No applications have yet been filed to license any cannabis-based products in Malta, according to the Malta Medicines Authority.
The news comes after the Medicines Authority told Lovin Malta it was listening to stakeholders regarding medicinal use of cannabis. The authority also said it was “months” away from recommending approval of Sativex®, a CBD spray that can be used in patients with multiple sclerosis. Sativex® is already licensed in the EU, in countries such as Italy, the UK and Ireland.
“We have not yet recommended the licensing of Sativex® as a medicinal product but we have no objection to do so if an application comes in and all the requirements are met,” a spokesman for the MMA told Lovin Malta.
The authority also said that use of other products could be considered in exceptional circumstances. This would occur if a specialist in any of the areas of neurology, oncology, radiotherapy, psychiatry, anaesthetics and intensive care medicine were to file a request to the Superintendent of Public Health, for a medical preparation of cannabis on a case-by-case basis for patients who have not responded to other treatment.
The case is different with Bedrocan, which is the marijuana plant in its raw bud form. This cannot be given a marketing authorisation because it does not fall under the definition of a medicinal product. The Authority is currently listening to stakeholders’ feedback regarding other possible routes of authorisation for such products.
Lovin Malta is informed that clinical trials are currently being undergone around the world for various other cannabis-based products.
Just yesterday, Germany voted to legalise cannabis for medical purposes.