The cost of cul­ti­va­tion: gov­ern­ment pub­lishes medic­i­nal cannabis pro­duc­tion fees

The Malta Independent on Sunday - - NEWS -

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.

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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