The therapeutic use of narcotic drugs is of great importance in relieving patients ' pain. The advances made, in recent years, in the knowledge of the pathophysiological mechanisms of pain, have made it possible to develop new drugs for their treatment and the use of new routes of administration. All of this has allowed the number of medications and presentations available to increase considerably, which is important improvements in the pharmacological treatment of pain.

On the other hand, the risk of misuse and diversion to the illicit trafficking of narcotic drugs makes it necessary to establish in its prescription and dispensing specific requirements to prevent abuse and diversion. towards the illegal market for these medicines and, at the same time, ensuring the availability and accessibility of patients to them. By means of these controls, derived from Law 17/1967 of 8 April, by which the existing rules on narcotic drugs are updated, adapting them to the provisions of the United Nations Single Convention of 1961 on Narcotic Drugs, Spain also complies with the commitments made at international level.

With this standard, the prescription and dispensing of narcotic drugs are simplified and the accessibility of the patients to the treatments is facilitated, without diminishing the necessary controls thanks to the use of the new technologies.

The enactment of Law 29/2006, of July 26, of guarantees and the rational use of medicines and medical devices, updated the legal framework in all aspects related to medicines. Therefore, as part of their regulatory development, the provisions governing the prescription of medicinal products for both human and veterinary use have been updated.

Royal Decree 1132/2010 of 10 September, amending Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products, adapted the content of this standard to the regulation adopted in recent years. incorporating, inter alia, new provisions relating to the prescription for the prescription of veterinary medicinal products, the office of which was regulated by Order of 31 August 1935, on rules for the acquisition of narcotic drugs by In order to ensure that the requirements of the Directive are not complied with, it is necessary to for the supply of veterinary medicinal products.

Royal Decree 1718/2010, of December 17, on medical prescription and dispensing orders, introduces modifications in relation to the prescription that make necessary a revision of the current regulations on the official prescription of drugs for human use in order to improve the accessibility of the patients to these treatments, maintaining the precise controls but simplifying them and incorporating the new technologies in the prescription, dispensing and control of the same.

The Order of 25 April 1994 regulating prescriptions and the special requirements for the prescription and supply of narcotic drugs for human use, therefore required an update, on the one hand, on the In order to facilitate the prescription and dispensing of these drugs and, on the other hand, to introduce the possibility of the application of computer systems in the mechanisms of control and processing of the official prescription of narcotic drugs.

This new Royal Decree extends the possibility of prescription of narcotic drugs for human use in respect of the treatment period, allowing the prescription to protect the medication for three months, facilitating the use of these drugs in patients undergoing prolonged pain treatment.

Moreover, the prescription, dispensing and control of narcotic drugs for veterinary use is included in the field, which so far did not have specific legal regulations in this respect.

Also updated is the regulation of the book of accounting of drugs that was collected in the Royal Decree of 8 July 1930, of the provisional regulation on the restriction of narcotic drugs.

In the same way, the activities of the pharmacy offices, pharmaceutical services and health authorities of the autonomous communities and cities of Ceuta and Melilla are reviewed and adapted as regards the control and processing of the recipes, in order to improve coordination and efficiency in the implementation of these regulations.

The orders for intra-hospital treatment of narcotic drugs are also regulated in this Royal Decree for prescriptions corresponding to intra-hospital treatment and drug vouchers for the purchase of drugs. by offices and services of pharmacy, distribution stores and pharmaceutical laboratories.

One of the highlights is the incorporation of new technologies for these prescriptions that will allow the official prescription of narcotic drugs to be integrated into a single document and the medical prescription of use in the the scope of public health assistance, making it possible for the dispensation in this field to require the submission of a single document against the two necessary so far.

Likewise, the other documents and control records, both relating to the prescription and to the dispensation, including the accounting books, may also be replaced by electronic records.

With the aim of making the most complete regulation possible, this Royal Decree updates the official prescription drug model and establishes the assumptions and requirements for its use and control. independence from the provisions of the second provision of Royal Decree 1718/2010, of 17 December 2010, on medical prescription and dispensing orders.

In accordance with the provisions of Article 80.3 of Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products, this rule establishes the format and requirements for the official prescription of narcotic drugs. veterinarian.

In the elaboration of this Royal Decree the autonomous communities and the cities of Ceuta and Melilla have been consulted, having been submitted to the full Interterritorial Council of the National Health System. The sectors concerned have been heard and the Administrative Mutuals have also been consulted. It has also submitted a report from the Consumer and Users ' Council and the Spanish Data Protection Agency.

This rule is dictated by the provisions of Articles 19.6 and 77.6 of Law 29/2006 of 26 July, and under the provisions of Article 149.1.16. of the Constitution, which confers exclusive competence on the State in the field of legislation on pharmaceutical products; except for Articles 9, 15, 17, 18, and additional second and fourth provisions, which are given under exclusive competence in the field of bases and general coordination of health, attributed to the State in that same constitutional precept.

