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Eur J Pharm Sci. 2016 May 25;87:47-51. doi: 10.1016/j.ejps.2015.10.014. Epub 2015 Oct 19.

Licensing failure in the European decentralised procedure.

Author information

1
Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, PO Box 80 082, 3508 TB Utrecht, the Netherlands; Medicines Evaluation Board, PO Box 8275, 3503 RG Utrecht, the Netherlands. Electronic address: J.Langedijk@uu.nl.
2
Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, PO Box 80 082, 3508 TB Utrecht, the Netherlands; Division of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, PO Box 80 082, 3508 TB Utrecht, the Netherlands. Electronic address: H.Ebbers@uu.nl.
3
Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, PO Box 80 082, 3508 TB Utrecht, the Netherlands. Electronic address: A.K.Mantel@uu.nl.
4
Medicines Evaluation Board, PO Box 8275, 3503 RG Utrecht, the Netherlands. Electronic address: AG.Kruger@cbg-meb.nl.
5
Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, PO Box 80 082, 3508 TB Utrecht, the Netherlands; Medicines Evaluation Board, PO Box 8275, 3503 RG Utrecht, the Netherlands. Electronic address: H.G.M.Leufkens@uu.nl.

Abstract

The majority of the licensing applications in the European Union are submitted via the decentralised procedure. Little is known about licensing failure (i.e. refusal or withdrawal of a marketing authorisation application) in the EU decentralised procedure compared to the EU centralised procedure and the approval procedure in the United States. The study aim was to determine the frequency of and determinants for licensing failure of marketing authorisation applications submitted via this procedure. We assessed procedures that failed between 2008 and 2012 with The Netherlands as leading authority and assessed the remaining major objections. In total 492 procedures were completed, of which 48 (9.8%) failed: 8 refused, 40 withdrawn. A wide variety of major objections was identified and included both quality (48 major objections) and clinical (45 major objections) issues. The low failure rate may be related to the regular interaction between competent authorities and applicants during the procedure. Some degree of licensing failure may be inevitable, as it may also be affected by the financial feasibility or willingness to resolve major objections, as well as other reasons to withdraw an application besides the raised major objections.

KEYWORDS:

Bioequivalence; Decentralised procedure; Failure; Generic; Marketing authorization; Therapeutic equivalence

PMID:
26493584
DOI:
10.1016/j.ejps.2015.10.014
[Indexed for MEDLINE]

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