# C_2022198EN.01002301.xml

| 16.5.2022 | EN | Official Journal of the European Union | C 198/23 |
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16.5.2022

EN

Official Journal of the European Union

C 198/23

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Request for a preliminary ruling from the Bundesverwaltungsgericht (Austria) lodged on 21 January 2022 — Apotheke B. v Bundesamt für Sicherheit im Gesundheitswesen (BASG)

(Case C-47/22)

(2022/C 198/33)

Language of the case: German

Referring court

Bundesverwaltungsgericht

Parties to the main proceedings

Appellant: Apotheke B.

Respondent authority: Bundesamt für Sicherheit im Gesundheitswesen (BASG)

Questions referred

| 1. | (a) | Must Article 80(b) of Directive 2001/83 (1) be interpreted as meaning that the requirement deriving from that provision is fulfilled even where, as in the main proceedings, a holder of distribution authorisation obtains medicinal products from other persons who are also authorised or entitled to supply medicinal products to the public under national law but who are not themselves in possession of such distribution authorisation or who are exempt from the obligation to obtain such distribution authorisation under the terms of Article 77(3) of that directive, and only small quantities are supplied? |
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1.

(a)

Must Article 80(b) of Directive 2001/83 (1) be interpreted as meaning that the requirement deriving from that provision is fulfilled even where, as in the main proceedings, a holder of distribution authorisation obtains medicinal products from other persons who are also authorised or entitled to supply medicinal products to the public under national law but who are not themselves in possession of such distribution authorisation or who are exempt from the obligation to obtain such distribution authorisation under the terms of Article 77(3) of that directive, and only small quantities are supplied?

| (b) | If Question 1(a) is answered in the negative, is it relevant to compliance with the requirement laid down in Article 80(b) of Directive 2001/83 whether a supply of medicinal products obtained in the manner described in the main proceedings and in Question 1(a) is made only to persons authorised or entitled to supply medicinal products to the public under Article 77(2) of that directive or also to those who are themselves holders of distribution authorisation? |
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(b)

If Question 1(a) is answered in the negative, is it relevant to compliance with the requirement laid down in Article 80(b) of Directive 2001/83 whether a supply of medicinal products obtained in the manner described in the main proceedings and in Question 1(a) is made only to persons authorised or entitled to supply medicinal products to the public under Article 77(2) of that directive or also to those who are themselves holders of distribution authorisation?

| 2. | (a) | Must Articles 79(b) and 80(g) of that directive, in conjunction with point 2.2 of the Guidelines on Good Distribution Practice of medicinal products of 5 November 2013, be interpreted as meaning that the staffing requirements are fulfilled even where, as in the main proceedings, the responsible person is (physically) absent from the premises for a period of four hours but can be contacted by telephone during that time? |
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2.

(a)

Must Articles 79(b) and 80(g) of that directive, in conjunction with point 2.2 of the Guidelines on Good Distribution Practice of medicinal products of 5 November 2013, be interpreted as meaning that the staffing requirements are fulfilled even where, as in the main proceedings, the responsible person is (physically) absent from the premises for a period of four hours but can be contacted by telephone during that time?

| (b) | Must Directive 2001/83, in particular Articles 79 and 80(g) thereof, in conjunction with the first paragraph of point 2.3 of the Guidelines on Good Distribution Practice of medicinal products of 5 November 2013, be interpreted as meaning that the staffing requirements provided for in those provisions and guidelines are met where, as in the main proceedings, in the event that the responsible person is absent as described in Question 2(a), the staff present on the premises are not able, in particular in the event of an inspection by the competent authority of the Member State, to provide information themselves on the written procedures relating to their respective areas of responsibility? |
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(b)

Must Directive 2001/83, in particular Articles 79 and 80(g) thereof, in conjunction with the first paragraph of point 2.3 of the Guidelines on Good Distribution Practice of medicinal products of 5 November 2013, be interpreted as meaning that the staffing requirements provided for in those provisions and guidelines are met where, as in the main proceedings, in the event that the responsible person is absent as described in Question 2(a), the staff present on the premises are not able, in particular in the event of an inspection by the competent authority of the Member State, to provide information themselves on the written procedures relating to their respective areas of responsibility?

| (c) | Must Directive 2001/83, and in particular Articles 79 and 80(g) thereof, in conjunction with point 2.3 of the Guidelines on Good Distribution Practice of medicinal products of 5 November 2013, be interpreted as meaning that, in assessing whether an adequate number of competent personnel is involved in all stages of the wholesale distribution activities, account must also be taken of activities outsourced to third parties (or activities carried out by third parties on behalf of the establishment), as occurred in the case in the main proceedings, and does that directive preclude or even require the obtaining of an expert report for the purposes of that assessment? |
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(c)

Must Directive 2001/83, and in particular Articles 79 and 80(g) thereof, in conjunction with point 2.3 of the Guidelines on Good Distribution Practice of medicinal products of 5 November 2013, be interpreted as meaning that, in assessing whether an adequate number of competent personnel is involved in all stages of the wholesale distribution activities, account must also be taken of activities outsourced to third parties (or activities carried out by third parties on behalf of the establishment), as occurred in the case in the main proceedings, and does that directive preclude or even require the obtaining of an expert report for the purposes of that assessment?

| 3. | Must Directive 2001/83, in particular Articles 77(6) and 79 thereof, be interpreted as meaning that the authorisation to engage in activity as a wholesaler in medicinal products must also be revoked where it is established that a requirement under Article 80 of that directive is not fulfilled — for example, medicinal products are obtained in a manner contrary to Article 80(b) of that directive, as may be the case in the main proceedings — but that requirement is then once more complied with, in any event at the time of the decision by the competent authority of the Member State or the court before which the matter is brought? If not: what other requirements for that assessment exist under EU law, and, in particular, when must the authorisation be (merely) suspended instead of revoked? |
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3.

Must Directive 2001/83, in particular Articles 77(6) and 79 thereof, be interpreted as meaning that the authorisation to engage in activity as a wholesaler in medicinal products must also be revoked where it is established that a requirement under Article 80 of that directive is not fulfilled — for example, medicinal products are obtained in a manner contrary to Article 80(b) of that directive, as may be the case in the main proceedings — but that requirement is then once more complied with, in any event at the time of the decision by the competent authority of the Member State or the court before which the matter is brought? If not: what other requirements for that assessment exist under EU law, and, in particular, when must the authorisation be (merely) suspended instead of revoked?

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(1)  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 (OJ 2001 L 311, p. 67).

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