Under the proposal of the Minister for Health, Social Services and Equality and the Minister for Agriculture, Food and the Environment, with the prior approval of the then Minister for Territorial Policy and Administration Public, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 14 December,

DISPONGO:

CHAPTER I

General Provisions

Article 1. Object and scope of application.

1. This Royal Decree is intended to:

a) Regular the characteristics of the official prescription of narcotic drugs for both human and veterinary use.

b) Establish requirements for prescription and dispensing of narcotic drugs.

c) Determine the obligations of exchange of information regarding the movements of the same.

2. This Royal Decree shall apply to all actions relating to the prescription and supply of medicinal products, both for human use and for veterinary use, containing narcotic substances included in Schedule I of the Convention. The only one of 1961 on Narcotic Drugs and subsequent modifications, as well as those which at national level are considered to be regulated as such.

3. The prescription and supply of narcotic drugs, of human or veterinary use, included in Schedule II and III of the Single Convention on Narcotic Drugs of 1961, shall be carried out in the corresponding medical prescription or veterinary prescription. the official prescription of narcotic drugs is accurate.

Article 2. Definitions.

For the purposes of this Royal Decree:

1. 'official prescription for narcotic drugs' means a standard and compulsory health document whereby doctors, dentists and veterinary surgeons, who are legally empowered to do so, and in the field of their respective powers, prescribe medicinal products for human and veterinary use containing narcotic substances included in List I of the 1961 Single Convention on Narcotic Drugs.

2. "Intra-hospital order for the supply of narcotic drugs" means the document, which is of a health and compulsory nature, through which the doctors and dentists of the hospital services request, to the services of hospital pharmacy, and for the patients admitted, medicinal products containing narcotic substances included in List I of the 1961 Single Convention on Narcotic Drugs.

3. "Narcotic drug" means a document of a sanitary, standardised and compulsory nature by which the offices and services of pharmacy, distribution stores and pharmaceutical laboratories acquire the drugs and drugs accurate for the performance of the activity that they are authorized to do.

Article 3. General considerations.

1. The prescription and supply of medicinal products containing narcotic substances included in List I of the 1961 Single Convention on Narcotic Drugs and subsequent amendments, as well as those which are regulated at national level considered as such, will be made in official prescriptions subject to the provisions of this Royal Decree, in all cases, in medicinal products for human use both in the field of public health care and in which it is practiced with private, and in veterinary medicines.

2. The official prescription of narcotic drugs, as a document that endorses the provision of prescription and valid for the entire national territory, will be published in the official language of the State and in the respective co-official languages in the communities. The Commission shall, in accordance with the provisions of Articles 37 (5) and 77.3 of Law 29/2006 of 26 July, provide for guarantees and the rational use of medicinal products and medical devices.

3. The official prescription for narcotic drugs, the orders for intra-hospital treatment of narcotic drugs and the narcotic vouchers referred to in Annex I may be issued on paper, for manual or computerised completion, or in electronic support.

4. The orders for intra-hospital supply of narcotic drugs shall contain at least the following data:

a) The name and two surnames of the responsible practitioner.

b) The number of colegate or identification code assigned by the competent National Health System Administrations.

c) The narcotic drugs that are requested.

d) Any additional data required for the corresponding control actions.

CHAPTER II

Official Prescription for Narcotic Drugs for Human Use

Article 4. Requirements and format of the official prescription for narcotic drugs for human use.

1. All official prescriptions for narcotic drugs must include the name "Official Narcotic Recipe", with the exception of those that are issued in electronic format.

2. Official paper-based narcotic prescriptions for manual completion must meet the following requirements:

a) Having a numbering system that allows for a unique identification.

b) To be presented in numbered talonaries, with 50 equally numbered recipes, each of which will be accompanied by a patient information sheet, in which the information of the necessary treatment will be collected to facilitate the appropriate use of the medicinal product; in both documents the same numbering shall appear. Each carcase shall also include a supporting evidence of receipt thereof.

c) The patient information sheet must be differentiated from the prescription itself, and may be separated from the recipe by copying or climbing.

(d) These prescriptions must bear the stamp or other system of unambiguous identification of the institution through which the talonary has been distributed, either the health administration or the corresponding official college.

3. The prescription, the optional will sign and date the official prescription of narcotic drugs and the patient information sheet.

Article 5. Specifications of the official prescription for narcotic drugs in private healthcare.

1. In private health care, the official prescription for manual completion drugs shall be used and the requirements laid down in Article 4 shall be met.

2. The official prescription model for private manual completion drugs, patient information sheet, and the receipt of the talonary should be adjusted to the content, the basic criteria and the technical specifications set out in the Annex II to this Royal Decree.

