(Case C-165/21 Request for a preliminary ruling from Københavns Byret (Denmark) lodged on 11March 2021– Orion Corporation v Lægemiddelstyrelsen

Request for a preliminary ruling from Københavns Byret (Denmark) lodged on 11March 2021– Orion Corporation v Lægemiddelstyrelsen

(Case C-165/21)

Language of the case: Danish

Referring court

Københavns Byret

Parties to the main proceedings

Applicant: Orion Corporation

Defendant: Lægemiddelstyrelsen

Intervener: Teva Danmark A/S

Questions referred

In the light of Article12(2) of Regulation No726/2004¹ (formerly Article12[2] of Regulation No2309/1993)² and Section 2.3 of Chapter 2 of the EU Commission’s Notice to Applicants, can a medicinal product, such as Precedex at issue in this case, which was granted a marketing authorisation in a Member State in accordance with its national rules prior to the Member State’s accession to the European Union, but after the medicinal product received a negative evaluation from the CPMP [now CHMP] under Regulation No2309/1993 on the same clinical basis, in a situation where the national marketing authorisation has not been updated with new clinical documentation or related expert report, after the Member State’s accession to the European Union, be considered to be a reference medicinal product within the meaning of Article10(2)(a) of Directive 2001/83 and can therefore provide the basis for a ‘global marketing authorisation’ under Article6[1] of Directive 2001/83?³

Can a medicinal product, such as Precedex at issue in this case, which is authorised in a Member State under its national rules prior to the Member State’s accession to the European Union, without the competent authority of the Member State having access to the restricted part of the ASM in the European Drug Master File procedure (now the Active Substance Master File procedure), in a situation where the national marketing authorisation has not been updated with the restricted part of the ASM after the Member State’s accession to the European Union, be considered to be a reference medicinal product within the meaning of Article10(2)(a) of Directive 2001/83 and can therefore provide the basis for a ‘global marketing authorisation’ under Article6[1] of Directive 2001/83?

Is the answer to Question 1 or 2 affected by the fact the national marketing authorisation concerned cannot provide the basis for mutual recognition under Article28 of Directive 2001/83?

Is the national competent authority of a reference Member State or a Member State concerned under the decentralised procedure provided for in Article28 of Directive 2001/83 for a generic medicinal product, entitled or required to refuse the use of a medicinal product as a reference medicinal product if the medicinal product in question is authorised in another Member State before its accession to the European Union, under the circumstances set out in Question 1 and/or 2?

Is the answer to Question 4 affected by the fact that the national competent national authority of a reference Member State or Member State concerned had information showing that the medicinal product in question had received a negative evaluation from the CPMP under Regulation No2309/1993 prior to authorisation in another Member State before that Member State’s accession to the European Union?

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¹ Regulation (EC) No726/2004 of the European Parliament and of the Council of 31March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L136, p.1).² Council Regulation (EEC) No2309/93 of 22July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L214, p.1).³ 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).