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Order Spi/2958/2010, Of 16 November, Which Establishes The Procedure For Inclusion Of Dietary Foods For Special Medical Purposes In The Offer Of The National System Of Health-Dietetic Products And Application D...

Original Language Title: Orden SPI/2958/2010, de 16 de noviembre, por la que se establece el procedimiento para la inclusión de los alimentos dietéticos para usos médicos especiales en la oferta de productos dietéticos del Sistema Nacional de Salud y para la aplicación d...

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Royal Decree 1030/2006 of 15 September establishing the portfolio of common services of the National Health System and the procedure for updating it contains, in Annex VII, the content of the provision with Dietary products. Point 2.3 of that Annex provides that the eligible dietetic products are those registered in the General Health Register of Food as dietary foods for special medical purposes and included in the Offer (Nomenclator) of Dietary products, noting that the procedure for the inclusion of products in the Offer will be established by ministerial order.

In the development of this provision, Order SCO/3858/2006 of 5 December, which regulates certain aspects related to the provision of dietary products from the National Health System, established the procedure for the inclusion in the Offering of the said products, as well as the alteration of the Offer and the necessary requirements in each case.

Royal Decree 1205/2010 of 24 September laying down the basis for the inclusion of dietary foods for special medical purposes in the provision of dietetic products from the National Health System and for the Article 4.3 of the Ministry of Health, Social Policy and Equality will lay down the procedure for the application of the maximum amounts of funding for both products and products. included in the Offer to the entry into force of this royal decree as to those whose inclusion or alteration is requested. In addition, Article 7.1 provides that the procedure for the inclusion in the Offer, or for the alteration of the conditions of supply of a product which may be covered by one of the types or subtypes listed in Annex I thereto, shall be established. by order of the person holding the Ministry of Health, Social Policy and Equality.

Moreover, the practical application of this royal decree requires the extension of the functions of the Advisory Committee for the provision of dietetic products, in order to ensure that the criteria for the establishment of maximum amounts financing and for the inclusion of dietetic foods for special medical uses in the offer of dietetic products of the National Health System be determined with the participation of the health administrations involved in the management of the provision of dietetic products.

This order is intended to make effective the aforementioned forecasts of Royal Decree 1205/2010, of 24 September and of Royal Decree 1030/2006, of 15 September, in establishing the procedure for the inclusion of a food dietetic for special medical uses in the offer of dietetic products of the National Health System and for the alteration of the conditions of supply, as well as for the application of the maximum amounts of financing, in addition to extending the functions of the Advisory Committee for the provision of dietetic products.

In its handling, the Inter-Ministerial Commission has been informed precept for the study of issues with budgetary implications for the financial balance of the National Health System or economic implications. significant, the Advisory Committee of the National Health System and the Interterritorial Council of the National Health System. The sectors concerned and the Autonomous Communities have also been consulted.

This order is made in use of the privileges conferred by the final disposition of Royal Decree 1205/2010 of 24 September 2010.

In its virtue, with the prior approval of the Minister of Territorial Policy and Public Administration, I have:

Article 1. Object.

The purpose of this standard is to establish the procedure for the inclusion of dietary foods for special medical purposes in the offer of dietary products of the National Health System (hereinafter "Offer") and for the implementation of the maximum amounts of funding.

Article 2. Offer of dietary products from the National Health System.

1. Offer the set of dietary foods intended for special medical purposes with which the portfolio of common services of delivery with dietetic products of the National Health System is made effective.

2. Only dietary products registered in the General Health Register of Food as dietary foods for special medical purposes and included in the Offering shall be eligible for financial support by the National Health System.

3. The Deputy Directorate-General for High Inspection and Services of the Ministry of Health, Social Policy and Equality, as the body responsible for the definition of the policy for the management of benefits, shall keep the updated the Offering.

Article 3. Identification of the products in the Offering.

1. Each presentation of dietary foods for special medical purposes included in the Offer shall be identified with a code to be assigned to it by the Ministry of Health, Social Policy and Equality.

2. For the purposes of the management and control of the supply, as well as of the invoicing of the products financed by the National Health System, each unit of sale of the products shall be provided, outside, with a seal identification with the product data and the characteristics set out in Annex I.

The use of this seal is reserved for the products indicated, the use of which is prohibited in those presentations to which the identification code has not been granted.

3. The units of sale which are supplied directly to the health centres shall not be provided with the said identification seal or, where appropriate, said seal must have been previously and conveniently unused by the undertaking. marketer.

4. In any event and without prejudice to the information to be incorporated in the seal, the products covered by this order must comply with all the labelling requirements that apply to them, in accordance with the provisions of the Royal Decree No 1091/2000 of 9 June 2000 approving the specific technical-health regulation of dietary foods for special medical purposes.

Article 4. Requests to include in the Offering.

