representatives of the Peripheral Pharmaceutical Services and the Agency for a period of 2 years. For exceptional reasons and where no candidate is present, he may take this charge in a row for a maximum period of 4 years.

5. They are the functions of the Peripheral Pharmaceutical Services Coordination Committee, the following:

(a) Promote the harmonisation of criteria, establish protocols and encourage the efficient development of external trade inspection and control actions on medicinal products, medical devices, cosmetics and products personal hygiene.

b) Facilitate the development of the pharmaceutical inspection activities on medicinal products, medical devices, cosmetics and personal hygiene products, in the case of the corresponding protocols, in accordance with the quality standards that are applicable.

c) To promote the exchange of information and the harmonization of requirements and criteria in the analysis of narcotic and psychotropic substances in the network of laboratories of peripheral pharmaceutical services.

d) Develop and approve documents that collect the basic principles of the quality assurance systems of the laboratory network for the analysis of narcotic and psychotropic substances in pharmaceutical services peripherals as well as the specific procedures involved.

e) To know and analyse documents and reports from International Agencies on medicines, medical devices, cosmetics and personal hygiene products, as well as those relating to the analysis of narcotic and psychotropic substances.

f) Approve the creation and dissolution of the Technical Working Groups, define their scope of action and approve their operating rules.

g) Choosing the Chairman and Vice-Chair of the Peripheral Pharmaceutical Services Coordination Committee.

h) Approve the Committee's Rules of Procedure and its amendments.

i) Approve the annual summary of the Committee's activities.

j) Any other function assigned to you within your competence scope.

6. The functioning of the Peripheral Pharmaceutical Services Coordination Committee shall be provided by the Agency's general appropriations.

Article 29. Common rules for the functioning of the Committees.

1. In the absence of specific provisions of this Statute, the Committees shall adjust their action, as far as they apply, to the provisions of Chapter II of Title II of Law No 30/1992 of 26 November 1992.

2. The Committees shall draw up their rules of procedure and their procedures for action and operation. Each year they shall present a report on their activities and approve the action programme for the following year.

3. The Committees may require the collaboration of all experts to consider appropriate, without prejudice to their composition, in order to discuss those aspects which, due to their specialisation, would make it necessary.

4. If requested, the adoption of reports may be carried out by written procedure, without the need for members of the Committees to meet in person.

Section 5. Administrative Structure

Article 30. Administrative structure.

1. The following units shall be directly dependent on the Agency Director:

a) The General Secretariat.

b) The Department of Medicinal Products for Human Use,

c) The Department of Veterinary Medicines.

d) The Department of Inspection and Control of Medicines

e) The Health Products Department.

2. There shall be a Delegated Intervention of the General Intervention of the State Administration attached to the Director of the Agency

Article 31. The General Secretariat.

The General Secretariat of the Agency shall be responsible for the exercise of the following tasks:

1. The selection of work staff, as well as the management and training of human resources under the supervision of the Director and following the criteria and guidelines of the Governing Council.

2. The processing of procurement files for the acquisition of goods and services, as well as the enablement of the material, and in a special way, the management and allocation of computer media, in addition to the analysis and previous design of the information necessary for the performance of the tasks of the Agency.

3. The management of revenue and expenditure, the implementation of charges and payments, and the management of the Agency's treasury, as well as the proposal for the establishment and modification of the fees resulting from the exercise of the powers of the Agency. Agency, and the application of the fees and penalties resulting from the agency's inspection.

4. The updated training and maintenance of the inventories of movable and immovable property, both own and attached, as well as the custody of the latter and the processing of the files for acquisition, leasing, attachment and/or description.

5. The publication of the marketing authorisations for medicinal products for human and veterinary use, as well as the suspensions, revocations or cancellations thereof, and the monitoring of the legal consequences of such formal acts.

6. The edition of the official information offices, annual reports and any other publications of the Agency.

7. The instruction of the sanctioning procedures in the field of the body's powers and the relations with the Courts of Justice.

