In detail
Who needs an authorisation
Under § 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 § 4(14) AMG, manufacture comprises obtaining, preparing, compounding, processing, decanting (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 also applies to testing on which the release for placing on the market is based.
Exemptions
Subsection 2 exempts, among others, pharmacies in the course of normal pharmacy business, hospital operators authorised to dispense medicines, and wholesalers and retailers for certain decanting, 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 §§ 20b and 20c AMG (subsection 1a).
Competent authority and investigational medicinal 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 authorisation 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 § 14 AMG, its limitation to a site, products and dosage forms in § 16 AMG, and the three-month decision period in § 17 AMG. Imports from outside the EU and EEA additionally require an import authorisation under § 72 AMG.
In practice at A&O Pharma
A&O Pharma holds its own manufacturing authorisation under § 13 AMG. Under this authorisation we perform QP certification of investigational medicinal products under Regulation (EU) No 536/2014 and EU batch release of authorised medicinal products in line with Annex 16. We also package and label investigational medicinal products for clinical trials.
QP Batch ReleaseFrequently asked questions
Does labelling count as manufacture under the AMG?
Yes. Under § 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 § 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 § 13 AMG apply to investigational medicinal products?
Yes. Under § 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.
