The “How To” of manufacturing Medical Marijuana in Malta
If you’ve always dreamt of having a factory producing medical marijuana in Malta, then rejoice: legislation providing for the production of cannabis for medicinal use has finally been published.
Following on the government’s pledges to reform cannabis in Malta, this is among the first legal steps towards reforming cannabis laws in Malta.
The bill, which deals strictly with medicinal cannabis, lays out the government’s idea of regulating the manufacturing of medicinal cannabis.
The bill does not address some important points, such as specific trade rules, or how the companies can go about buying and selling the product, among other things.
Any company can be sure to adhere to strict regulations, be open to random spot checks of their facilities, and must be ready to pass strict due diligence criteria.
1. The Minister responsible for the Medicines Authority will run the industry
The current Medicines Authority is run by Parliamentary Secretary Deo Debattista, who is under the watch of Minister Owen Bonnici. The administration of this act is in Dr Debattista’s hands if he remains at the Medicines Authority’s helm when this bill becomes law.
2. And Malta Enterprise needs to approve all interested companies
A company would need to send a ‘letter of intent’ to Malta enterprise to get the ball rolling. Their role is ensuring that the company is solely interested in ‘production’ of the medicine.
If Malta Enterprise gives the go ahead, it counts as a ‘preliminary approval’.
Malta Enterprise falls under the portfolio of Labour Deputy Leader for Party Affaird Chris Cardona.
3. Once Malta Enterprise gives the go ahead you’ll need to comply with all current and past laws and regulations
And that may include international regulations such as those set forth by the United nations.
4. As well as all Good Manufacturing Practices, quality standards and all due diligence
The quality of the products for medical will be determined under the Medicines Act, and you’ll need to submit all relevant documents to ensure you fulfil the government’s due diligence.
5. There will be a Licensing Appeals Board for any companies that are refused a license
The Minister will appoint a board made up of a Chairperson and three members, one of which must be a qualified scientist for no less than seven years. These members will be appointed for five years, and may only be removed from office by the Prime minister.
If someone wants to appeal the decision of the licensing board, they can appeal to the Court of Appeal within twenty days from the Board’s decision.
6. The Minister has the final say on all licensing conditions
He also has say over the granting, renewal, suspension, transfer, or cancellation of the license. He will also regulate the inspections to be carried out on the premises, as well as prescribe for inventory controls and things like registers and records, as well as keeping any financial guarantees which the licence holder would have given.
7. There are penalties of up to €100,000
Anyone found breaking the law in regards to the production of medical cannabis could be fined up to €100,000 and €1,000 for each day afterwards until it is paid.
8. The police commissioner can step in at any time
That is, if he believes that a crime took place on the premises.
9. If you are licensed, you become exempt from drug laws that could effect you
Certain drug laws relating to cannabis – like the manufacturing of cannabis medicines – will not apply to licensed companies anymore.
Source: 420 Intel – Europe