1. The company responsible for the marketing of a dietary food for special medical purposes, which wishes to be financed by the National Health System, must request the Ministry of Health, Social Policy and Equality to fill in the the application, the model of which is set out in Annex II, for each of the presentations of the product for which the financing is intended. This application model will be available on the website of the Ministry of Health, Social Policy and Equality.

Applications shall be addressed to the Spanish Food Safety and Nutrition Agency and shall be accompanied by the documentation specified in that Annex.

2. The Spanish Food Safety and Nutrition Agency shall transfer to the Subdirectorate General of High Inspection and Portfolio of Services, the body responsible for the instruction of the procedure, of the said application together with the precise information to assess the origin or non-financing of the product and its proposal of the type and sub-type that would correspond to the product under Royal Decree 1205/2010 of 24 September 2010.

Article 5. Procedure for the inclusion in the Offer and for the application of the maximum amounts of funding.

1. The Subdirectorate General of High Inspection and Portfolio of Services in the light of the documentation received and taking into account the characteristics of the product, the regulations in force regulating the supply with dietetic products, as well as the criteria proposed by the Advisory Committee for the provision of dietetic products, shall determine whether the product is eligible or not, and where appropriate, shall assign to each presentation the relevant identifying code.

2. Within the maximum period of six months, the holder of the Directorate-General for Vocational Management, Cohesion of the National Health System and the High Inspectorate shall give a reasoned decision which shall be notified to the person concerned, with the expression of the proceed. After that period without any express resolution, the application may be understood, in the terms provided for in Article 43 of Law 30/1992, of 26 November.

This resolution will not terminate the administrative route, being appealed in a show of time, within one month, as provided for in Articles 114 and 115 of Law 30/1992 of 26 November of the Legal Regime of the Public Administrations and the Common Administrative Procedure.

3. When determining the inclusion of the product in the Offering, in the corresponding resolution, the applicant shall be notified of the identification code and the offer price of each presentation, as well as the type and subtype of the assigned product.

Article 6. Alterations to the Offering.

1. Changes in the composition, indications, or any of the data collected in the identification of a presentation included in the Offer, as well as in its offer price, imply the need to request the corresponding alteration of the Offering.

2. The offer price revisions shall not be altered as a result of the general updates of the maximum amounts of funding provided for in Article 5 of Royal Decree 1205/2010 of 24 September 2010.

Article 7. Override in the offer price.

1. Where an alteration leads to a change in the offer price, the new price may not exceed the maximum amount of financing that corresponds to the presentation according to the sub-type to which it belongs after the change. The new price shall apply from the time the new packaging is placed on the market, except as provided for

the following paragraph.

2. If the alteration relates only to a change in the offer price, without involving any other changes, the new offer price shall enter into force within three months of the notification to the undertaking of the acceptance of such alteration. In this case, the acceptance of the new offer price will mean that the company will not be able to request a further change in the price until at least one year after the date of the aforementioned notification of acceptance, except in the case of revisions to be determined by the Ministry of Health, Social Policy and Equality on the basis of Article 5 of Royal Decree 1205/2010 of 24 September 2010.

Article 8. Other alterations.

1. Where the alteration of the Offer is motivated by a substantial modification of the composition involving a new type or sub-type, or by a modification of the size of the package or the content thereof, a new identification code shall be assigned to the each of the presentations concerned, with the resulting reduction in the original Code or Code Offering, which will be carried out simultaneously with the new code being produced.

2. If the alteration of the Offering of a product involves the modification of its subtype, the selling price of the company for each presentation of that product will be valued according to the maximum amount of financing corresponding to the new product subtype.

Article 9. Procedure for altering the Offering.

1. Companies responsible for the marketing of a dietary food wishing to make an alteration of their offer must apply to the Ministry of Health, Social Policy and Equality, through the completion of the model established in Annex III, for each of the presentations of the product for which the alteration is intended. This application model will be available on the website of the Ministry of Health, Social Policy and Equality.

2. Applications shall be addressed to the Spanish Food Safety and Nutrition Agency and shall follow the same procedures as provided for in Articles 4 and 5.

Article 10. Obligations of companies.

1. Once the inclusion of a product has been accepted in the Offer or the alteration of one already included, the company responsible for its marketing must communicate to the Directorate General of Professional Management, Cohesion of the National System of Health and High Inspection, with a minimum of one month in advance, the date foreseen for the beginning of the marketing of each of the presentations of the said product, attaching the definitive identification seal. This obligation shall not apply in the case of the supply changes provided for in paragraph 7.2.

2. If, on the expiry of a period of six months, from the date of notification of the decision to accept the inclusion of a product or the acceptance of the alteration of the Offer, no marketing is produced, the company in question waives its request for inclusion or alteration of the Offer and, consequently, will proceed to the cancellation of the corresponding registration and its identification code.