3. With the exception of the expected date of dispensing (day, month, year) and the number indicating the order of dispensation, the prescriber must record in the prescription and in the patient information sheet all the data set out in the Article 3 of Royal Decree 1718/2010, of December 17, on medical prescription and dispensing orders. In addition, the telephone number of the doctor or dentist shall be entered.

4. The numbering system for these recipes will be unique throughout the national territory.

Article 6. Specifications of the official prescription of narcotic drugs in the National Health System.

1. The official medical prescriptions of the health services and the National Institute of Health Management, in paper format for manual or computerized fulfillment, will have the consideration of official prescriptions of drugs when in their edition include the legend "Official Narcotic Recipe", in diagonal and in capital letters.

Likewise, in the framework of the home care plans that the health services of the autonomous communities have in place, they may have the official prescription of drugs for the medical prescriptions of the National Health System issued in paper format for manual fulfillment, in which the optional prescriber incorporates a stamp with the caption "Official Narcotic" and his telephone number, according to the established in the paragraph 3 of Article 5.

2. In the fulfillment of the recipes mentioned in the previous section, it will be necessary to include all the data that determines the Royal Decree 1718/2010, of December 17, for the official medical prescriptions of the National Health System. In addition, these recipes shall be adapted to the common characteristics set out in the Annex to the said Royal Decree.

3. In the form of a paper for the manual completion, the persons who are the holders or beneficiaries of the special social security schemes managed by the administrative mutual societies, who have opted for receive healthcare through the private insurance entities agreed with such mutual funds, the model of the prescription set out in Annex II to this Royal Decree shall be used.

When these prescriptions are made to the holders or beneficiaries of the administrative mutual societies attached, by the established procedure, to the health services of the Autonomous Communities or to the INGESA, the The health service of the corresponding autonomous community may choose to use the recipe model in Annex II of this Royal Decree, or to use the official prescription of the corresponding manual fulfillment narcotic health service. However, in one case or another, any of these prescriptions must be accompanied inexorably by the official medical prescription for the manual completion of the corresponding mutuality.

4. In addition, the medical prescriptions of the National Health System issued in electronic support will have the consideration of official prescriptions for narcotic drugs when they are identified with the name "Official Narcotic Recipe", or computer systems that support them identify as such to prescribed medications.

Article 7. Clothing, editing and distribution.

1. Official prescriptions for narcotic drugs on paper for manual or computerised completion shall be made out of materials that prevent or hinder their falsification, or through the introduction of safety measures in the system which ensure their authenticity.

2. The publication, elaboration and distribution of the talonaries of the official prescriptions for the narcotic drugs for the manual fulfillment and the drug vouchers, will be carried out by the competent organ of the autonomous community that corresponds, or, in the assumption of the National Institute of Health Management, by the corresponding body of the General Administration of the State, who will be responsible for the management, control and inspection of the printing, as well as for their delivery.

3. The official prescription of narcotic drugs for private health care shall be distributed free of charge to the official colleges of doctors and colleges of dental practitioners in the quantities which are accurate for the purposes of their delivery to the Members of the European Commission

the European Commission.

4. In the case described in the previous paragraph, the prescriber when receiving the talonary of official prescription of narcotic drugs, will sign the document of receipt, which will be held by the college or entity that would have facilitated it.

5. The person who ceases in the professional year in a given autonomous community shall return to the official college concerned or to the entity which provided it the talonary in use.

6. For at least five years, the relevant documents and records of the delivered books shall be kept at the disposal of the competent health authorities of the competent health authorities and shall contain at least the identifying data of the doctor or dentist to which you are supplied, the date of delivery and the number of carvings.

7. The talonaries of the official prescriptions of narcotic drugs of the National Health System must be expressly edited to these effects, and will be of exclusive distribution, by the health administrations, to doctors and dentists.

8. The narcotic vouchers shall be delivered free of charge, by the competent authority of the autonomous community concerned, to the authorized entities which request them and in general to meet the basic criteria and the model which set out in Annex I to this Royal Decree. These vouchers must have a numbering system that allows for a unique identification.

9. The prescriber will be responsible for the preservation and custody of the talonaries received. In the case of loss or subtraction of the talonaries or of official narcotic prescriptions, the corresponding police report shall be filed and shall be communicated immediately to the official college or entity that provided them, obtaining in that act the justification for having made the communication.

Article 8. Prescription conditions.

1. A single drug may be prescribed in each prescription.

2. The prescription given in an official prescription for narcotic drugs may cover the maximum of the medication for three months of treatment and without exceeding a total of four containers.

3. Only medicines that are fully available for immediate administration to the patient may be prescribed.

4. The prescriber will give the patient the prescription attached to the information sheet. The patient, in no case, will be required to show the information sheet to the pharmacist.

Article 9. Dispensing conditions.

1. For the supply of private health care, only the official prescription of narcotic drugs must be presented at the pharmacy office.

