In detail
Who needs an authorisation
Under Section 13(1) of the German Medicinal Products Act (AMG), an authorisation is required for the commercial or professional manufacture of
medicinal products,
active substances of human, animal or microbial origin and active substances produced by genetic engineering,
other substances of human origin intended for the manufacture of medicinal products.
Under Section 4(14) AMG, manufacture comprises obtaining, preparing, compounding, processing, transferring including filling, packaging, labelling and release. Anyone who only packages, labels or releases is therefore a manufacturer within the meaning of the Act. Under the third sentence of subsection 1, the authorisation requirement applies accordingly to testing on the basis of which release for placing on the market is declared.
Exemptions
Subsection 2 exempts, among others, pharmacies within normal pharmacy operations, hospital operators entitled to dispense, and wholesalers and retailers for certain transfer, packaging and labelling activities. Under subsection 2a these exemptions generally do not apply to blood preparations, tissue preparations, sera, vaccines, allergens, advanced therapy medicinal products, and xenogeneic and radioactive medicinal products. Tissues and tissue preparations are subject to separate authorisations under Sections 20b and 20c AMG (subsection 1a).
Competent authority and investigational products
The authorisation is granted by the authority of the federal state in which the site is or will be located (subsection 4). For blood and tissue preparations, sera, vaccines, allergens, advanced therapy medicinal products, products manufactured by genetic engineering and certain other product groups, it decides in consultation with the competent federal authority. Under subsection 5, the authorisation to manufacture investigational and auxiliary medicinal products is granted in accordance with Article 61 of Regulation (EU) No 536/2014. Under subsection 6 the holder must enable the Qualified Person to carry out their duties.
Link to other provisions
The grounds on which the authorisation may be refused are set out in Section 14 AMG, its limitation to a site, products and dosage forms in Section 16 AMG, and the three-month decision period in Section 17 AMG. Imports from outside the EU and EEA additionally require an import authorisation under Section 72 AMG.
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 under Regulation (EU) No 536/2014 and EU batch release of authorised medicinal products in accordance with Annex 16. We also package and label trial medication for clinical studies.
Medicinal Product ReleaseFrequently asked questions
Does labelling count as manufacture under the AMG?
Yes. Under Section 4(14) AMG, packaging and labelling are part of manufacture, as is release. Anyone carrying out these activities commercially or professionally generally needs an authorisation under Section 13 AMG unless an exemption applies.
Which authority grants the manufacturing authorisation?
The competent authority of the federal state in which the site is or will be located. For certain product groups such as vaccines or advanced therapy medicinal products, it decides in consultation with the competent federal authority.
Does Section 13 AMG apply to investigational medicinal products?
Yes. Under Section 13(5) AMG, the authorisation to manufacture investigational and auxiliary medicinal products is granted in accordance with Article 61 of Regulation (EU) No 536/2014.
