The last regulation of the medical prescription in Spain is that of Royal Decree 1910/1984 of 26 September, and since then there has been an important evolution of health care and the Spanish and European legal framework in pharmaceutical material. In particular, the enactment of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices incorporates new and important provisions in the field of medicinal products and related medical devices. to its guarantees and rational use that need to be developed regulatively.

More recently, Law 28/2009, of December 30, amending Law 29/2006, of July 26, of guarantees and rational use of medicines and medical devices introduces in our legal order two novelties of maximum relevance: it incorporates the podiatologists, together with the doctors and dentists, as medical professionals empowered to prescribe, in the field of their competencies, medicinal products subject to medical prescription. At the same time, it provides for the participation of nurses, through the order of dispensation, in the use, indication and authorization of the dispensing of certain medications and medical devices.

On the other hand, the progressive use of new technologies in the field of prescription and dispensing of medicines and medical devices, in particular by the introduction of the electronic prescription, determines the need for the legislation on this matter to be in accordance with the principles and criteria set out in Law 11/2007 of 22 June, on the electronic access of citizens to public services and legal provisions application, in order to enable the creation of a communications network linking the systems of information from Spanish public administrations and allow the exchange of information and services between them.

For all this, it is necessary to establish a new legal framework for the medical prescription and the order of dispensation that will allow to deepen the improvement of the rational use of the medications, in the public and private areas and that, While contributing to the simplification of the task of healthcare professionals, it strengthens the guarantees of citizens.

Medical prescription and dispensing orders as standard documents, are a fundamental means for the transmission of information among healthcare professionals and a guarantee for the patient, which makes it possible to therapeutic compliance and obtaining the maximum efficiency of the treatment, without prejudice to its role as a support for the management and billing of the pharmaceutical provision received by the users of the National Health System.

Furthermore, it is necessary to develop the provisions of Article 77 (6) and (8) of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices as regards the order of Hospital supply, to optimize and promote the quality and efficiency of the supply to the external patients from the hospital environment, establishing the requirements that must be of general application in order to ensure the the accessibility of all citizens, in conditions of effective equality throughout the Spanish territory, to the pharmaceutical provision of the National Health System.

This royal decree is dictated by the development of Articles 19.6 and 77.6 and 8 of Law 29/2006, of July 26, of guarantees and the rational use of medicines and medical devices, and under the exclusive powers that in Article 149.1.16 of the Constitution is attributed to the State by legislation on pharmaceutical products and bases for the general coordination of health.

Pursuant to Articles 37 (h) of the Organic Law 15/1999 of 13 December on the Protection of Personal Data and 5 (b) of the Statute of the Agency, approved by Royal Decree 428/1993 of 26 March 1993, This standard has been submitted to the previous report of the Spanish Data Protection Agency.

In accordance with the provisions of Article 24.3 of Law 50/1997 of 27 November 1997, the Government has been subject to a prior report by the Ministry of Territorial Policy. Also, in accordance with the provisions of article 67.2 of Law 16/2003, of 28 May, of cohesion and quality of the National Health System, it has been the subject of prior report by the Advisory Committee and the Plenary Session of the Interterritorial Council of the National Health System.

In the process of drawing up this standard, the Autonomous Communities, the Consumers ' Council and Users and the sectors concerned have been consulted among others.

In its virtue, on the proposal of the Minister of Health, Social Policy and Equality, with the prior approval of the First Vice President of the Government and Minister of the Presidency, in agreement with the State Council and after deliberation of the Council of Ministers at its meeting on 17 December 2010,

DISPONGO:

CHAPTER I

Definitions and Scope

Article 1. Definitions.

For the purposes of this royal decree, it is understood by:

(a) Medical Recipe: the medical prescription is the document of a sanitary, standardized and compulsory nature by which doctors, dentists or podiatologists, legally empowered to do so, and in the field of their competences They prescribe to the patients the medicinal products or medical devices subject to medical prescription, for dispensing by a pharmacist or under his supervision, in the offices of pharmacy and botiquines dependent on them or, as as provided for in the legislation in force, in other health facilities, units care or pharmaceutical services of primary care structures, duly authorised for the dispensing of medicinal products.

b) Hospital dispensing order: the order of hospital dispensing for patients not admitted is the document of a health status, standardized and mandatory for the prescription by doctors, dentists and podiatrists of hospital services, for medicinal products requiring particular surveillance, supervision and control, to be provided by the hospital pharmacy services to such patients.

(c) Order of supply: the order of supply, as referred to in the second paragraph of Article 77.1 of Law 29/2006 of 26 July, of guarantees and the rational use of medicinal products and medical devices, is the health status, standardised and compulsory by means of which the professional nurses, in the field of their skills, and once they have been individually empowered by the corresponding accreditation, provided for in the provision (a) additional information referred to in Article 3 (1) of Regulation (EU) Regulation (EU) no authorisation. (a) the provision of medicinal products and medical devices by a pharmacist or under his supervision, in the offices of pharmacy and botiquines which are dependent on them or, as provided for in the legislation in force, in other healthcare facilities, care units or pharmaceutical services of primary care structures, duly authorised for the dispensing of medicinal products.

Article 2. Scope.

1. The regulation of this royal decree will apply to the performance of authorized healthcare professionals, in the exercise of their functions, in the field of health care and pharmaceutical care of the National Health System, including Special Regulations of the General Mutuality of Civil Servants of the State (MUFACE), of the Social Institute of the Armed Forces (ISFAS) and of the General Judicial Mutuality (MUGEJU), as well as of the other entities, medical consultations, public or private similar health facilities or services, including dependent on the Military Health Network of the Ministry of Defence, as well as social and health centres, without prejudice to the specific features which, where appropriate, should be established.

2. The characteristics and other application requirements for medical prescriptions and dispensing orders, in the respective areas of public and private health care, including those specific to the extended and/or edited in support computer, are subject to the provisions of this royal decree.

3. The medical prescription is valid throughout the national territory and will be published in the official language of the State and in the respective official language in the autonomous communities that have it, according to the current regulations.

The prescription will ensure that the prescribed treatment can be dispensed to the patient at any pharmacy office in the national territory.

CHAPTER II

Common requirements for public and private medical prescriptions

Article 3. Common formats and data for medical prescriptions.

1. Medical prescriptions, public or private, may be issued on paper, for manual or computerised fulfillment, and in electronic support, and must be supplemented by a patient information sheet, which is required to be delivered to the patient. the information on the treatment necessary to facilitate the proper use of the prescribed medicinal products or medical devices shall be collected.

