# C_2022138EN.01000601.xml

| 28.3.2022 | EN | Official Journal of the European Union | C 138/6 |
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28.3.2022

EN

Official Journal of the European Union

C 138/6

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Request for a preliminary ruling from the Verwaltungsgericht Wien (Austria) lodged on 10 December 2021 — Kwizda Pharma GmbH

(Case C-760/21)

(2022/C 138/07)

Language of the case: German

Referring court

Verwaltungsgericht Wien

Parties to the main proceedings

Complainant: Kwizda Pharma GmbH

Respondent authority: Landeshauptmann von Wien

Questions referred

The Verwaltungsgericht Wien refers to the Court of Justice the following questions concerning the interpretation of Regulation (EU) No 609/2013 (1) and of Directive 2002/46/EC: (2)

| 1(a) | In order to be categorised as a food for special medical purposes, must a product be demonstrably capable of achieving the claimed disease- or condition-specific results solely in the context of the dietary management indicated by that disease or condition with respect to the food-intake requirements of that condition or disease? |
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1(a)

In order to be categorised as a food for special medical purposes, must a product be demonstrably capable of achieving the claimed disease- or condition-specific results solely in the context of the dietary management indicated by that disease or condition with respect to the food-intake requirements of that condition or disease?

| 1(b) | In that context, is dietary management to be assumed only in the case where a person changes his or her diet in such a way as to consume other or additional nutrients which are absorbed by the body by way of digestion? |
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1(b)

In that context, is dietary management to be assumed only in the case where a person changes his or her diet in such a way as to consume other or additional nutrients which are absorbed by the body by way of digestion?

| 1(c) | For the purposes of categorisation as a food for special medical purposes, is it also necessary that the condition or disease for which the product is intended requires dietary management in order to ensure that the patient ingests the nutrients contained in the product which cannot be absorbed through the normal diet? |
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1(c)

For the purposes of categorisation as a food for special medical purposes, is it also necessary that the condition or disease for which the product is intended requires dietary management in order to ensure that the patient ingests the nutrients contained in the product which cannot be absorbed through the normal diet?

| 1(d) | Must the food for special medical purposes achieve its medical effect solely by virtue of the fact that it contains some or all of those nutrients which cannot be absorbed through the normal diet but are absolutely necessary or required in order for the patient to maintain his or her vital functions? |
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1(d)

Must the food for special medical purposes achieve its medical effect solely by virtue of the fact that it contains some or all of those nutrients which cannot be absorbed through the normal diet but are absolutely necessary or required in order for the patient to maintain his or her vital functions?

If those questions are answered in the negative: What type of ingredients must a product contain in order to meet the requirements for a food for special medical purposes?

| 2(a) | Does the categorisation of a product as a food supplement preclude the possibility of that product also being categorised as a food for special medical purposes? |
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2(a)

Does the categorisation of a product as a food supplement preclude the possibility of that product also being categorised as a food for special medical purposes?

| 2(b) | If that question is answered in the negative: What criteria should be used to determine that a particular food supplement cannot be categorised as a food for special medical purposes? |
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2(b)

If that question is answered in the negative: What criteria should be used to determine that a particular food supplement cannot be categorised as a food for special medical purposes?

| 2(c) | Can the use of ‘food supplements’ within the meaning of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements constitute, in itself, ‘dietary management’ within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013? |
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2(c)

Can the use of ‘food supplements’ within the meaning of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements constitute, in itself, ‘dietary management’ within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013?

| 2(d) | Does a food already become a food for special medical purposes if it contains nutrients which can also be ingested by way of food supplements or other foods, but which are formulated specifically for a particular disease or condition? |
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2(d)

Does a food already become a food for special medical purposes if it contains nutrients which can also be ingested by way of food supplements or other foods, but which are formulated specifically for a particular disease or condition?

| 3. | What criteria should be used as a basis for distinguishing a medicinal product from a food for special medical purposes or, alternatively, is it possible to draw a distinction between them? |
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3.

