# C_2020215EN.01002201.xml

| 29.6.2020 | EN | Official Journal of the European Union | C 215/22 |
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29.6.2020

EN

Official Journal of the European Union

C 215/22

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Request for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 23 March 2020 — Novartis Pharma GmbH v Abacus Medicine A/S

(Case C-147/20)

(2020/C 215/27)

Language of the case: German

Referring court

Landgericht Hamburg

Parties to the main proceedings

Applicant: Novartis Pharma GmbH

Defendant: Abacus Medicine A/S

Questions referred

| 1. | Can it lead to an artificial partitioning of the markets within the meaning of the case-law of the Court of Justice if the safety features of original outer wrapping/original packaging which are provided for under Article 54(o) and Article 47a of Directive 2001/83/EC (1) can, in the event that the parallel trader retains that original packaging, be replaced in compliance with Article 47a(1)(b) of that directive only in such a way that visible traces of opening remain after the originally existing safety features have been partly or fully removed and/or covered? |
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1.

Can it lead to an artificial partitioning of the markets within the meaning of the case-law of the Court of Justice if the safety features of original outer wrapping/original packaging which are provided for under Article 54(o) and Article 47a of Directive 2001/83/EC (1) can, in the event that the parallel trader retains that original packaging, be replaced in compliance with Article 47a(1)(b) of that directive only in such a way that visible traces of opening remain after the originally existing safety features have been partly or fully removed and/or covered?

| 2. | Is it of significance for answering the first question whether the traces of opening become visible only when the medicinal product has been thoroughly inspected by wholesalers and/or persons authorised or entitled to supply medicinal products to the public, such as pharmacies, in fulfilment of their obligation under Articles 10, 24 and 30 of Regulation (EU) 2016/161, (2) or may be overlooked in a superficial inspection? |
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2.

Is it of significance for answering the first question whether the traces of opening become visible only when the medicinal product has been thoroughly inspected by wholesalers and/or persons authorised or entitled to supply medicinal products to the public, such as pharmacies, in fulfilment of their obligation under Articles 10, 24 and 30 of Regulation (EU) 2016/161, (2) or may be overlooked in a superficial inspection?

| 3. | Is it of significance for answering the first question whether the signs of opening become visible only when the packaging of a medicinal product is opened, for example by the patient? |
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3.

Is it of significance for answering the first question whether the signs of opening become visible only when the packaging of a medicinal product is opened, for example by the patient?

| 4. | Is Article 5(3) of Regulation (EU) 2016/161 to be interpreted as meaning that the barcode containing the unique identifier within the meaning of Article 3(2)(a) of that regulation must be printed directly on the packaging, so that Article 5(3) is not complied with if a parallel trader affixes the unique identifier to the original outer packaging using an additional external sticker? |
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4.

Is Article 5(3) of Regulation (EU) 2016/161 to be interpreted as meaning that the barcode containing the unique identifier within the meaning of Article 3(2)(a) of that regulation must be printed directly on the packaging, so that Article 5(3) is not complied with if a parallel trader affixes the unique identifier to the original outer packaging using an additional external sticker?

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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).

(2)  Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ 2016 L 32, p. 1).

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