Both the previous Law 29/2006 of 26 July, guarantees and the rational use of medicines and medical devices, in Article 77, as the current recast text of the Law on guarantees and the rational use of medicines and Article 79.1 of the Royal Decree of Law 1/2015 of 24 July 2015 has provided that doctors, dentists and podiatologists, in the field of their respective competences, are the only professionals to be able to provide medical services. prescribers, that is, with the ability to prescribe medicinal products subject to medical prescription.

However, the application of the principle of comprehensive health care to the reality of the existence of competing spaces shared by different healthcare professionals and the need to establish organizations In the case of multiprofessionals in which the work on equipment based on criteria of knowledge and professional competence has been used, they have served as the basis for materializing some of the modifications that were introduced in today's repealed article 77 of the Law 29/2006, of July 26, by Law 28/2009, of December 30, amending that Law.

Currently, Article 79 of the recast text of the Law on the guarantees and rational use of medicines and medical devices gives nurses the ability to autonomously indicate, use and authorize the dispensing of all medicinal products not subject to medical prescription and human health products related to their professional exercise, by means of the appropriate dispensing order.

Likewise, and in accordance with the fourth paragraph of Article 79 (1), it is up to the Government to establish, with the participation of the collective organizations of nurses and doctors, the criteria general, specific requirements and procedures for the accreditation of nurses, as a prerequisite and necessary to be able to indicate, use and authorize the dispensing of medicinal products and medical devices for human use. In this sense, the bases of the system of accreditation of nurses, both those responsible for general care and those responsible for specialized care, for the indication, use and authorization of the nurses are incorporated into this standard. dispensing of medicinal products and medical devices for human use.

As for medicinal products subject to medical prescription, the government is also responsible for regulating the professional actions of nurses, in the framework of the principles of comprehensive health care and for the continuity of care, and as provided for in Article 7 of Law 44/2003, of 21 November, of management of the health professions, through the application of protocols and guidelines for clinical and care practice, for joint development, agreed with the relevant collective organisations and validated by the Directorate-General Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality.

In relation to these nurses ' actions regarding medicinal products subject to medical prescription, and as the Supreme Court has pointed out in its judgment of 3 May 2013, it is not a matter of granting new professional skills in favour of those who are the professional attribution of doctors, since the subjection to medical prescription cannot be altered by the fact that protocols for the activity of indication and use can be established by the nurses, after the corresponding medical diagnosis and subsequent prescription by the competent health professionals. In other words, in the words of the Supreme Court itself, the right of prescription for medicinal products is not modified and, therefore, prior diagnostic competence.

On the other hand, it must also be taken into account the provisions of Royal Decree 1718/2010, of December 17, on medical prescription and dispensing orders, as well as in the judgments of the Supreme Court of 20 March, 6 of The Court of First Instance held that the Court of First Instance held that the Court of First Instance held that the Court of First Instance held that the Court of First Instance held that the Court of First Instance held that the Court of First Instance held that the healthcare professionals, as well as being a guarantee for the patient, and that enable correct compliance therapeutic and to obtain the maximum efficiency of the treatment.

For all of the above, the purpose of this standard is to regulate, on the one hand, the professional actions of the nurses regarding the indication, use and authorization of dispensing of medicinal products and medical devices of use The Commission is also responsible for the implementation of the programme for the implementation of the programme, as well as the procedure for the validation of protocols and guidelines for clinical and care practice by the Directorate-General for Public Health, Quality and Innovation, and participation of the relevant collective organisations in the general criteria, specific requirements and procedures for the accreditation of nurses, both those responsible for general care and those responsible for specialized care, as a prerequisite and necessary in order to be able to carry out the actions provided for in Article 79 of the recast text of the Law on the guarantees and rational use of medicinal products and medical devices, and always within the distribution of the professional competence laid down in Law 44/2003 of 21 November, and in the other rules that are applicable.

The elaboration of the protocols and guidelines for clinical and care practice will be carried out within the Standing Committee of Pharmacy of the Interterritorial Council of the National Health System, guaranteeing the representation of both of the Ministry of Health, Social Services and Equality, as well as of the Autonomous Communities, the mutual societies of officials, the Ministry of Defence and the General Councils of the Medical and Medical Officers.

This royal decree is dictated by the exclusive competence which in the field of bases and general coordination of health attributes to the State Article 149.1.16. of the Constitution.