2. The prescriber shall record in the prescription and in the patient information sheet the basic mandatory data, which are essential for the validity of the medical prescription, as follows:

a) Patient data:

1. º The name, two surnames, and year of birth.

2. In medical prescriptions for public health assistance, the patient's personal identification code, collected on his/her individual health card, assigned by his/her Health Service or by the competent authorities of the special health care schemes. In the case of foreign nationals who do not have the said card, the code assigned on their European health card or their temporary replacement certificate (PSC) or the passport number for foreign nationals shall be entered in the Community. In any case, the patient's membership regime must also be entered.

3. In the medical prescriptions of private healthcare, the number of DNI or NIE of the patient. In the event that the patient does not have such documentation, the identity card or NIE of any parent or, where applicable, the guardian, and for foreign nationals the passport number shall be entered in the case of minors.

b) Drug data:

1. The name of the active substance/s or name of the medicinal product.

2. Dosification and pharmaceutical form and, where appropriate, the mention of the recipients: infants, children, adults.

3. Path or form of administration, if necessary.

4. Format: Number of units per pack or content of the same by weight or volume.

5. Number of containers or number of specific units of the drug to be dispensed.

6. Posology: number of units of administration per intake, frequency of doses (per day, week, month) and total duration of treatment.

The data referred to in the headings 4. º and 5. º shall only be required to be recorded in the medical prescriptions issued on paper. Medical prescriptions issued in electronic form shall only be filled in by the prescriber when the electronic system does not automatically generate them.

c) Prescriber data:

1. º The name and two surnames.

2. º The population and address where you exercise. The reference to institutions or public bodies may only appear in the official medical prescriptions of such establishments.

3. º Number of colegate or, in the case of medical prescriptions of the National Health System, the identification code assigned by the competent administrations and, where appropriate, the officially accredited specialty that it exercises.

In the medical prescriptions of the Military Health Network of the Armed Forces, instead of the number of the collegiate, the number of the Military Card of Identity of the optional can be entered. It shall also include, where appropriate, the officially accredited specialty it exercises.

4. The signature will be stamped personally once the mandatory consignment data and the prescription object of the prescription are completed. Electronic signatures shall be required for electronic signatures, which shall be produced in accordance with the criteria laid down by Law 11/2007 of 22 June of electronic access of citizens to public services.

In the prescriptions of the National Health System, the data of the prescriber, referred to in the headings 2. º and 3. º may be recorded in such a way as to guarantee the identification of the prescriber and allow the mechanization of such data by the health services and the mutual societies of officials.

d) Other data:

1. º The date of prescription (day, month, year): date of the day on which the prescription is filled.

2. º The expected date of dispensing (day, month, year): date from which the prescription is to be dispensed, in the case of successive waivers of chronic treatments or renewable dispensing drugs.

3. No. of order: number indicating the order of prescription dispensing, in the case of successive waivers of chronic treatments or renewable dispensing drugs.

The data referred to in the headings 2. º and 3. º shall only be required to be recorded in the medical prescriptions on paper.

In addition to the data indicated in the above headings, if necessary, the visa must be entered by the health authorities, in accordance with Royal Decree 618/2007 of 11 May, which regulates the procedure for the establishment, by means of a visa, of special reservations concerning the conditions for the prescription and dispensing of medicinal products. In the case of electronic prescriptions, the visa shall be in the form provided for in Article 8.7 of this royal decree.

In the medical prescriptions on paper paper and in the patient information sheet for the electronic prescription case, a clause will be included that informs the patient in the terms established in the Organic Law 15/1999, 13 of December, personal data protection.

3. The information sheet for the patient shall be differentiated from the prescription and may be separable from the prescription, or constitute an independent form, where the prescriber may relate all prescribed medicinal products and medical devices, providing the patient with complete treatment information and diagnosis, if appropriate, in the prescriber's judgment.

4. All the particulars and instructions given in the medical prescription must be clearly legible, without prejudice to their possible additional coding with optical characters. Medical prescriptions shall not submit amendments or cross-cuts in the mandatory consignment data unless they have been saved by the new signature of the prescriber.

Article 4. Clothing, editing and distribution.

1. Medical prescriptions on paper for manual or computerised completion shall be made out of materials which prevent or hinder their falsification, or by the introduction of safety measures in the system which ensure their authenticity, and according to the criteria set out in the annex to this royal decree.

2. Models of medical prescriptions to be used for verification, quantification, settlement, processing, checking or similar purposes may include references or data which are appropriate and carry out the copies relevant.

3. Entities, establishments or services referred to in Article 2 (1) and the general advice of the corporate collective organisations of doctors, dentists, podiatologists and nurses with private activity and/or free exercise professional, will be responsible for the editing, management, control and inspection of the printing, distribution and delivery of their books and printed prescriptions and dispensing orders. They shall take all necessary measures to prevent or correct any fraud, abuse, corruption or diversion in this field.

4. The editing, elaboration and distribution of the official narcotic prescription talonaries will be carried out in accordance with their specific regulations.

CHAPTER III

Official medical prescriptions of the National Health System on paper support

Article 5. Characteristics of the official medical prescription of the National Health System.

1. The official medical prescriptions used in the pharmaceutical provision of the National Health System shall be prescribed by the authorized healthcare professionals, in the exercise of their functions, within the scope of the National Health System, and shall be comply with the provisions of this royal decree, with the specifications contained in this chapter and the requirements which the competent health authorities introduce in the framework of their powers.

The official medical prescriptions for computerised fulfillment will preferably be adapted to the basic criteria of differentiation by colors of the user's membership and contingency regimes, which are specified in this royal decree. However, by the competent authorities and agencies of the National Health System, it may be agreed in such official medical prescriptions for computer editing, to suppress the differentiation by colour of the different regimes, owing to the ensure, in any event, the unequivocal identification of the patient's membership regime, for the purposes of dispensing, charging of the corresponding contribution, and billing.

For the purposes of identification and control and for the necessary coordination of the National Health System, the official prescriptions of the National Health System will be edited with a single-label code of the recipe readable by IT procedures. The structure of this code and the type of optical coding shall be assigned by the Ministry of Health, Social Policy and Equality and shall include elements of numbering and control of each autonomous community and mutual of officials.

