Documents · Authorisation
Manufacturing and Import Authorisation (MIA) Efringen-Kirchen
Manufacturing and import authorisation (MIA) under §§ 13 and 72 AMG for the Efringen-Kirchen site.
The authorisation under §§ 13 and 72 AMG (manufacturing and import authorisation, MIA) permits the manufacture and import of medicinal products. It is the legal basis that allows A&O Pharma to release batches under its own authorisation, in accordance with Annex 16 of the EU GMP Guide, Delegated Regulation (EU) 2017/1569 and Commission guideline C(2017) 8179 for investigational medicinal products, and § 16 AMWHV.
For clients, this means that you do not need your own manufacturing authorisation to have a batch certified for the EEA market. Release under our authorisation requires the corresponding registration.
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