Ministerial Order 14/2022 was published on 5 January 2022 to introduce the first amendment to Ministerial Order 83/2021 of 15 April 2021.
The recently introduced amendment is intended to address the insufficient regulation of some issues relating to the cultivation of the cannabis plant for medical and non-medical purposes.
Changes have also been made to the rules on applications for authorisation for activities relating to the cultivation, manufacture, wholesale trade, import, export, transport and movement of medicinal products, preparations and substances based on the cannabis plant for medicinal, medical or veterinary purposes, or for purposes of scientific research.
For activities involving the manufacture of medicines, substances or preparations based on the cannabis plant for medicinal purposes, Ministerial Order 83/2021 will also require the technical manager to be a pharmacist with a pharmaceutical industry specialist qualification only in the case of the manufacture of medicines, substances and preparations.
Ministerial Order 14/2022 also introduces changes in the documentation that must be submitted to engage in the activity of wholesale distribution of medicines, preparations and substances based on the cannabis plant for medicinal purposes.
Finally, in the inspection of facilities for activities for medicinal, medical-veterinary or scientific research purposes, it is no longer necessary to submit proof of industrial licensing at the time of the inspection request.