Medicinal products frequently inquired about for compassionate use, named patient

Medicinal Products Frequently Inquired About for Compassionate Use, Named Patient

CBD with Up to 1% THC 

There is one approved CBD medicinal product on the Norwegian market: Epidyolex. This product is approved for the treatment of rare forms of epilepsy in children. Due to its high cost, Epidyolex is rarely used for other conditions. 

All doctors with prescription rights group A can apply to NOMA for compassionate use, named patient for CBD products containing up to 1% THC. 

Currently, NOMA is aware of several suppliers of unregistered CBD products that can be distributed through Norwegian pharmacies and applied for in the usual way via e-prescription, for example:

• Glostrup Pharmacy supplies CBD drops without measurable amounts of THC. 
• Cannabisbureau (office in the Dutch Ministry of Health) supplies Bedrolite from the Dutch producer Bedrocan. This is ground cannabis plant with 9% CBD and less than 1% THC.
• Adven
• Stenocare 

Medicinal Cannabis with More Than 1% THC 

Only specialists employed at public or private hospitals can apply for compassionate use, named patient for cannabis products containing more than 1% THC. The application is submitted in the usual way via e-prescription. There is a relatively long delivery time for cannabis, so it is recommended to plan future delivery with the patient well in advance. Remember to specify the quantity (or dosage and period) in the application. All applications must include a brief description of the indication, previous treatment, and any experiences with cannabis use. NOMA cannot store personal data, so the prescriber cannot refer to information provided in previous applications. 

Procedure for treatment with medicinal cannabis within the current regulations homeopathic medicines 

Homeopathic medicines

An application for compassionate use, named patient is required for homeopathic and anthroposophic medicines that are not registered in Norway. If the requested products have marketing authorisation or registration in another EEA country, the applications can be processed directly at the pharmacy (notification). This also applies to homeopathic medicines of biological origin according to the Medicinal Products Regulation § 2-1 third paragraph. 

Vitamins, Minerals, and Certain Other Products 

Some patient groups need higher doses of vitamins than what is permitted under the Norwegian Food Safety Authority’s regulations for dietary supplements. Vitamins and minerals for oral use are not automatically considered medicinal products even if they exceed the limits allowed in dietary supplements. Therefore, there are many products that cannot be sold as legal dietary supplements but are not necessarily considered medicinal products either. NOMA has therefore allowed vitamin and mineral supplements, amino acids, glucose tablets, and certain other products to be provided through the compassionate use, named patient scheme (notification scheme), even though the products are not necessarily considered medicinal products in Norway. The purpose is to give doctors and patients the opportunity to obtain necessary products through safe channels. 

Melatonin 

With several melatonin medicinal products now approved in Norway, the need for melatonin products via the compassionate use, named patient scheme is minimal. See more information about approved melatonin products.

Melatonin with a recommended daily dose of up to 1 mg can be regulated under legislation other than medicinal product legislation, under certain conditions. 

Medicinal products manufactured outside Norway 

Compassionate use, named patient for magistral medicinal products manufactured outside Norway is granted only if there is no medicinal product with a marketing authorisation in the EU/EEA and it is not feasible to have it manufactured by a pharmacy in Norway. Applications for magistral medicinal products from abroad must be approved by NOMA before dispensing, except for certain products listed on the dispensing list.

Before a pharmacy/wholesaler can import pharmacy-manufactured medicinal products (without MA) directly from the pharmacy manufacturer, an import permit must be obtained from NOMA.