In accordance with the provisions of Articles 67.2 and 71 of Law 16/2003 of 28 May, of the cohesion and quality of the National Health System, this standard has been the subject of prior report by the Council. Interterritorial of the National Health System and its Advisory Committee.

Likewise, in the processing of this royal decree has issued precept report the Spanish Agency for Data Protection, in accordance with article 37.h) of the Organic Law 15/1999, of December 13, of Data Protection Personal Character.

In its virtue, on the proposal of the Minister of Health, Social Services and Equality, with the prior approval of the Minister of Finance and Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers at their meeting on 23 October 2015,

DISPONGO:

CHAPTER I

General character provisions

Article 1. Object and scope of application.

1. It is the object of this royal decree, in the framework of the principles of integral health care and for the continuity of care, and in accordance with the provisions of Article 79 of the recast of the Law on the guarantees and the rational use of the medicines and medical devices, approved by Royal Legislative Decree 1/2015 of 24 July, in conjunction with Articles 7 and 9.1 of Law 44/2003 of 21 November 2003 on the management of health professions:

(a) The actions of nurses regarding the indication, use and authorization of dispensing of medicinal products and medical devices for human use, related to their professional practice.

b) The elaboration and validation of the protocols and guidelines for clinical and care practice for the indication, use and authorization of the dispensing of medicinal products subject to medical prescription by the nurses.

c) The procedure for accreditation of the nurse, both the general care officer and the specialist care officer, as a prerequisite and necessary for the full development of the actions referred to in the Articles 2 and 3.

2. The provisions of this royal decree will apply whether the activities are carried out in public health services or developed in the area of private health.

CHAPTER II

Indication, use and authorization of dispensing of medicinal products and human health products related to their professional exercise by nurses

Article 2. Indication, use and authorization of dispensing of medicinal products not subject to medical prescription and human health products.

1. Nurses, in the exercise of their professional activity, may indicate, use and authorize the dispensing of medicinal products not subject to medical prescription and human health products, autonomously, by means of a dispensing order. which shall have the characteristics set out in Article 5.

2. For the development of these actions, both the nurse responsible for general care and the nurse responsible for specialized care must be holders of the corresponding accreditation issued by the General Management Directorate Professional of the Ministry of Health, Social Services and Equality as established in this royal decree.

Article 3. Indication, use and authorisation of the supply of medicinal products for human use subject to medical prescription.

1. Nurses, in the exercise of their professional activity, as provided for in Article 79 of the recast of the Law on the guarantees and rational use of medicinal products and medical devices, in conjunction with Article 7 of Law 44/2003, 21 November, and in accordance with the provisions of the following paragraph, may indicate, use and authorize the supply of medicinal products subject to medical prescription, by means of the corresponding order of supply which the characteristics of set out in Article 5.

2. For the development of these actions, both the nurse responsible for general care and the nurse responsible for specialized care must be holders of the corresponding accreditation issued by the General Management Directorate Professional of the Ministry of Health, Social Services and Equality as established in this royal decree.

In any case, in order for accredited nurses to carry out the actions referred to in this article in respect of medicinal products subject to medical prescription, it will be necessary for the corresponding professional prescriber has previously determined the diagnosis, the prescription and the clinical and health care protocol or guidance to be followed, validated in accordance with Article 6. It shall be within the framework of such a guide or protocol to which the actions are to be carried out, which shall be monitored by the health care professional who has determined it for the purposes of its suitability, as well as of the the safety of the process and the effectiveness achieved by the treatment.

Article 4. Liability insurance.

1. Those responsible for health centres shall verify that in the case of insurance against civil liability, the guarantee or other financial guarantee covering the actions of the professional nurses providing services to the health centres is included in the guarantee of liability arising from the professional activities referred to in this royal decree in accordance with the provisions of Law 44/2003 of 21 November.

2. Professional Colleges shall verify that nurses who develop the free exercise of the profession are provided with a liability insurance, guarantee or other financial guarantee on the same terms as provided for in the previous paragraph.

Article 5. Dispensing order.

1. The indication, use and authorization of supply of medicinal products and medical devices for human use by previously accredited nurses may be performed only by order of supply and under the conditions set out above. in Article 1 (c) of Royal Decree 1718/2010 of 17 December 2010 on medical prescription and dispensing orders.

2. Where the supply of medicinal products and medical devices for human use is indicated, used or authorized by the professional nurse, the person must include in the order of supply, among his/her identification data, his/her status as accredited, and in the case of medicinal products subject to medical prescription also the information corresponding to the protocol or the clinical practice and care guide on which it is based.