2. For the dispensing of drugs, by the pharmacy offices, in the field of the pharmaceutical provision of the National Health System, only "the official prescription of the National Health System drugs" will be specified.

However, in the case of Administrative Mutuals, the presentation and delivery at the pharmacy office of the official prescription of narcotic drugs, in accordance with the provisions of Article 6, will be necessary. paragraph 3, together with the official medical prescription for the manual completion of these Mutuals.

3. Narcotic drugs may be dispensed by a pharmacist in any authorized pharmacy office.

4. The pharmacist, where reasonable doubt arises as to the authenticity or validity of the prescription presented, 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) to be brought to the attention of the health authority which is competent for the purpose of determining the existence of possible administrative or criminal offences.

5. You must also check the identity of the person who comes to withdraw the medication, noting in the prescription the number of DNI or document assimilated to foreigners. When the prescription system is used in electronic prescription, the identification of the patient may be carried out by means of the insured information system of the corresponding autonomous community.

6. 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. The prescription will be left in its power and invalidated for a new dispensation.

7. The pharmacist shall record in the narcotic accounting book the dispensation made.

8. Pharmacy services may dispense, to non-admitted patients, narcotic drugs requiring particular surveillance, supervision and control, in accordance with the provisions of Article 2.6.b of Law 29/2006 of 26 July. The prescription of these medicinal products shall be carried out in the appropriate orders for the hospital supply of narcotic drugs, appropriately identified.

Article 10. Validity of the official prescription of narcotic drugs on paper.

For prescriptions to be valid for dispensing purposes, they must meet the following requirements:

a) Medicines will be prescribed in an official narcotic prescription.

(b) They must include the stamp or other system of unambiguous identification of the institution through which the distribution of the prescriptions has been carried out.

(c) All mandatory data shall be entered in accordance with Articles 4, 5 and 6.

(d) Recipes shall not submit amendments or delete entries in the mandatory consignment data unless they have been saved by the new signature of the prescriber.

e) They shall be submitted for dispensing before the expiry of their term of validity, which shall be 10 calendar days from the date of the prescription.

CHAPTER III

Official Prescription for Narcotic Drugs for Veterinary Use

Article 11. Requirements and format of the official prescription of narcotic drugs for veterinary use.

1. The official prescription of narcotic drugs in support of paper for manual fulfillment, will have a system of numbering and unique model for the entire national territory and will include its identification as " Official Recipe of Drugs ".

The official prescriptions for computerised completion drugs will also have a unique model and will lead to an unambiguous identification system generated by the procedures established by the competent administration. to issue them.

2. The aforementioned recipes will be presented in numbered talonaries, with 50 recipes also numbered. The legend 'VETERINARY' shall be included in all of them. Each carcase shall also include a supporting evidence of receipt thereof.

3. They shall include the seal or other unambiguous identification system of the institution through which the distribution of the same is carried out.

4. The official prescription model for narcotic drugs must comply with the content, basic criteria and technical specifications set out in Annex III to this Royal Decree.

5. Each recipe, in the form of manual or computerised completion, must be one original for the pharmacy office and two copies, one for the owner or responsible for the animal and one for the prescriber veterinarian.

Article 12. Clothing, editing and distribution.

1. Official paper-based narcotic prescriptions, for manual or computerised completion, shall be made out of materials that prevent or hinder their falsification, or by introducing security measures into the system which ensure their authenticity.

2. The editing, elaboration and distribution of the talonaries of the official prescriptions of narcotic drugs for the veterinary use of manual fulfillment, shall be carried out by the competent organ of the appropriate autonomous community, who shall be responsible the same, of the management, control and inspection of the printing, as well as of its delivery.

3. The talonaries shall be distributed to the official colleges of veterinary surgeons, for the purpose of their delivery to the collegiate veterinarians, with sufficient guarantees of safety and no charge.

4. The veterinarian, upon receipt of the talonary of official narcotic prescriptions, shall sign the receiving document, which shall be held by the college or entity that has provided it.

5. The veterinarian who ceases to work in a given autonomous community shall return to the relevant official college or entity which he has provided the talonary in use.

6. For five years, the relevant documents and records of the carvings delivered to the competent authorities shall be kept at the disposal of the competent authorities and shall contain at least the particulars of the veterinarian to whom the is supplied to you, the delivery date and the talonary number.

Article 13. Prescription conditions.

1. Only one medicinal product and one animal may be prescribed in each prescription.

2. The prescribed quantity shall be limited to the minimum required for the treatment in question, according to the criterion of the prescriber veterinarian, and taking into account the authorised formats of the medicinal product most appropriate for that purpose.

3. The prescription for a prescription for narcotic drugs may be used for a maximum of one month for treatment. Such treatment shall always be carried out under the supervision of the veterinarian.

