Opium Act Exemption

An Opium Act exemption (opiumontheffing) is required for manufacturing, processing, selling, delivering, or transporting controlled substances listed on List I or List II of the Dutch Opium Act. Without this exemption, handling these substances is prohibited.

The exemption is granted by the Ministry of Health, Welfare and Sport (VWS). It applies to pharmaceutical companies, research institutions, laboratories, and other businesses that work with controlled substances for medical, scientific, or industrial purposes. Applications are assessed on the intended use, security measures, and record-keeping procedures. The exemption specifies which substances are covered, in what quantities, and under which conditions they may be handled.

Requirements

  • Legal or natural person: The applicant must be a legal entity or natural person with a registered business.
  • Purpose: The purpose of the activity must be scientific, medical or otherwise legitimate.
  • Security measures: Adequate security and storage facilities must be in place.
  • Regulations: The applicant must comply with all requirements of the Opium Act and related regulations.

Procedure

  • Application: The application must be submitted in writing to the Ministry of Health, Welfare and Sport.
  • Assessment: The application is assessed for safety, legitimacy of purpose and compliance with the law.
  • Inspection: An inspection of facilities and procedures may take place.
  • Decision: The ministry makes a decision on granting the exemption.

Restrictions

  • Limited validity: The exemption is often limited to specific substances, quantities and purposes.
  • Supervision: Regular supervision takes place by the Health and Youth Care Inspectorate.
  • Reporting obligation: Certain activities and incidents must be reported to the authorities.
  • Revocation: The exemption can be revoked in case of violation of the conditions.