Standard approval
The German Federal Ministry of Health can issue standard approvals on the basis of an authorization in Section 36 of the Medicines Act .
A standard authorization exempts certain drugs from the authorization requirement . The prerequisite is that no risk to humans or animals is to be feared. The approval of the Federal Council , the Federal Ministry of Economics and Technology and possibly other competent federal ministries is required.
There are standard approvals , for example, for many medicinally effective teas (e.g. based on Senna alexandrina ), but also for drugs with chemically defined substances such as acetylsalicylic acid or paracetamol .
Notification requirement
Since January 1, 2010, according to Section 67 (5) AMG, the use, but also the non-use of standard approvals, is subject to notification for all public pharmacies in Germany. H. the Federal Institute for Drugs and Medical Devices must be informed whether and, if so, which standard approvals are used by the respective pharmacy, regardless of whether the drug is only available for pharmacy or over the counter.
