Lobbying on Details for the application dossier for the authorisation of a veterinary medicine | OpenLobby.EU

Details for the application dossier for the authorisation of a veterinary medicine

Food safety

This initiative will provide the technical details for the application dossier for a marketing authorisation of a veterinary medicine.

Links

Public consultation

ID: 11574

Lobbying Activity

4 responses

Consultation response

European Confederation of Pharmaceutical Entrepreneurs, 8 Dec 2020

Please find attached the comments of the European Confederation of Pharmaceutical Entrepreneurs AISBL (EUCOPE).

Consultation response

AnimalhealthEurope, 8 Dec 2020

AnimalhealthEurope welcomes the opportunity to comment on this draft delegated act. We are pleased to see improvements in the text from the EMA Scientific Advice including the inclusion of bacteria in the scope of the multistrain dossier, the approach to field efficacy trials for vaccines, the…

Consultation response

Access VetMed, 5 Dec 2020

EGGVP is grateful for the opportunity to provide comments on this draft delegated act. Our comments are enclosed. Please note these refer to the Annex only.

Consultation response

, 4 Dec 2020

Lack of data available on environmental risk assessment for veterinary medicinal products other than biological veterinary medicinal products Environmental risk assessments are necessary in order to obtain marketing authorisation for veterinary medicinal products. When laboratory testing with…