In detail
Grounds for refusal
Under Section 14(1) of the German Medicinal Products Act (AMG), the authorisation may only be refused if one of the grounds listed there applies. The grounds include:
There is not at least one person with the expertise under Section 15 AMG who is responsible for the activity under Section 19 AMG (no. 1).
The Qualified Person or the applicant lacks the necessary reliability (no. 3).
The Qualified Person cannot fulfil their obligations on a permanent basis (no. 4).
Suitable premises and equipment for manufacture, testing and storage are lacking (no. 6).
The manufacturer cannot ensure that manufacture and testing follow the current state of science and technology (no. 6a).
Further numbers concern medical expertise in the collection of blood and stem cells under the German Transfusion Act.
The Qualified Person across the provisions
Section 14 AMG names the function but does not set out its qualifications or duties in detail. The expertise is defined in Section 15 AMG, responsibility for each batch in Section 19 AMG and the release procedure in Section 16 of the Ordinance on Medicinal Products and Active Substance Manufacture (AMWHV). The heads of production and quality control, who must be independent of each other, are governed by Section 12 AMWHV. Under Section 16(7) AMWHV the authorisation holder must provide the Qualified Person with all necessary resources, and under Section 16(6) AMWHV the QP may only be deputised by persons with the expertise under Section 15 AMG. An unforeseen change must be notified to the authority without delay under Section 20 AMG.
Activities outside the site and deficiencies
Under subsection 4, parts of the activity may take place outside the manufacturer's own site, for example testing at contracted facilities or the manufacture of investigational medicinal products in a contracted pharmacy. This requires suitable premises and equipment there, work in line with the current state of science and technology, and that the Qualified Person can exercise their responsibility. If the application documents are deficient, the authority must under subsection 5 give the applicant the opportunity to remedy them within a reasonable period.
In practice at A&O Pharma
Through its interim management service, A&O Pharma provides Qualified Persons under Section 14 AMG on a temporary basis at your site. Under our own manufacturing authorisation pursuant to Section 13 AMG, our Qualified Persons release investigational medicinal products and perform EU batch release of authorised medicinal products.
Interim ManagementFrequently asked questions
Why is it called Qualified Person under Section 14 rather than Section 15 AMG?
The Act itself coins the term in Section 14(1) no. 1 AMG, which makes the function a condition for the manufacturing authorisation. Section 15 AMG only governs the expertise this person must demonstrate.
Can the authority refuse the authorisation on other grounds?
No. Under Section 14(1) AMG the authorisation may only be refused on the grounds listed there. If the documents have deficiencies that can be remedied, the authority must first give the applicant the opportunity to do so under subsection 5.
Who heads production and quality control?
This is governed not by the AMG but by Section 12 AMWHV. The duties of both heads must be laid down in writing or electronically, and the two functions must be independent of each other.