CHAPTER III

Elaboration and validation of protocols and guidelines for clinical and care practice for the indication, use and authorization of dispensing by nurses of medicinal products subject to medical prescription

Article 6. Elaboration and validation of protocols and guidelines for clinical and care practice.

1. The elaboration of the protocols and guidelines for clinical and care practice will be carried out within the Standing Committee of Pharmacy of the Interterritorial Council of the National Health System.

2. For the purposes of the elaboration of the protocols and guidelines for clinical and care practice, the representation of the Ministry of Health, Social Services and Equality, as well as of the Autonomous Communities, the mutual societies of officials, the Ministry of Defence and the General Councils of the Official Colleges of Nurses and Doctors, as follows:

(a) Three members representing the Ministry of Health, Social Services and Equality, appointed by the person holding the Ministry.

b) Three members representing the Autonomous Communities, designated by the Interterritorial Council of the National Health System.

(c) A member representing the mutual societies of officials (General Mutuality of Civil Servants of the State, Social Institute of the Armed Forces, and General Judicial Mutuality), designated by them.

d) A member of the Ministry of Defense's Military Corps of Health, designated by the General Inspection of Defense Health.

e) Four members representing the General Council of Nursing Officers of Spain, appointed by the Council.

f) Four members representing the General Council of Medical Officers, appointed by the Council.

3. For these purposes, the Standing Committee of Pharmacy shall be in accordance with the provisions of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure, and their Agreements shall be adopted, where appropriate, by consensus, in accordance with Article 73 of Law 16/2003 of 28 May of the Cohesion and Quality of the National Health System.

4. The protocols and guidelines for clinical and care practice, once developed by the Standing Committee of Pharmacy, will be validated by the person who holds the General Directorate of Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality and published in the "Official State Gazette" by means of the corresponding resolution, for its application.

Article 7. Functions of the Standing Committee of Pharmacy on protocols and guidelines for clinical and care practice.

1. The Standing Committee of Pharmacy will develop the protocols and guidelines for clinical and care development, without prejudice to those that are expressly entrusted to it within the Interterritorial Council of the National Health System. The following functions:

(a) Establish the general criteria as well as the minimum structure and content that must be collected in all protocols and guidelines for clinical and care practice in the field of indication, use and authorization of medicinal products subject to medical prescription.

b) Establish the general criteria for the analysis and evaluation of the protocols and guidelines for clinical and care practice for the use, indication and authorization of dispensing of medicinal products subject to medical prescription.

c) Set the list of drugs and drug groups, with the correct identification of the same in the official Nomenclator of the pharmaceutical delivery of the National Health System, as well as the treatments pharmacology or processes to be included in the protocols and guidelines for clinical and care practice, in accordance with the provisions of Article 19.1 of the recast of the Law on the guarantees and rational use of medicinal products and medical devices.

d) Promote the protocols and guidelines for clinical and care practice that are considered to be of particular interest to the National Health System, taking into account, where appropriate, those that may exist with prior character.

e) Elevate the protocols and guidelines for clinical and care practice, as well as their modifications, to the Directorate General of Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality for their validation.

2. Clinical and clinical practice protocols and guidelines must meet the following requirements:

a) Be elaborated and developed with technical and scientific criteria.

b) Be elaborated with multidisciplinary participation of nurses and physicians.

c) Being applicable throughout the national territory.

3. The Standing Committee on Pharmacy, for the development of the functions referred to in the previous paragraph, may act in plenary or through working groups.

CHAPTER IV

Accreditation of nurses for the indication, use and authorization of dispensing of medicinal products and human health products

Article 8. General aspects of accreditation.

1. It is the responsibility of the head of the Directorate-General for Vocational Management of the Ministry of Health, Social Services and Equality to grant the accreditation of nurses, both those responsible for general care and responsible for specialised care, for the indication, use and authorisation of the supply of medicinal products and medical devices for human use subject to the requirements and procedure laid down in Articles 9 and 10 respectively, in which The General Council of Nursing Officers will be involved in the process. from Spain.

2. The acquisition by the nurses of the accreditation referred to in the preceding paragraph shall not, by itself, constitute a change in the place of employment, without prejudice to the fact that it may be regarded as merit for the provision of jobs. where provided for in the relevant legislation.

3. The accreditation of the nurse, both the general care officer and the specialist care officer, will be incorporated into the State Register of Health Professionals and will be part of the public data in accordance with the provided in paragraph 3 of the additional provision of Law 16/2003 of 28 May.