8. Security, internal arrangements, general affairs, and the coordination and inspection of the Agency's units, facilities and services.

9. The planning and implementation of the policy of occupational risks, as well as the medical service of enterprise and the safety and hygiene at work.

10. To exercise the secretariat of the Rector Council and the Agency's Control Committee.

11. To exercise when delegated by the Director the functions referred to in points (f), (g) and (i) of Article 14 (2) of this Statute.

12. To manage horizontal issues that do not correspond to competencies specifically attributed to other units of the Agency, as well as any other matters attributed to it by statutory or regulatory standards.

Article 32. The Department of Medicinal Products for Human Use.

The Department of Medicinal Products for Human Use shall be responsible for the management of the following functions, always referred to in the field of medicinal products for human use:

1. To evaluate, authorise, modify, renew, restrict, suspend or revoke the marketing authorisation of industrially manufactured medicinal products and special medicinal products.

2. Authorise, modify, suspend or revoke clinical trials of medicinal products for human use.

3. To authorise individual access to investigational medicinal products, temporary authorisations for use and foreign medicinal products and to establish recommendations for the use of medicinal products used under conditions other than those of authorised, with the participation of the Directorate-General of Pharmacy and Health Products, in the corresponding processes.

4. Establish and publish the Spanish Official Denominations (DOE).

5. To manage the activities of the Spanish Royal Pharmacopoeia and those required in relation to the European Pharmacopoeia Commission, in relation to the production of monographs of active substances and excipients, analytical methods and establishment of reference materials.

6. Manage and keep the Human Use Drug Registry up to date.

7. To develop and promote the distribution of information on medicinal products for human use intended for health professionals, other health authorities and society in general, in the framework of activities to promote the rational use of medicines.

8. Carry out and promote studies of the use of medicines in Spain.

9. Identify, assess and manage the risks arising from authorised medicinal products. To coordinate the Spanish Pharmacovigilance System and act as a national reference centre for pharmacovigilance and for the relevant European networks.

10. Promote, perform and coordinate pharmacologic studies, in accordance with the provisions of the pharmacovigilance regulations.

11. To classify and coordinate the evaluation of the post-authorisation studies promoted by the industry or other health professionals or bodies. To evaluate post-authorisation studies linked to the authorisation of medicinal products and/or included in the risk management plan.

12. To determine the drugs of special medical control for safety reasons and to define the monitoring programs to be met.

13. To develop reports of therapeutic use of medicinal products.

14. Promote, implement, coordinate and monitor the activities of batch release of human biological products, as well as the examination of raw materials, intermediate products and other components of medicinal products during the process of authorization.

15. Maintain a strategic state deposit of medicines and medical devices for emergencies and catastrophes as well as for international cooperation and coordinate the supply of vaccines, medicines and medical devices for health campaigns, together with the different administrations.

16. Carry out the tasks assigned to the Agency in the field of external trade in authorised medicinal products for human use, including, where appropriate, the issue of the certificates necessary for the authorisation of their import or export by Customs.

17. To manage the remaining powers assigned to the Agency in Article 7 related to medicinal products for human use and not explicitly assigned to other Departments.

Article 33. The Department of Veterinary Medicinal Products.

The Department of Veterinary Medicinal Products shall be responsible for the following tasks, in the field of veterinary medicinal products:

1. To evaluate, authorise, modify, renew, restrict, suspend or revoke the marketing authorisation of industrially manufactured veterinary medicinal products.

2. Authorise, amend, suspend or revoke clinical trials and clinical research products in veterinary medicinal products.

3. Authorize medications with temporary authorization of use.

4. Promote the availability of veterinary medicinal products for all livestock species.

5. Register, maintain and update the Registry of Industrially Elaborated Veterinary Medicinal Products.

6. Carry out the tasks assigned to the Agency in the field of external trade in authorised veterinary medicinal products, import of veterinary medicinal products not registered by therapeutic vacuum, import of active substances and trade intra-Community parallel, including, where appropriate, the issue of the certificates required for the authorisation of export by Customs.

