Applying for an exemption from the Opium Act

The Dutch Opium Act (Opiumwet) regulates which drugs and other substances are banned in the Netherlands. You are not allowed to have these banned substances on your business premises. Furthermore, you may not manufacture, prepare, treat, process, sell, supply, provide, or transport these substances. 

Unless an exception applies, you need an Opium Act exemption to work with these substances:

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

For substances covered by list IA, different conditions and exceptions apply.

How to apply for an exemption?

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

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

Do you want to work with hemp (cannabis), hashish, hemp oil, or preparations of these substances? You apply to the Dutch Office of Medicinal Cannabis (Bureau voor Medicinale Cannabis, BMC) for an exemption from the Opium Act.

An exemption is valid for at most 5 years.

To renew your BMC exemption, you must apply to extend it. Read more about the BMC application procedure. 

Do you want to work with other substances covered by the Opium Act? You apply to Farmatec for an exemption from the Opium Act (in Dutch). You must complete the application form and send it to Farmatec (in Dutch).

You have to pay an application fee and an annual fee for both exemptions separately. 

To renew a Farmatec exemption, you must re-apply no later than 3 months before it expires and pay an application fee for the renewal. Complete the application form and send it with the requested documents (see part 4 of the form, in Dutch).

No exemption needed

In some cases, you do not need an exemption for activities involving substances on list I or II. Under article 5 of the Opium Act (in Dutch), this applies, for example, under certain conditions to:

• physicians, pharmacists, dispensing general practitioners, veterinarians, and hospitals
• persons or institutions designated by the government
• persons and institutions that obtained the substances legally and need them for medical, dental or veterinary practice or for their own medical use
• persons and institutions that obtained the substances legally and are required by law to keep the substances in stock

Import and export

You may not import or export substances on list I or II without the required exemptions. As a pharmaceutical company, you must have a valid Opium Act exemption and a separate import or export exemption for each shipment.

Cannabis, cannabis extracts, and cannabis resin may only be imported or exported by the Office of Medicinal Cannabis.

If you want to import or export other substances on list I or II, you apply for an import or export exemption by letter to Farmatec (in Dutch). 

An import exemption is valid for 3 months and applies to 1 shipment only. In some cases, you can apply for a 6-month import exemption, for instance if you import substances from the United States, India, or China. An export exemption is valid until the foreign import document expires. If you need more time, you must apply for a new exemption.

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 applications.