MEDICAL CANNABIS IN EUROPE - THE GMP STANDARDS GUIDE PART 2 (EXTRACT)

Netherlands – The EU GMP Standard Report

How the Netherlands regulates cannabis with focus on the opportunity to export to Italy and Poland.

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Overview

The Netherlands government has been regulating the Cannabis plant under the 1928 Opium Act, which contains regulations concerning opium and other narcotic substances. The Opium Act has been amended several times, and still stands as the primary legislation that dictates manufacturing of medicinal cannabis in the Netherlands.

 

As one of approximately 148 signatories to the United Nations drug conventions, the Netherlands conforms to the United Nations Guidelines from the Single Convention on Narcotic Drugs of 1961 and United Nations Convention against illicit traffic in narcotic drugs and psychotropic substances (collectively, "the Conventions"). Together, the Conventions afford provisions for the procurement and use of cannabis for specific purposes and entities within a nation and to engage in trade with other nations. With well-defined exemptions, the Dutch Opium Act provides the requirements to produce, import, or export cannabis under a debated monopolistic program.

 

The Opium Act clearly makes it “illegal to grow, prepare, treat, process, sell, supply, provide, transport, possess and manufacture cannabis or cannabis derived substances.”  The Conventions establish the regulatory framework for the Dutch Opium Act, which was developed from the perspective of fighting against “illicit traffic” and “drug addicts.” Fortunately, the Dutch Opium Act considers the “interest of public health” as good cause for having a national cannabis program. For countries wishing to operate a cannabis program, such as the Netherlands, the Conventions ultimately provide a framework for the operation of a national cannabis program.


The Opium Act and Opium Act exemptions

The Netherlands has been considered a utopia, where one can purchase and consume cannabis without legal repercussions. While this is fundamentally true, it should be noted that cannabis in all forms is still illegal, as formal legalization would be in direct violation of the UN Conventions. Rather, the Netherlands takes a harm reduction approach and avoids incarceration unless personal choices of drug use affect others or are a nuisance.

 

Cannabis and its derivative products are defined as List I and List II substances. The Dutch Opium Act defines Hemp, Hashish, and Hemp Oil, with Hemp and Hashish on List II and Hash Oil on List I. It places cannabis in the same categories of prescription opioids and benzodiazepines such as buprenorphine (Buprenex), alprazolam (Xanax), and zolpidem (Ambien). Any of these List I & II drugs require an exemption that allows for their manufacturing. Cannabis is no different.

 

It is important to note that when applying for a manufacturing exemption of List I and II substances, for example Hemp and Hemp Oil, two separate exemption applications must be submitted. In accordance with the Act, the Bureau voor Medicinale Cannabis (BMC) or Office of Medicinal Cannabis (OMC) is the government office responsible for the control of production and distribution of cannabis for medical and scientific purposes, and is a division of the Dutch Ministry of Health, Welfare and Sports. Unique to this market, the OMC acts as the distributor of all exempted products, thus creating a monopoly on the market.

 

Currently, Bedrocan is the only producer of cannabis flower to have been granted an exemption through the OMC, leaving the market open to high-quality producers wishing to capitalize on operational markets, should they be able to prove market demand to the OMC. Bedrocan currently produces six formulae that have specifications on the concentration of THC and CBD in their flower.


Netherlands Unique Export Model

A special health inspector, appointed by the Health Care Inspectorate has the full authority of the Health Ministry and oversees the application process for exemption. These exemptions are temporary, lasting five years, and subject to revocation at any time if they are found to be non-compliant at any time.

 

Entities that are successful at securing  an exemption status are allowed to produce the desired product within strict limits that are set in proportion to a defined need in the international community. Entities must sell exclusively to the Netherlands’ minister within four months of production and destroy any surplus. Sale of products directly to another international entity is strictly prohibited, and this is monitored by the Public Health Inspectorate and Tax department.  

 

Ultimately, all cannabis is delivered to the OMC, which then distributes it either within the Netherlands, or to the country of import. Although the OMC controls all aspects of distribution, it leaves the licence holders accountable for the legwork required to be granted exemptions for export and coordination with the authorized exemption/licence holder of the destination country.


The EU GMP Standards Report

To further understand how the international cannabis export model works, read the full report that will be published this month. It describes the export mechanisms built into Netherlands cannabis regulations in relation Italy and Poland, and how EU Good Manufacturing Practices that apply to cannabis manufacturers.

 

This content was provided by Orion GMP Solutions, a Pharmaceutical Engineering firm specialising in implementation of International Pharmaceutical Good Manufacturing Practices and Quality Management Systems for cannabis. Reach out to Orion GMP Solutions for international cannabis standards expertise in helping you develop a EudraLex GMP compliant manufacturing organisation.


Guide to be published March 2018. Please contact stephen@prohibitionpartners.com for more information.