4. The prescribing veterinarian shall record the number of dosing units for the daily treatment. Accordingly, the total number of packages prescribed shall be entered in point. Done the prescription, sign and date the prescription.

5. Where there is no veterinary medicinal product authorised for a disease, the veterinarian may, under his direct personal responsibility and in particular to avoid unacceptable suffering, make an exceptional prescription for a Narcotic drug in accordance with the provisions laid down in Articles 81 and 82 of Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products.

6. The veterinarian shall keep a specific record of the prescriptions. Such registration shall contain at least the identification of the prescribed medicinal product as well as the data provided for in the applicable rules, which shall depend on whether the prescription is for narcotic drugs intended for production animals or animals. company. The veterinarian shall keep the corresponding copy of the prescriptions for five years at the disposal of the competent authorities.

Article 14. Data to be reported.

In the completion of the official prescription of narcotic drugs for veterinary use it will be necessary to include all the data that determines the article 80.4 of the Royal Decree 109/1995, of January 27, on veterinary medicines. They will also include the following additional data:

1. Telephone number of the prescribing veterinarian or of the establishment, institution or public body where he exercises.

2. Stamp of the official veterinary college which has carried out the distribution of the carcase.

3. The posology, indicating the number of units per day and day, the total duration of treatment, route of administration, and the waiting time, where appropriate.

4. The exceptional prescription for therapeutic vacuum of a stupefying medicinal product must be entered in the official prescription of narcotic drugs for veterinary use, with the caption 'EXCEPTIONAL PRESCRIPTION'.

Article 15. Dispensing conditions.

1. Only authorised pharmacy offices may dispense narcotic drugs with veterinary use. For dispensing it will be necessary to present and deliver the prescriptive prescription of narcotic drugs for veterinary use.

2. The existence of these narcotic drugs in other approved establishments for the supply of veterinary medicinal products is prohibited.

3. Only the legally established offices of pharmacy are authorized for the elaboration and dispensing of master formulas and official preparations for the livestock holding or the animal listed in the corresponding prescription. (i) official of narcotic drugs, in accordance with the provisions of Royal Decree 109/1995 of 27 January 1995 on veterinary medicinal products.

4. The pharmacist, where reasonable doubt arises as to the authenticity or validity of the prescription presented, shall not dispense the requested medicinal products unless he/she is able to verify the legitimacy of the prescription, otherwise he/she shall bring it to the attention of the of the Health Administration which is competent for the purpose of determining the existence of possible administrative or criminal offences.

5. In addition, the pharmacist must check the identity of the person who comes to withdraw the medication, noting in the prescription the ID number or the document assimilated to foreigners.

6. The pharmacist shall enter the prescription for the identification of the pharmacy office, the date of the dispensation and his signature. The prescription will be left in its power and invalidated for a new dispensation. The performance shall be recorded in the narcotic accounting book or computer support that replaces it.

7. The autonomous communities shall, in the field of their competence, establish the system applicable to the effect that veterinary hospitals and clinics may have medicinal products for hospital use for clinical use.

Article 16. Validity of the recipe.

For official narcotic prescriptions to be valid for dispensing by pharmacy offices, they must meet the following requirements:

1. The medicinal products shall be prescribed in an official prescription for narcotic drugs.

2. All mandatory data, as provided for in Article 14, shall be entered.

3. The prescriptions shall not contain any amendments or cross-cuts in the mandatory consignment data unless they have been saved by the new signature of the prescriber.

4. They shall be submitted for dispensing before the expiry of their period of validity which shall be 10 calendar days from the date of the prescription.

CHAPTER IV

Control of official drug prescriptions

Article 17. Information system.

1. The prescriptions dispensed, with the exception of the official prescriptions of the National Health System, which will follow the procedure established for the prescriptions of this system, will remain in the hands of the pharmacy office that has carried out the dispensation, and at the disposal of the relevant health authority, for a period of five years, without prejudice to the instructions which each autonomous community may issue in this respect, in the field of its powers.

2. The pharmacist will guarantee the safety of the prescriptions dispensed, their correct preservation and confidentiality. After the end of the storage period, it shall be destroyed, using methods to ensure that the reconstruction of the document is not possible.

3. In addition, the orders for hospital supply on the basis of which the hospital pharmacy services dispense drugs and the orders for the intra-hospital supply of narcotic drugs will be held by them, and the provision of the relevant health authority for a period of five years, without prejudice to the instructions to be issued by each autonomous community in the field of its powers.

4. During the month of January each year, the pharmacy offices and services will send to the autonomous community the relationship of all the drug movements held annually, completing the data contained in the printed models that for medicines and for narcotic substances are included as Annex IV to this Royal Decree. In this data, and in accordance with that Annex, the dispensations of medicinal products and narcotic substances for human use or for veterinary use shall be differentiated.