7. Manage exceptional authorizations for therapeutic vacuum use.

8. Identify, assess and manage the risks arising from veterinary medicinal products. To coordinate the Spanish Veterinary Pharmacovigilance System and to act as a national reference centre for veterinary pharmacovigilance and for the relevant European networks.

9. To carry out and promote studies of the use of the drugs in Spain, in relation to the activities of pharmacovigilance and pharmacoepizootiology, therapeutic utility and promotion of the correct use of the drugs.

10. To promote, coordinate and supervise the performance of pharmacoepizootiological studies by industry or other bodies or professionals. Coordinate the assessment and management of post-authorisation studies linked to the authorisation of veterinary medicinal products and/or included in the risk management plan.

11. To assess and communicate the risks arising from quality problems of authorised veterinary medicinal products in Spain.

12. To develop the functions relating to restrictions and conditions for the prescription of veterinary medicinal products. 13. Manage the other powers assigned to the Agency in Article 7, related to veterinary medicinal products and not explicitly assigned to other Departments.

14. Promote, execute, coordinate and monitor the activities of batch release of biological products, as well as the examination of the raw materials, intermediate products and other components of the medicinal products during the authorization process.

Article 34. The Department of Inspection and Drug Control.

The Department of Inspection and Control of Medicinal Products shall be responsible for the exercise of the following functions in the field of medicinal products for human and veterinary use:

1. To grant, modify, restrict, suspend and revoke the authorization of the activity of pharmaceutical laboratories for medicinal products for human and veterinary use and to maintain the Registry of pharmaceutical laboratories.

2. To verify, by means of inspections, compliance with the standards of good manufacturing practice, standards of good clinical practice, standards of good practice of pharmacovigilance, good laboratory practice and good practice distribution in the field of competence of the General Administration of the State.

3. Authorise the import and export and intra-Community trade in non-registered medicinal products, which are to be subsequently placed on the market in a Member State of the European Union or in a third country, including, where appropriate, the issue of certificates required for the authorisation of their import or export by Customs.

4. Maintain and publish the catalog of drug wholesale stores

5. Assess and manage risks arising from quality problems of authorised medicinal products in Spain

6. Manage drug supply issues as appropriate to the General Administration of the State.

7. To develop the state functions and responsibilities of inspection and control in the field of traffic and lawful use of narcotic drugs and psychotropic substances.

8. To develop the control functions in the field of medicinal products, including competences relating to illegal and falsified, which fall within the scope of the Agency's competence.

9. Develop and publish the National Form.

10. To coordinate the operation of the Health and Social Policy Areas and Dependencies in the activities of external health and pharmaceutical inspection activities in the field of medicinal products and their raw materials, as well as in the activities relating to the illicit trafficking of narcotic and psychotropic substances in their technical-analytical content.

11. To assume the remaining management and coordination powers assigned to the Agency in Article 7, in relation to the inspection and control of medicinal products, and which are not explicitly assigned to other Departments.

Article 35. The Department of Health Products.

The Health Products Department will be responsible for the following functions:

1. To assess health suitability and compliance with the current rules for medical devices, cosmetics, personal hygiene products and biocidal products for clinical and personal use, establishing such conformity or authorising their placing on the market, proceed, as well as update your national unified records.

2. Amend, restrict, suspend, renew and revoke the certifications and authorizations of medical devices, cosmetics, personal hygiene products and products for clinical and personal use, and may limit, restrict, prohibit or subdue special conditions for placing on the market, putting into service, distribution, use, dispensing or sale.

3. To grant, modify, restrict, suspend, renew or revoke the authorisations of activities of the manufacturers, importers, stitchers and sterilizers of sanitary products, cosmetics and personal hygiene products. All this with the exception of the manufacturing activities of tailor-made medical devices.

