Documents · Authorisation
Manufacturing / Import Authorisation Efringen-Kirchen
Authorisation under § 13 AMG (MIA) for manufacturing and import at the Efringen-Kirchen site.
The authorisation under § 13 AMG (Manufacturing and Importation Authorisation, MIA) permits the manufacture and import of medicinal products. It is the legal prerequisite for A&O Pharma to release batches under its own authorisation, in accordance with EU GMP Guide Annex 13 and 16 and AMWHV § 16.
For clients, this means: you do not need your own manufacturing authorisation to place a batch on the market in the EEA. A corresponding registration is required for release under our authorisation.
Related
The service behind this document.
If you were looking for this document, this area is relevant to you, with a permanent contact named in person.
