Pharmaceutical Manufacturing or Wholesale License

If you manufacture, prepare, or wholesale medicines, active pharmaceutical ingredients (APIs), blood products, or bodily materials, you need a license from the Ministry of Health, Welfare and Sport. This license ensures that the production and distribution of medicines meets strict quality and safety standards under Dutch and European pharmaceutical legislation.

The license is mandatory for pharmaceutical manufacturers, compounding pharmacies, hospital pharmacies, and wholesale distributors of medicines. You must demonstrate compliance with Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) standards. The Health and Youth Care Inspectorate (IGJ) supervises licensed businesses through regular inspections and can suspend or revoke your license if you fail to maintain the required standards.