Pharmaceutical compliance support in Germany
Local rules, connected to your global model.
Local compliance support for pharmaceutical and biotech companies working in Germany, connecting German law and the FSA's self-regulatory codes to your global governance, with a named DACH business partner.
Discuss this service
What we can take on
Pharmaceutical compliance in Germany: scope of support
HCP and patient organisation engagement review
Local transparency and disclosure requirements
Promotional and non-promotional material review
Market-entry compliance assessment
Responsible person and local representative support
What this gives you
Germany requirements built into your global processes
A named local partner for questions and escalation
Local support without unnecessary fixed headcount
The rules in Germany
What shapes compliance in Germany…
A short guide to the main legal and self-regulatory frameworks. Each summary links to its official source below.
FSA self-regulatory codes
The FSA (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V.) is the industry's self-regulatory body; its member companies account for around 75% of the German pharmaceutical market. Its codes cover collaboration with healthcare professionals and medical institutions (FSA-Kodex Fachkreise), cooperation with patient organisations (FSA-Kodex Patientenorganisationen) and transparency (FSA-Transparenzkodex). Breaches can lead to fines and, in serious cases, public reprimands.
Advertising of medicines: the HWG
The Heilmittelwerbegesetz (HWG) governs advertising in the healthcare sector. Section 7 prohibits offering, announcing or granting gifts and other promotional benefits, and prohibits healthcare professionals from accepting them, subject to narrow exceptions such as items of low value.
Anti-corruption in healthcare: §§ 299a and 299b StGB
The German Criminal Code makes it an offence for a healthcare professional to request or accept an advantage (§ 299a), and for anyone to offer or grant one (§ 299b), in return for unfairly favouring another party when prescribing medicines, medical aids or devices, purchasing them for direct use, or referring patients or examination material.
Transparency and disclosure
Under the FSA-Transparenzkodex, member companies commit to transparency about their collaboration with healthcare professionals and healthcare organisations, alongside the EFPIA Code disclosure framework that applies across Europe.
Primary references
Your local partner
Hans provides compliance business-partner support across DACH, bringing local context into global governance and operating models.
This overview is informational and does not constitute legal advice. Scope and application should be confirmed for the organisation, market, activity and counterparty in question. Sources checked September 2026.
Questions, answered
Pharmaceutical compliance in Germany FAQs
Do the FSA codes apply to our company?
The FSA codes bind FSA member companies. Whether and how they apply to you depends on membership and your activities in Germany, and we confirm this at the start of each engagement. German law, including the HWG and the StGB, applies regardless of membership.
Can you review HCP engagements and gifts for Germany?
Yes. We review planned engagements, hospitality and promotional items against the HWG, the relevant FSA code and your global policy, and document the rationale and approvals.
Do we need our own staff in Germany?
Not necessarily. Many compliance-support needs can be met through a named local business partner working within your global compliance model. The right set-up depends on your legal obligations and activities.
Tell us what is on your desk.
We will listen, ask a few questions and recommend the right scope—without obligation or pressure.
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