Article 9. Requirements to be met by nurses to obtain accreditation.

1. In the field of general care, the requirements to be met by nurses to obtain accreditation for the indication, use and authorization of the dispensing of medicinal products and human health products are as follows:

a) Be in possession of the degree of Undergraduate in Nursing, or equivalent.

(b) Having acquired the necessary powers to indicate, use and authorise the supply of medicinal products and medical devices for human use as provided for in Annex I (1) (a) by means of the corresponding excess the training programme referred to in paragraph 2 of that Annex.

2. In the field of specialized care, the requirements to be met by nurses to obtain accreditation for the indication, use and authorization of the dispensing of medicinal products and human health products are as follows:

a) Be in possession of the degree of Undergraduate in Nursing, or equivalent.

b) Being in possession of the title of Specialist Nurse referred to in the additional provision sixth of Royal Decree 639/2014 of 25 July, which regulates the high-quality, backbone and the areas of Specific training, the rules applicable to the annual testing of access to training places and other aspects of the health training system specialised in Health Sciences are laid down and certain titles are created and modified. specialist.

(c) Having acquired the necessary powers to indicate, use and authorise the supply of medicinal products and medical devices for human use as provided for in Annex I (1) (b), by means of the corresponding excess the training programme referred to in paragraph 2 of that Annex.

Article 10. Procedure for the accreditation of nurses.

1. The procedure for accreditation of the nurse, both for the general care officer and for the specialist care officer, will always be initiated at the request of the person concerned.

The filing of the application shall be made in accordance with the terms of Article 38.4 of Law 30/1992 of November 26, or by electronic means in accordance with the provisions of Law 11/2007, of June 22, of electronic access. of citizens to public services.

The application for accreditation, which shall be in accordance with the model set out in Annex II, shall be addressed to the Directorate-General for Vocational Management of the Ministry of Health, Social Services and Equality and shall be accompanied by documents certifying compliance with the requirements laid down in Article 9, as requested by the accreditation for the field of general care, for the field of specialised care or both at the same time, being able to carry out through the electronic headquarters of that Ministry.

2. The competent authority for the instruction and processing of this procedure shall be the General Secretariat for Vocational Management. This body will analyze the application and its documentation to verify and verify compliance with the requirements set out in this royal decree, and can obtain the necessary information and documentation.

In any case, a mandatory report will be requested from the General Council of Nursing Officers of Spain, which, in the field of its competences, will have to issue it within one month.

As the previous procedure has been completed, the Subdirectorate General for Professional Management will make the corresponding motion for a resolution.

3. After the procedure has been completed and the relevant proposal received, the Director-General of Professional Management shall give the decision to terminate the proceedings.

The deadline for resolving and reporting the resolution will be six months. In accordance with the provisions of Article 43.1 of Law No 30/1992 of 26 November 1992, the absence of a resolution within that period shall have an estimated effect on the request made.

Against the termination of the proceedings, an appeal may be brought, within one month, in accordance with the provisions of Articles 114 and 115 of Law No 30/1992 of 26 November 1992, before the Secretariat General of Health and Consumer Affairs of the Ministry of Health, Social Services and Equality.

4. The favourable resolution of accreditation, be it for the field of general care, for the field of specialized care or both at the same time, will have effects on the entire State, whatever the autonomous community in which it is have met the requirements for obtaining them.

Article 11. Protection of personal data.

The use of personal data affected by this royal decree will be in line with the provisions of the Organic Law 15/1999 of 13 December on the Protection of Personal Data.

Additional disposition first. Particularity relating to midwives.

The forecasts of this royal decree are without prejudice to the provisions of Royal Decree 1837/2008 of 8 November, which incorporate into the Spanish legal order Directive 2005 /36/EC of the European Parliament and of the Council of 7 September 2005 and Council Directive 2006 /100/EC of 20 November 2006 on the recognition of professional qualifications, as well as certain aspects of the exercise of the profession of lawyer, which attributes to the midwives activities for the diagnosis, supervision, assistance of the pregnancy, birth, postpartum or normal newborn, by appropriate technical and clinical means.

Additional provision second. Regime applicable to nurses of the Armed Forces.

In accordance with the provisions of the second provision of the recast text of the Law on the guarantees and rational use of medicinal products and medical devices, the system applicable to the indication, use and authorisation of medicinal products and medical devices for human use by the nurses of the Armed Forces shall be governed, in respect of their professional activity, by their specific regulations.