3. Without prejudice to the above paragraph, the responsible undertaking may request an extension of the period indicated for a maximum period of three months, provided that it provides sufficient and duly justified causes to prevent the placing on the market of the product within the prescribed period.

4. Where a temporary suspension of the placing on the market of a product or of any of its presentations is provided for, the undertaking must communicate it, before the date on which this assumption occurs, for which the model must be completed. is set out in Annex IV. This application model will be available on the website of the Ministry of Health, Social Policy and Equality.

5. If a definitive cessation of the marketing of the product is to occur, the responsible undertaking shall communicate it at least three months in advance and using the model set out in Annex IV for this purpose.

Article 11. Advisory committee for the provision of dietetic products.

1. The Advisory Committee for the provision of dietetic products, attached to the Directorate-General for Vocational Management, Cohesion of the National Health System and the High Inspectorate, is the coordinating body between the health administrations. involved in the management of this provision and will aim at coordinating the actions and monitoring of the provision of dietetic products. Its activity will be linked to the Commission on benefits, insurance and funding, as set out in Article 9 of Royal Decree 1030/2006 of 15 September.

2. The Advisory Committee for the provision of dietetic products shall have the following composition:

(a) President: The Director General of Professional Management, Cohesion of the National Health and High Inspection System.

b) Vocals:

A representative designated by each of the Autonomous Communities.

A representative appointed by each of the following mutual societies: General Mutual Affairs of Civil Servants of the State (MUFACE), Mutual General Judicial (MUGEJU) and Social Institute of the Armed Forces (ISFAS).

A representative appointed by each of the following agencies: Spanish Food Safety and Nutrition Agency; National Institute of Health Management; Carlos III Health Institute.

A representative of the General High Inspection and Service Portfolio Subdirectorate.

Two specialists from the National Health System, experts in nutrition and dietetic, appointed by the head of the Ministry of Health, Social Policy and Equality, after consulting the Interterritorial Council of the National Health System.

(c) Secretary: An official of the General Secretariat of High Inspection and Portfolio of Services, who will act with voice but without a vote.

3. An alternate member shall be designated for each vowel. Where duly justified circumstances are present, the members ' members may be replaced by the alternate members. The replacement shall be communicated to the Secretary of the Committee at least 24 hours before the date set for the conclusion of the respective meeting.

4. Where the nature of the subjects so advises and at the invitation of the President, the experts deemed necessary, acting as advisers, may be incorporated into the Committee, with a voice but without a vote.

5. The Committee shall meet annually, and extraordinary meetings may be convened where it is deemed necessary. Where it is considered necessary for its operation, working groups of a permanent or temporary nature may be set up for the study of specific subjects relating to the subjects of their competence. These groups shall meet with the periodicity required by the mission entrusted to them.

6. Support for the Committee will be provided with the current human and material resources of the Ministry of Health, Social Policy and Equality, so that its operation does not increase public expenditure.

7. Without prejudice to the peculiarities provided for in this order, the Committee shall adjust its operation to the provisions of Chapter II of Title II "Collegiate Bodies", of Law No 30/1992 of 26 November 1992, of the Legal Regime of Administrations. Public and the Common Administrative Procedure.

Article 12. Functions of the Advisory Committee for the provision of dietetic products.

The functions of the Advisory Committee for the provision of dietetic products will be as follows:

(a) Develop, approve and amend the Rules of Procedure of the Committee itself.

b) Detect any difficulties that may arise in complying with the regulations regarding the provision of dietetic products and resolve doubts about their interpretation and application.

c) Propose the updating of the requirements for access to the provision of dietetic products, as well as the criteria for the allocation of type and subtype of such products and their inclusion in the financing, clinical situations of the patient to justify the need for the indication of these treatments and the subsidiary pathologies of enteral enteral nutrition or of congenital metabolic disorders susceptible to treatment dietoterapics.

d) Propose the basis for the review, detail and update of the criteria for the establishment of maximum amounts of funding for dietetic products and annually assess the appropriateness of carrying out a review of the maximum amounts of funding, where appropriate, the proposal concerned.

e) Propose special conditions for prescribing, dispensing, and financing dietary foods for special medical purposes, already included in the provision of National Health System dietetic products.

f) Propose the information on the supply of dietetic products to be transmitted by the Autonomous Communities, the National Institute of Health Management and the Mutualities of officials to the Directorate General of Professional Management, Cohesion of the National Health and High Inspection System, for the purpose of having an information system that facilitates the management and allows the monitoring of the supply with dietetic products.

g) To periodically evaluate information on the consumption of supply with dietary products and to propose measures that correspond to the rational use of dietary products.

h) Propose uniform criteria for the execution of the provision with dietary products of the National Health System.

