Cannabis flos, cannabidiol-rich variety (CBD) as active ingredient from Macedonian producers

All applicants should own and submit following documents:

  1. Flow-chart for traceability of any legal entity (s) performing activities from procurement phase of the material for sowing / planting, breeding, harvesting, drying, selection, processing, fertilization, decontamination and other stages to packaging in contact packing
  2. Proof of registration of each legal entity / persons in the Central Registry of RSM for the relevant activities performed in the process
  3. Quality specifications of used seed material or other sowing / planting material, soil and water issued by a certified / accredited laboratory
  4. Laboratory findings from the analysis of used seed material or other seed / planting material, soil and water issued by a certified / accredited laboratory
  5. Variety of Cannabis herb and its part (herb, flower, leaf etc.) which ends in transport packaging
  6. Licenses, certificates, accreditations held by a legal entity that is part of the process of cultivation of Cannabis (GACP) and all subsequent phases of vegetable processing leading to a dry vegetable mass in transport packaging (Certificate of Conformity is required) Good Manufacturing Practice – GMP, issued by MALMED, ISO standards and Certificate of Compliance with EU GMP norms for relevant activities).
  7. Specification for the quality of dried plant mass (parameter “Loss with drying” to be <10%) and laboratory finding, issued by a certified / accredited laboratory
  8. Certificates for suitability of the contact pack material for intended purpose
  9. Available documentation: certificates / specifications regarding traceability of material storage and transportation conditions at all stages (GDP, relevant ISO standards)
  10. When submitting the application, it is necessary to submit a sample for physic-chemical analysis of the herb for determination of its composition again. The outcome will determine further agreeing on the terms and details of the cooperation (agreed quantities and prices).Further negotiations and cooperation will depend from this outcome.