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FDA Law in the Netherlands refers to the legal framework governing the approval, regulation, marketing, and monitoring of food, drugs, medical devices, cosmetics, and related products. While the term "FDA Law" is more common in the United States, the Netherlands enforces similar regulations through its own national authorities as well as European Union (EU) laws. The aim is to ensure that products are safe, effective, properly labeled, and in compliance with public health standards before being placed on the Dutch or EU market.
Navigating FDA Law in the Netherlands can be complex, especially for businesses and individuals involved in the development, distribution, or sale of food, pharmaceuticals, and healthcare products. Common situations where legal expertise is recommended include:
Several Dutch laws and EU regulations shape the landscape of FDA Law in the Netherlands. The most prominent national authority is the Dutch Medicines Evaluation Board (CBG-MEB), which oversees the regulation of medicines. The Netherlands Food and Consumer Product Safety Authority (NVWA) is another key player, ensuring the safety of food products, cosmetics, and consumer goods. At the EU level, the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) set further requirements.
Key legal areas include:
A medicinal product is any substance or combination of substances presented with properties for treating or preventing disease in humans or animals, or administered to make a medical diagnosis or restore, correct, or modify physiological functions.
New drugs can be authorized nationally by the CBG-MEB or via centralized procedures through the European Medicines Agency if intended for the EU market. Approval requires comprehensive documentation of safety, efficacy, and quality.
The Netherlands Food and Consumer Product Safety Authority (NVWA) monitors compliance with food safety laws, labeling, and health claims, while the European Food Safety Authority (EFSA) offers scientific advice and standards.
Food products must be labeled in accordance with EU Regulation 1169/2011, which mandates clear ingredient lists, allergen information, nutritional details, origin, and expiration dates in Dutch. Misleading or unsubstantiated health claims are prohibited.
Yes, these are subject to the Warenwet and additional specific regulations for supplements. Certain substances are restricted and approval must be obtained before marketing.
You must inform the competent authority, remove affected products from the market, notify customers, and take remedial actions. A legal adviser can assist in managing regulatory reporting and public communications.
Limited advertising is permitted for over-the-counter medicines but must comply with strict rules regarding content, target audience, and the avoidance of misleading or comparative claims.
Medical devices must comply with the EU Medical Device Regulation (EU MDR 2017/745) and require conformity assessments, CE marking, and ongoing post-market surveillance.
Penalties include administrative sanctions, product recalls, fines, withdrawal of authorizations, or even criminal prosecution in cases of serious health risks or intentional misconduct.
Imports must meet all Dutch and EU regulatory requirements, including proper registrations, certifications, and documentation. Customs declarations and checks are standard procedures, and non-compliance can result in seizure or rejection of products.
Those seeking further guidance or support may benefit from contacting the following Dutch and EU bodies:
If you believe you need legal assistance in FDA Law in the Netherlands:
Seeking early legal advice can increase your chances of successful approval, compliance, or resolution of disputes under FDA Law in the Netherlands.