5. Having received the information referred to in paragraph 4, the competent health authorities of the autonomous communities shall apply the control and control programmes as well as those agreed with the Ministry of Health, Social and Equality.

6. Within the first quarter of each year, the health authorities of the autonomous communities shall forward to the Ministry of Health, Social Services and Equality, information on the movements of narcotic drugs in their territorial area, corresponding to the previous year.

7. The autonomous communities for the purposes of the referral of the information referred to in paragraph 6 may agree with the Spanish Agency for Medicinal Products and Sanitary Products, which the pharmacy offices and services of its community refer, directly to that Agency, the data on the movement of narcotic drugs referred to in paragraph 4, through the computer application established for that purpose.

Article 18. Coordination of administrations.

The health administrations of the state and the autonomous communities will act in coordination and collaboration to ensure the safety, proper control, editing, elaboration and distribution of the official drug prescriptions, as well as the control and control programs and requirements resulting from international agreements in the field.

Article 19. Data protection.

1. In the case of official prescriptions for narcotic drugs and other control documents, and especially in their processing and electronic processing, it must be ensured, as the rules prevent The Commission is also responsible for the implementation of the directive on the protection of the environment, the protection of the environment, the protection of the environment, the environment and the environment. To this end, the security measures provided for in the Organic Law 15/1999 of 13 December on the protection of personal data and their 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 disposal of the data resulting from the implementation of information systems based on the official prescription of narcotic drugs on paper or electronic media, in accordance with Articles 6.1, 7.3 and 11 (2) (a) of the Organic Law 15/1999 of 13 December on the protection of personal data in relation to Article 77.8 of Law 29/2006 of 26 July.

Article 20. Narcotics accounting book.

1. All entities that manufacture, distribute or dispense substances and/or narcotic drugs must have a narcotic accounting book. In it they will log all the movements that occur, and keep it updated.

2. The narcotic accounting book may be issued on paper, for manual or computerised completion, or in electronic form and must be authorised by the competent health administration.

3. For each substance or medicinal product the following data shall be entered:

a) Date.

b) Recipe, dispensing order, or voucher.

c) Input or output identification.

d) Provider or prescriber.

(e) Remarks: where appropriate, the requirements for veterinary use shall be stated.

4. One or more of the books of the accounting book will be dedicated to each of the substances or drugs, so that at all times and as quickly as possible a balance of drugs can be made.

5 The edition of these books will correspond to the official colleges of pharmacists and for their validation and distribution will follow the procedures established by the Autonomous Communities or, where appropriate, the health services referred to in Article 44.2 of Law 14/1986 of 25 April, General of Health.

Article 21. Documents in electronic form.

1. As not provided for in this Royal Decree, the prescription and dispensing of narcotic drugs for human use in electronic prescription must comply with the general medical prescription criteria set out in Royal Decree 1718/2010, 17 December, on prescription and dispensing orders.

2. All the official prescription drug models, as well as the control, information and processing documents provided for in this Royal Decree, may be replaced by electronic formats, provided the corresponding systems They comply with the principles of security, integrity, change traceability and accessibility and have been validated.

3. In addition, these systems should have a favourable report from the corresponding autonomous community, or from the Spanish Agency for Medicines and Health Products, in their respective fields of competence. These reports shall be issued after verification by the competent administration of the principles listed in the previous paragraph and the validation of that system.

4. Where authorisations concern systems for the prescription or supply of narcotic drugs for veterinary use, the Agency shall consult the Ministry of Agriculture, Food and the Environment in advance.

5. The official prescription for narcotic drugs issued in electronic format shall permit the prescription, dispensing and control measures in accordance with the requirements set out in this Royal Decree.

Additional disposition first. Conditions of the official prescription of narcotic drugs in the field of the Armed Forces.

1. In the field of the Armed Forces shall be required for official prescriptions for narcotic drugs for human use and for veterinary use on paper for manual fulfillment, the conditions set out in Articles 4 and 11, respectively, of this Royal Decree and will be sent, by the Spanish Agency for Medicines and Health Products, to the General Inspection of Health of the Ministry of Defense, the precise talonaries for distribution, free of charge, to military medical doctors and to military, non-collegiate veterinary doctors with sufficient guarantees of security. The proof of receipt of the official prescription for narcotic drugs, as well as in the prescription itself, may be entered, instead of the number of the collegiate, the number of the Military Card of Identity of the optional. This shall also include, where appropriate, the officially accredited speciality which it exercises. In the same way, the Spanish Agency for Medicines and Health Products will send to the Ministry of Defense's General Inspection of Health, the vouchers for the purchase of drugs.

2. The military pharmacies, the pharmacy services of the military hospitals and clinics, the health units in national territory or deployed in operations abroad shall carry out the actions identified in Article 17 (4). As far as the control of drug prescriptions is concerned, I refer to the General Inspection of Defence Health the list of all drug movements that have been held annually.

