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 the manufacturing and import authorisation (MIA). The German Medicinal Products Act (AMG) implements it in two provisions: § 13 AMG for manufacture and § 72 AMG for imports from states that are neither EU Member States nor EEA contracting states. §§ 14 to 20a AMG apply accordingly to the import authorisation, so a Qualified Person is required here as well. For investigational and auxiliary medicinal products, § 13(5) and § 72(2a) AMG refer to Article 61 of Regulation (EU) No 536/2014.
What the authorisation covers
Under § 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 § 13(1) AMG. Under § 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 (§ 13(4) AMG). The authorisation may only be refused on the grounds listed in § 14 AMG, for example if
- there is no Qualified Person with the expertise required under § 15 AMG,
- suitable premises and equipment for manufacture, testing and storage are lacking,
- it cannot be ensured that manufacture and testing follow the current state of scientific and technical knowledge.
Under § 17 AMG the authority decides on an application within three months and, as a rule, on changes to products or premises within one month. Under § 20 AMG any change to the particulars under § 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, § 72a AMG requires, for many medicinal products and active substances, a certificate or attestation confirming that they are manufactured in the country of origin to standards equivalent to EU GMP. Under § 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 § 13 AMG. On this basis we carry out QP certification of investigational medicinal products and EU batch release of authorised medicinal products in accordance with Annex 16. For our clients, this means release takes place under an existing authorisation granted by the competent authority.
QP Batch 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 § 72 AMG. For many products a certificate under § 72a AMG is required as well.
How long does it take to obtain a manufacturing authorisation?
Under § 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 deadline set for doing so expires.
Does a laboratory performing release testing need an authorisation?
Yes. Under the third sentence of § 13(1) AMG, the authorisation requirement applies accordingly to testing on the basis of which a medicinal product is released.
