Independent LPPV and National Pharmacovigilance Contact Person Services
Houben Healthcare Consultancy provides independent Local Pharmacovigilance (LPPV) services in the Netherlands to pharmaceutical companies, Marketing Authorisation Holders (MAHs) and pharmacovigilance service providers.
As a Netherlands-based pharmacovigilance consultant and native Dutch speaker, Remco Houben supports companies requiring a national pharmacovigilance contact person in the Netherlands.
With over 22 years of professional experience in global and local pharmacovigilance, Remco combines extensive drug safety expertise with practical knowledge of Dutch pharmacovigilance requirements and regulatory procedures.
Services are tailored to individual client requirements, including ongoing LPPV responsibilities and additional local pharmacovigilance support.
When Is a National Pharmacovigilance Contact Person Required in the Netherlands?
According to the Dutch Medicines Evaluation Board (CBG-MEB), a Marketing Authorisation Holder should appoint a national pharmacovigilance contact person when its EU Qualified Person Responsible for Pharmacovigilance (EU QPPV):
- Resides outside the Netherlands; or
- Is not fluent in the Dutch language.
This requirement applies when a medicinal product is marketed in the Netherlands.
The CBG-MEB clarifies that a national pharmacovigilance contact person is not required when a medicinal product is not marketed in the Netherlands or is only available through a compassionate use programme.
Official guidance: CBG-MEB – National Contact Person for Pharmacovigilance
Dutch Regulatory Requirements for the National PV Contact Person
The CBG-MEB and the Dutch Health and Youth Care Inspectorate (IGJ) have outlined requirements for the national pharmacovigilance contact person.
These include:
Dutch Language Proficiency
The contact person should have a thorough command of spoken and written Dutch, enabling communication with Dutch regulatory authorities, healthcare professionals and patients.
Knowledge of Dutch Pharmacovigilance Requirements
The contact person should be familiar with relevant Dutch pharmacovigilance legislation, guidelines and procedures.
Medical Expertise
The contact person should be medically qualified or have documented access to a person with appropriate medical training.
Communication with the EU QPPV
The contact person should maintain appropriate communication with the EU QPPV concerning local pharmacovigilance responsibilities and relevant safety information.
Back-up Arrangements
A clearly documented back-up procedure should ensure continuity during periods of absence. A formally designated deputy is not necessarily required.
An additional national contact person may be registered, either as a deputy or for responsibility over part of the product portfolio.
Further details are available in the official CBG-MEB guidance.
LPPV Services Provided by Houben Healthcare Consultancy
Houben Healthcare Consultancy offers local pharmacovigilance support tailored to the requirements of individual MAHs and PV service providers.
Depending on the agreed scope of services, activities may include:
- National Pharmacovigilance Contact Person (LPPV/LCPPV): Acting as the designated national contact person for pharmacovigilance in the Netherlands.
- Dutch Regulatory Intelligence: Monitoring and assessing relevant Dutch pharmacovigilance developments, including publications, safety communications and regulatory updates from the CBG-MEB, IGJ, Netherlands Pharmacovigilance Centre Lareb and Ministry of Health, Welfare and Sport (VWS), as well as other relevant national sources.
- Local Literature Monitoring: Screening and evaluating Dutch medical and scientific literature for potentially relevant safety information.
- Local Safety Information Assessment: Assessing local safety information and communicating relevant findings to the appropriate global pharmacovigilance functions.
- EU QPPV Communication: Maintaining communication with the EU QPPV regarding Dutch pharmacovigilance responsibilities and regulatory developments.
- Regulatory Authority Communication: Acting as a local pharmacovigilance contact point and supporting responses to safety-related enquiries from Dutch authorities.
- Local PV Procedures and Documentation: Supporting the development and maintenance of local pharmacovigilance procedures, work instructions and related documentation.
- Back-up and Continuity Arrangements: Supporting appropriate availability and back-up arrangements for the national contact person function.
24/7 availability can be provided where required under agreed contractual arrangements.
Services are performed in accordance with the applicable pharmacovigilance system and procedures of the client.
Experience and Qualifications
Remco Houben holds a Master’s degree in Medical Biology and has extensive experience in global pharmacovigilance, including medical safety assessment, signal management, benefit-risk assessment and regulatory compliance.
His professional background includes senior medical safety responsibilities within major international pharmaceutical companies and specialised pharmacovigilance consultancy organisations.
Since establishing Houben Healthcare Consultancy in 2017, Remco has supported pharmaceutical companies and PV service providers with both global and local pharmacovigilance responsibilities.
His experience with local pharmacovigilance activities in the Netherlands predates 2020, and he has provided ongoing LPPV services since 2020.
This combination of global and local PV experience enables him to work effectively within established pharmacovigilance systems and collaborate closely with EU QPPVs, global safety teams and regulatory stakeholders.
For further information about his professional background, please visit the About Remco Houben page.
National Pharmacovigilance Requirements Across Europe
Requirements for national pharmacovigilance contact persons differ across European Union Member States.
The European Medicines Agency (EMA) publishes an overview of these country-specific requirements for human medicinal products, including those applicable in the Netherlands.
Official reference: EMA – Information on Member States’ Requirements for National Pharmacovigilance Contact Persons (PDF, Revision 5, August 2025)
Registration of the National Pharmacovigilance Contact Person
Marketing Authorisation Holders should register their designated national pharmacovigilance contact person with the CBG-MEB using the official registration form.
The registration process also allows for the notification of changes or the appointment of an additional contact person.
Where appropriate, Houben Healthcare Consultancy can support clients with the information and documentation required for registration.
Official registration form: CBG-MEB – National Pharmacovigilance Contact Person Registration
Dutch Pharmacovigilance Information Sources
Important Dutch sources for pharmacovigilance regulatory intelligence include:
- Medicines Evaluation Board (CBG-MEB): Regulatory guidance, medicinal product safety communications and national pharmacovigilance requirements.
- Health and Youth Care Inspectorate (IGJ): Regulatory supervision, inspections and compliance-related information.
- Netherlands Pharmacovigilance Centre Lareb: Suspected adverse drug reaction reports, safety signals and other relevant drug safety information.
- Ministry of Health, Welfare and Sport (VWS): Relevant healthcare policy, legislation and regulatory developments.
These sources are monitored alongside other relevant national publications and regulatory communications, depending on client requirements.
Looking for LPPV Support in the Netherlands?
Are you a pharmaceutical company, Marketing Authorisation Holder or pharmacovigilance service provider looking for an experienced national pharmacovigilance contact person in the Netherlands?
Houben Healthcare Consultancy provides independent LPPV services supported by extensive experience in global and local drug safety.
Contact Remco Houben to discuss your requirements and potential collaboration.