A marketing authorization is not a finish line — it's the start of a standing set of duties. As the authorization holder in Germany you must appoint named officers, run a live safety system, and keep the whole supply chain GxP-compliant. Here's what that actually involves.
As a marketing-authorization holder (MAH) you carry continuing legal obligations in Germany: a pharmacovigilance system with a Europe-based QPPV and a national graduated-plan officer (Stufenplanbeauftragter); an information officer for advertising and scientific claims; GMP / GDP compliance and qualified-person batch release across the supply chain; and advertising that complies with the HWG. These are staffed, audited, ongoing functions — not one-time filings — and they don't stop until the authorization does.
Most entrants budget for getting approved. Fewer budget for staying compliant — which is a permanent, staffed operation.
Under the German Medicines Act (Arzneimittelgesetz, AMG) and EU pharmacovigilance law, holding an authorization means running live safety, quality and information functions for as long as the product is on the market. Regulators expect named, reachable people in defined roles — and inspect against them. For a foreign company without a German affiliate, these functions have to be built or coordinated locally before launch, not after.
You don't get authorized and walk away. You get authorized and staff up.
German and EU law requires specific, named responsible persons. Regulators expect to reach them by name — and hold the company accountable through them.
These roles can be filled in-house by a German affiliate, or contracted to specialist service providers — but they must be real, qualified and continuously staffed. A gap here is a compliance finding, not a paperwork delay.
Quality obligations run across the whole supply chain, from manufacturing to the pharmacy shelf.
For imported products in particular, the QP-release and importation setup is often the practical bottleneck — and it has to exist before the first box ships.
Findings can suspend batch release, trigger recalls or, in serious cases, put the authorization itself at risk. The obligations are continuous because the oversight is continuous.
In a focused session we outline the officers you'll need, the PV and GxP setup, the batch-release path for imports, and how it all lines up with your reimbursement and commercial plan.