License and registration of medicine, API and medicinal cannabis

When do you have to register a product like medicinal cannabis in the Netherlands?

A Dutch attorney may facilitate the application for a license in the Netherlands for medicine, active pharmaceutical ingredients (APIs) and medicinal cannabis. Depending upon the product you need to register either the medical device or yourself as a manufacturer at the CIBG in the Netherlands. For manufacturers, importers and distributors of APIs an obligation to register will apply in the future (see Article 52(2) of the European directive adopted on 8 June 2011: Directive 2011/62/EU. Only persons registered with Farmatec may act as brokers in medicine.

Registration Netherlands for medicine and API’s

For manufacturers, importers and distributors of active pharmaceutical ingredients (APIs) an obligation to register will apply in the future (see Article 52(2) of the directive). These companies must contact Farmatec in the Netherlands and indicate which active ingredients they use and which actions/activities take place. Any legal objections you may encounter could be handled by a Dutch lawyer. The Directive entered into force on 2 January 2013 and is currently being implemented in Dutch legislation. At present, the relevant amendments to the Medicines Act (Geneesmiddelenwet) and the Medicines Act Regulation (Regeling Geneesmiddelenwet) are being prepared. In principle, a directive only applies once it has been ‘translated’ into national legislation. That means that there are currently no registration requirements for dealers in APIs and brokers in the Netherlands.

License Opium Act Netherlands

In the Netherlands the Office for Medicinal Cannabis (OMC) is the government office which is responsible for the production of cannabis for medical and scientific purposes. For the production hemp (cannabis), hashish, hemp oil, CBD or preparations of the above you may apply for an exemption from the prohibition in the Opium Act. Exemptions for cannabis related products are granted in the Netherlands for the following purposes: public health, animal health (with a distinction between exemptions for training sniffer dogs and other exemptions), academic or chemical analytical research, training and trade-related purposes. The exemption covers also import and export of products covered by the Opium act. A Dutch Attorney can facilitate the application for a license for cannabis related products. If you wish to import or export drugs referred to in the Opium Act to or from the Netherlands you will need an export licence from the Healthcare Inspectorate (IGZ).

Legislation on pharmaceuticals, medicine and medicinal hemp in the Netherlands

International:

European directive adopted on 8 June 2011: Directive 2011/62/EU

The Single Convention on Narcotic Drugs and the Convention on Psychotropic Substances

Directive 93/42/EEC (and 90/385/EEC) on medical devices

Directive 98/79/EC on In Vitro Diagnostics

National:

The Medicines Act (Geneesmiddelenwet) and the Medicines Act Regulation (Regeling Geneesmiddelenwet)

Dutch Cannabis legislation The Opium Act (Opiumwet), the Opium Act Decree (Opiumwetbesluit), the Opium Act Implementation Regulations (Uitvoeringsregeling Opiumwet) and the Policy Rules on Exemption from the Opium Act (Beleidsregels opiumwetontheffingen).

Feel free to ask a specialized Dutch Attorney of Blenheim to sort out the formalities to apply for a license on registration of a product in the Netherlands.

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