Applying for an exemption from the Opium Act

The Dutch Opium Act (Opiumwet) regulates which opioids and other narcotics are banned in the Netherlands. You are not allowed to have these banned substances on your business premises. Furthermore, you may not prepare, treat, process, sell, supply, provide, or transport these substances. You can only do so when you have an Opium Act exemption. This concerns:

• hard drugs (list I of the Opium Act, in Dutch)
• soft drugs (list II of the Opium Act, in Dutch)

How to apply for an exemption?

An exemption from the Opium Act allows you to use banned substances for:

• public health
• animal health
• scientific (academic) or analytical chemical research
• instructive purposes (such as training sniffer dogs)
• trade-related purposes (food additives)

Do you want to work with hemp (cannabis) or hemp-derived products? You apply for an exemption from the opium act with the Dutch Office of Medicinal Cannabis (Bureau voor Medicinale Cannabis, BMC).

Do you want to work with non-hemp-based products banned by the Opium Act? You apply for an exemption from the opium act to Farmatec (in Dutch). You must complete the application forms and send them to Farmatec.

You have to pay an application fee and an annual fee for both exemptions separately. Each exemption is valid for at most 5 years. To renew an exemption, you must re-apply 3 months before your exemption expires and pay a re-application fee. You submit your request for renewal combined with an additional form (in Dutch) and information on any relevant changes to your business operation.

No exemption needed

In some cases you do not need an exemption:

• physicians, pharmacists, GP surgery dispensaries, and hospitals that meet the conditions (in Dutch)
• persons or institutions designated by the government
• if you have drugs in stock to practice medicine, dentistry, or animal care, or for private medicinal use.

Import and export

You may not import and export substances banned by the Opium Act. Hemp or hemp-based products may only be imported or exported by the Office of Medicinal Cannabis. If you want to import or export other banned substances, you apply for an import or export exemption to Farmatec.

This exemption is valid for 3 months for 1 shipment only. In some cases you can apply for a 6-month exemption, for instance when exporting from the United States, India or China. You must complete your import and export activities within this period or you must re-apply.

Supervision

The Dutch Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) supervises companies and institutions that have an Opium Act exemption. They check for instance if your administration and security measures are in order. The inspectorate also advises Farmatec and BMC on their decisions.