4. Authorize, modify, suspend or revoke clinical investigations with medical devices.

5. To authorise, suspend or limit the exceptional use of medical devices for reasons of health concern.

6. To plan, develop and manage the monitoring systems for health products and cosmetics, acting as a national reference centre in the relevant European networks.

7. Carry out the tasks assigned to the Agency in the field of external trade in medical devices, cosmetics, personal hygiene products, and biocidal products for clinical and personal use, including, where appropriate, the issue of certificates necessary for the authorisation of their import or export by Customs.

8. To develop the inspection and control of medical devices, cosmetics, personal hygiene products and products for clinical and personal use, including functions related to illegal and counterfeit products, corresponds to the General Administration of the State.

9. Coordinate the operation of the Health, Social Policy Areas and Dependencies in the activities of external health and in the activities of pharmaceutical inspection in the health products, cosmetics, hygiene products personnel and biocidal products for clinical and personal use.

10. To manage the other powers assigned to the Agency in Article 7, in respect of the competences related to medical devices, cosmetics, personal hygiene products and products for clinical and personal use and which are not explicitly assigned to other Departments.

Article 36. Independence, transparency of the actions and duty of confidentiality of the information.

1. All staff at the service of the Agency shall be governed by the principles contained in Articles 52 to 54 of Law 7/2007 of 12 April of the Basic Staff Regulations. In addition, the Agency's staff, as well as the experts and members of its committees, will have to respect the Codes of Conduct established by the European Network of Competent Authorities, the European Medicines Agency, and the European Medicines Agency. Agency.

2. The activities of the Agency shall be governed by the principle of transparency. The authorisations of medicinal products, their modifications, suspensions and revocations, when they are firm, and the authorisations of pharmaceutical laboratories shall be publicly accessible. The report on the evaluation of medicinal products shall also be published, subject to the deletion of any commercial information of a confidential nature.

3. All staff at the service of the Agency, as well as experts and members of committees, shall maintain confidentiality, even after they have ceased their duties, on the data contained in the dossiers relating to medicinal products, medical devices, cosmetics, personal hygiene products, which they know in the performance of their tasks and without the possibility of undue use of the information obtained in accordance with the provisions of the legal order.

4. Membership of the Governing Council and the Committees governed by this Statute shall be incompatible with any kind of personal interest arising from the manufacture, marketing, representation, distribution or sale of medicinal products for use. human and veterinary, medical devices, cosmetics, personal hygiene products.

5. Without prejudice to the obligations of cooperation with the health authorities of the Member States of the European Union or the European Medicines Agency, the members of the Committees, as well as those involved in their meetings or groups of work, keep secret of the deliberations, as well as of all data or information of which they have knowledge in the performance of their duties.

6. Each member of the Agency's collegiate bodies shall make a declaration of conflicts of interest and update it, in the event of a change, at least once a year. External experts or observers invited to participate in the meetings of the Committees, or the Advisory Committees, shall also present a statement to the Secretariat of each Committee or, where appropriate, to the Secretariat-General of the Agency. prior to conflicts of interest.

As long as those affected by this obligation have the consideration of staff at the service of the General Administration of the State or are senior positions, a copy of that statement shall be forwarded to the Office of Conflict of Interests.

7. The declaration of conflicts of interest to be made by the management staff, by the members of the Agency's collegiate bodies and by the experts or observers invited to participate in the meetings of the Committees or in the The Advisory Committees shall refer only to the person who carries out it and shall include the following: the performance of any activity for a company in relation to a particular product or group of products, the concurrency of economic interests in a pharmaceutical company, ownership of the patent of a product and profit personnel arising from the receipt of grants or other funds from the pharmaceutical industry by the obligation on which that person works.

Section 6. Network of Experts

Article 37. Network of Experts.

1. The Spanish Agency for Medicinal Products and Sanitary Products shall designate a network of experts in medicinal products, medical devices and other matters of interest to the Agency for scientific and clinical advice on safety, efficacy and quality of these products, as well as for carrying out studies and research that are accurate to improve their knowledge and health guarantees.