Additional provision third. Adequacy of provisions that regulate the functions of nurses.

The provisions, of equal or lower rank, that regulate the functions that correspond to the nurses in the field of indication, use and authorization of dispensing of medicinal products and medical devices of human use will be adapted to the forecasts of this royal decree as soon as they object to it.

Additional provision fourth. Recognition of accreditation of nursing professionals from Member States of the European Union and third countries.

The accreditation of nurses from other Member States of the European Union and third countries may be recognised for the indication, use and authorisation of the supply of medicinal products and medical devices for use both in the field of general care and in the field of specialized care, prior to the justification of the fulfillment of the forecasts and the requirements of accreditation regulated in this royal decree.

Additional provision fifth. Health Services of the National Institute of Health Management.

The references made in this royal decree and its annexes to the Health Services will be understood as referring to the National Institute of Health Management in the area of the cities of Ceuta and Melilla.

Single transient arrangement. Transitional arrangements for obtaining the professional competence nurses on the indication, use and authorization of dispensing of medicinal products and medical devices for human use for the accreditation of nurses.

1. Nurses with the title of Health Technical Assistant, University Diplomat in Nursing or Specialist Nurse, both in the field of general care and in the field of specialized care, who would not have acquired the skills on the indication, use and authorisation for the supply of medicinal products and medical devices for human use as provided for in Annex I at the time of entry into force of this royal decree, they shall have a period of five years from their entry into force. (a) the acquisition of such skills and the acquisition of the relevant accreditation.

2. The autonomous communities, the universities, the General Council of Nursing Officers of Spain and other professional nurses who promote their continuous professional development will be able to develop the training offer to which refers to Annex I, paragraph 2, which allows the nurses referred to in the previous paragraph to acquire the competences on the indication, use and authorisation of the supply of medicinal products and medical devices for human use.

3. By way of exception, the nurses who until the entry into force of this royal decree have developed functions of indication, use and authorization of dispensing of medicinal products and medical devices for human use as a consequence of the application of existing autonomous rules on the subject, may access the accreditation regulated in Chapter IV by submitting the application provided for in Annex II, which must accompany a certificate from the Health Service concerned accreditable that the person concerned has acquired the professional skills indicated, according to the cases, in paragraph 1 of Annex I and which has a professional experience of at least three months in the field of the indication, use and authorisation of the supply of medicinal products and medical devices for human use, or in the exercise thereof, nurse responsible for general care, as well as a specialist nurse.

In any case, in order for the nurses accredited in accordance with this section to develop the competencies in respect of the medical prescription drugs mentioned in this royal decree, it will be necessary also the prior validation of the corresponding protocols and guidelines for clinical and care practice by the Directorate General of Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality.

Final disposition first. Competence title.

This royal decree is issued in accordance with the provisions of Article 149.1.16 of the Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health.

Final disposition second. No increase in public spending.

The measures and actions envisaged or derived from this royal decree should be met with the ordinary budget allocations of the Ministry of Health, Social Services and Equality and will not be able to generate (a) the provision of remuneration and other personnel costs for the public sector.

Final disposition third. Amendment of Royal Decree 1416/1994 of 25 June 1994 regulating the advertising of medicinal products for human use.

An additional fourth provision is added to Royal Decree 1416/1994 of 25 June for regulating the advertising of medicinal products for human use, with the following literal wording:

" Additional provision fourth. Persons empowered to indicate, use and authorize the dispensing of medicinal products.

The indications and forecasts contained in this royal decree concerning persons empowered to prescribe or dispense medicinal products should also be understood to be to the persons empowered to indicate, use and authorize the dispensing of medicinal products, in accordance with the provisions of Article 79 of the recast of the Law on the guarantees and rational use of medicinal products and medical devices, approved by Royal Legislative Decree 1/2015 of 24 July, in particular with regard to the advertising of medicinal products and medical visit. "

Final disposition fourth. Amendment of Royal Decree 640/2014 of 25 July, which regulates the State Register of Health Professionals.

Royal Decree 640/2014 of 25 July, which regulates the State Register of Health Professionals, is amended as follows:

One. A paragraph (u) is added to Article 5 with the following wording:

"(u) Accreditation for the indication, use and authorisation of dispensing of medicinal products and medical devices for human use."

