In detail
Legal basis in the EU and in Germany
Article 40 of Directive 2001/83/EC requires an authorisation for total and partial manufacture, including packaging and presentation, and expressly also for imports from third countries. In EU terminology this is called the Manufacturing and Import Authorisation. The German Medicinal Products Act (AMG) implements it in two provisions: Section 13 AMG for manufacture and Section 72 AMG for imports from states that are neither EU Member States nor EEA contracting states. Sections 14 to 20a AMG apply accordingly to the import authorisation, including the requirement for a Qualified Person. For investigational and auxiliary medicinal products, Section 13(5) and Section 72(2a) AMG refer to Article 61 of Regulation (EU) No 536/2014.
What the authorisation covers
Under Section 4(14) AMG, manufacture also includes packaging, labelling and release. Testing on the basis of which a medicinal product is released also requires an authorisation under Section 13(1) AMG. Under Section 16 AMG the authorisation applies only to a specific site and to specific medicinal products and dosage forms. Where it covers testing, the type of testing must be stated.
Requirements and procedure
The competent authority is that of the federal state in which the site is located (Section 13(4) AMG). The authorisation may only be refused on the grounds listed in Section 14 AMG, for example if
- there is no Qualified Person with the expertise required under Section 15 AMG,
- suitable premises and equipment for manufacture, testing and storage are lacking,
- manufacture and testing in line with the current state of science and technology cannot be ensured.
Under Section 17 AMG the authority decides on an application within three months and, as a rule, on changes concerning products or premises within one month. Under Section 20 AMG any change to the particulars under Section 14 AMG must be notified in advance, and an unforeseen change of Qualified Person without delay.
Imports from third countries
In addition to the import authorisation, Section 72a AMG requires for many medicinal products and active substances a certificate or attestation that manufacture in the country of origin follows standards equivalent to EU GMP. Under Section 72a(1a) AMG this certificate requirement does not apply to medicinal products intended for clinical trials.
In practice at A&O Pharma
A&O Pharma holds its own manufacturing authorisation under Section 13 AMG. Under this authorisation we perform QP release of investigational medicinal products and EU batch release of authorised medicinal products in accordance with Annex 16. For our clients, release therefore takes place under an existing authorisation granted by the competent authority.
Medicinal Product ReleaseFrequently asked questions
Is a manufacturing authorisation sufficient for imports from third countries?
No. In Germany, commercial or professional imports from outside the EU and EEA require an import authorisation under Section 72 AMG. For many products a certificate under Section 72a AMG is required as well.
How long does it take to obtain a manufacturing authorisation?
Under Section 17 AMG the authority must decide within three months. If it asks the applicant to remedy deficiencies, the time limit is suspended until they are remedied or the set deadline expires.
Does a laboratory performing release testing need an authorisation?
Yes. Under the third sentence of Section 13(1) AMG, the authorisation requirement applies accordingly to testing on the basis of which a medicinal product is released.