(i) Report, where required by the Interterritorial Council of the National Health System or the health administrations represented in the Committee, on matters affecting benefits with Dietary products.

j) Serve as a permanent means of collaboration, communication and information between the various Health Services of the Autonomous Communities, the General Administration of the State and other agents involved in the management of the benefit.

(k) Those other that may be entrusted to it by the Ministry of Health, Social Policy and Equality or by the Interterritorial Council of the National Health System for the proper coordination between the health administrations in supply with dietetic products.

First transient disposition. Adaptation of the products included in the Offering.

1. Dietary foods for special medical purposes that are included in the Offer to the date of entry into force of this order shall be adapted to the requirements of Royal Decree 1205/2010 of 24 September 2010 and other regulations Regulation of the provision of dietetic products.

2. To this end, within two months of the date of entry into force of this provision, the undertakings responsible for placing the products on the market must submit to the Subdirectorate-General for High Inspection and Services the proposed sale price of the company by means of the application for adaptation in Annex V, accompanied by the labelling of each product. This application model will be available on the website of the Ministry of Health, Social Policy and Equality.

3. Within the maximum period of six months from the receipt of the information referred to in paragraph 2, the holder of the Directorate-General for Vocational Management, Cohesion of the National Health System and High Inspection, shall give a reasoned decision, shall be notified to the person concerned with the expression of the resources. After such a period has not been expressed by express resolution, the application for administrative silence may be understood, in the terms provided for in Article 43 of Law 30/1992, of 26 November.

These resolutions shall not terminate the administrative route, where they may be brought to an end within one month, as provided for in Articles 114 and 115 of Law No 30/1992 of 26 November.

4. The resolution to be delivered shall be in accordance with any of the following assumptions:

a) Resolver your stay in the Offer for those presentations whose sale price of the company does not exceed the corresponding maximum amount of financing, according to the subtype to which they belong, and which satisfy the others requirements laid down in the existing legislation on the provision of dietetic products.

b) Resolute the permanence in the Offer conditional on its adequacy, for those presentations whose sale price of the company exceeds the corresponding maximum amount of financing or for those that do not satisfy some of the the requirements laid down in the legislation in force on the provision of dietetic products.

When the decision to remain conditional on the Offer is due to a sale price of the company above the maximum amount of financing, within the maximum period of one month following receipt of such notification, the the company must communicate a sales price of the company adjusted to the maximum amount of financing according to the sub-type to which it belongs.

When the resolution of permanence in the Conditional Offer is due to the non-compliance of any of the other requirements established in the current regulations, within the same period indicated above, the company will have to send a commitment to the adequacy of the submission to the aforementioned regulations, which must be made effective within the maximum period of the following ten months, by submitting the corresponding request for alteration of the Offer.

c) Resolve the exclusion of the Offering for those submissions for which your companies have not submitted completed the application for adaptation in Annex V or have not been adapted to the requirements set out in the regulations and proceed to the consequent cancellation of your registration.

5. In all cases of exclusion from the Offer, a duly substantiated resolution shall be notified, including the resources to be made and the time limits for bringing them into effect.

Second transient disposition. Procedures for processing the date of entry into force of this provision.

The procedures for the inclusion or alteration of the Offer that will be processed to the date of entry into force of this provision will be resolved in accordance with the procedure in force prior to that date, If the provisions of Article 6 of Royal Decree 1205/2010 of 24 September 2010 apply to them.

Single repeal provision. Regulatory repeal.

As many provisions of the same or lower rank are repealed, the provisions of this order and in particular Order SCO/3858/2006 of 5 December 2006 on certain aspects relating to the supply with dietary products from the National Health System.

Final disposition first. Competence title.

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

Final disposition second. Application of offer prices.

1. The offer prices will be applied ten months from the date of entry into force of this order, at which time the companies will commercialize their products, for the purpose of their financing by the National Health System, at the price of offer, except as provided for in paragraph 2.

2. Where the adequacy of a presentation to the maximum amount of funding amounts to a reduction of more than 10% of the non-tax sale price communicated by the company to the Ministry of Health, Social Policy and Equality in the year 2010, the latter may to request that the adequacy be carried out in two stages. The first, applicable ten months after the entry into force of this rule, in which the product is to be financed at the amount resulting from the reduction of at least 10% by the said selling price, and the second, after the following six months, time from which it will already be financed at the offer price.

This two-stage adequacy request shall be reflected in the corresponding heading of the fiche that is collected as Annex V.

3. The Autonomous Communities, the National Institute of Health Management, the General Mutuality of Civil Servants of the State (MUFACE), the General Judicial Mutuality (MUGEJU) and the Social Institute of the Armed Forces (ISFAS), in their respective management areas and for the purpose of establishing the amounts of turnover of the pharmacy offices or as a maximum reference for the purchase of dietetic products to be provided through healthcare facilities to patients not admitted, shall apply the offer prices within 12 months of the entry into force of this order, except for those products which, as referred to in paragraph 2, have applied for the application of the maximum amounts in two stages, in which case the quantity accepted in the first stage shall be applied at the first stage and six months later offer.

