Decree No. 235 / 2022 Coll.
Decree on the cultivation and processing of hemp plants for therapeutic use
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Order
Effective from 27.08.2022
Text versions:
27.08.2022
12.08.2022
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235
DECLARATION
of 5 August 2022
on the cultivation and processing of hemp plants for therapeutic use
According to § 44c (5) and to implement § 24b (7) and § 24d (b) and (c) of Act No. 167 / 1998 Coll., on addictive substances and on amending certain other laws, as amended by Act No. 273 / 2013 Coll. and Act No. 366 / 2021 Coll.:
Preliminary provisions
This decree provides
(a) rules of good cultivation practice for growing hemp plants for therapeutic use;
(b) rules on safe storage, the camera system and other security measures to ensure the cultivation of hemp plants for therapeutic use;
(c) the manner and extent of the logging and registration of activities related to the cultivation, harvesting and processing of hemp plants for the therapeutic use and disposal of plant waste.
Definitions
For the purposes of this decree:
(a) a grower of a person growing cannabis plants for therapeutic use under Section 24b of the addictive act;
(b) a lot of one harvest of the species and variety of identical units of hemp plants for therapeutic use which have been grown from the same growing material, in a place with the same conditions and harvested at one time;
(c) the basic processing of operations to obtain an intermediate product of hemp for therapeutic use, in particular washing of the plant, cutting part of the plant containing the flower before drying and drying,
(d) an intermediate product of hemp for therapeutic use, a basic processed hemp plant for therapeutic use containing a peak.
Rules of good cultivation practice
The rules of good cultivation practice include:
(a) rules governing the management of the quality management system;
(b) staff requirements and training;
(c) laying down hygiene standards;
(d) requirements for premises;
(e) rules on documentation management;
(f) rules on the handling of propagating material;
(g) cultivation rules;
(h) the rules governing the holding of the harvest;
(i) rules and procedures for basic processing into a cannabis intermediate for therapeutic use;
(j) packaging requirements;
(k) storage requirements; and
(l) the requirements for plant protection.
Quality management system
(1) The breeder grows and processes cannabis plants for therapeutic use to ensure that the resulting intermediate of cannabis for therapeutic use is suitable for the production of cannabis for therapeutic use.
(2) In order to achieve the required quality of cannabis plants for therapeutic use and the resulting intermediate product of hemp for therapeutic use, the grower sets and puts into practice a quality assurance system which meets the minimum requirements for the quality assurance system laid down in this decree. The breeder shall monitor the efficiency of the quality assurance system on an ongoing basis, make and retain records of the monitoring and, in the event of detected deficiencies, amend or update the system.
(3) The quality assurance system shall include repeated internal controls to monitor compliance with the rules of good cultivation practice and to enable corrective action to be taken where necessary. Such internal controls and any corrective measures subsequently taken shall be kept and kept by the grower.
Staff and training
(1) The breeder shall establish employment relationships with such a number of eligible and trained staff as to ensure, in accordance with good growing practice and at the same time in such a way as to ensure the required quality of the resulting intermediate cannabis for therapeutic use and protection against loss, misuse or theft of plant material, that:
(a) the continuous growing process of cannabis plants for therapeutic use;
(b) the basic processing of hemp plants for therapeutic use into the intermediate product of hemp for therapeutic use;
(c) storage, packaging and storage.
(2) The breeder shall provide each employee with work obligations resulting from the nature of the work agreed upon, in writing. The growers shall inform the staff members of their duties at the latest before the start of the operations in the work referred to.
(3) The breeder shall determine the relationship between the individual staff members of the management and subordination scheme; the working obligations and organisational schemes are approved in accordance with the producer's internal rules.
(4) The breeder provides all its employees with initial and continuous practical training and theoretical training related to the cultivation of cannabis plants for therapeutic use, processing, packaging and storage. In particular, training on compliance with good cultivation practice, training in cultivation techniques used in the cultivation of cannabis plants for therapeutic use, and safety training on the treatment of addictive substances. The grower shall keep records of the training carried out.
Sanitary standards
The breeder shall establish effective hygiene standards for all activities carried out by his staff, which shall form part of the internal rules of the breeder and shall verify compliance with them on an ongoing basis. By means of specified hygiene standards, the grower shall at least ensure that:
(a) any person entering a growing plant shall wear protective clothing appropriate to the nature of the activities carried out;
(b) persons suffering from infectious diseases shall be confined to places where they may come into contact with plant material;
(c) persons with open wounds, inflammation and infectious skin diseases shall be excluded from the places where they may come into contact with plant material, except where they have suitable protective clothing which includes protective gloves until the wounds have been fully healed; and
(d) persons located in a growing plant must not drink, eat, smoke or perform any other activity through which plant material may be contaminated.
