Ordinance no. 14/2022, dated 5 January, alters the framework on the authorisation for activities relating to the growing, manufacture, wholesale trade, transport, distribution, import and export of medicines, preparations and substances derived from the cannabis plant, originally established by Ordinance no. 83/2021, dated 15 April.
The main purpose of the alteration is to make clear and differentiate procedures applicable to the growing of cannabis for industrial purposes, as well as to clarify certain licensing requirements previously introduced in respect of cannabis for medicinal purposes activities.
As per the new framework, instead of a notification, producers wishing to grow cannabis for industrial purposes are now required to direct to the General-Directorate of Food and Veterinary (DGAV) an authorisation request in respect of this activity.
Ordinance no. 14/2022 also establishes technical requirements to grow cannabis for industrial purposes, namely:
- The obligation to grow cannabis in open air and the prohibition to resort to greenhouses, shelters or similar structures on any phase of the plants’ development;
- Agricultural exploitation sites must have a minimum area of 0.5 hectares and the sowing density cannot be below 30kg of seeds per hectare;
- Prohibition to use open seed packages that contain leftover seed not used in the agricultural season for which it was purchased in the following year, farmers being obliged to keep documents proving the destination of those leftovers;
- Flowering juices, whether they do or not contain seeds, cannot be transported outside of the agricultural exploitation site.
Furthermore, a clear distinction is made regarding operations for medicinal, veterinary or scientific research purposes that only involve primary processing, cutting, and drying, as those activities do not require an industrial licensing, but merely compliance with good manufacturing practices as established on the Commission Delegated Regulation (EU) no. 1252/2014, of 28 May 2014.
Ordinance no. 14/2022 enters into force on 06.01.2022 and is applicable to ongoing authorisation procedures.