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Legal aspects of the Ruma Marker System

The polyethylene glycols used by us find applications in many domains as carrier substance, because they are neither metabolised by the body nor do they react with other substances. They are

  • not medicines
  • not medical devices
  • not diagnostic agents

For example, cough syrup for children or sports ointments is areas of application.

From a legal perspective, it means the following:

  • No approval is required for a substance, which cannot do anything and does not do anything other than “just being there”. Various national and international authorities have confirmed this in writing. This includes EMA at European level and FDA/CDER for USA. You can find the corresponding communication in the Download-Bereich.
  • The same is applicable for the often asked question about CE Sign. CE-Zeichen.
  • As our PEGs do not do anything and cannot do anything, they do not come under laws, which forbid intervention with body functions during drug testing or make such interventions dependent on consent by the person to be tested. You can find more information about this under in Strafvollzug/Bewährungshilfe.
  • In case of pregnant patients, lhe attending physician reserves the right to take decision whether the application of marker is indicated.

You can find further documents on legal regulations as well as our certificate of clearance in Download Centre..