In detail
Legal basis
Anyone wishing to practise as a pharmacist in Germany needs the Approbation under Section 2(1) of the Federal Pharmacists' Code (Bundes-Apothekerordnung, BApO). Under Section 4 BApO it is granted on application if, among other things, the pharmaceutical examination has been passed after a total training period of five years, twelve months of which are practical training, there is no unreliability or health-related unsuitability, and the applicant has the necessary command of German. Section 2(3) BApO expressly counts the development, manufacture and testing of medicinal products in the pharmaceutical industry as pharmaceutical activities.
Relevance for the Qualified Person
Section 15(1) of the German Medicinal Products Act (AMG) sets out two ways to prove the expertise required of a Qualified Person under Section 14 AMG: the Approbation as a pharmacist, or a certificate of a completed university degree of at least four years in pharmacy, chemistry, pharmaceutical chemistry and technology, biology, human or veterinary medicine. The requirement for professional experience follows this list in the statute and therefore applies to both routes: at least two years in qualitative and quantitative analysis and other quality testing of medicinal products.
Additional requirements
Proof of the core subjects under Section 15(2) AMG, such as analytical chemistry, pharmacology and toxicology, is required only for the degree route.
Under Section 15(4) AMG the practical experience must be gained at a site holding a manufacturing authorisation from an EU or EEA state or a state with a mutual recognition agreement. This also applies to pharmacists.
For blood preparations, sera, vaccines, allergens, advanced therapy medicinal products and radiopharmaceuticals, Section 15(3) and (3a) AMG replace the practical experience with specific requirements.
Under Section 20 AMG a change of Qualified Person must be notified to the authority in advance, or without delay if the change is unforeseen.
A common misunderstanding
The Approbation alone does not make someone a Qualified Person. Without practical experience in the quality testing of medicinal products, the expertise under Section 15 AMG has not been demonstrated. Conversely, the Approbation is not mandatory: chemists, biologists or physicians with a suitable degree can also become a Qualified Person.
In practice at A&O Pharma
A&O Pharma provides Qualified Persons under Section 14 AMG for batch release under its own manufacturing authorisation under Section 13 AMG. Through interim management, a Qualified Person can also work at your site for a limited period, for example if the current post holder becomes unavailable at short notice.
Medicinal Product ReleaseFrequently asked questions
Is the Approbation as a pharmacist enough to become a Qualified Person?
No. Section 15(1) AMG additionally requires at least two years of practical experience in qualitative and quantitative analysis and other quality testing of medicinal products, gained at a site holding a manufacturing authorisation.
Can you become a Qualified Person without the Approbation?
Yes. A completed university degree of at least four years, for example in chemistry, biology or medicine, is sufficient if the core subjects under Section 15(2) AMG are demonstrated and the practical experience has been gained.
How long does it take to obtain the Approbation?
Section 4 BApO requires a total training period of five years, twelve months of which are practical training, completed by the pharmaceutical examination.