2. It will ensure that the network has representation of the different areas of knowledge and experience needed to undertake the functions of scientific-technical advice, research, evaluation and planned studies.

3. An updated list of experts will be maintained which will be accessible to the public.

CHAPTER IV

Agency Staff Regime

Article 38. From staff to the Agency's service.

1. Staff at the service of the Agency may be an official or a work officer and, where appropriate, statutory.

2. The official staff and staff shall be governed by the rules governing the legal status of public servants of the General Administration of the State, with the specialities provided for in Law 28/2006 of 18 July. State agencies for the improvement of public services and in this Statute. In addition, for statutory staff, the provisions of Law 55/2003 of 16 December 2003 on the Staff Regulations of the Staff Regulations of the Staff Regulations of Officials of the European Communities of 16 December 2003 shall apply, where the nature or content of the act to be adopted so requires. health, and its rules of development, without prejudice to the provisions of the fourth transitional provision of the royal decree approving this Statute.

3. The work staff will be governed by the Royal Legislative Decree 1/1995 of 24 March, approving the recast of the Law of the Workers ' Statute and other labor legislation, by the standard standard that applies to it, and also by the provisions of Law 28/2006 of 18 July, as well as of Law 7/2007 of 12 April.

4. The posts may be provided, in accordance with the various selection and provision procedures set out in Articles 19 and 20 of Law 28/2006 of 18 July, by staff of the General Administration of the State or, where appropriate, other public administrations, if necessary, for their particular nature and functions in terms of the management contract. To this end, the working relations shall be established by making this provision possible and in accordance with that management contract.

Article 39. Of the management of the jobs.

1. The employment relationship of the Agency shall determine the basic elements thereof in accordance with the provisions of Articles 74 and concordant of Law 7/2007 of 12 April 2007 and Article 15 of Law 30/1984 of 2 August.

2. As a general rule, the posts will be filled by official staff. To this end, the employment relations shall determine those posts which may also be occupied by labour staff, and in any event the provisions of Articles 9.2 of Law 7/2007 and 15 of Law No 30/1984 of 2 May 2007 must be respected. August.

3. In addition, the employment relations shall establish posts which may be filled by statutory staff or by staff of other public administrations.

4. The employment relationship shall be drawn up by the Director of the Agency and approved by its Governing Board, within the framework of action in the field of human resources established in the Management Contract, and its content shall be adjusted to the principles laid down in Article 15 of Law 30/1984 of 2 August, with determination of the way in which the jobs are provided.

5. The staff providing their services at the Agency shall be recognised as being entitled to the promotion within an evaluable professional career, within the meaning of Law 7/2007, of 12 April.

Article 40. From the Steering Staff.

1. Management staff of the Agency shall be considered to be the head of the units listed in Article 30.1 of the Staff Regulations.

2. The management staff of the Agency shall be appointed and terminated by the Governing Council at its job, on a proposal from the Director, on the basis of criteria of suitability, competence, professional experience and equality between women and men, Group A officials, subgroup A1, of those listed in Article 76 of Law 7/2007, of 12 April, of the Basic Staff Regulations, and by means of a procedure that guarantees merit, capacity and free competition.

3. The management staff of the Agency shall remain in the active service situation in their respective body or scale, and must maintain confidentiality, even after they have ceased their duties, on the data contained in the files to those who have access by reason of their charge and without being able to misuse the information obtained in accordance with the provisions of the legal order.

4. The management staff of the Agency shall be subject to the legislation of incompatibilities provided for the official staff at the service of the General Administration of the State.

In any event, such staff shall carry out their duties with exclusive dedication and may not exercise any public or private activity except those referred to as activities other than the incompatibilities in Article 19 of the Treaty. Law 53/1984 of 26 December.

5. The assessment of management personnel shall be carried out on the basis of criteria of effectiveness, efficiency, compliance with legality, responsibility for the management and control of results in relation to the objectives set out in the Management Contract, the remuneration for productivity of such staff is linked to that assessment.

