Overview
Pharmacovigilance and Regulatory Affairs services in Germany
Insuvia works with pharmaceutical and biotech companies in Germany to deliver Pharmacovigilance and Regulatory Affairs services that meet EU directives and German regulatory requirements. We provide clear guidance through every step of compliance.
We deliver country-specific PV and RA insights, assign a local person for pharmacovigilance, and conduct literature monitoring for local regulatory compliance. Our services include DCP/MRP national phase implementation and national regulatory affairs support in Germany.
Services in Germany
Local Affiliate Services with An Integrated Cross-Functional Expertise
Local Pharmacovigilance
- Local QPPV / Local Person for PV (LPPV)
- Local Literature Screening
- Local ICSR Management
- Local PV regulatory intellingence
- Implementation of aRMMs (Educational Materials, DHPC)
Local Regulatory Affairs
- Health Authority contact
- Professional advice and regulatory consulting
- New MAA & Product Approval
- Product life-cycle management
- Local Regulatory Intelligence
- Artwork review & management
- Promotional Materials review and approval
Market Access
- Regulatory Intelligence
- Pricing applications
- Consulting on national reimbursement strategy
- Reimbursement applications
- Price negotiations with national authorities
- Support with risk sharing agreements
- Support with early access programs (EAP, CUP, NPP)
QA & Compliance
- Stock management support (shortage/stock out, product recalls, quality issues)
- Management of product quality complaints (PQC)
- Consulting on local GDP requirements
- Management of serialization requirements, liaison with NMVOs
- Review of HCP engagement, HCP/events sponsorship disclosure
- Promotional Materials & Activities Compliance
Legal & Regulatory Context in Germany
Pharmacovigilance
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Is an LPPV Required in Germany?
Yes, the Local Person for Pharmacovigilance is required in DE.
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LPPV Requirements
- The requirements for the local PV person in Germany (the “Stufenplanbeauftragter” / Graduated Plan Officer) are equal to those of the EU QPPV. In addition to the “Stufenplanbeauftragter”, a Deputy with equal qualifications is required, and 24/7 availability must be ensured;
- There is no requirement for the Graduated Plan Officer to speak German or be a resident of Germany, theoretically, he/she can be resident of any Member State of the European Union. However, as explained by BfArM, the “Stufenplanbeauftragter” has to communicate with the BfArM and the competent authorities in the federal states (Landesbehoerden) and this communication is done almost exclusively in the German language, therefore it is almost impossible for the Graduated Plan Officer to fulfill his role without being able to speak German.
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References
- As defined by the section 63a of the German Drug Law (AMG), Germany
requires the nomination of a local PV responsible person in Germany, referred
to as the “Stufenplanbeauftragter” (the Graduated Plan Officer – GPO). This
function is not dependent on a marketing authorization but is mandatory for every company who places finished medicinal products on the market in Germany (independently if the company is MAH or not); - The specific legal obligations of the “Stufenplanbeauftragter” are defined in the AMG and in the regulation “Arzneimittel- und Wirkstoffherstellverordnung.- AMWHV”. They are similar to those of the EU-QPPV but not identical (e.g. quality complaints in the AMWHV). Some important particularities are that:
- The GPO has to be reliable (as proven by criminal recordcertificate);
- The GPO is responsible for technical complaints and recalls;
- The GPO is personally liable.
- As defined by the section 63a of the German Drug Law (AMG), Germany
Regulatory Affairs
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Local RA Person Requirements in Germany
Local RA person not mandatory. RA role may be managed by any EU Person; German language skill C1 (better: C2) is highly recommended.
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Other mandatory local roles?
Pricing/Reimbursement – may be managed by a person seated in EU. PoA for such person is needed. It may be outsourced person.
Authorities
National Competent Authorities in Germany
Contact
Contact us for more information
Contact type
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