Final disposition third. Entry into force.

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

Madrid, 16 November 2010. -Minister for Health, Social Policy and Equality, Leire Pajin Iraola.

ANNEX I

Identifying seal characteristics

Each unit of sale of a dietary product included in the Offer of Dietary Products of the National Health System will carry on its outside a seal that will identify unequivocally to each presentation and that it will Gather the following features:

1. The seal shall be self-adhesive, removable, so that it can be used as proof of dispensing and shall be equipped with the safety measures detailed in this Annex.

2. The characteristics of the seal shall be such that, when separating it, there is no deterioration of the unit of sale and in the space in which it was located, the following sentence is left with clearly legible characters: "DISPENSED TO THE SNS". Type of letters: Arial 13 bold red, pantone number 032, and with text inclination: 30º.

3. It shall be ensured that the location of the seal is in an area as visible as possible to the unit of sale and that it is arranged so that the optical reading is not prevented or difficult (i.e. it is not situated on a edge so that it is not folded or in an easy-to-rock zone that causes it to deteriorate, etc.).

4. The seal shall be made up of two distinct parts (A and B zones) between which there is no dividing line or a printed signal and which shall contain the following information:

4.1 Zone A (top), will have the following data:

(a) First Line: Signs S.N.S. (adjusted to the left) and code of the type of dietary product assigned by the organ of the Ministry of Health, Social Policy and Equality responsible for the management of benefits (adjusted to the right).

b) Second line: Name of the marketing company (adjusted to the left).

c) Third line: Product name, contents of the package (expressed in grams or millilitres), number of packages included in the unit of sale and type of package (bottle, bag, etc.) (adjusted to the left).

d) Fourth line: Identification code of the presentation assigned by the organ of the Ministry of Health, Social Policy and Equality responsible for the management of benefits preceded by the acronym C.I. (centered).

In addition, this zone A will take you as security measures:

a) Legend only visible to the ultraviolet light, which covers this area of the seal, crossed into the text, in which it is repeatedly mentioned "SNS" with a Time Bold source of 12 points and 45º of inclination.

b) Microprint text located next to the right side edge of zone A with the caption "SNS" repeated with a body of 240 microns.

4.2 Zone B (bottom) that will be adapted to the developments in information systems and technologies, will collect an EAN-13/SF bar code with the appropriate standardization guarantees.

5. The entire seal will carry a security background with encrypted message with the text "SNS", which will be read with a decoder lens. The bottom will be contiguous with fine line design, in pantone 2995, so that the automatic reading of the barcodes will be possible.

6. The dimensions of the self-adhesive seal shall be 34 mm wide by 25 mm high.

Zone A: Width 34 mm, high 10 mm.

Zone B: Width 34 mm, high 15 mm (Barcode 30 mm × 15 mm).

Self-adhesive identification seal example:

Imagen: img/disp/2010/280/17760_001.png

ANNEX II

Inclusion Request Model in the National Health System Dietary Product Offering and Identification Code Assignment

The product for special medical purposes called ................................................. and with registration number has been entered in the General Health Register of Food ...................................................................................................

Whereas it complies with the conditions laid down in the existing rules governing the provision of dietetic products, in particular as laid down in Article 6 of Royal Decree 1205/2010 of 24 September 2010, laying the foundations for the inclusion of dietary foods for special medical purposes in the provision of dietary products of the National Health System and the establishment of their maximum amounts of funding.

Requested: The inclusion of such a product in the National Health System Offering of Dietary Products and the identification of the identification code as set out in Article 3 (1) of the SIP/ 2010 Order of , establishing the procedure for the inclusion of dietary foods for special medical purposes in the offer of dietary products of the National Health System and for the application of the maximum amounts of funding, as well as the allocation of the corresponding type and sub-type of dietary product, according to the Annexes I and II to Royal Decree 1205/2010 of 24 September 2010.

To do this, it is attached:

-Summary of technical data (this tab will reflect the different product presentations for which inclusion in the offering and assignment of identification code)

-Qualitative and quantitative composition of the product accompanied by a brief1 product description and the processing process in which they are indicated the raw materials used and the source and type of protein, carbohydrates, lipids, and the content in micronutrients (vitamins and minerals), and the source and type of fiber, if it contains it

-Original label of each presentation.

-Removable identification seal (after notification of the inclusion resolution in the Offer will be referred to the final seal prior to placing on the market)

-Justifier to have paid the rates noted in the art. 32 of Law 53/2002, of December 30, of Fiscal, Administrative and Social Order Measures (Model 791-code 607)

Date and Signature

Fdo.:

How to: .................................... of the company ....................................................

