What is the difference between a raw material on analysis certificate and a licensed raw material?

A raw material on analysis certificate is different from a raw material with a permit number. A product with only an analysis certificate conforms to a certain monograph but offers no certainty about the overall quality of the raw material produced. It may theoretically be the case that there are impurities at the bottom of the raw material bulk; but because the sample at the top is taken conform. Labs can also make an analysis certificate based on 2-3 parameters, while actually more parameters need to be tested.

In a good quality system, the compliant sample analyzed must be representative of the entire bulk. This is not always the case for raw materials on analysis certificate.

However, if the raw material on analysis certificate comes from a supplier with permits, it can be assumed that this is the case.

A product with a license number provides considerably more quality assurance: the analysis has been carried out in accordance with an official monograph, the raw material comes from a synthesizer that is checked, the filling is done in clean rooms, ...

For that reason, the legislator has proposed that raw materials on analysis certificate may only be used in magistral preparations (non-official preparations). The idea behind this is that there is more flexibility to process other raw materials in a magisterial way and the doctor has more therapeutic freedom. After all, it is practically impossible to have all raw materials licensed.

However, there are a few exceptions that ensure that certain raw materials are not licensed: the raw material is a mixture (cream base) so that there is no unambiguous official monograph; the product only exists in nutritional qualities; ...