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Dutch Pot-Growing Contractor Guidelines

Netherlands Growing Guidelines for Dutch Medical Cannabis Crops

Office of Medicinal Cannabis

Guidelines for Cultivating Cannabis for Medicinal Purposes Annex to the Regulation of the Minister of Health, Welfare and Sport of 9 January 2003, GMT/BMC 2340685.

(authorised English translation)

1) Introduction:

Under certain conditions, the Dutch government permits the cultivation of cannabis for medicinal purposes. In the case of herbal drugs, the cultivation method and primary processing of the plant determines the ultimate properties of the active pharmaceutical ingredient.

Starting materials of herbal origin have a complex composition and can only be characterized to a limited extent through chemical or biological analysis.

Therefore, an effective quality assurance system in the steps leading up to the production of the active pharmaceutical ingredient is needed in order to guarantee reproducible quality.

These steps are cultivation, harvesting and primary processing.

The following guidelines for cultivating, harvesting and primary processing of cannabis constitute a quality assurance system that meets these requirements. The Office of Medicinal Cannabis (Bureau voor Medicinale Cannabis) will test on the basis of these requirements.

These guidelines have been derived from the general rules for Good Agricultural Practice of the Working Group on Herbal Medicinal Products of the European Medicines Evaluation Agency (EMEA).

This is a non-authorized translation of the official version in Dutch.

2) General:

2.1 These guidelines apply to the cultivation, harvesting and primary processing of cannabis plants intended for medicinal use or the preparation of medicinal drugs.

These guidelines must be read in connection with the European Good Manufacturing Practice (GMP) guidelines for active pharmaceutical products. They apply to all methods of production including organic cultivation.

These guidelines also provide additional standards for the production and processing of herbal starting materials insofar as they identify the critical production steps that are needed to ensure good, reproducible quality.

2.2 The main objective of these guidelines is to increase the reliability of the medicines prepared from cannabis by establishing an appropriate quality standard for the herbal medicine cannabis. > In particular, it is important that the cannabis:

-is produced hygienically to keep microbiological contamination to a minimum;

-is produced such that negative effects on the plants during cultivation, processing and storage are kept to a minimum;

- is produced under conditions that ensure that the therapeutic properties of the end product are constant and reproducible.

3) Personnel and training:

3.1 Training

3.1.1 Personnel must have received adequate botanical/horticultural training before performing the tasks given to them.

3.1.2 Production personnel must be trained in the production techniques used.

3.1.3 Primary processing procedures must comply with the regulations on food hygiene.

3.2 Hygiene

3.2.1 All personnel entrusted with handling the herbal material must maintain proper personal hygiene.

3.2.2 Persons suffering from infectious diseases transmittable via food, including diarrhea, or carriers of these diseases must be forbidden access to areas where they could come into contact with the herbal material.

3.2.3 Persons with open wounds, inflammations and skin-infections must be suspended from areas where they could come into contact with herbal material, unless they wear protective clothing or gloves until they have recovered completely.

3.2.4 Personnel must be protected from contact with toxic or potentially allergenic herbal material by means of adequate protective clothing.

4) Buildings and facilities

4.1 Rooms used in the processing of harvested crops must be clean, well ventilated and must never be used for other activities.

4.2 Buildings must be designed in a manner that protects the crops against pests and domestic animals.

4.3 The medicinal cannabis must be stored:

- in a suitable packaging