Food Risk Management Subdirectorate General-Spanish Food Safety and Nutrition Agency. Ministry of Health, Social Policy and Equality.

1 Do not exceed 4 DIN A4 sheets.

Note: Present in duplicate.

Technical data sheet of the different product presentations for which inclusion in the National Health System Dietary Product Offering and identification code assignment is requested

Imagen: img/disp/2010/280/17760_002.png

(Reverso of the Technical Data Sheet)

1 The name to be proposed must be a fantasy name or a generic name accompanied by a trademark or the name of the owner or manufacturer of the product.

It shall not be a name equal to or similar to that of other financial or non-financial dietetic products, medicinal products or medical devices, in such a way that its prescription and dispensing does not mislead other products of the same or another company. The name must also not lead to errors in relation to its particulars. In addition, in the case of household enteral nutrition products, the name must not suggest other routes of administration other than the enteral tube or refer to food for ordinary consumption.

2 Mark la/s option/is that they correspond: The child is understood to be 12 months old, child, up to 12 years inclusive, adult, over 12 years old.

3 Indicate age range, pointing to the age (minimum and maximum) age for which the product is indicated.

4 Mark the appropriate option. The household enteral nutrition products shall be eligible only if they are for use by probe or mixed (oral and probe), and the route of administration must be reflected in the labelling.

5 Mark the appropriate option. The household enteral nutrition products must be presented in the form of liquid or powder. In the case of products presented in the form of powder, they must pass directly to liquid by the addition of water, and the final preparation must be guaranteed the appropriate nutritional contribution. Therefore, they cannot be of cream texture, puree, pudding, etc.

6 Expressed in grams of product per 100 millilitres of solvent.

7 Expressed in kilocalories per milliliter of product (for powdered products will refer to caloric density of the standard solution). In the case of formulas for home enteral nutrition the final product prepared shall have a caloric density of 0,5 to 2,1 kilocalories per millilitre.

8 Expressed in miliosmoles per liter of dissolution.

9 Expressed in miliosmoles per litre of solvent.

10 Expressed in daltons. Complete in the case of formulas with protein hydrolysates.

11 Expressed in grams of fiber per 100 millilitres. In the case of products that are present in the form of powder, the amount of fibre shall refer to 100 millilitres of the standard solution.

12 Code of the type and sub-type of dietary product proposed by the company among those listed in Annex I to Royal Decree 1205/2010 of 24 September 2010 laying down the basis for the inclusion of food dietetic for special medical purposes in the provision of dietetic products of the National Health System and the establishment of their maximum amounts of funding.

13 Reflect for which pathologies and clinical situations, from those listed in Annex VII to Royal Decree 1030/2006, of 15 September, establishing the portfolio of common services of the National Health System and the procedure for updating, the product would be indicated.

14 Each tab is scheduled for up to four presentations. In case the product has more than four presentations, as many tokens as are required to collect all the submitted presentations will be completed.

15 All packaging in the same presentation (unit of sale) must have the same flavor.

16 Price of each unit of sale of the product without tax or distribution margins that the company proposes to the National Health System.

ANNEX III

Request for Alteration Request Model for a Dietary Product included in theHealth System's1Dietary Product Offering

Product Name: ..................................................................................................

Product Registration No.: ...........................................................................................

On the basis of the following changes to the above product (reflect all the reasons that give rise to the alteration of the Offering, e.g. Composition modification, name, format, etc.) ...............................................................................................

and considering that once the changes have been made, the product still complies with the conditions laid down in the current regulations governing the provision of dietary products,

Requested: The alteration of the Offering and, if applicable, the assignment of new identification code or new type or subtype.

This is accompanied by:

-Brief2 justifying explanation of the changes produced.

-Original label of each presentation

-The technical data sheet (this tab will reflect the new information from the different presentations according to the product offering alteration that is request)

-New identifying seal extractable (after notification of the acceptance resolution of the alteration of the offer will be submitted the definitive seal, prior to its placing on the market)

-Justicizer of have paid the fees indicated in the art. 32 of Law 53/2002, of December 30, of Fiscal, Administrative and Social Order Measures (Model 791-code 607)

Date and Signature

Fdo.:

How: ................................. of the company ......................................................

Food Risk Management Subdirectorate General-Spanish Food Safety and Nutrition Agency. Ministry of Health, Social Policy and Equality.

1 A single override request model will be completed for all presentations of the same health record number that have the same alteration type.

2 Do not exceed 4 DIN A4 sheets.

Note: Present in duplicate.

