In detail
Grounds for refusal
Under § 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 § 15 AMG who is responsible for the activity under § 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).
Other grounds in the list concern medical expertise in the collection of blood and stem cells under the German Transfusion Act.
How the provisions on the Qualified Person fit together
§ 14 AMG names the function but does not set out its qualifications or duties in detail. The expertise is defined in § 15 AMG, responsibility for each batch in § 19 AMG and the release procedure in § 16 of the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV). The Head of Production and the Head of Quality Control, who must be independent of each other, are governed by § 12 AMWHV. Under § 16(7) AMWHV the authorisation holder must provide the Qualified Person with all necessary resources, and under § 16(6) AMWHV the QP may only be deputised by persons with the expertise under § 15 AMG. An unforeseen change of QP must be notified to the authority without delay under § 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 that follows the current state of science and technology, and a Qualified Person who is able to exercise their responsibility. If the application documents are deficient, under subsection 5 the authority must 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 § 14 AMG at your site on a temporary basis. Under our own manufacturing authorisation (§ 13 AMG), our Qualified Persons certify investigational medicinal products and perform EU batch release of authorised medicinal products.
Interim ManagementFrequently asked questions
Why is it called Qualified Person under § 14 rather than § 15 AMG?
The term derives from § 14(1) no. 1 AMG, which makes the function a condition for granting the manufacturing authorisation. § 15 AMG only governs the expertise this person must demonstrate.
Can the authority refuse the authorisation on other grounds?
No. Under § 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.
Which rules govern the Head of Production and the Head of Quality Control?
Not the AMG but § 12 AMWHV. It requires the duties of both heads to be laid down in writing or electronically, and the two functions to be independent of each other.
