The Malta Independent 16 July 2020, Thursday

The cost of cultivation: government publishes medicinal cannabis production fees

Sunday, 25 November 2018, 08:00 Last update: about 3 years ago

Companies producing medicinal cannabis in Malta will be subject to annual fees amounting to a maximum of €63,000 if all related activities are undertaken, and an initial application fee of a maximum of €100,000, according to a Legal Notice published by the government on Friday.

Following the publication of the fees and guidelines, companies with a Letter of Intent from Malta Enterprise will be able to apply for a license with the Medicines Authority.

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The fees published on Friday pertain to those intending to carry out importation, wholesale distribution, cultivation and processing, and/or production of cannabis, and any other activity related to cannabis for medicinal use and/or research purposes.

The application fee for a manufacturing site licence for medicinal cannabis has been set at €35,000, with an annual fee of €35,000. 

Such facilities will also be subject to an additional fee per footprint allocated for cultivation purposes. These have been pegged at: €5 per square metre up to 2,000 square metres; €20 per square metre for the part of the footprint exceeding 2,000 square metres up to 4,000 square metres; €40 per square metre for the part of the footprint exceeding 4,000 square metres up to 6,000 square metres; and €100 per square metre for the part of the footprint exceeding 6,000 square metres.

A licence for non-commercial research activities will cost an initial €10,000 and have an annual fee of €8,000.

A Good Manufacturing Practice (GMP) certification related to cannabis for medicinal purposes (involving an inspection in Malta or within the EU/EEA) will cost €15,000 and an annual fee of €5,000.

GMP certificate related to cannabis for medicinal purposes (involving an inspection in a third country outside the EU/EEA) will cost €25,000 plus €600 per day per inspector plus all inspectors' travel expenses. The annual fee will run at €15,000.

Other initial fees will include additional data integrity, research, and security inspections/audits, at €5,000 per audit consultations of scientific matters (at €200 per man hour).

Companies will also pay €1 per unit product towards research and education to be undertaken by the regulatory authority.

The fees are exclusive of any additional fees that may be charged by other competent authorities for ancillary and supporting documentation, reports, or other services that may be required by the Regulatory Authority to process the application and issue the requisite licences, certificates, or permits.

Any additional expenses incurred by the Regulatory Authority will also be charged to the applicant separately.

It is understood that while Maltese production has not yet started, two companies are importing cannabis products: Bedrocan Netherlands, licensed to import one product, and Pedanios Gmbh, a German company owned by Canada's Aurora Cannabis, licensed to import two products. At least six other importation applications are awaiting approval, including some for oils.

 


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