Li­te­ra­ture on 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:

Austria

Denmark

Finland

Great Britain

The Netherlands

Norway

• 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.

State­ment of no ob­jec­tion