2. For the prescription of official medical prescriptions of the National Health System, the prescriber will collect the individual health card from the patient and can verify, if necessary, his or her identity and correspondence with what is indicated in the patient's health card. card.

3. Official medical prescriptions will cover, in accordance with the criteria set out in the annex to this royal decree, the treatments financed and unfunded, in the field of health care of the National Health System and dispensed in pharmacy offices open to the public or in botiquines dependent on them, as well as in the pharmacy services of health centres and primary care structures, as provided for in Article 2.6 of Law 29/2006, 26 of July, guarantees and rational use of medicines and medical devices.

4. The official medical prescription in support of the National Health System will be in accordance with the prescription criteria on the number of medications and the packaging, validity and duration of treatment, as specified below.

5. Prescription criteria, prescription validity, and duration of treatment.

a) Prescription criteria:

1. In each paper-holder prescription, a single medicinal product and a single package of medicinal products may be prescribed, with the exceptions provided for in paragraphs 2 and 5.

2. In the case of the medicinal products that are related, only one drug and up to four containers per prescription may be prescribed:

i. Single-dose and parenteral presentations of the therapeutic group "J01 Antibacterials for systemic use", with the exception of subgroups J01E, J01M and J01R.

In the case of oral presentations, it should be noted that up to two containers may be prescribed as long as they have the same International Common Name (INN), dose, pharmaceutical form and format.

ii. Multidose vials (except multidose cartridges) of the therapeutic group A10A 'Insulin and analogues'.

iii. Medicinal products containing narcotic substances included in List I of the 1961 Single Convention on Narcotic Drugs, in accordance with the specific rules of application.

iv. Hospital diagnostic drugs.

3. Official formulas and official preparations may not be jointly prescribed in the same medical prescription with other medicinal products and in each prescription only a master formula or an official preparation may be prescribed.

4. In the case of medical devices financed by the National Health System, a medical device may be prescribed. They may not be prescribed together with medicinal products.

5. For presentations of authorised single-dose medicinal products for which the outer packaging coincides with their immediate packaging, a single medicinal product and package may be prescribed, with the exceptions provided for medicines referred to in paragraph 2. By resolution, the Directorate-General for Pharmacy and Health Products of the Ministry of Health, Social Policy and Equality may authorise a larger number of packages per prescription.

b) Recipe Validity:

In each official medical prescription on paper paper, the prescription date will be entered. In the case of recipes on paper and for successive supply of chronic treatments or medicinal products for renewable supply, the consignment of the date laid down for dispensing shall be compulsory, when several prescriptions are issued with the Date of prescription. In addition to the requirements for the latter case, the order number for each prescription must be stated.

The official medical prescription on paper is valid for a dispensing by the pharmacy office with a maximum period of ten calendar days from the date of prescription or, when it is stated, the date set by the prescriber for dispensing. On the expiry of this period, no medicinal products or medical devices may be ordered or dispensed with their presentation.

In the case of medicines or medical devices subject to the visa the term of validity of the prescription will be counted from the date of the visa.

Due to the special characteristics of the individual anti-allergic vaccines and bacterial individual vaccines, the period of validity of these prescriptions will be a maximum of ninety calendar days from the date stated. In addition, the period of validity of the official medical prescription may be less than ten days, in the case of medicinal products subject to specific provisions by the Ministry of Health, Social Policy and Equality.

c) Duration of treatment:

1. In general, the maximum duration of treatment that can be prescribed in a prescription is three months. The Directorate-General for Pharmacy and Health Products of the Ministry of Health, Social Policy and Equality may, by means of a resolution, set a different time limit for the presentations of authorised single-dose medicinal products for which the outer packaging matches your primary packaging.

2. When determined by the competent health authorities, the duration of treatment may be extended up to a maximum of six months, for the prescription of patients with chronic treatment of medicinal products subject to medical prescription for renewable supply, and for those treatments deemed necessary by those Administrations for the performance of specific health programmes and in expressly approved centres, report to the Interterritorial Council of the National Health System. In such cases, the prescriptions which are necessary with the maximum limit of six months of the treatment and in which the intended date of supply shall be set shall be completed simultaneously with the same prescription date. for each of them.

The extension referred to in the preceding paragraph shall not apply to the prescription of treatments for chronic patients with narcotic drugs listed in List I of the 1961 Single Convention on Narcotic Drugs, in accordance with its specific rules of application.

CHAPTER IV

The official electronic medical prescription of the National Health System

Article 6. General criteria.

The prescription and dispensing of medicines and medical devices in electronic medical prescription in the National Health System must comply with the general medical prescription criteria according to the provisions of this practice. decree, with the specific features included in this chapter and the requirements that the competent health authorities introduce in the framework of their competences.

Article 7. Coordination in the National Health System.

1. The treatments prescribed to the patient in electronic medical prescription may be dispensed in any pharmacy office of the national territory or in botiquines dependent on them, as well as in the pharmacy services of the health centers. and the structures of primary care, as provided for in Article 2.6 of Law 29/2006, of July 26, of guarantees and the rational use of medicines and medical devices. In order to guarantee this right to patients, the Ministry of Health, Social Policy and Equality, as a national node for the electronic exchange of health information, will act among the health administration of the origin of the electronic prescription. and the competent health administration in the locality where the corresponding dispensation is made.

For these purposes, the Ministry of Health, Social Policy and Equality shall provide access to all other health administrations, including the mutual societies of officials, to their electronic systems. univocal identifier of the user of the National Health System and of the official Nomenclator of pharmaceutical products of the System in which the unambiguous identification codes for medicinal products and medical devices are given, their forms Pharmaceutical products, routes and dosage units, as well as the content of the commercial packaging and its financing conditions in the National Health System and also its possible dispensation in specific units. Access to other databases of the Ministry of Health, Social Policy and Equality providing information on authorised medicines and medical devices in Spain will also be provided.

2. In order to ensure interoperability between the different health services, the electronic medical prescriptions of each of the health administrations will necessarily need to incorporate the univocal identifier of the System users. National Health and, on an exclusive basis, the identification code of the medicinal product or the medical device and the other parameters for the definition of the prescribed treatment, which appear in the official Nomenclature of pharmaceutical products of the National Health System.