What criteria should be used as a basis for distinguishing a medicinal product from a food for special medical purposes or, alternatively, is it possible to draw a distinction between them?

| 4. | Is the requirement in Article 2(2)(g) of Regulation (EU) No 609/2013, according to which the ingredients relevant to categorisation as food for special medical purposes must produce their effect in the context of dietary management which cannot be achieved by modification of the normal diet, to be interpreted as meaning that a patient in respect of whose disease or condition the food for special medical purposes is placed on the market is not able to meet his or her nutritional requirements adequately via the intake of generally available foods? |
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4.

Is the requirement in Article 2(2)(g) of Regulation (EU) No 609/2013, according to which the ingredients relevant to categorisation as food for special medical purposes must produce their effect in the context of dietary management which cannot be achieved by modification of the normal diet, to be interpreted as meaning that a patient in respect of whose disease or condition the food for special medical purposes is placed on the market is not able to meet his or her nutritional requirements adequately via the intake of generally available foods?

| 5(a) | Is the phrase ‘whose dietary management cannot be achieved by modification of the normal diet alone’ in Article 2(2)(g) of Regulation (EU) No 609/2013 relative in nature in so far as fulfilment of that requirement is also to be assumed in the case where the nutrient intake required in the context of the disease or condition in question can be achieved by means of generally available foods (in particular, food supplements) only in a particularly burdensome manner? |
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5(a)

Is the phrase ‘whose dietary management cannot be achieved by modification of the normal diet alone’ in Article 2(2)(g) of Regulation (EU) No 609/2013 relative in nature in so far as fulfilment of that requirement is also to be assumed in the case where the nutrient intake required in the context of the disease or condition in question can be achieved by means of generally available foods (in particular, food supplements) only in a particularly burdensome manner?

| 5(b) | If that question is answered in the affirmative, what criteria should be used to determine that the burden associated with the intake of generally available foods meets the requirement ‘whose dietary management cannot be achieved by modification of the normal diet alone’ in Article 2(2)(g) of Regulation (EU) No 609/2013? In particular, is it to be assumed that that requirement is met in the case where a patient would be required to take several generally available food supplements separately? |
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5(b)

If that question is answered in the affirmative, what criteria should be used to determine that the burden associated with the intake of generally available foods meets the requirement ‘whose dietary management cannot be achieved by modification of the normal diet alone’ in Article 2(2)(g) of Regulation (EU) No 609/2013? In particular, is it to be assumed that that requirement is met in the case where a patient would be required to take several generally available food supplements separately?

| 6(a) | What is to be understood by a ‘nutrient’ within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013? |
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6(a)

What is to be understood by a ‘nutrient’ within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013?

| 6(b) | What criteria should be used to determine whether a certain ingredient of a product is to be categorised as a nutrient within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013? |
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6(b)

What criteria should be used to determine whether a certain ingredient of a product is to be categorised as a nutrient within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013?

| 7(a) | Is the requirement ‘to be used under medical supervision’ in Article 2(2)(g) of Regulation (EU) No 609/2013 already met in the case where that product is supplied in a pharmacy without the need to obtain beforehand a doctor’s prescription? |
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7(a)

Is the requirement ‘to be used under medical supervision’ in Article 2(2)(g) of Regulation (EU) No 609/2013 already met in the case where that product is supplied in a pharmacy without the need to obtain beforehand a doctor’s prescription?

| 7(b) | What criteria should be used to determine whether the requirement of use under medical supervision within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013 is met with regard to a certain product? |
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7(b)

What criteria should be used to determine whether the requirement of use under medical supervision within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013 is met with regard to a certain product?

| 7(c) | What is the consequence of the eventuality that that requirement of use under medical supervision within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013 is not met in a specific case, or even in general? |
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7(c)

What is the consequence of the eventuality that that requirement of use under medical supervision within the meaning of Article 2(2)(g) of Regulation (EU) No 609/2013 is not met in a specific case, or even in general?

| 8(a) | Is the existence of a food for special medical purposes to be assumed only in the case where it is NOT possible to use that food without medical supervision? |
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8(a)

Is the existence of a food for special medical purposes to be assumed only in the case where it is NOT possible to use that food without medical supervision?

| 8(b) | If that question is answered in the affirmative, what criteria should be used in order to determine whether a food can also be used without medical supervision? |
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8(b)

If that question is answered in the affirmative, what criteria should be used in order to determine whether a food can also be used without medical supervision?

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(1)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ 2013 L 181, p. 35).

(2)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ 2002 L 183, p. 51).

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