Two. Article 6.1 (c) is amended, which is worded as follows:

(c) the other ministerial departments and the public bodies linked to or dependent on them, and in particular the Ministry of Justice, the Ministry of the Interior, the Ministry of Employment and Social Security and the Ministry of Health, Social Services and Equality, regarding healthcare professionals included in their personnel records. In relation to the latter ministerial department, also in respect of accreditations for the indication, use and authorization of dispensing of medicinal products and medical devices for human use. "

Three. A paragraph (u) is added to Annex I with the following content:

"(u) Accreditation for the indication, use and authorisation of dispensing of medicinal products and medical devices for human use."

Four. The following content is added in Annex II:

" u) Accreditation for the indication, use, and authorization of dispensing of medicinal products and human health products

-Ministry of Health, Social Services, and Equality.	-Ministry of Health, Social Services, and Equality. "

Final disposition fifth. Amendment of Royal Decree 1718/2010, of December 17, on medical prescription and dispensing orders.

Royal Decree 1718/2010, of December 17, on medical prescription and dispensing orders, is amended as follows:

One. Article 1 (c) is amended as follows:

" (c) Order of supply: the order of supply, referred to in Article 79 of the recast of the Law on the guarantees and rational use of medicinal products and medical devices approved by the Royal Decree Legislative 1/2015, of 24 July, is the document of a sanitary, standardised and compulsory nature by which the professional nurses, in the field of their competences, and once they have been individually empowered by the corresponding accreditation, indicate or authorize, under the conditions and with the requirements which it regulates establish, supply of medicinal products, whether or not subject to medical prescription, and medical devices by a pharmacist or under his supervision, in the offices of pharmacy and botiquines dependent on them or, as provided for in the existing legislation, in other health facilities, care units or pharmaceutical services of primary care structures, duly authorised for the supply of medicinal products. "

Two. The first subparagraph of paragraph 4 of the Annex is worded as follows:

" The order of supply referred to in Article 1 (c) of this royal decree, as a general rule, shall comply with the basic criteria laid down in this Annex for the medical prescription and shall be in accordance with the characteristics which are described in the corresponding model. In any case, the data relating to the nurse, his accreditation, and the cases referred to in the case of medicinal products subject to medical prescription, the identification code and the name of the nurse must be included in the order of supply. corresponding protocol or guide for clinical and care practice and its name. "

Three. The model of order of supply referred to in Article 1 (c) of this royal decree is amended and set out at the end of the Annex, which is as follows:

Here are several images in the original. See the official and authentic PDF document.

Final disposition sixth. Enabling regulatory development.

The person holding the Ministry of Health, Social Services and Equality is enabled to make the necessary provisions for the execution and development of the provisions of this royal decree.

Also, the person holding the Ministry of Health, Social Services and Equality is enabled to dictate the corresponding order of creation of the file with personal data relating to accredited nurses.

Final disposition seventh. Entry into force.

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

Given in Oviedo, on October 23, 2015.

FELIPE R.

The Minister of Health, Social Services and Equality,

ALFONSO ALONSO ARANEGUI

ANNEX I

Competencies necessary to indicate, use and authorize the dispensing of medicinal products and human health products and characteristics of the training programs

1. Competencies to be possessed by nurses to be accredited:

a) In the field of general care:

1. To know the different groups of drugs, the principles of their indication, use and authorization, as well as the mechanisms of action of them.

2. Know the indication and use of healthcare products linked to nursing care.

3. Indication and use of medicinal products, assessing the expected benefits and associated risks and/or effects arising from their administration and consumption.

4. Apply the health care information and communication technologies and systems.

(b) In the field of specialised care, in addition to the competences listed in subparagraph (a) above:

1. Learn about the principles of the indication, use, and authorization of the various medicinal products and medical devices for human use in the field of specialized care.

2. To know the different groups of drugs, the principles of their indication, use and authorization, as well as the mechanisms of action of them, in the field of specialized care.

3. Use of medicinal products, assessing the expected benefits and associated risks and/or effects arising from their administration and consumption, in the field of specialized care.

4. Apply the health care information and communication technologies and systems.

2. Characteristics and duration of the training programmes.

a) Characteristics: Semi-face-to-face training, favoring tutoring self-learning and taking into account the uniqueness of the students.

b) Duration:

1. In the field of general care: 180 hours of training or its equivalent in ECTS credits.

2. In the field of specialized care: 180 hours of training or its equivalent in ECTS credits, once the credits or training hours foreseen for the scope of the general care are exceeded or recognized.

ANNEX II

Request for accreditation of nurses for the indication, use and authorization of dispensing of medicinal products and human health products

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