6. In addition, the management staff of the Agency shall, at the time of their appointment, make a declaration of conflict of interest, which shall be updated in the event of a change of situation, and in any form, at least once a year. As long as those affected by this obligation have the consideration of personnel at the service of the General Administration of the State or are high positions, a copy of that statement shall be sent to the Office of Conflict of Interest.

Article 41. From the remuneration scheme.

1. The remuneration concepts of the official and statutory staff of the Agency are those laid down in the regulation for the Public Service of the General Administration of the State, and their amounts shall be those that appear in the corresponding relations in the context of the management contract, in full compliance with the quantitative limits laid down in the annual laws of the State General Budget.

2. The remuneration of the labour force is determined in the applicable collective agreement and in the respective employment contract, and its amounts shall be fixed in accordance with the terms of the management contract.

3. The compensation to be paid on the basis of travel expenses and other individual costs arising as a result of the provision of services, will always be in accordance with the provisions of Royal Decree 462/2002 of 24 May 2002. on compensation for service reason.

4. The amount of the wage bill for the official staff productivity supplement, or equivalent concept for the workforce, shall be in any case linked to the extent to which the objectives set out in the contract are met. management.

5. For the allocation of the productivity supplement, account shall be taken of the outcome of the performance assessment at the job, and where appropriate, the performance of the unit or collective unit in which it is integrated. All in accordance with the target system to be set.

CHAPTER V

The Management Contract and the Annual Action Plan

Article 42. The Management Contract.

1. The Agency shall draw up its proposal for a Management Contract with the content and within the time limits provided for in Articles 13 and 14 of Law 28/2006 of 18 July, for approval by joint order of the Ministries of Health, Social Policy and Equality, of Territorial Policy and Public Administration, and of Economy and Finance.

2. The Management Contract shall be valid for two years for the initial and four years for the successive years, and its beginning and end shall coincide with those of the corresponding budgetary years.

The Management Contract shall be approved within the maximum period of three months from its submission. When this time limit has been exhausted, the previous management contract shall remain in force.

3. The Director of the Agency shall draw up the proposal for a management contract which, after its debate and possible amendment, shall be approved by the Governing Council and presented by its President to the holders of the Ministries of Health, Social Policy and Equality, of Territorial Policy and Public Administration, and of Economy and Finance.

4. The Governing Council of the Agency, through its President, shall inform the Ministries of Health, Social Policy and Equality, of Territorial Policy and Public Administration, and of Economic and Financial Affairs, of the implementation and enforcement of the objectives set out in the Management Contract with the periodicity to be determined in the order of approval of that Contract.

5. The content of the Management Contract shall be in accordance with the provisions of Article 13.2 of Law 28/2006 of 18 July of State Agencies for the Improvement of Public Services.

Article 43. Annual Action Plan, annual activity report and accounts.

1. The Director of the Agency shall draw up and propose its approval to the Governing Board of the Annual Action Plan, the general activity report and the annual accounts, within the time limits laid down in Article 15 of Law 28/2006, of 18 December 2013. July.

2. The documentation referred to in the previous point shall be available on the Agency's website.

CHAPTER VI

Wealth and procurement regime

Article 44. Estate regime.

1. For the purposes of this purpose, the Agency shall be endowed with its own assets, other than that of the General Administration of the State, consisting of the set of assets and rights of which it is a holder.

2. The management and administration of its own property and rights, as well as those of those of the State Heritage that are assigned to it for the fulfillment of its purposes, shall be in accordance with the provisions established for the public bodies in Law 33/2003, of 3 of November, a Heritage of Public Administrations.

3. The Agency shall form and keep up to date the inventory of its assets and rights, as well as those which have been assigned to it for the fulfilment of its purposes, with the exception of those of a fungible nature, as laid down in Law 33/2003, of 3 November.

4. The disposal of their own movable property and securities by the Agency shall require the prior agreement of the Governing Board.

