30.11.2020

Official Journal of the European Union

C 414/13

(Case C-602/19) (*)

(Reference for a preliminary ruling - Articles 34 and 36 TFEU - Free movement of goods - Quantitative restrictions - Measures having equivalent effect - Refusal to approve an amendment to the particulars and documents relating to a medicinal product which is the subject of a parallel import licence - Protection of the health and life of humans - Directive 2001/83/EC)

(2020/C 414/15)

Language of the case: German

Referring court

Parties to the main proceedings

Applicant: kohlpharma GmbH

Defendant: Bundesrepublik Deutschland

Operative part of the judgment

Articles 34 and 36 TFEU must be interpreted as precluding the competent authority of a Member State from refusing to approve amendments to the particulars and documents relating to a medicinal product which is covered by a marketing authorisation in another Member State and by a licence for parallel import into the first Member State, on the sole ground that the marketing authorisation of reference in the first Member State has expired and the proposed amendments are based on both the indications authorised in the other Member State for the parallel-imported medicinal product and the indications relating to a medicinal product with the same therapeutic indication, which is covered by a marketing authorisation in the two Member States concerned and which is essentially manufactured with the same active ingredient but in a different pharmaceutical form, where the parallel import licence at issue is still valid and there is insufficient evidence of a risk to the effective protection of the life and health of humans.

(*)

Language of the case: German