Limited market applications in the EU: experiences under Regulation EU 2019/6
Introduction
In September 2009, the European Medicines Agency (EMA) first implemented its MUMS (MinorUse Minor Species)/limited market policy for veterinary medicinal products (VMPs). The aim of this initiative is to facilitate market access for products that would otherwise not be developed under the current market conditions by two measures: limited data requirements and financial incentives (fee reductions/exemptions). On January 28, 2022, Regulation EU 2019/6 became applicable, repealing Directive 2001/82/EC. The current Regulation introduced for the first time the legal basis for granting marketing authorizations for limited market products.
DATE »
03.07.2023
AUTHORS »
Huettinger, C., Hellmann, K.
Klifovet GmbH, Part of the Argenta Group,
PUBLISHED »
EAVPT Congress 2023, Bruges, Belgium