Article 45. Legal regime for own property.

The Agency may acquire all kinds of goods and rights for any of the modes admitted to the legal system.

The acquisition of real estate or property rights will require the prior favorable report of the Ministry of Economy and Finance.

Article 46. Legal status of property attached.

The management and dispossession of goods by the General Administration of the State shall be governed by the legislation of the patrimony of the public administrations, retaining their qualification and ownership. (a) legal protection, protection, administration, conservation, maintenance and other actions required by the Agency for the exercise of demanial powers and corresponding to the Agency for the exercise of demanial powers; use of the same and how many prerogatives relating to public domain and property State assets are legally established.

Article 47. Participation in commercial companies or foundations.

1. For the best performance of its purposes, the Agency may establish or participate in commercial companies or foundations, the purpose of which is in accordance with the purposes of the Agency.

2. The approval of the proposal for the creation or participation must be submitted to the Rector Council, and in any case the authorization provided for in Article 169 of Law 33/2003, of 3 November, or in Article 45 of Law 50/2002, of December 26, from Foundations, according to state mercantiles or state public sector foundations.

Article 48. Contracting Scheme.

1. The Agency shall adjust its contractual activity to the rules governing the procurement of the public sector.

2. The Director shall be the contracting authority of the Agency and may delegate the conclusion of contracts to the Secretary-General.

3. The Agency may be the holder of the management mandate provided for in Article 15 of Law No 30/1992 of 26 November for the performance of works and tasks which are not covered by the Agency's powers.

CHAPTER VII

From Legal Assistance to the Agency

Article 49. Legal Assistance.

In accordance with the provisions of the fourth additional provision of Law 28/2006 of 18 July, the legal advice of the Agency will be carried out by the State Advocate at the Ministry of Health, Social Policy and Equality, without prejudice to the fact that, in the context of the establishment of the management contract and in accordance with the needs of the Agency, the signing of a Convention on Legal Assistance may be agreed in the terms of Article 14 of the Legal Service of the State, approved by Royal Decree 997/2001 of 25 July, and even the establishment of a permanent State Advocate in the Agency itself.

CHAPTER VIII

Economic, budgetary, accounting, and control regime

Article 50. Economic resources and their management.

1. They constitute the Agency's economic resources:

(a) Transfers entered in the General Budget of the State.

b) The fees that, according to the laws, it is up to you to collect.

(c) Your own income as a consideration for the activities you carry out under contracts, agreements, or legal provision for other public, private or natural persons.

(d) Revenue from the exercise of the power of sanction referred to in Article 8 of this Statute, as well as its collection.

e) The proceeds from the disposal of the assets and securities that constitute their assets.

f) Performance from your assets and heritage rights

g) Voluntary contributions, donations, inheritances and legacies and other contributions free of charge from private and private entities, provided they do not compromise their neutrality and independence.

h) Revenue received from natural or legal persons as a result of sponsorship of activities or facilities

i) Other public or private law income that you are entitled to receive.

j) Any other resources that may be attributed to you.

2. The resources referred to in paragraphs (c), (g), (h) and (i) of the previous paragraph, and not initially provided for in the Agency's budget, may be used to finance higher expenditure by agreement of the Director, provided that there are guarantees sufficient of their effectiveness, with the exception of the provisions of Article 51.3 in respect of staff costs.

3. It is revenue from private law to the other person who receives the Agency for the provision of services or the performance of activities which are his or her own as long as they do not have the nature of public fees or charges in accordance with general legislation.

4. The Agency assumes the management and collection of the revenue from public law which is affected, and in particular the management and collection of sanctions imposed by the Agency on a voluntary basis.

5. The Agency may use to obtain the effectiveness of its debits with a public right, the administrative procedure for the award, provided that such debits are in the executive period. The Agency may agree with the State Agency for Tax Administration to collect revenue from its public law in the form provided for in the General Rules of Collection, approved by Royal Decree 939/2005 of 29 July.

