The Ministry of Infrastructure and Water Management (IenWMinistry of Infrastructure and Water Management ) is responsible for the regulations that protect people and the environment during activities involving genetically modified organisms (GMOs) and has the task of developing policy and regulations.

The Minister of IenW makes decisions on permit applications on the basis of the Genetically Modified Organisms Decree.

Definition of parties associated with the clinical research

Applicant/permit holder: the applicant/permit holder is the legal entity that bears final responsibility for the work to be carried out. This is usually the Executive Board (directors) of the hospital (the institution) where the treatment is to be carried out.

The permit holder must be able to enforce compliance with the licensing regulations when the work is carried out. It is therefore essential that the permit holder has authority over the employees involved in the clinical activities. The employees must therefore be employed directly by the permit holder. In cases where the permit holder does not have authority over an employee, for example because a physician providing treatment is a member of a partnership that is independent of the permit holder, a work agreement must be arranged for the execution of the licensed work, for example by means of a zero-hours employment contract with the applicant. With regard to the responsibility for any non-clinical activities that are not carried out in the institution in question, a contract must be entered into with the executing party (or parties) of these activities, such that the final responsibility remains with the permit holder.