3. The electronic medical prescription system of each of the health administrations of the National Health System will enable the identification of the patient's membership system, for the purposes of collecting the contribution that in each case corresponds, and the execution of the billing of the pharmacy offices to the corresponding Health Administration by means of telematic means, with the necessary safety and control measures that guarantee their correspondence with the dispensed dispenses. The competent health authorities shall determine the necessary data to which pharmacists may access the invoicing of the electronic medical prescription and the development of quality programmes for the pharmaceutical supply. In any event, the access of pharmacists shall be provided enabling the development of the functions referred to in Article 84.1 of Law 29/2006 of 26 July, of guarantees and the rational use of medicinal products and medical devices, in the conditions to be laid down by the competent health authorities.

4. Public health administrations are responsible for the management of electronic prescription systems, so they will ensure the custody of the prescription and dispensing databases and establish the criteria for authorisation and control of access to such databases. This is without prejudice to the general access criteria set out in this royal decree.

Article 8. From the prescription in the electronic prescription.

1. The prescriber will access the electronic prescription system through an integrated computer in the electronic recipe system that must be authenticated, guaranteeing encrypted communications. The prescriber must accredit his/her identity and sign the prescription electronically. To prescribe the patient's medication, you will request the individual health card to enter the personal identification code into the system.

2. The electronic medical prescription system shall generate the ratio of prescribed medicinal products and medical devices to the patient and shall include, in addition to the mandatory consignment data specified in Article 3, the following:

(a) The code or the identification number of the prescription for each medicinal product and medical device, which shall be assigned by the electronic system with unique and unrepeatable character.

b) Information on the active relationship of medication for ongoing treatments.

3. One or more medicines and medical devices may be prescribed in the official electronic medical prescription of the National Health System.

Medicines and medical devices shall be prescribed in accordance with the prescribed therapeutic plan, based on defined treatment intervals which may not exceed one year, with the limitations laid down in regulation for the prescription of narcotic drugs listed in List I of the 1961 Single Convention on Narcotic Drugs.

However, each dispensation may not exceed one month of maximum duration of treatment, unless the format of the medicinal product or medical device to be dispensed according to the prescription corresponds to a period of top treatment according to your technical tab.

4. The system will allow the prescriber to follow the treatment of the prescribed treatment and allow in the course of the treatment, informing the patient, modification or cancellation, attending to any event or circumstance over the patient's clinical situation, as well as therapeutic compliance criteria.

5. The patient will be able to request protection and confidentiality at the time of the treatment of any treatment. In these cases the treatment will be differentiated for dispensing, being able to be done through a prescription on paper or through the procedures to be determined by the health administrations.

6. When prescribing by means of the electronic prescription system, a prescribed treatment information document shall be printed and delivered to the patient. The competent health authorities, depending on the characteristics of the system in place, if they consider it appropriate, shall establish as a patient information document the printing of an active medication sheet and information to the patient, being able to adopt the criteria of the Annex.

In the case of persons who credit a disability situation that prevents or hinders access to the content of the documents referred to in the previous paragraph, the competent health authorities, depending on the characteristics of the implanted electronic prescription system, they will promote the incorporation of the tools that allow these patients to receive the information in accessible digital format, by means of sending to the e-mail address that they indicate or other the appropriate channel or channel for this purpose.

7. The visa will be carried out by electronic procedures and in accordance with the provisions of Royal Decree 618/2007, of 11 May, which regulates the procedure for the establishment, by means of a visa, of singular reservations to the conditions of prescription and dispensing of medicinal products. In the case of a visa refusal, the prescriber shall be notified electronically and the user shall be informed.

Article 9. From the pharmaceutical dispensing in the electronic medical prescription.

1. The supply shall be carried out by the pharmacy offices connected to the electronic medical prescription system, by means of the standard procedure established by the competent health authorities, which shall determine their specific conditions, the electronic certificate of the holder of the pharmacy office, or, where appropriate, of the regent pharmacist, deputy or substitute, issued by the competent body, is required.

2. After the patient's unequivocal identification, and where appropriate, the person to whom he delegates, the pharmacist may only access the equipment installed at the pharmacy office, with the requirements and conditions set out in the next, to the data necessary for correct administration and follow-up of the treatment and will dispense exclusively, from among the prescriptions to be dispensed, that the patient requests.

3. The access of pharmacists to the electronic system will only be permitted by means of the patient's health card duly recognised by the electronic prescription system, and must be returned immediately to the holder and without it being possible. held at the pharmacy office. The access of the pharmacist will always be recorded in the aforementioned system.

4. At the time of the dispensation, the electronic prescription systems must incorporate and forward to the corresponding health administrations the identification data of the product dispensed, coded according to the official Nomenclator pharmaceutical products of the National Health System, number of packages dispensed and their unit identification where possible, identification of the office of dispensing pharmacy, using the NIF/CIF of its holder, as well as the number Identification of the pharmacy office granted by the Health Administration competent, and the date of dispensing, in the format that the national exchange node has established for the purpose. This information shall be the only information to be left for the purposes of invoicing in the collegial pharmaceutical organisation, as long as it is responsible for it, and shall be available to the competent health authorities in accordance with its application rules.

5. The electronic system shall check that the number of containers dispensed corresponds to the pattern indicated by the prescriber. Where the pharmacist replaces a prescribed medicinal product in accordance with the legal criteria in force, he shall introduce the cause of such substitution into the system, the code of the medicinal product being registered. This replacement shall be recorded in the electronic system to enable it to be consulted by the prescriber. In the same way, they will be used in cases of replacement of medical devices.

6. The electronic system will allow the pharmacist to block the dispensing of a prescribed medication cautiously when the existence of manifest error in the prescription is appreciated, inadequate to the concomitant medication, recent safety or any other reason that may pose a serious and obvious risk to the patient's health. This circumstance shall be communicated in a telematic form to the prescriber. The pharmacist will report the blockage to the patient.

The prescriber must review the blocked prescription by proceeding to its cancellation or reactivation as it considers.

Article 10. Term of validity of the electronic medical prescription.

In the electronic prescription, the period of validity during which the patient may collect the medication or medical device at the pharmacy will be ten calendar days in the case of a first dispensation, counted from of the date of the prescription or of the visa if applicable.

For the prescriptions of individualised anti-allergic vaccines and individual bacterial vaccines and of medicinal products subject to specific provisions in this respect by the Ministry of Health, Social Policy and Equality, apply the periods of validity referred to in Article 5.5.b).

The term of validity of the second or successive dispensations, starts ten calendar days before the date of completion of the medication of the previous dispensation and ends at the date of completion of the treatment established by the prescriber, without prejudice to the fact that other time limits may be set by the competent health authorities for control or management needs.

