Art. 48 Federal Act of 8 October 2004 on the Transplantation of Organs, Tissues and Cells (Act) - Regulations of the Federal Council
Art. 48 Act · Regulations of the Federal Council
The Federal Council shall issue regulations concerning the handling of organs, tissues and cells of animal origin. In particular, it shall specify: a. requirements concerning the handling of donor animals; b. requirements concerning the quality of the animal organs, tissues or cells; c. the requirements concerning tests to monitor the health of recipients and donor animals; d. the preconditions for authorisation and the authorisation procedure; e. the duration and nature of retention of recorded data and transactions and biological samples that have been taken; f. the pathogenic agents or markers for which tests must be carried out; g. the circumstances in which organs, tissues and cells of animal origin for which the test results are reactive may be transplanted; h. the labelling of organs, tissues or cells of animal origin which have been obtained from genetically modified animals; i. the requirements concerning: 1. information of and consent by the recipient, 2. information of medical personnel and their consent to measures affecting them, and 3. information of the recipient's close contacts.
The Federal Council may: a. restrict or prohibit the use of certain species of animals for transplantation purposes; b. grant exemptions from mandatory testing according to Article 45 if it can be ensured by other means that infection with pathogenic agents can be excluded; c. specify other duties of the holder of the authorisation and duties of the recipient if required by changing circumstances; d. declare Articles 6–42 to be applicable to the handling of organs, tissues or cells of animal origin.