# C_2021426EN.01000801.xml

| 21.10.2021 | EN | Official Journal of the European Union | C 426/8 |
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21.10.2021

EN

Official Journal of the European Union

C 426/8

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JUDGMENT OF THE COURT

of 15 July 2021

in Case E-7/20

Criminal Proceedings against M & X AG

(Directive 2001/83/EC – Directive 2011/62/EU – Medicinal products – Wholesale distribution of medicinal products – Brokering of medicinal products – Freedom of establishment)

(2021/C 426/05)

In Case E-7/20, Criminal Proceedings against M & X AG – REQUEST to the Court under Article 34 of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice by the Princely Court of Appeal (Fürstliches Obergericht) concerning the interpretation of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, the Court, composed of Páll Hreinsson, President, Per Christiansen, and Bernd Hammermann (Judge-Rapporteur), Judges, gave judgment on 15 July 2021, the operative part of which is as follows:

| 1. | The determination of whether a product falls within the definition of a medicinal product in point 2 of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use must be decided on a case-by-case basis taking into account the factors set out in that provision, such as the product’s presentation or pharmacological, immunological or metabolic properties.
  A product, such as that at issue in the main proceedings, which is intended to be administered intravenously, presented as being in accordance with the formula of a medical practitioner and as alleviating the symptoms of diseases in human beings, constitutes a medicinal product within the meaning of point 2 of Article 1. |
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1.

The determination of whether a product falls within the definition of a medicinal product in point 2 of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use must be decided on a case-by-case basis taking into account the factors set out in that provision, such as the product’s presentation or pharmacological, immunological or metabolic properties.

A product, such as that at issue in the main proceedings, which is intended to be administered intravenously, presented as being in accordance with the formula of a medical practitioner and as alleviating the symptoms of diseases in human beings, constitutes a medicinal product within the meaning of point 2 of Article 1.

| 2. | In circumstances, such as those of the main proceedings, where a medicinal product has been sold at the wholesale and/or retail level in EEA States, it must be considered as having been intended to be placed on the market in EEA States for the purposes of Directive 2001/83/EC. |
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2.

In circumstances, such as those of the main proceedings, where a medicinal product has been sold at the wholesale and/or retail level in EEA States, it must be considered as having been intended to be placed on the market in EEA States for the purposes of Directive 2001/83/EC.

| 3. | A medicinal product is prepared industrially or manufactured by a method involving an industrial process if its preparation or manufacture involves an industrial process characterised, in general, by a succession of operations, which may be mechanical or chemical, in order to obtain a significant quantity of a standardised product. |
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3.

A medicinal product is prepared industrially or manufactured by a method involving an industrial process if its preparation or manufacture involves an industrial process characterised, in general, by a succession of operations, which may be mechanical or chemical, in order to obtain a significant quantity of a standardised product.

| 4. | A medicinal product that has not been prepared in accordance with the prescriptions of a pharmacopoeia or is not intended to be supplied directly to the patients served by the pharmacy in question cannot benefit from the exception contained in Article 3(2) of Directive 2001/83/EC. |
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4.

A medicinal product that has not been prepared in accordance with the prescriptions of a pharmacopoeia or is not intended to be supplied directly to the patients served by the pharmacy in question cannot benefit from the exception contained in Article 3(2) of Directive 2001/83/EC.

| 5. | The activity of procuring, supplying and exporting medicinal products, apart from supplying medicinal products to the public, constitutes wholesale distribution of medicinal products within the meaning of point 17 of Article 1 of Directive 2001/83/EC even if a wholesale distributor has not physically handled those products. |
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5.

The activity of procuring, supplying and exporting medicinal products, apart from supplying medicinal products to the public, constitutes wholesale distribution of medicinal products within the meaning of point 17 of Article 1 of Directive 2001/83/EC even if a wholesale distributor has not physically handled those products.

| 6. | A national measure subjecting an activity constituting ‘wholesale distribution of medicinal products’ within the meaning of point 17 of Article 1 of Directive 2001/83/EC to an authorisation requirement in conformity with Article 77(1) of that directive is compatible with EEA law. |
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6.

A national measure subjecting an activity constituting ‘wholesale distribution of medicinal products’ within the meaning of point 17 of Article 1 of Directive 2001/83/EC to an authorisation requirement in conformity with Article 77(1) of that directive is compatible with EEA law.

| 7. | The fact that a product is not classified in one EEA State as a medicinal product does not have an influence on whether the competent authorities of another EEA State may classify it as a medicinal product in accordance with Directive 2001/83/EC. |
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7.

The fact that a product is not classified in one EEA State as a medicinal product does not have an influence on whether the competent authorities of another EEA State may classify it as a medicinal product in accordance with Directive 2001/83/EC.

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