Article 11. Protection of data confidentiality.

The electronic medical prescription system will ensure security in the access and transmission of information, as well as the protection of data confidentiality, in accordance with the provisions of the Organic Law 15/1999, December 13, personal data protection. High-level security measures, as provided for in the legislation on the protection of personal data, will be implemented. In order to ensure these levels of safety, this information shall be accessible only from the pharmacy office for the purpose of dispensing, permanently residing in the electronic prescription systems managed by the Health Administrations and it may not be stored in the repositories or servers other than those established for billing, once it has been produced.

CHAPTER V

The private medical prescription

Article 12. General criteria.

The private medical prescription may be issued on paper, for manual or computerised completion, and in electronic support, as set out in Article 3 of this royal decree, and in accordance with the common requirements established for public and private medical prescriptions in Chapter II.

Article 13. Private medical prescription on paper support.

The private medical prescription in paper support will be adjusted for prescription of medications and sanitary products subject to prescription, to the same criteria established for the official medical prescriptions of the National System. Health in Article 5.5, as regards the number of medicinal products or, where appropriate, medical devices, the number of containers, the validity and duration of the treatment.

It should also be taken into account that medicinal products containing medical devices cannot be co-prescribed in the same medical prescription.

Article 14. Electronic private medical prescription.

1. One or more medicinal products and medicinal products may be prescribed in the electronic private medical prescription, subject to the limitations laid down in regulation for the prescription of narcotic drugs listed in List I of the Single Convention of 1961 on Narcotic Drugs.

2. The prescription shall be made in accordance with the provisions of Article 8 of this royal decree. Access to the electronic private medical prescription system will be made through the patient's electronic ID certificate and in the event of impossibility it will be accessed through the National Identity Document or in the case of the parent or guardian. of the electronic certificate of the prescriber.

3. The prescriber may make the impression of the active medication sheet, depending on the characteristics of the implanted system.

4. The treatments prescribed to the patient in electronic private medical prescription may be dispensed in any pharmacy office in the national territory. In order to guarantee this right to patients, it will be established by the general councils of the corporate collegial organizations of doctors, dentists, podiatologists, nurses and pharmacists in coordination with the health administrations, the the procedure for approval of the electronic private prescription system enabling its interoperability, preserving the right of the patient to the protection of the data in his/her medical history, and taking into account the provisions of Article 11 of this royal decree and also ensuring compliance with the mandatory requirements for the medical prescriptions set out in this provision.

CHAPTER VI

Dispensing of medical prescriptions

Article 15. Pharmacy office pharmacist's performances at the dispensation.

1. In accordance with the provisions of Article 84.3 of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices, pharmacy offices are required to dispense medicinal products which are required for them. Regulatory conditions established.

The pharmacist will dispense the prescribed medication. In the case of having to replace it, it shall take into account the legal criteria in force, informing the patient about the replacement. In the case of substitution, the pharmacist responsible for the supply shall enter the prescription for the medicinal product which he dispenses, the date and his signature and the reason for the replacement.

2. In the case of dispensing, the pharmacist shall record in the prescription the identification of the pharmacy office, the date of dispensing and his signature. It may also provide additional information in writing to the patient for the best drug-therapeutic monitoring of the medication dispensed and describe in the space for the effect of the packaging of the medicinal product, the dosage, duration of the treatment and frequency of the doses of the medicine dispensed.

3. The pharmacist shall provide the patient with a receipt stating the identification of the pharmacy office and the date of the dispensation, the name of the medicine dispensed and, where appropriate, the specific units thereof, the sale price to the public and the the patient's contribution, if any.

4. The pharmacist, where reasonable doubt arises as to the authenticity or validity of the prescribed medical prescription, shall not dispense the medicinal products requested by the patients or users, unless he/she can verify the legitimacy of the prescription, in case (a) shall bring it to the attention of the health authority which is competent for the purpose of determining the existence of possible administrative or criminal offences.

5. In the case of medicinal products containing narcotic substances included in lists I and II of the 1961 Single Convention on Narcotic Drugs, or psychotropic substances included in lists II, III and IV of Annex 1 to the Royal Decree 2829/1977, of 6 October, the pharmacist must check the identity of the person who comes to withdraw the medication, noting in the medical prescription the number of National Identity Document or document assimilated to foreigners.

6. The pharmacist shall record in the prescribed book the dispensations required by his or her specific regulations and those other than that determined by the Ministry of Health, Social Policy and Equality for special control requirements, as well as those which may be be established by the competent health authorities. The prescription book of the pharmacy office may be issued on paper, for manual or computerised completion, or in electronic form, and must be authorized by the competent health administration.

7. The following data must be entered in the book:

a) Dispensing date (day, month, year).

b) Recipe record number, formed by the consecutive number that corresponds to it.

(c) The optional prescription is transcribed in accordance with the following paragraph.

d) Number of containers or number of dispensing units in your case.

e) Name and surname of the prescriber, and number of collegiate, or identification code assigned by the competent authorities in the prescriptions of the National Health System, or the number of the Military Identity Card in the case of recipes from the Military Health Network of the Armed Forces and, where appropriate, the officially accredited specialty it exercises.

f) Code of identification of the patient assigned by the competent authorities in the prescriptions of the National Health System, number of the DNI in the prescriptions of the private sector, and for foreign citizens assigned in the European health insurance card or temporary replacement certificate (PSC), or NIE or passport number for non-EU foreign nationals, as specified in Article 3.2.a), 2. and 3. of this royal decree.

g) Remarks.

The mandatory dispensing identification data will be as follows:

h) For masterways: require a prescription for dispensing and the complete optional prescription should be transcribed as found in the prescription, as well as the registration number of the elaboration.

i) For presentations of medicinal products or specific units of the same: data shall be entered to allow for unambiguous identification.

j) For official preparations that respond to a prescription, the name shown on the National Form will be entered, noting the name, or the minimum data for identification and lot number.

The Ministry of Health, Social Policy and Equality will be able to update and establish the characteristics and requirements of the book.

8. The electronic prescription dispensing shall comply with the provisions set out in the preceding paragraphs with the particularities inherent in their technology.

Article 16. Dispensing and billing of official medical prescriptions from the National Health System.