Space
(1) The breeder shall ensure that premises are used as a grow house
(a) pure;
(b) with appropriate air circulation; and
(c) in the past, not used for animal husbandry.
(2) The breeder shall ensure that the growing plant:
(a) have been designed in a way that ensures the protection of cannabis plants for therapeutic use from animals; and
(b) have all premises equipped with means for pest control and control; This appropriation may be used and maintained only by staff or contractors who meet the professional requirements under the legislation governing professional qualifications (1).
(3) The breeder shall ensure that the grow room is equipped with a dressing room and sanitary facilities.
(4) To avoid the risk of contamination, the grower uses an easy-to-clean plant for harvesting, cultivation and basic processing, which keeps clean and in good condition.
(5) The breeder shall ensure that the equipment used for fertiliser and pesticide application is calibrated as recommended by the manufacturer. The breeder ensures its regular service and maintenance and keeps records of their execution.
(6) In order to prevent cross-contamination with chemical and other undesirable substances, the equipment referred to in paragraph 5 shall be made of suitable, easy-to-clean materials. Parts of the plant coming into direct contact with harvested plant material shall be regularly cleaned in such a way that they are free of lubricants and impurities, including residues of plant substances.
Documentation
(1) The breeder shall ensure that all activities related to the cultivation, harvesting and basic processing of hemp plants for therapeutic use and the disposal of plant waste are recorded.
(2) The breeder shall establish, maintain and regularly update a system of managed documentation governing the manner and extent of the implementation of the protocol and record keeping of activities related to the cultivation, harvesting and processing of hemp plants for therapeutic use and the disposal of plant waste and the keeping of other records. The breeder shall establish a clear and understandable system that does not raise doubts as to which particular persons are required to carry out the protocol and keep records.
(3) Records of specific activities shall be recorded immediately after the activity concerned has been carried out in such a way that each individual activity can be traced back.
(4) All documents relating to the cultivation, harvesting and basic processing of hemp plants for therapeutic use shall be kept in paper or electronic form for at least 5 years from the date of the receipt of the document or, where appropriate, from the last entry therein, whichever is the later. The documentation shall be kept in such a way as to prevent the destruction, loss, damage, destruction, misuse or theft of documents, while at the same time allowing for the immediate presentation of documents to the inspection authorities.
(5) All processes and procedures which may affect the quality of cannabis plants for therapeutic use are to be recorded in the dossier for each batch individually.
(6) In particular, the following information shall be provided:
(a) the name and, where appropriate, the names and the name of the grower;
(b) place of cultivation (address, room designation),
(c) the number of the lot actually grown,
(d) the nature, origin and quantity of the initial plant material;
(e) the designation of individual cannabis plants for therapeutic use, their registration and location;
(f) plant protection products (2), fertilisers (3) and other substances used during cultivation;
(g) conditions of cultivation;
(h) incidents occurring during cultivation, harvesting and basic processing which could affect the chemical composition of the product;
(i) pest control measures;
(j) the harvest balance,
(k) date and time of harvest;
(l) basic processing operations;
(m) drying conditions;
(n) an entry for each individual lot certifying that the cultivation, harvesting and basic processing has taken place in accordance with the requirements of good cultivation practice;
(o) the date, designation and quantity of plant waste generated; and
(p) the date, designation and quantity of plant waste disposed of.
(7) The treatment of cannabis intermediate for therapeutic use shall be kept in the manner laid down by the legislation governing the registration and documentation of addict4).
(8) The breeder introduces a system of batch labelling. A lot of cannabis plants for therapeutic use must be clearly and unmistakably traceable, including the number of plants that are part of the batch.
Reproduction material
(1) The breeder shall ensure that propagating materials are botanically identified by species, variety, type and genotype. The breeder shall also ensure that the origin of the plant material is traceable.
(2) For the cultivation of hemp plants for therapeutic use, the grower is entitled to use only female plant cuttings.
Cultivation
(1) Cannabis plants for therapeutic use are grown by the breeder in a non-contaminated substrate, in particular heavy metals, pesticide residues or other chemicals.
(2) The breeder shall ensure that:
(a) all plant nutrition products have been applied in a cost-effective manner according to the needs of the plant species and in such a way as to limit their leaching from the substrate; and
(b) irrigation has been managed and carried out exclusively according to the needs of cannabis plants.
