Literature on the Ruma® Marker-System
Quod est demonstrandum.
The Ruma Marker-System is a scientific procedure, verified by numerous studies and confirmed in various expert opinions. Scientific backing is also provided in a vast number of publications.
On this page we would like to provide an overview of a range of published literature within the context of application of the Ruma Marker-System. Here you can find both our own content as well as information provided by external contributions.
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
Areas of application are, for example, cough syrup for children or sports ointments.
From a legal perspective, this means the following:
- No approval is required for a substance that cannot do anything and exhibits no activity beyond "just being there". Various national and international authorities have confirmed this in writing. This includes EMA at the European level and FDA/CDER for the USA.
- Statements on the applicability of the Ruma Marker-System have also been issued for the following countries:
- The same applies to CE marking - something we are asked about often.
- Since our PEGs don't do anything and have no abilities, they are not subject to laws that 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 our section Penal System and Probation Services.
- With pregnant patients, the decision of whether using the marker is indicated lies with the treating physician.
Our statement of no objection regarding the polyethylene glycols we use includes all relevant information on the legal classification of the substances.