Tobias, T. J.
Vernooij, J. C. M.
van Nes, A.
Article History
Received: 28 August 2022
Accepted: 9 December 2022
First Online: 16 January 2023
Declarations
:
: The study was approved by the Dutch Medicines Authority (CBG) as a regulatory clinical trial for extension of the registration dossier of MS Ferrosafe, an iron supplement product, by needle-free administration. According to EC Directive 2010/63/EU and the Dutch law on animal experimentation (Wod), this law does not apply to animals used in veterinary clinical trials (Wod, article 1b, sub 7-c). Clinical trials therefore are exempted from an ethical evaluation by the Central Committee on Animal Experimentation (CCD). The study design was however reviewed by the local Animal Welfare Body of Utrecht University (AWB Utrecht) and the exemption for formal animal welfare evaluation was confirmed by both the CCD and the AWB Utrecht.
: Not applicable.
: The authors declare that they have no competing interests.