Overview
Pharmacovigilance and Regulatory Affairs services in the Netherlands
In the Netherlands, Insuvia provides Pharmacovigilance and Regulatory Affairs services that meet EU directives and Dutch national rules. We help you maintain compliance across the entire product lifecycle.
We offer country-specific PV and RA insights, provision of a local QPPV, and local journals surveillance. Our experts also oversee regulatory filings and provide local RA operational support in the Netherlands.
Services in the Netherlands
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 Netherlands
Pharmacovigilance
-
Is an LPPV Required in the Netherlands?
Yes, Local Person for Pharmacovigilance is required in NL.
-
LPPV Location & Availability Rules
The local PV person in Netherlands must:
- Master Dutch language in speech and writing;
- Be knowledgeable with the relevant Dutch legislation, guidelines, and
procedures; - Have a good back up procedure in place in case of absence;
- Report to the QPPV (reporting in this context relates to
pharmacovigilance tasks and responsibilities and not necessarily to line management); - Be medically qualified (basic medical training at an academic level), or have access to a person with medical training (MD). This access shall be duly documented.
-
References
The Medicines Evaluation Board (MEB) and Health and Youth Care Inspectorate (IGJ) of the Netherlands requires a PV contact person at a national level in the Netherlands, if the QPPV resides outside the Netherlands or if the QPPV does not master the Dutch language in speech and writing
Regulatory Affairs
-
Local RA Person Requirements
No mandatory role is required, NL specific submission requirements are provided on HMA website. When product is brought to the market, notification is required, as well as situations of shortages.
-
Other mandatory local roles?
A local DSO is required when product is marketed, and EU-QPPV is not located in the Netherlands or does not speak Dutch.
Authorities
National Competent Authorities in the Netherlands
Contact
Contact us for more information
Contact type
Thank you for submitting. We will get in touch with You as soon as possible.
Thank you for submitting. We will get in touch with You as soon as possible.