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sunset clause

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.

Legal basis:

  • implementation of Section 28 para 5 of Directive 2001/82 as amended by Directive 2004/28
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