What does § 15 AMG regulate?

Context

Under § 14(1) no. 1 AMG, a manufacturing authorisation may be refused if there is not at least one person with the expertise required under § 15 who is responsible for the activity described in § 19. The role is therefore called the Qualified Person under § 14 AMG. § 15 governs only the qualification and § 19 the responsibility for ensuring that each batch has been manufactured and tested in accordance with the law.

Basic rule under subsections 1 and 2

• Education: a licence to practise as a pharmacist (Approbation), or a completed university degree of at least four years in pharmacy, chemistry, pharmaceutical chemistry and technology, biology, human or veterinary medicine.

• Experience: at least two years in qualitative and quantitative analysis and other quality testing of medicinal products or veterinary medicinal products. With a degree of at least five years this period is reduced by one year, with a degree of at least six years by one and a half years.

• Course content: for the degree route, knowledge of core subjects such as experimental physics, analytical chemistry, pharmaceutical chemistry, microbiology, pharmacology, pharmaceutical technology and toxicology must be demonstrated. Missing subjects can be completed at a university after graduation.

Special rules under subsections 3 and 3a

For blood preparations, sera, vaccines and allergens, the practical experience is generally replaced by at least three years in medical serology or medical microbiology, with further variations for individual blood products. Advanced therapy medicinal products, xenogeneic medicinal products, tissue preparations, radiopharmaceuticals and active substances have their own experience requirements, for example three years in nuclear medicine or radiopharmaceutical chemistry for radiopharmaceuticals.

Where the experience must be gained, and moving to another authority

Under subsection 4 the practical experience must be gained at a site holding a manufacturing authorisation from an EU or EEA state, or from a state with which mutual recognition has been agreed under § 72a AMG. Once one authority has reviewed the expertise, subsection 6 generally allows the person to work in the area of another authority as well, unless there are reasonable grounds to believe that the expertise is not sufficient for the new activity.