# C_2015294EN.01002701.xml

| 7.9.2015 | EN | Official Journal of the European Union | C 294/27 |
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7.9.2015

EN

Official Journal of the European Union

C 294/27

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Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 June 2015 — Hecht-Pharma GmbH v Hohenzollern Apotheke, owned by Winfried Ertelt

(Case C-276/15)

(2015/C 294/33)

Language of the case: German

Referring court

Referring court

Bundesgerichtshof

Parties to the main proceedings

Parties to the main proceedings

Applicant: Hecht-Pharma GmbH

Applicant:

Defendant: Hohenzollern Apotheke, owned by Winfried Ertelt

Defendant:

Questions referred

Questions referred

| 1. | Do points (1) and (2) of Article 3 of Directive 2001/83/EC (1) preclude a national provision such as point (1) of Paragraph 21(2) of the Arzneimittelgesetz (Law on medicinal products) according to which no marketing authorisation is required for medicinal products that are intended for administration to humans and, on account of the proven frequency with which they are the subject of medical and dental prescriptions, the essential manufacturing steps for such are carried out in a pharmacy as part of the normal pharmacy business producing in the course of one day up to one hundred packages ready for dispensation and intended for supply under the existing pharmacy operating licence?
  If Question 1 is answered in the affirmative: |
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1.

Do points (1) and (2) of Article 3 of Directive 2001/83/EC (1) preclude a national provision such as point (1) of Paragraph 21(2) of the Arzneimittelgesetz (Law on medicinal products) according to which no marketing authorisation is required for medicinal products that are intended for administration to humans and, on account of the proven frequency with which they are the subject of medical and dental prescriptions, the essential manufacturing steps for such are carried out in a pharmacy as part of the normal pharmacy business producing in the course of one day up to one hundred packages ready for dispensation and intended for supply under the existing pharmacy operating licence?

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If Question 1 is answered in the affirmative:

| 2. | Does this conclusion also apply where a national provision such as point (1) of Paragraph 21(2) of the Arzneimittelgesetz is interpreted to mean that no marketing authorisation is required for medicinal products that are intended for administration to humans and, on account of the proven frequency with which they are the subject of medical and dental prescriptions, the essential manufacturing steps for such are carried out in a pharmacy as part of the normal pharmacy business producing in the course of one day up to one hundred packages ready for dispensation and intended for supply under the existing pharmacy operating licence, provided that the medicinal product is either supplied to an individual patient in accordance with a medical prescription, not necessarily submitted before the preparation of the medicinal product, or is prepared in the pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to patients? |
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2.

Does this conclusion also apply where a national provision such as point (1) of Paragraph 21(2) of the Arzneimittelgesetz is interpreted to mean that no marketing authorisation is required for medicinal products that are intended for administration to humans and, on account of the proven frequency with which they are the subject of medical and dental prescriptions, the essential manufacturing steps for such are carried out in a pharmacy as part of the normal pharmacy business producing in the course of one day up to one hundred packages ready for dispensation and intended for supply under the existing pharmacy operating licence, provided that the medicinal product is either supplied to an individual patient in accordance with a medical prescription, not necessarily submitted before the preparation of the medicinal product, or is prepared in the pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to patients?

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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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