3. The General Inspection of Defence Health shall assume the requirements of the autonomous communities in paragraphs 5, 6 and 7 of Article 17, referring to the Ministry of Health, Social Services and Equality, information on the movements of drugs in the field of defence, corresponding to the previous year.

Additional provision second. Control of narcotic drugs in other health centers, services and establishments.

1. The competent health authorities of the autonomous communities shall, where appropriate, provide the necessary instructions for the supply of narcotic drugs to duly authorised health or social health centres and services, which have deposits of authorised medicinal products. These supplies must be made through the pharmaceutical services or pharmacy offices of which the said deposits are dependent, using special vouchers, the model of which will be established by each autonomous community in such a way as to content to enable the control measures provided for in this Royal Decree to be carried out.

2. The pharmacist responsible for the deposit of medicinal products shall have an official record of the accounting of narcotic drugs, including the name of the patient, the narcotic administered and the date, for the control of the same.

3. In accordance with Article 19 (2) of Law No 17/1967 of 8 April, which updates the existing rules on narcotic drugs and adapting them to the provisions of the United Nations Convention of 1961, the Botiquines may to provide exclusively the narcotic preparations which have been supplied to them by the office of pharmacy of which they are dependent.

Additional provision third. Application to the cities of Ceuta and Melilla.

The references contained in this Royal Decree to the Autonomous Communities, will be understood to be made to the cities of Ceuta and Melilla, within the framework of their competences.

Additional provision fourth. Control of the narcotic drugs listed in List II.

The pharmacist will record in the prescription book the dispensations of drugs containing narcotic substances included in Schedule II of the Single Convention of 1961 on Narcotic Drugs, as well as those at the level of are legally considered to be such.

The accounting of the narcotic substances included in Schedule II of the Single Convention of 1961 on Narcotic Drugs will be carried out in the narcotic book.

Additional provision fifth. Manual recipe for computerized fulfillment and electronic prescription of narcotic drugs of the Administrative Mutuals.

1. The General Mutuality of Civil Servants of the State, the Social Institute of the Armed Forces and the General Judicial Mutuality when they have computerized prescription systems, similar to those established for health services, may be subject to the provisions of Article 6.1 for such prescriptions.

2. The General Mutuality of Civil Servants of the State, the Social Institute of the Armed Forces, and the General Judicial Mutuality that have electronic prescription systems may benefit from the provisions of Article 21.2.

Additional provision sixth. Control documents in electronic form in laboratories and distribution stores.

Drug control documents and systems established in the regulations for the laboratories manufacturers or importers and distribution stores, may be replaced by the corresponding in format electronic, in accordance with the provisions of Article 21.

Additional provision seventh. Documents with evidentiary value.

In no case shall the destruction of the supporting documents be carried out as long as their evidentiary value of rights and obligations of natural or legal persons in any administrative or legal proceedings may be judicial that can relate to them.

Single transient arrangement. Coexistence of recipe models.

In line with the provisions of the second transitional provision of Royal Decree 1718/2010 of 17 December 2010, the official prescriptions for narcotic drugs, which are in line with what is indicated, may coexist until 1 January 2014. this Royal Decree with those in force at the time of publication. After the expiry of the said period, only official narcotic prescriptions which are adapted to the provisions of this provision shall be valid.

Single repeal provision. Regulatory repeal.

Any provision, of equal or lower rank, which is opposed to the provisions of this Royal Decree and, expressly, the Order of the Ministry of Health and Consumer Affairs of 25 April 1994 governing the prescriptions, is hereby repealed. and special requirements for the prescription and supply of narcotic drugs for human use.

Final disposition first. Amendment of Royal Decree 1246/2008 of 18 July 2008 regulating the procedure for the authorisation, registration and pharmacovigilance of industrially manufactured veterinary medicinal products.

The second paragraph of the fourth additional provision of Royal Decree 1246/2008 of 18 July 2008 governing the procedure for the authorisation, registration and pharmacovigilance of manufactured veterinary medicinal products industrially, it is worded as follows:

"The coding system that allows the information collected in Article 33 to be recovered by electronic means shall be operational once the relevant rules are issued, which shall determine the system to be applied."

Final disposition second. Competence title.

1. This Royal Decree is issued in accordance with the provisions of Article 149.1.16a of the Constitution, which attributes exclusive competence to the State in matters of legislation on pharmaceutical products.

2. Articles 9, 15, 17, 18, the second provision and the fourth additional provision are made in accordance with Article 149.1.16a of the Constitution, which confers exclusive competence on the State in the field of bases and general coordination of health.

Final disposition third. Regulatory development and implementation.

The head of the Ministry of Health, Social Services and Equality is empowered to make the necessary provisions for the execution and development of the provisions of this Royal Decree and the updating of its attachments.

Final disposition fourth. Rules for extra-age.

