Olainfarm v Latvijas Republikas Veselibas ministrija: ECJ 23 Oct 2014

ECJ Judgment – Reference for a preliminary ruling – Approximation of laws – Industrial policy – Directive 2001/83/EC – Medicinal products for human use – Article 6 – Marketing authorisation – Article 8(3)(i) – Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials – Derogations relating to pre-clinical tests and clinical trials – Article 10 – Generic medicinal products – Concept of ‘reference medicinal product’ – Whether the holder of a marketing authorisation for a reference medicinal product has an individual right to oppose the marketing authorisation of a generic of the reference product – Article 10a – Medicinal products of which the active substances have been in well-established medicinal use within the European Union for at least 10 years – Whether it is possible to use a medicinal product for which authorisation has been granted on the basis of the derogation provided for in Article 10a as a reference medicinal product for the purpose of obtaining a marketing authorisation for a generic product

T von Danwitz, P
C-104/13, [2014] EUECJ C-104/13
Bailii
Directive 2001/83/EC 8(3)(1)

European

Updated: 22 December 2021; Ref: scu.538006