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When IMPs are imported outside the EU; how could I set up a working relationship as a contract QP when it comes to liability and insurance?

17/07/2021 | 2324

Similar question:

Reply:

As a contract QP you are a “normal” contracting party (i.e. just like any other service provider for the company but with the specific legal responsibilities and risks of a QP) and therefore no employee of the company. That means that you are not covered by any of the insurance programmes which companies usually provide for their employees (e.g. D&O insurance). As a result, you should mention that fact – and the related legal risks – during your contract negotiations with the company.
Ideally, there should be an indemnification clause in the service contract providing for that ‘the company indemnifies the contract QP any and all third party claims related to the services which the contract QP may perform under the service contract’. If your current contract does not contain such provision, you should ask the company to sign an amendment with aforesaid clause.
You can also ask the company to get yourself explicitly included in its D&O insurance contract (some insurers may actually be ready to do so because of the specific situation of the contract QP).This inclusion could be the first part of the contractual provision, followed by the indemnification clause mentioned above.

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  • GMPc Vietnam JSC
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  • Home
  • About Us
    • Summary information
    • Key Personnel
  • Services
    • WHO GMP Pharmaceutical facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce
      • Announcement of Imported Cosmetic
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
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  • Contact
 
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