Article 9 of the Veterinary Medicines Decree states that the
registration of veterinary medicines that have not been marketed
for three successive years legally lapses. This condition is termed
the sunset clause.
‘Marketed’ is understood to mean: the actual availability for
use in the Netherlands which can, if necessary, be demonstrated by
a sales transaction of at least one packaging to a legitimate
person in this respect.
- implementation of Section 28 para 5 of Directive 2001/82 as
amended by Directive 2004/28