In Legally Mandated Roles
Marketing Authorization Holders and pharmaceutical manufacturers in Germany are required to assign specific regulatory functions within their organizations to employees with precisely defined qualifications. These roles include: The Qualified Person for Pharmacovigilance (QPPV) (“Stufenplanbeauftragter,” as defined in Section 63a of the German Medicinal Products Act – AMG), responsible for the continuous monitoring of drug safety. The Information Officer (“Informationsbeauftragter,” pursuant to Section 74a AMG), ensuring that scientific and promotional communications are consistent with the product’s registration documents. The Qualified Person (QP) (“Sachkundige Person,” as stipulated in Section 15 AMG), accountable for compliance with all regulatory requirements related to manufacturing, testing, and batch release. Certain functions –such as QP and QPPV – must be available 24/7, reflecting their critical importance to the safe and legal supply of medicines.
Diapharm assumes the responsibility for these legally required roles in full compliance with the German Medicinal Products Act (AMG) – either on an interim basis (e.g., as vacation cover or during personnel transitions) or as a permanent solution.
Manufacturer for Batch Release
Diapharm goes beyond standard consultancy and, upon request, assumes direct responsibility as the releasing manufacturer for medicinal products and investigational medicinal products. Our Qualified Persons handle batch release and/or EU batch certification for imports.
This service is particularly valuable for:
- Distributors who prefer not to maintain their own internal quality assurance and EU-GMP-compliant batch release structures,
- Companies outside the EU seeking to import medicinal products or controlled substances into the EU,
- Contract manufacturers who do not wish to assume full responsibility for final batch certification.
Diapharm ensures that registered and GMP-compliant products are released to the market in full compliance with all applicable regulations.
Additionally, Diapharm can act as the Marketing Authorization Holder, reliably managing existing marketing authorizations on behalf of the pharmaceutical industry.
Diapharm also acts as the responsible manufacturer or authorized representative for medical devices.
