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: ghazarian@gmx.de
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