The regulated environment of medicinal cannabis in the Netherlands

Since 1 January 2001 the Organisation of Medicinal Cannabis (OMC) has been the government agency responsible for implementing the Single Convention on Narcotic Drugs. The OMC also processes applications for exemptions from the Opium Act relating to medicinal cannabis.

Organisation of Medicinal Cannabis (OMC) = Bureau voor Medicinale Cannabis (BMC).

What is the Office of Medicinal Cannabis (OMC)?

The OMC is the national cannabis office and responsible for:

• Production of cannabis for medical and scientific purposes
• Supplying legal medicinal cannabis to pharmacies, universities, and research institutes
• Ensuring the quality of medicinal cannabis
• Providing information about medicinal cannabis.

Pharmaceutical quality of medical cannabis

Medicinal cannabis is used as a medicine and must therefore meet a number of strict pharmaceutical requirements. The most important of these is that every type of medicinal cannabis available in pharmacies always has the same composition and also comparable strength.

The cannabis used by the OMC is grown under standardized conditions that are derived from the Good Agricultural Practice (GAP) rules. This ensures that the medicinal cannabis has a consistent composition. The amount of active ingredients is the same in each new crop of a particular product, so that the user always gets a product of the same strength.

Patients safety

Patients, companies and researchers must be able to trust that the product that the OMC supplies consistent pharmaceutical quality and is free of heavy metals, pesticides and microbial contamination. This means that the cultivated and delivered medicinal cannabis must meet international quality requirements and standards.

Testing of medicinal cannabis

Tests are performed to make sure there is no mould, bacteria, heavy metals or other undesirable additions in the cannabis. These quality requirements are documented in the ‘Cannabis flos’ monograph drafted by a certified company in cooperation with the OMC.

Supervision of chain partners (e.g., grower, independent laboratories, logistics service provider)

The quality of the medicinal cannabis is guaranteed by a constant supervision of the grower and the logistic service provider.

Medicinal cannabis supply chain and the applicable regulations

Production (growers)

A professional company cultivates the medicinal cannabis very carefully. This company grows medicinal cannabis in accordance with applicable EU guidelines for herbal medicines.

The OMC contracts the grower through a European tender procedure that anyone can apply for. Strict requirements are imposed on the grower, such as standardized cultivation according to the Good agricultural Practices (GAP) and Good Manufacturing Practices (GMP) guidelines.

The grower must hold an opium exemption and conclude an agreement with the OMC. The grower may only grow what is ordered by the OMC, the entire harvest is bought (provided it complies with the monograph) and physically removed from the grower. The grower is monitored by OMC and IGJ.

Independent laboratories

In order to guarantee to users that the medicinal cannabis of the OMC meets all requirements, independent laboratories test the medicinal cannabis produced for the presence of unwanted substances such as heavy metals and pesticides and for the presence of possible pathogens.

This external laboratory is contracted by the OMC through a European tender procedure. A sample (made by an employee of the OMC) is sent to the lab from every harvest of cannabis. This sample must meet the requirements as laid down in the monograph. The lab is monitored by IGJ.

OMC releases

After approval from these laboratories, the OMC releases the medicinal cannabis for delivery to the pharmacies, universities, and research institutes

Logistic service providers (including with regard to packaging)

Packaging

The logistic service provider that is used for the packaging and distribution (logistics services) of the medicinal cannabis. Each harvest is collected from the grower in bulk bags after an OMC employee has checked the product and weighed all the bags. These bulk bags are repackaged at the packer in 5 gram jars. A OMC employee checks whether the pots have been properly weighed and the total packaged weight of medicinal cannabis. The packer is monitored by OMC and IGJ.

Distribution

The logistic service provider takes orders from pharmacists and ensures delivery of the product within 24 hours. The logistics service provider also takes care of the invoicing to the pharmacists. The logistics service provider is controlled by the CIBG, BMC and IGJ.

The requirements for logistic service providers are laid in down in framework agreements. The logistics service provider works in accordance with GMP / GDP guidelines.

Pharmacies, universities, and research institutes

Identified and certified organizations that allowed to order the medicinal cannabis for intended use. These organizations are monitored by the IGJ.

Are you ready to enter the medicinal cannabis supply chain with a GMP certification?

Rescop combines 25 years of international experience within the GxP regulated and pharmaceutical industry including medicinal cannabis. Through the combination of our consulting services and quality management software, we provide an out-of-the-box solution for medicinal cannabis producers (growers) to obtain and maintain the GMP certificate in an efficient and paperless manner. Initial activities include:

•        Application for opium exemption
•        Design Quality Management System
•        GMP design of facilities and product flow
•        Create Standard Operating Procedures and Work Instructions
•        Implement Quality Management software (RC-QMS)
•        Train personnel in Quality Management System
•        Perform any required validation and qualification activities
•        Support during the GMP certification audit

Do you want to know how we can help you with your GMP proof facility or are you interested in high quality (GMP certified) medicinal cannabis as Active Pharmaceutical Ingredient?

For more information contact us! or send message: info@rescop.com

Sources and relevant websites:

Office of Medicinal Cannabis (OMC): www.cannabisbureau.nl

The OMC works with a number of different partners in the Netherlands and maintains strong contacts with similar initiatives abroad. On the OMC website (www.cannabisbureau.nl) you will find answers to the most frequently asked questions about the medical use of cannabis.

Institute for Responsible Medication Use: www.medicijngebruik.nl

On behalf of the OMC the Institute for Responsible Medication Use (IVM) has produced a publication on the theme of ‘medicinal cannabis’ containing information for care providers on supporting patents who (want to) use medicinal cannabis

International Association for Cannabinoids as Medicine: www.cannabis-med.org

The website www.cannabis-med.org of the International Association for Cannabinoid Medicine (IACM) includes a database of scientific studies on cannabis and its therapeutic value in various conditions.

Medicinal cannabis abroad: www.hetcak.nl

Medicinal cannabis is covered by the Opium Act. This means that doctors, pharmacists and patients must adhere to specific rules when prescribing, supplying and using medicinal cannabis. Visit the website for more information on this topic.

European Medicines Agency (EMA) https://www.ema.europa.eu/en/human-regulatory/herbal-medicinal-products

The Committee on Herbal Medicinal Products (HMPC) issues scientific opinions on herbal substances and preparations, along with information on recommended uses and safe conditions, on behalf of the European Medicines Agency (EMA).

Good Agricultural practices (GAP0: http://www.fao.org/home/en/

Good agricultural practice (GAP) is a certification system for agriculture, specifying procedures (and attendant documentation) that must be implemented to create food for consumers or further processing that is safe and wholesome, using sustainable methods.

Disclaimer

Cannabis online and on social media Use of cannabis for treating diseases and symptoms is popular. More and more people are buying CBD oil from chemists or online. The origin of these products is unknown, and their production is not controlled. The quality of these products, what exactly they contain and in what quantity is unclear, and there are no guarantees that the production process is sufficiently clean. Therefore, if you have questions, please contact the Office of Medicinal Cannabis (OMC) of the CIBG, Ministry of Health, Welfare and Sport.