In detail
Context
Under Section 14(1) no. 1 AMG, a manufacturing authorisation is refused if there is not at least one person with the expertise required under Section 15 who is responsible for the activity described in Section 19. The role is therefore called the Qualified Person under Section 14 AMG. Section 15 governs only the qualification; Section 19 governs 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: Approbation as a pharmacist, 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 experience is gained and change of 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 Section 72a AMG. Once an authority has reviewed the expertise, subsection 6 generally allows the person to work within the remit of another authority, unless there are reasonable grounds to believe that the expertise is not sufficient for the new activity.
In practice at A&O Pharma
A&O Pharma's Qualified Persons carry out QP release of investigational medicinal products and EU batch release of authorised medicinal products under the company's own manufacturing authorisation under Section 13 AMG. Through interim management, a Qualified Person under Section 14 AMG can also work at your site for a limited period, for example to cover a vacancy.
Medicinal Product ReleaseFrequently asked questions
What is the difference between Section 14 and Section 15 AMG?
Section 14 AMG sets out when a manufacturing authorisation is refused and requires at least one Qualified Person. Section 15 AMG defines the education and professional experience this person must demonstrate.
Does the two-year experience requirement also apply to pharmacists?
Yes. In the statutory text the requirement follows both educational routes and therefore also applies to holders of the pharmacist Approbation.
Can the experience period be shortened?
Yes. Under Section 15(1) sentence 3 AMG it is reduced by one year for a university degree of at least five years and by one and a half years for a degree of at least six years.