For the regulation of the subject matter of this Royal Decree, and as not provided for in it, it will result from application, in the matter of medicinal products for human use, as established in Royal Decree 1718/2010, of 17 of December, on medical prescription and dispensing orders and, in the field of veterinary medicinal products, the provisions of Royal Decree 109/1995 of 27 January on veterinary medicinal products.

Final disposition fifth. Entry into force.

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

Given in Madrid, on December 14, 2012.

JOHN CARLOS R.

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

SORAYA SAENZ DE SANTAMARIA ANTON

ANNEX I

Basic criteria and technical specifications for drug vouchers for pharmacy offices and services, distribution warehouses and pharmaceutical laboratories

Narcotic delivery vouchers for pharmacy offices and services, distribution stores and pharmaceutical laboratories shall be adapted to the common characteristics set out in this Annex.

1. In the upper left corner of the model that is incorporated in this annex, both in the delivery and receipt diligence sheet (in matrix and receipt) and in the voucher (in matrix and voucher), the identity of the Administration issuing the vouchers.

The dimensions of the spaces for each of the data to be shown in the matrix and in the voucher will be adapted to the editing or printing requirements that the Health Administrations establish.

2. Each voucher shall be used exclusively for a stupefaciente active substance and in medicinal products for a single package size.

3. Technical specifications for official drug delivery vouchers for pharmacies, warehouses and laboratories:

a) Size 21 by 10.5 centimeters.

b) Double numbering across all vouchers (in array and voucher), printed in black.

c) Printed cover to 1/1 inks on 150 g/m couche paper².

d) In each talonary, as a first page, a sheet in blue paper for delivery and receipt diligence.

e) Each talonary will consist of 100 sheets (vouchers), plus one additional, printed to 1/1 ink on white-paper 80 g/m-white paper².

f) Pantone blue P-2925 color.

g) The binding will be performed on sheets raised and sewn with staple. Covered cover.

h) The manufacture of the "dry blow" anti-counterfeiting measure shall be included in the manufacturing process.

ANNEX II

Basic criteria and technical specifications of the official prescription models for human drugs for private healthcare and manual fulfillment

Official prescriptions for human drugs for private health care and manual completion shall be adapted to the common characteristics set out in this Annex.

1. The identity of the Administration issuing the prescription shall be entered in the upper left corner of the model of receipt of the talonary which is incorporated in this Annex.

2. The identity of the Administration issuing the prescription shall be given in the central lower part of the recipe model which is incorporated in this Annex.

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.

3. The conditions of use may be included in the counter-cover of the official prescription for narcotic drugs.

4. Technical specifications of the talonaries of official prescriptions for narcotic drugs for human use:

a) The carvings will be numbered and will have a printed cover to two inks, in a couche paper of 150 g/m².

b) A talonary receiving Justicizer, printed to a 90-gram Offset paper ink, white.

c) Each talonary will consist of 50 numbered recipes, in a self-copying chemical paper, formed each recipe by the recipe itself, and a patient information sheet. The recipe in white paper and the information sheet in green color. Printing to an ink.

d) approximate recipe size: 22 per 12 centimeters for all recipes on paper support, both manual and computerized fulfillment.

e) The binding of the talonaries shall be carried out by means of the left margin to facilitate the separation of the recipes, and shall include the proof of receipt of the carcase.

Narcotic prescriptions published by the Autonomous Communities shall be in accordance with the model set out in this Annex, without prejudice to the idiom and identification differences established by them.

ANNEX III

Basic criteria and technical specifications of the official prescription of narcotic drugs for veterinary use

Official prescriptions for narcotic drugs for veterinary use shall be adapted to the common characteristics set out in this Annex.

1. In the upper left corner of the model which is incorporated in this annex, both in the matrix and in the recipe, the identity of the administration issuing the recipe and in the upper right corner (matrix and recipe) the number of recipe.

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. The conditions of use may be included in the counter-cover of the official prescription for narcotic drugs.

3. Technical specifications for the official prescription of narcotic drugs for veterinary use:

a) The carvings will be numbered and will have a cover printed to two inks on two sides of 150 g/m²paper.

b) A talonary receiving Justicizer, printed to a 90-gram Offset paper ink, white.

c) Each talonary will consist of 50 numbered recipes, in a self-copying chemical paper, formed each recipe by original and two copies. The original in pink paper and the two copies in white. Printing to an ink.

d) approximate recipe size: 20 per 10 centimeters for all recipes on paper support, both manual and computerized fulfillment.

e) The binding of the talonaries shall be carried out by means of the left margin to facilitate the separation of the recipes, and shall include the proof of receipt of the carcase.

Narcotic prescriptions published by the Autonomous Communities shall be in accordance with the model set out in this Annex, without prejudice to the idiom and identification differences established by them.

ANNEX IV

ANNUAL DECLARATION OF NARCOTIC DRUGS