In the case of immunological veterinary medicinal products containing GMO (genetically modified organisms), documentation as per Art. 28 of the Release Ordinance (RO, SR 814.911) must be submitted over and above the requirements of therapeutic products legislation.
According to Art. 43 RO, Swissmedic must submit the documentation accompanying the authorisation application to the specialist bodies (Federal Office for the Environment, Federal Office of Public Health, Federal Food Safety and Veterinary Office, Federal Office for Agriculture, Swiss Expert Committee for Biosafety and Federal Ethics Committee on Non-Human Biotechnology) for assessment. This means that Swissmedic may only approve a veterinary medicinal product with GMO if it meets the conditions of the Release Ordinance in addition to the requirements of therapeutic products legislation. The decision regarding the latter is made by the specialist bodies listed above.