1. For the dispensing of the official medical prescriptions of the National Health System, in accordance with Article 94.3 of Law 29/2006, of July 26, of guarantees and rational use of the medicines and medical devices, the users will be obliged to justify their right to the corresponding form of contribution in the pharmacy office, by presenting the individual health card of the recipient of the prescriptions. The competent health authorities shall draw up contingency plans for emergency situations and users who do not have this document.

2. Once the dispensation has been made, and for invoicing, the pharmacist shall enter the tax identification number or code and the identification number of the pharmacy office granted by the competent health authority in the prescription, and adherira the seal or voucher vouchers. Where appropriate, it shall complete the equivalent procedure established by means of telematic means, when this is possible for the identification number of each package checked.

3. Users shall pay the pharmacist the financial contribution according to the arrangements corresponding to the medicinal product and/or product dispensed and the type of user. The remaining quantity shall be paid to the pharmacist by the health service or public health administration concerned and after the checks to verify its validity. In the case of medical prescriptions for accidents at work or occupational disease, they shall be invoiced to the corresponding Entity or Mutua.

CHAPTER VII

Public and private hospital dispensing order

Article 17. Formats, prescription and dispensing.

1. Orders for hospital supply, extended in public and private hospitals, may be issued on paper, for manual or computerised completion, and in electronic form, and shall be edited in accordance with the general criteria specified in the Annex to this royal decree and the requirements which the competent health authorities or, where appropriate, the competent authority of the Armed Forces, introduce in the framework of their powers.

2. The order of hospital dispensation shall be waived by the pharmacy service or by the pharmacist responsible for the medical deposit of the hospital in which it has been prescribed. In the Special Regiments of the Mutualities of Officials and in the National Health System for the patients referred to in reference hospitals, mechanisms may be established to enable the dispensing of the hospital order by the patients. pharmacy services of the hospitals to be determined by the competent authorities.

3. The responsibility in the use of the order of hospital dispensation and the obligation of its conservation and custody, will be in accordance with the provisions of article 18 of this royal decree for the medical prescription. Once dispensed, the hospital pharmacy services will retain the orders for hospital supply, at least for six months, in accordance with the criteria and time limits laid down in Law 41/2002 of 14 November, basic regulation of the autonomy of the patient and of rights and obligations regarding information and clinical documentation.

4. The period of validity and the criteria for prescribing and dispensing established in this standard for the medical prescription shall apply to orders for hospital supply with the particularities and characteristics of the pharmaceutical supply in this care scope.

One or more medications may be prescribed in each order of hospital dispensing, and one or more of the medications may be prescribed.

Drug dispensing will be done according to the specific protocol of each type of treatment. The pharmacy service shall establish the most appropriate communication mechanisms with the medical services that allow the patient's integrated and corresponding care, communicating to the prescriber the incidences that he/she detects in the monitoring of the patient's treatment, with particular attention to compliance and the occurrence of adverse events. Taking into account the special characteristics of these treatments, pharmacists in the pharmacy service responsible for dispensing will be able to access the clinical data necessary to ensure the effectiveness and safety of the dispensing of the medicinal product.

5. The order of electronic hospital dispensing will be in accordance with the common criteria established for the electronic medical prescription and, where appropriate, the specific ones of the National Health System, with the corresponding adaptation to the hospital environment. In order to enable the treatment of the treatments in the case referred to in Article 17.2 of this royal decree, the interoperability of the electronic hospital dispensing order system will be implemented, as established in the Article 7.2.

CHAPTER VIII

Custody and Data Protection

Article 18. Preservation and custody of the prescription.

1. The prescriber will be responsible for the preservation and custody of the printed and talonaries of medical prescriptions, as well as the access and use of data for electronic prescription. The institutions in which prescribers provide their services shall provide the means necessary for the fulfilment of these obligations.

In the Mutualities of Officials that distribute the talonaries and printed prescriptions of the medical prescriptions to their beneficiaries, they will be responsible for their conservation and custody, without prejudice to the possibility of such Mutualities to entrust the custody of the printed matter to the entities and professionals assigned to them.

2. In the case of loss or subtraction of printed and medical prescriptions, as well as unauthorized access to the electronic prescription system, the corresponding police complaint will be filed and will be immediately communicated to the the body or entity which has provided them, the supporting document being sought in that act.

3. Once dispensed and diligent, medical prescriptions on paper support will be kept in the pharmacy office for three months. The pharmacist will ensure your safety, proper preservation and confidentiality. After the end of the storage period, it shall be destroyed, using methods which guarantee the impossibility of rebuilding the document. However, medical prescriptions for narcotic drugs or psychotropic drugs and those other than those required for subsequent management or control procedures shall be processed by the pharmacist in accordance with the rules and instructions. specific applicable in each case.

4. In the electronic medical prescriptions of the National Health System the pharmacist will be responsible for access to the data available for dispensing from his pharmacy office. Once the prescribed and signed and validated products have been dispensed, the pharmacy office may retain the information and/or computer records necessary for the billing in accordance with the provisions of Article 9.4. of this royal decree In private electronic medical prescriptions, these prescriptions will be retained the same period as the medical prescriptions on paper, and must cancel the computer records finalized the term of conservation.

Article 19. Data protection in medical prescriptions and hospital dispensing orders.

1. In the case of medical prescriptions and orders for hospital supply, and especially in the processing of information and in electronic processing, it must be ensured, as it prevents the specific regulations of the application, confidentiality of medical and pharmaceutical assistance, personal and family privacy of citizens and the protection of their personal data. To this end, the security measures provided for in the Organic Law 15/1999 of 13 December, the protection of personal data and in its development regulations will be implemented in the processing of data.

2. The consent of the data subject shall not be required for the processing and transfer of data which is a consequence of the implementation of medical prescription based information systems on paper or electronic support, in accordance with the provisions of the Articles 7 (3) and 7 (6), 8; and 11 (2) (a) of the Organic Law 15/1999 of 13 December 1999 on the protection of personal data. The above mentioned actions should aim to facilitate the medical and pharmaceutical assistance to the patient and to allow the control of the pharmaceutical provision of the National Health System, including the different special regimes of the Officials ' mutual societies.

CHAPTER IX

Sanctioning Regime

Article 20. Fouls and penalties.

Failure to comply with this royal decree will have the consideration of an infringement in the field of drugs and will apply to it the sanctioning regime provided for in Law 29/2006, of July 26, of guarantees and use rational use of medicinal products and medical devices.

Additional disposition first. Requirements for the use of medical prescriptions for narcotic drugs or psychotropic drugs.

