Making notifications regarding medicinal products with standard authorization
Source: BUS Rheinland-Pfalz
The Federal Ministry of Health (BMG) can exempt certain medicinal products from the obligation to obtain individual marketing authorization. This exemption is called standard authorization and is granted by a legal ordinance issued by the BMG. The prerequisite for this is that a risk to humans and animals can be ruled out. To this end, the requirements for quality, efficacy and safety must be proven.
In the case of standard marketing authorizations, the spectrum of medicinally active ingredients ranges from chemical substances such as paracetamol to effective teas.
If you as a pharmaceutical entrepreneur use a standard marketing authorization, you must notify the Federal Institute for Drugs and Medical Devices (BfArM). This obligation to notify also applies if you no longer have a standard marketing authorization or if there are changes that require notification.
In such a notification, you must provide the following information, among others:
- manufacturer
- the name used
- non-active ingredients used, unless they are specified by law, and
- the actual composition of the medicinal product, insofar as differences are permitted in this respect.