New technical data sheet of the different presentations of the dietary food intended for special medical uses for which the alteration of the Offering is requested

Imagen: img/disp/2010/280/17760_003.png

(Reverso of the New Technical Data Sheet)

1 The name to be proposed must be a fantasy name or a generic name accompanied by a trademark or the name of the owner or manufacturer of the product.

It shall not be a name equal to or similar to that of other financial or non-financial dietetic products, medicinal products or medical devices, so that its prescription and dispensing does not mislead other products of the same or another company. The name must also not lead to errors in relation to its particulars. In addition, in the case of household enteral nutrition products, the name must not suggest other routes of administration other than the enteral tube or refer to food for ordinary consumption.

2 Mark la/s option/is that they correspond: The child is understood to be 12 months old, child, up to 12 years inclusive, adult, over 12 years old.

3 Indicate age range, pointing to the age (minimum and maximum) age for which the product is indicated.

4 Mark the appropriate option. The household enteral nutrition products shall be eligible only if they are for use by probe or mixed (oral and probe), and the route of administration must be reflected in the labelling.

5 Mark the appropriate option. The household enteral nutrition products must be presented in the form of liquid or powder. In the case of products presented in the form of powder, they must pass directly to liquid by the addition of water, and the final preparation must be guaranteed the appropriate nutritional contribution. Therefore, they cannot be of cream texture, puree, pudding, etc.

6 Expressed in grams of product per 100 millilitres of solvent.

7 Expressed in kilocalories per milliliter of product (for powdered products will refer to the caloric density of the standard solution). In the case of formulas for home enteral nutrition the final product prepared shall have a caloric density of 0,5 to 2,1 kilocalories per millilitre.

8 To be expressed in miliosmoles per litre of dissolution.

9 It will be expressed in miliosmoles per litre of solvent.

10 Expressed in daltons. Complete in the case of formulas with protein hydrolysates.

11 Expressed in grams of fiber per 100 millilitres. In the case of products that are present in the form of powder, the amount of fibre shall refer to 100 millilitres of the standard solution.

12 Code of the type and sub-type of dietary product proposed by the company among those listed in Annex I to Royal Decree 1205/2010 of 24 September 2010 laying down the basis for the inclusion of food dietetic for special medical purposes in the provision with dietetic products of the National Health System and the establishment of their maximum amounts of funding. For products that are indicated for both children and adults, they will be classified in the adult subtype.

13 Reflect for which pathologies and clinical situations, from those listed in Annex VII to Royal Decree 1030/2006, of 15 September, establishing the portfolio of common services of the National Health System and the procedure for updating, the product would be indicated.

14 Each tab is scheduled for up to four presentations. In case the product has more than four presentations, as many tokens as are required to collect all the submitted presentations will be completed.

15 The identification code of the presentations for which the Offering is requested to be altered.

16 All packaging in the same presentation (unit of sale) must have the same flavor.

17 Price of each unit of sale of the product without tax or distribution margins that the company proposes to the National Health System.

ANNEX IV

Marketing or Low Temporary Suspension Communication Model in the National Health System Dietary Product Offering

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(Reverso of Annex IV: Marketing or Low-Offer Temporary Suspension Communication Model)

1 Please indicate what is applicable.

2 The temporary suspension shall be communicated in advance in accordance with the provisions of Article 9 (4) of the SIP/ /2010/, Order of which the procedure for inclusion is established. for dietary foods for special medical purposes in the National Health System Offering of Dietetic Products and for the application of the maximum amounts of funding.

3 It shall be communicated at least three months in advance in accordance with Article 9 (5) of Order SIP/ /2010/, of which the procedure for the inclusion of food is established. dietetic for special medical purposes in the National Health System Offering of Dietary Products and for the application of the maximum amounts of funding.

4 All presentations of the product whose temporary or low suspension is communicated will be entered.

ANNEX V

Request for the adaptation of the products included in the Offer (Transitional Disposition first, of Order SIP/ 2010 /de de, establishing the procedure for the inclusion of dietary foods for medical purposes Special in the offer of dietary products from the National Health System and for the application of the maximum amounts of funding)1

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(Reverso de la Ficha de remittance de los ventas de venta de la empresa proposeas)

For the completion of Annex V the following shall be taken into account:

1 The company shall, in a single shipment, forward the relationship of all its products, including the Offer to the date of entry into force of the Order, in accordance with the provisions of the first transitional provision, sorted in ascending order by record number and for each record number in ascending order of the identifying code of each presentation. In the case of those submissions which are not entered, the undertaking shall be deemed to give up the fact that they are eligible for financing by the SNS, and in such a case the corresponding registration of such presentation shall be abolished in the Offer.

The product relationship will be accompanied by the attached information tab for each product presentation along with the authorized labeling of each presentation.

2 Reflect if the company considers that the presentations of the products that are related meet the requirements established by the current regulations on the provision of dietary products or not.

