Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting, supported by ACT EU, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 11 September 2024, 13:00 (CEST) to 11 September 2024, 17:30 (CEST)

Agenda of the CHMP meeting 16-19 September 2024

Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6 - Scientific guideline

Withdrawn application: Sialanar, 06/09/2024

Summary of opinion: Fasenra, 19/09/2024 Positive

Summary of opinion: Zavicefta, 19/09/2024 Positive

Clinical Trial Information System (CTIS) evaluation timelines

Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline

Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline

Summary of opinion: Yurvac RHD, 12/09/2024 Positive