Marketing authorisations were initially limited to five years according to Section 31 of the Medicinal Product Act (AMG). The authorisation for a veterinary medicinal product expired five years after it was granted, unless an application for renewal was submitted by the marketing authorisation holder. Initially, renewals were carried out every five-years; with the 14th AMG amendment, only a single renewal procedure after five years was required and thereafter the marketing authorisation was valid for an unlimited period. For a renewal, the marketing authorisation holder had to submit a revised version of the documentation with regard to quality, safety and efficacy as well as a consolidated list of the changes. The BVL re-examined the risk-benefit balance on the basis of these documents and issued a renewal notification if the assessment was positive.

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