3 In the event that the company considers that a presentation does not meet any requirements of the current regulations, but wishes to adapt it to the same one will be stated under the heading for the purpose of the said Annex V, by entering the relevant let/s/s to the grounds/s by the/s not complying with the current rules on the provision of dietetic products:

a) It is not indicated for the pathologies and clinical situations listed in Annex VII to RD 1030/2006.

(b) It does not belong to any of the types and subtypes listed in Annex I to Royal Decree 1205/2010 of 24 September 2010 laying down the basis for the inclusion of dietary foods for special medical purposes in the supply of dietary products from the National Health System and for the establishment of their maximum amounts of funding.

(c) Your presentation (type of packaging and size) and composition to the nutritional requirements of patients in the clinical indications and situations to which they are intended are not adjusted.

d) It is available as capsules, tablets, tablets, or other forms similar to those of medicines.

e) It does not clearly reflect on the labelling the indications for which the product is financed or includes phrases, drawings or other graphic reasons which lead to confusion with respect to the financial indications, or contains allusions to other products.

f) Has a name equal to or similar to that of other financial or non-financial dietary products, medicines, or medical devices.

g) Has indications exclusively for hospitalized patients in detention.

In addition, in the case of formulas for enteral enteral nutrition:

h) The name suggests other routes of administration other than the enteral probe or refers to food for ordinary consumption.

i) It is not a complete diet, consisting of a defined mixture of macro and micronutrients, in quantity and distribution suitable for use as the sole nutritional source.

j) It is not intended to be administered by enteral tube (nasogastric or ostomy).

k) Does not have a caloric density of 0.5 to 2.1 kcal/ml in the final product prepared.

l) It is not available as a liquid or powder. In case it is present in powder form, it does not pass directly to liquid by the addition of water, or the final preparation to the standard solution does not guarantee adequate nutritional input.

m) It is a nutritional supplement.

n) It has been wholly or partially obtained by dehydration or direct crushing of food, or by mixing food, ordinary consumption, simple or elaborate, or carries some natural ingredient (may carry oils as a source of lipids or natural ingredients for the sole purpose of flavorings of the product up to a maximum limit of 2% of the total product content).

o) Has a composition or characteristics similar to that of a drug.

p) Your name refers to administration paths other than probe paths.

q) Other (specify).

Information tab for each of the dietary food presentations for special medical uses included in the Offer1

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(back of the Sheet)

1 A tab for each of the presentations listed in Annex V shall be completed and shall be accompanied by the authorised labelling of each presentation. They shall be presented in the same order as the relation in Annex V, i.e. by ascending registration number and for each registration number in ascending order of the identification code for each presentation.

2 Proposal of subtype for each product of those listed as Annex I Royal Decree 1205/2010 of 24 September 2010 laying down the basis for the inclusion of dietary foods for medical purposes Special provisions for the provision of dietetic products from the National Health System and for the establishment of their maximum amounts of funding.

3 The proposed company's sales price (excluding VAT). This amount may not exceed the maximum amount of funding obtained from applying to each product the value of the reference indicator for the corresponding subtype, as set out in Annex III to Royal Decree 1205/2010 of 24 September 2010. agreement with the formula in Annex IV to that royal decree. In the case of presentations that will apply the maximum amounts in two stages, it will be the final offer price to be applied in the second stage.

4 Complete only for products for which the application of maximum amounts is requested to be performed in two stages. This application may be made for those products which are in accordance with the maximum amount of financing corresponding to their sub-type, with a reduction of more than 10% of their sales price without VAT from the year 2010 provided for Ministry of Health, Social Policy and Equality. In the first stage, ten months after the entry into force of this rule, the product shall be financed at the proposed amount resulting from the reduction of at least 10% of the sale price of the undertaking, and the second, after six months. next, at the offer price.

5 Mark the option/s that correspond: The child is understood to be 12 months old, up to 12 years inclusive, regardless of the fact that the product may be further indicated in less than 12 months; adult, older than 12 years, although it may also be indicated in minors of that age.

6 Indicate age range, pointing to the age (minimum and maximum) age for which the product is indicated.

7 Expressed in kilocalories per milliliter of product (for powdered products will refer to the caloric density of the standard solution). In the case of formulas for home enteral nutrition the final product prepared shall have a caloric density of 0,5 to 2,1 kilocalories per millilitre.

8 CI: Total sales unit content referred to each reference indicator (total kilocalories, proteins, amino acids, etc.) multiplied by the value of the subtype reference indicator (VI) expressed in euro, allows the calculation of the maximum amount of financing (IMF) by the following formula: IMF= VI x CI.

9 Expressed in grams per 100 millilitres. In the case of products which are presented in powder form, the quantity shall cover 100 grams of product.

10 The protein component shall be expressed in grams of protein equivalent in the appropriate cases.