# C_2019357EN.01002401.xml

| 21.10.2019 | EN | Official Journal of the European Union | C 357/24 |
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21.10.2019

EN

Official Journal of the European Union

C 357/24

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Request for a preliminary ruling from the Verwaltungsgericht Köln (Germany) lodged on 9 August 2019 — Kohlpharma GmbH v Bundesrepublik Deutschland

(Case C-602/19)

(2019/C 357/30)

Language of the case: German

Referring court

Verwaltungsgericht Köln

Parties to the main proceedings

Applicant: Kohlpharma GmbH

Defendant: Bundesrepublik Deutschland

Questions referred

| 1. | Do the principle of the free movement of goods laid down in Article 34 TFEU and the principles, developed on that basis, of the parallel import of medicinal products require the national authorising authority to consent to an amendment to the indications regarding the dosage of a parallel-imported medicinal product even if the reference authorisation has expired and the amendment is substantiated with an adoption of the indications regarding a domestically produced medicinal product with essentially the same active ingredient and different form of administration in combination with the indications approved in the exporting State for the parallel-imported medicinal product? |
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1.

Do the principle of the free movement of goods laid down in Article 34 TFEU and the principles, developed on that basis, of the parallel import of medicinal products require the national authorising authority to consent to an amendment to the indications regarding the dosage of a parallel-imported medicinal product even if the reference authorisation has expired and the amendment is substantiated with an adoption of the indications regarding a domestically produced medicinal product with essentially the same active ingredient and different form of administration in combination with the indications approved in the exporting State for the parallel-imported medicinal product?

| 2. | Against the background of Articles 34 and 36 TFEU, can the national authority refuse to consent to such an amendment by noting that parallel importers are exempt from the obligation to submit periodic safety reports and, due to the lack of a domestic reference authorisation, there is no current data on the risk-benefit assessment, the existing domestic authorisation concerns a different form of administration and relates to a different active ingredient concentration from the authorisation for the same form of administration in the exporting State, and the combination of two forms of administration in the information texts is moreover inconceivable? |
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2.

Against the background of Articles 34 and 36 TFEU, can the national authority refuse to consent to such an amendment by noting that parallel importers are exempt from the obligation to submit periodic safety reports and, due to the lack of a domestic reference authorisation, there is no current data on the risk-benefit assessment, the existing domestic authorisation concerns a different form of administration and relates to a different active ingredient concentration from the authorisation for the same form of administration in the exporting State, and the combination of two forms of administration in the information texts is moreover inconceivable?

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