1. The use of medical prescriptions for narcotic or psychotropic drugs shall be in accordance with the provisions of this royal decree, without prejudice to the particular conditions and requirements to be determined by your specific legislation.

2. No registration shall be required in the book of prescription for the supply of medicinal products containing psychotropic substances in Annex 2 to Royal Decree 2829/1977 of 6 October on the regulation of psychotropic substances and preparations, as well as the audit and inspection of their manufacture, distribution, prescription and dispensing.

3. There is no effect on the compulsory use of official vouchers for the distribution of medicinal products in the composition of which contain psychotropic substances, as set out in points (B) of Articles 12, 15 and 16 of the Royal Decree 2829/1977 of 6 October for the regulation of psychotropic substances and preparations, as well as the supervision and inspection of their manufacture, distribution, prescription and supply.

Additional provision second. Updates.

The Ministry of Health, Social Policy and Equality, for appropriate coordination in the National Health System, will update:

1. The official prescription of narcotic drugs and the assumptions and requirements for their use and control.

Specific requirements will be contemplated regarding their use by the Armed Forces medical services, which will take into account the provisions of Article 3.2 (c) of this royal decree on data identifying the prescriber.

The regulations that will be developed will allow the distribution by the Ministry of Defense's General Health Inspection, with the corresponding control requirements in coordination with the State Health Administrations and of the autonomous communities, of the talonaries of official prescriptions of narcotic drugs, books of accounting of narcotic drugs and talonaries of vouchers for the acquisition of narcotic drugs.

2. The characteristics of the seal coupon or the treated telematic procedure, and the assumptions of its use as proof of the dispensing of the medical prescriptions of the National Health System.

Additional provision third. Prescription of unfunded medicines and medical devices.

The prescription by the National Health System of medicines and medical devices that are not financed by the National Health System and subject to medical prescription, will be carried out in the model of specific medical prescription, according to the criteria contained in the annex of this royal decree, and must be adjusted in all that affects them, including the requirements of prescription, to the provisions of chapters III and IV of this royal decree. The medical prescription model may also be used for the prescription of medicinal products and medical devices that are not financed by the National Health System not subject to medical prescription.

Additional provision fourth. Medical prescriptions of the Mutualities of Officials.

The medical prescriptions of the General Mutuality of Civil Servants of the State (MUFACE), of the Social Institute of the Armed Forces (ISFAS) and of the General Judicial Mutuality (MUGEJU) will have to conform to the provisions of this real decree, with the exception of Chapter V.

Additional provision fifth. Order to dispense with the second paragraph of Article 77.1 of Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and medical devices.

1. Dispensing orders, public or private, may be issued on paper, for manual or computerised completion, and in electronic support. In general, the order of dispensation will apply to all the provisions contained in this royal decree for the medical prescription, with the particularities that are peculiar to it.

2. Without prejudice to any additional provision by the Government on the matter, the order of supply shall be in accordance with the basic criteria of the Annex and shall meet the following requirements:

a) Include the necessary information that allows easy identification as a dispensing order and its differentiation with the prescription.

b) Include the personal data of the registered nurse for the indication or authorization of supply, in accordance with the additional provisions of Law 29/2006 of 26 July 2006, of guarantees and the rational use of the medicines and medical devices, rather than the prescriber data that is available as the prescription.

Additional provision sixth. Modification of provisions.

1. The third subparagraph of paragraph 2 of Annex V to Royal Decree 1030/2006 of 15 September establishing the common service portfolio of the National Health System and the procedure for updating it is amended, which is hereby amended. as follows:

" The prescription of medicinal products and other products included in the pharmaceutical supply, in the case of their dispensing through pharmacy offices, must be carried out in the corresponding official medical prescription model. or order to dispense with the National Health System, in accordance with the provisions of the current regulations. "

2. Royal Decree 9/1996 of 15 January 1996 regulating the selection of effects and accessories, their financing with social security funds or State resources affected by the health and their supply and supply arrangements is hereby amended. non-hospitalized patients, in the following terms:

Article 4 (2) is worded as follows:

" 2. The dispensing of the products by the pharmacy offices will require the presentation of the corresponding medical prescription or dispensing order, National Health System officers duly completed by the healthcare professional. authorized. "

The second paragraph of Article 7 is worded as follows:

" For dispensing through the office of pharmacy, the effects and accessories shall be incorporated in the coupon-seal of the Health Care of Social Security (A.S.S.S.), which will have to be adhered to the medical prescription or order of official dispensation, at the time of delivery to the beneficiary. "

Additional provision seventh. Treatment of information.

In the actions provided for in this royal decree that have a relation to the treatment, cession and custody of personal data will be provided for in the Organic Law 15/1999, of December 13, of data protection of a personal nature, and in Royal Decree 1720/2007 of 21 December, for which the regulation of the development of the Organic Law 15/1999, of 13 December, of protection of personal data is approved.

Additional disposition octave. Prescription of authorized medicinal products for the dispensing of specific units.

By the Ministry of Health, Social Policy and Equality, specific criteria and requirements may be established for the prescription, dispensing and, where appropriate, billing of prescriptions for medicinal products. You have authorized the dispensing of specific units.

First transient disposition. Proof of the dispensing of electronic medical prescriptions from the National Health System.

As long as the univocal identification of each unit of presentation of the medicinal products and medical devices is not implanted, allowing for their optical, electronic or automated reading, the health services of the communities Autonomous and competent authorities, in accordance with the general billing requirements, shall establish the procedure as well as the document for verification of the supply, where the stamps or vouchers shall be attached treated as supporting evidence of the same.

Second transient disposition. Period of adaptation of medical prescriptions.

As of the entry into force of this royal decree, during a period of twenty-four months, the medical prescriptions that conform to what this royal decree indicates with those in force at the time of its publication may coexist. After the expiry of the said period, only medical prescriptions which conform to the provisions of this standard shall be valid.

Transitional provision third. Official prescription for narcotic drugs.

Until the update of the model of the official prescription of narcotic drugs and the assumptions and requirements for its use and control, it will be applicable as established in the Order of the Ministry of Health and Consumer Affairs. of 25 April 1994 regulating prescriptions and special requirements for the prescription and supply of narcotic drugs for human use.

Single repeal provision. Regulatory repeal.

