Establishments that wish to have their test facilities listed in the register (Art. 14) must apply to the notification authority (Art. 8).
For each test facility, the application must include the following information:
name and address of the test facility;
site plans documenting the use of the individual premises;
organisation charts documenting the name and position of the test facility management, the personnel in charge of quality assurance and the study directors;
name and address of a contact person;
standard operating procedures for quality assurance;
a list of all standard operating procedures;
the relevant areas of expertise;
a list of all studies planned over the next six months with the relevant schedules;
a list of all studies conducted over the last six months, or still being carried out, in the relevant areas of expertise.
On request from the competent authority, the establishments must submit other information.
If conditions in a test facility are substantially modified, the establishment must submit a new application without delay. In this case the list pursuant to paragraph 2 letter i must include all studies since the last inspection. In the event of any doubt, the establishment must refer without delay to the notification authority to determine whether the modification is substantial. The notification authority gives its decision in agreement with the competent authorities concerned.