For Marketing Authorisation Holders (MAHs) planning to market medicinal products in the Netherlands, compliance with local pharmacovigilance (PV) regulations is essential. At ProPharma, we understand the complexities of regional pharmacovigilance requirements and provide expert support to ensure full regulatory compliance while enhancing operational efficiency.
This blog explores the unique obligations MAHs face in the Netherlands, particularly the requirement for a Local Person for Pharmacovigilance (LPPV), and how ProPharma can support you with meeting those requirements.
Regulatory Overview
As part of the European regulatory framework, all MAHs must appoint a Qualified Person responsible for Pharmacovigilance (QPPV) in accordance with:
- Article 23 of Regulation (EC) No 726/2004
- Article 103 of Directive 2001/83/EC, as amended by Regulation (EU) No 1235/2010 and Directive 2010/84/EU
Once marketing authorisation is granted by the Medicines Evaluation Board (MEB) in the Netherlands, the MAH is obligated to maintain a robust pharmacovigilance system that ensures the continued quality, efficacy, and safety of the product as required under Article 76a, Chapter 8 of the Dutch Medicines Act.
All updates to QPPV details must be submitted via the EMA's Article 57 database, streamlining communication and avoiding the need for direct notification to the MEB.
The Health and Youth Care Inspectorate (IGJ) oversees pharmacovigilance compliance within the Netherlands. MAHs are subject to a national inspection program and are risk-ranked based on information provided through a self-assessment PV questionnaire.
National Contact Person Requirement
In cases where the EU QPPV is located outside the Netherlands or does not speak Dutch fluently, MAHs must appoint a national contact person for pharmacovigilance. This individual acts as the primary liaison for:
- Regulatory authorities, such as the MEB and IGJ
- Healthcare professionals and patients seeking product-related safety information
This contact must be registered with the MEB and is only required once the product is marketed in the Netherlands. There is no need to appoint a national contact person if the product is not marketed locally or is only available through a compassionate use programme.
While the requirement is not codified in Dutch law, both the MEB and IGJ provide specific guidance for this role, outlining the following expectations:
- Fluency in Dutch, both written and spoken
- Thorough understanding of national PV legislation, guidelines, and procedures
- A medical qualification (e.g., graduate of a university-level medical program), or direct access to someone with such qualifications
- Close coordination with the EU QPPV on pharmacovigilance activities
- A documented back-up procedure in case of absence (this can be a process or an alternate contact)
Optionally, a second contact person can be registered to ensure continuity of communication.
How ProPharma Can Help
We provide tailored support to MAHs navigating the Dutch pharmacovigilance landscape. Our local experts serve as trusted LPPVs and national contact persons, ensuring seamless integration with your global PV systems. By outsourcing to our experienced team, you gain:
- In-depth knowledge of Dutch and EU PV regulations
- Efficient, compliant LPPV onboarding and maintenance
- Scalable support for growing pharmacovigilance operations
- Reduced operational burden and optimized resource use
Whether you are entering the Dutch market for the first time or are looking to enhance your existing pharmacovigilance systems, our experts are here to help. Contact us today to learn more about our LPPV and QPPV services.