Article 51. Budgetary and economic-financial arrangements.

1. The Agency's budgetary, economic-financial, accounting, intervention and control regime will be established for the State Agencies in Law 28/2006 of 18 July and Law 47/2003 of 26 November, General Budget.

2. The Ministry of Economy and Finance shall establish the structure of the Agency's budget as well as the documentation to accompany it.

3. The Agency's expenditure budget is estimated for the distribution of appropriations in economic categories, with the exception of expenditure on staff which is, in any case, limited and binding on its own. Total amount, and of the nominal and representative grants and contributions which shall be limited and binding whatever the level of economic classification to which they are established. The budget of the Agency shall be balanced.

4. The Governing Council shall approve the preliminary draft budget of the Agency on an annual basis in accordance with the Management Contract and with the structure of the Ministry of Economy and Finance and forward it to the Ministry of Health, Social and Equality for examination and transfer to the Ministry of Economy and Finance. Once analyzed by the latter, it will be incorporated into the Preliminary Draft General Budget of the State for approval by the Council of Ministers and referral to the General Cortes, consolidating with that of the other entities that make up the State public sector.

5. The implementation of the budget of the Agency shall be the responsibility of its Director, who shall send the Committee of Control, on a monthly basis, a budget statement.

6. Cash balances resulting from the liquidation of the financial year not affected by the financing of the budget for the following financial year may be applied to the revenue budget and shall be used to finance the increase in expenditure by agreement of the Director of the Agency, taking account of the Control Board. In any case, the credits for performance incentives shall be determined in accordance with the terms of the Management Contract.

The deficit arising from the non-compliance with the annual revenue estimate shall be offset in the form provided for in the Management Contract.

7. The Director may authorise budgetary changes which do not affect staff expenditure or the overall amount of the budget. It may also authorise the variation of the overall amount in the case referred to in Article 50.2 of the Staff Regulations. From these variations, the Control Commission will be immediately informed and the Directorate-General for Budgets of the Ministry of Economy and Finance will be informed for its reason.

8. The Agency may have management bank accounts for all types of income and payments in the Banco de España and in commercial banking.

Article 52. Accounting.

1. The Agency shall apply the public accounting principles provided for in Article 122 of Law 47/2003 of 26 November, as well as the development of the principles and rules laid down in the General Public Accounting Plan, for which it shall have an economic and financial information system which aims to show, through statements and reports, the true image of the assets, the financial situation, the results and the implementation of the budget; and provide information on the costs of your activity that is sufficient for a correct and efficient decision making.

2. The Agency shall also have a management accounting system in place to monitor compliance with the commitments made in the Management Contract.

3. The General Intervention of the State Administration shall establish the functional requirements and, where appropriate, the IT procedures to be observed by the Agency in order to comply with the provisions of the previous two paragraphs.

4. The annual accounts of the Agency shall be drawn up by the Director within three months of the end of the financial year. Once audited by the General Intervention of the State Administration, they shall be submitted to the Governing Council for approval by 30 June of the following year to which they relate.

5. Once approved by the Rector Board, the Director shall pay the annual accounts to the Court of Auditors, through the General Intervention of the State Administration.

Article 53. Control of economic and financial management.

1. The external control of the Agency's economic and financial management corresponds to the Court of Auditors in accordance with its specific rules.

2. The internal control of the economic and financial management of the Agency corresponds to the General Intervention of the State Administration, and will be carried out under the modalities of permanent financial control and public audit, under the conditions and in the terms laid down in Law 47/2003 of 26 November. The permanent financial control shall be carried out by the Delegation in the Agency, under the functional dependence of the General Intervention of the State Administration.

3. Without prejudice to the checks provided for in the preceding paragraphs, the Agency shall be subject to effective control which shall be exercised through the monitoring of the management contract by the Ministry of Health, Social Policy and Equality, which shall be intended to verify the degree of compliance with the objectives and the appropriate use of the resources allocated.