Loading...
Country's Decision or any other Communication (DEC)
  |  
BCH-DEC-BR-299955-1   |   PDF   |   Print   |  
| 
last updated: 13 Jul 2026
Amendment
No
General Information
Commercial Release of the Vaccine composed of genetically modified microorganisms of biological risk class 1, "Bovela ® - Modified live vaccine against type 1 and type 2 bovine viral diarrhea" - Technical Opinion No. 4594/2015.
EN
10 Jun 2015
No
Subject of the decision, notification, communication or declaration
  • Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
  • Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFP)
LMOs for intentional introduction into the environment
No
Yes
Yes
Yes
Yes
LMOs for direct use as food or feed, or for processing (LMOs-FFP)
  • LMOs for processing
No
Result of the decision
Approval of the import and/or use of the LMO(s) without conditions
Information sharing with other databases
Yes
Yes
Yes
No
No
LMO identification & risk assessment
  • BCH-LMO-SCBD-110717-2 Living Modified Organism Bovela® Vaccine
    Boheringer Ingelheim Química e Farmacêutica Ltda. | Production of medical or pharmaceutical compounds (human or animal) (Vaccines)
  • BCH-RA-BR-113493-1 Risk Assessment generated by a regulatory process Risk Assessment Bovela® Modified Live Vaccine against Type 1 and Type 2 Bovine Diarrhea Virus
    Bovela® Vaccine | BVDV-1, BVDV-2, Production of medical or pharmaceutical compounds (human or animal)
Document on the decision, communication, notification or declaration