(Case C-147/20 Request for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 23March 2020— Novartis Pharma GmbH v Abacus Medicine A/S

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

(Case C-147/20)

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

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 Article54(o) and Article47a of Directive 2001/83/EC¹ can, in the event that the parallel trader retains that original packaging, be replaced in compliance with Article47a(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?

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 Articles10, 24 and 30 of Regulation (EU) 2016/161,² or may be overlooked in a superficial inspection?

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?

Is Article5(3) of Regulation (EU) 2016/161 to be interpreted as meaning that the barcode containing the unique identifier within the meaning of Article3(2)(a) of that regulation must be printed directly on the packaging, so that Article5(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 6November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L311, 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).