Overview
Pharmacovigilance and Regulatory Affairs services in Denmark
Insuvia supports pharmaceutical and biotechnology companies in Denmark with PV and RA services designed to meet EU legislation and Danish national rules. We help you navigate compliance with ease.
We provide monitoring of local regulatory requirements, appoint a local pharmacovigilance responsible, and perform local literature surveillance for PV. Our experts also coordinate local variations and renewals and provide country-level regulatory compliance support in Denmark.
Services in Denmark
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 Denmark
Pharmacovigilance
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Is an LPPV Required in Denmark?
No, there are no specific requirements for the local PV person in Denmark.
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References
According to national legislation (Medicines Act § 53), the Danish Health and
Medicines Authority (DHMA) may require the MAH of a medicinal product for
human use to nominate a contact person in Denmark to represent the qualified
person referred to in subsection (1)(vii)
Regulatory Affairs
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Local RA Person Requirements in Denmark
Local RA role is not mandatory in Denmark.
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Other mandatory local roles?
There are no other mandatory local roles in Denmark.
Authorities
National Competent Authorities in Denmark
Contact
Contact us for more information
Contact type
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