EU marketing authorization subsequent to dissolution of the transferor and prior to effective transfer

Article type: Research Article

Authors: Ghazarian, Lucyne | Koenig, Christian

Affiliations: Center for European Integration Studies (ZEI), University of Bonn, Bonn, Germany | ZEI and Member of the Faculty of Law, University of Bonn, Bonn, Germany

Note: [] Corresponding author: Lucyne Ghazarian, Center for European Integration Studies (ZEI), University of Bonn, Bonn, Germany. E-mail: [email protected]

Abstract: Regulation (EC) No 2141/96 holds no explicit provision about the validity of a EU centralised marketing authorisation for a medicinal product during the time gap between dissolution of the transferor after granting of a favourable opinion by the EMA and effective authorisation by the European Commission. Marketing authorisations for medicinal products in terms of Article 3(1) of Regulation (EC) No 726/2004 are personal administrative acts, which, in principle, excludes a transfer unless otherwise and under exceptional terms allowed (enumeratio ergo limitatio). Regulation (EC) No 2141/96 constitutes such an exemption, laying down the procedural rules for a transfer of marketing authorisation. Though for this particular case the regulation holds no explicit provision about validity during the time gap. Despite the absence of a provision about validity the time gap has to be filled by teleological interpretation to ensure that amongst several possible interpretations the one will prevail which best guarantees the practical effect of existing Community law. The examination of the objectives of the Regulations (EC) No 726/2004 and No 2141/96 indicate the validity of the marketing authorisation and consequently the transferee's authorisation during that period of time.

Keywords: Centralised marketing authorisation, transfer, dissolution of the transferor

DOI: 10.3233/PPL-130358

Journal: Pharmaceuticals, Policy and Law, vol. 15, no. 1-2, pp. 29-35, 2013