Ministerial Order 14/2022 was published on 5 January to introduce the first amendment to Ministerial Order 83/2021 of 15 April. The original Ministerial Order sets out the requirements and procedures for granting authorisations for activities relating to the cultivation, manufacture, wholesale trade, transport, circulation, import and export of medicines, preparations and substances made from the cannabis plant.
The amendment now introduced is intended to address the
insufficient regulation of some issues relating to the cultivation
of the cannabis plant for medical and non-medical purposes.
Specifically, the amendment addresses the cultivation of hemp for
industrial purposes and differentiates it from the cultivation of
the cannabis plant for other purposes. It also regulates some
aspects of the cultivation of the cannabis plant for medicinal
purposes.
Article 3-A is added to Ministerial Order 83/2021 and it
establishes the technical requirements applicable to the
cultivation of cannabis plants for industrial purposes, including
the minimum limit of the area of cultivation of the cannabis plant
and the sowing density.
Changes are also 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. In addition to proof of an
authorisation granted by the competent authority to suppliers or
recipients of medicinal products, preparations and substances based
on the cannabis plant for medicinal purposes, for activities
relating to the export, import or intra-EU trade in the cannabis
plant, declarations of interest from these entities will also be
required.
Furthermore, 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 manufacture
of medicines, substances and preparations. The requirement for this
specialisation will be waived in cases where only active substances
for the pharmaceutical industry are manufactured.
Ministerial Order 14/2022 also introduces changes in the
documentation that has to be submitted to engage in the activity of
wholesale distribution of medicines, preparations and substances
based on the cannabis plant for medicinal purposes. Specifically,
it regulates the wholesale trade of the plant, part of the plant or
active 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. This applies in cases where the
operations to be carried out are exclusively primary processing,
cutting and drying, carried out in accordance with good
manufacturing practice for active substances for medicinal products
for human use approved by Commission Delegated Regulation (EU)
1252/2014 of 28 May 2014.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.