Any provision, of equal or lower rank, which is opposed to the provisions of this royal decree and, expressly, Royal Decree 1910/1984, of 26 September, of medical prescription, the Order of the Ministry of Health, is hereby repealed. and Consumption of 30 April 1986 laying down the criteria for the standardisation of medical prescriptions and the model of prescriptions for long-term treatment with medicinal products containing narcotic drugs and psychotropic substances, and the Order of the Ministry The Committee on Health and Consumer Affairs of 23 May 1994 on official medical prescription models for the pharmaceutical provision of the National Health System.

Final disposition first. Competence title and legal basis.

1. This royal decree is issued in accordance with the provisions of Article 149.1.16 of the Constitution, which gives the State exclusive competence in the field of legislation on pharmaceutical products.

2. Articles 7, 9, 15, 16, 17, paragraphs 2, 3, 4 and 5, 18 paragraphs 3 and 4, the sixth additional provision and the first transitional provision are given in accordance with Article 149.1.16 of the Constitution, which confers exclusive competence on the State in the field of basic and general health coordination.

Final disposition second. Regulatory development and implementation.

The Minister of Health, Social Policy and Equality is empowered to make the necessary provisions for the implementation and development of the provisions of this royal decree and the updating of its Annex.

Final disposition third. Entry into force.

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

Given in Madrid, on December 17, 2010.

JOHN CARLOS R.

The Minister of Health, Social Policy and Equality,

LEIRE PAJIN IRALA

ANNEX

Basic criteria for medical prescriptions and dispensing orders

First. Official Medical Recipe of the National Health System and Officials ' Mutuals. -Official medical prescriptions to be used for the pharmaceutical provision of the National Health System including those of the Mutualities of Officials, as well as those for unfunded medicinal products, shall be adapted to the common characteristics set out in this Annex.

1. In the upper left corner of the models that are incorporated in this annex, the identity of the competent authority or body issuing the prescription and in the upper right-hand corner of the National Health System shall be stated.

The dimensions of the spaces for each of the data to be included in the recipe will be adapted to the editing or printing requirements that the Health Administrations establish.

2. Technical specifications of the medical recipe models.

a) Approximate dimensions: 22 by 12 centimeters.

b) The colors that differentiate the user's membership regime or contingency in the official National Health System recipes on paper, will be configured on the shaded edges and will be as follows:

Green in asset prescriptions, for common illness or non-work accident.

Red in pensioner prescriptions, for common sickness or non-work accident.

Blue in work accident or occupational disease recipes.

Grey in the recipes of the Mutualities of officials.

White on prescriptions for unfunded drugs.

This color differentiation will be mandatory for recipe talonaries, being optional for paper-based recipes for computerized fulfillment.

In case of choosing not to differentiate the recipes in support paper for computerized filling in colors, these must be shown in diagonal a legend with the regime and mutual of belonging of the patient.

(c) As referred to in point 1, the name of the Management Entity or the Agency issuing the prescription shall be entered in the space for Administration or Competent Body.

In the space for "Contingency", the corresponding modality shall be entered: common sickness or non-work accident, accident at work or occupational disease, prescription for unfunded medicines.

In the space for "Use Regime", an asset or a pensioner shall be entered. For the Recipes of the Mutualities of Officials the condition of mutualist shall be entered.

These specifications will not be included in prescriptions for unfunded medicines.

The "Recipe Code" space will be reserved for the coded identification of the recipe.

The "Pharmacist and Visa Information" space, will be reserved for the information that the prescriber considers to be transferred to the pharmacist, and in case of requiring a visa to his entry.

(d) In the case of work accident or occupational disease prescriptions, the data corresponding to the name and address of the Company shall be further recorded following the data relating to prescriber and date of prescription.

e) In the recipes for unfunded medicines, the following caption is stated: "Not valid for invoicing". Spaces reserved for sealed or assimilated coupons shall not be included in the document, with the use of such space to record the aforementioned legend.

(f) Thalonaries shall be drawn up in accordance with the requirements laid down by the Health Services and the competent authorities of the Officials of Officials.

g) Patient information sheet: Approximate dimensions 22 by 12 centimeters or size DIN A-4, adopting the one that is best suited to facilitate the patient's treatment information.

3. Active medication sheet and patient information for the electronic prescription system.

a) Approximate dimensions: DIN A-4 size.

(b) As referred to in point 1, the name of the Management Entity or the Agency issuing the prescription must be listed. In relation to the data to be reported:

In the space for "Use Regime", an asset or a pensioner, or a mutualist, shall be entered in the Recipes of the Officials of Officials.

"Prescription Code" means a space reserved for the data allocated by the electronic system, with a unique and unrepeatable character, for the identification of the prescription of each medicinal product or medical device.

(c) They shall be drawn up in accordance with the requirements laid down by the Health Services and the competent authorities of the Officials of Officials.

Second. Medical Prescription for Private Health Care-Medical prescriptions used in healthcare that are developed outside the hospital setting and are not the official medical prescriptions of the National Health System, including those of The Mutualities of Officials shall, in their technical specifications, comply with the provisions of the first paragraph of this Annex, with the specific provisions relating to: assimilated, which will not be included in the document.

In the "Contingency" space, medical Recipe for private healthcare will be stated.

In the upper left corner, numbering elements and recipe identification codes can be included.

In the upper right corner, the name of the Institution may be entered, if applicable.

Third. Hospital Dispensing Order. -Hospital dispensing orders used in the hospital setting for patients not admitted, will be adapted to the medical prescription in this annex, with the corresponding caveats, as are the spaces for: Use regime, and seal or assimilated coupons, which will not be included in the document, as well as to enable the prescription of several medications.

In the "Contingency" space, a Hospital Dispensing Order will be stated.

In addition, in the Hospital Dispensing Order, the pharmacy service will be specified instead of the pharmacy office, including the number of Clinical History in the patient's data and the medical service or unit. clinic, in addition to the prescriber.

As proof of the dispensation, the patient's receipt date and signature will be recorded.

By hospitals, in private health care, as well as by competent administrations and agencies, where appropriate, references or data may be included in the orders for hospital dispensation; copies required for proper use and control.

Fourth. Order of dispensation.-The order of supply referred to in Article 1 (c) of this royal decree, in general, shall comply with the basic criteria laid down in this Annex for the medical prescription and shall be appropriate to the features described in the corresponding model.

In particular, the order of official dispensation of the National Health System including that of the Mutualities of Officials shall be in accordance with the basic criteria laid down in the first point, while the order of dispensation For private health care, the basic criteria laid down in the second subparagraph must be met.