(3) Water for irrigation must not be contaminated with sludge, heavy metals and toxic substances.
(4) The breeder shall ensure that crops and plant protection are managed in such a way that:
(a) all farming activities have been adapted to plant growth and requirements; and
(b) the use of pesticides has been restricted to the greatest extent possible; where appropriate, approved plant protection products shall be applied in a minimum effective quantity in accordance with the recommendation of the manufacturer or the competent authorities; the implementation of these funds is carried out only by qualified staff; the shortest interval between these applications and the harvest shall be consistent with the recommendation of the plant protection product manufacturer; the levels for pesticide residues are laid down in Article 2.8.13 of the European Pharmacopoeia.
(5) The breeder shall establish, maintain and regularly update a system of controlled documentation covering standard conditions for the cultivation of hemp plants for therapeutic use for the production of the required intermediate cannabis for therapeutic use containing target levels of delta- 9-tetrahydrocannabinol and cannadiol. The breeder shall ensure that hemp plants for therapeutic use are grown in accordance with a controlled dossier.
(6) The breeder shall ensure that there are no other plants and impurities which may be a source of contamination during all activities involving cannabis plants for therapeutic use and intermediate products for therapeutic use and at the place where such activities are carried out.
(7) In order to comply with the standard conditions during cultivation laid down in paragraph 5, the grower shall monitor, during the cultivation, compliance with the standard conditions for cultivation specified in the system of controlled documentation in the following parameters:
(a) cultivar of the starting plants;
(b) culture substrate,
(c) the length of the cycle of uninterrupted lighting and the length of the cycles of uninterrupted time without lighting in the individual biological periods of grown plants;
(d) light intensity,
(e) colour light temperature,
(f) humidity;
(g) temperature,
(h) irrigation; and
(i) the age of the plant at the time of harvest.
(8) The cultivation conditions of the grower shall be monitored and documented.
(9) In addition, written records of the cultivation conditions shall be checked by the competent staff member of the grower different from the staff member who carries out the records.
Harvest
(1) The breeder shall harvest when the plants achieve the required quality.
(2) Damaged or dead plants are disposed of as plant waste.
(3) The harvested plant material must not come into direct contact with the substrate.
(4) The breeder shall ensure that the plant material is treated at harvest in such a way as to avoid mechanical damage and compression of the plant material. In particular, it is necessary to prevent
(a) overloading of collection bags or other collection containers; and
(b) excessive stacking of packed collection bags.
Basic processing into a cannabis intermediate for therapeutic use
(1) The basic processing shall be carried out by the grower immediately after the harvest, in accordance with a controlled dossier, in such a way as to eliminate the heat and enzymatic degradation of the cannabis intermediate for therapeutic use.
(2) The breeder lays down the conditions for the technical drying of cannabis plants for therapeutic use, in particular the setting of circulation and humidity, temperature and drying times. The specified drying conditions shall be strictly respected, documented, recorded and stored in detail.
Packaging
(1) After basic processing, the grower packs the intermediate product of hemp for therapeutic use in a clean, dry and new packaging, which is labelled. The label shall be clearly affixed and made of non-toxic material.
(2) The label shall include at least the following information:
(a) the name and, where appropriate, the name of the grower and his registered office;
(b) the date of harvest,
(c) the lot number,
(d) the name of the type of hemp for therapeutic use, including those targeted by delta- 9-tetrahydrocannabinol and cannadiol, and
(e) the quantity of cannabis intermediate for therapeutic use.
(3) All packaging used to store plant material, in particular bags and other containers, must be clean. Currently unused packaging is kept by the grower in dry, clean areas in a way that prevents contamination.
Storage
(1) Intermediate cannabis products for therapeutic use are kept by the grower in dry, well-ventilated areas with a constant temperature. Storage conditions are monitored and recorded.
(2) Intermediate cannabis products for medicinal use are stored
(a) in the packaging provided for in Article 13,
(b) in dry, sufficiently ventilated rooms with concrete floors or other similar easy-to-clean material;
(c) on pallets or shelves,
(d) at a sufficient distance from the walls; and
(e) appropriately separated from other herbal active substances to prevent cross-contamination.
(3) The breeder shall store all plant waste as provided for in Article 24b (5) (a) (4) of the addictive act in such a way as to prevent its abuse.
Feeding plant security
(1) The breeder shall ensure that each grow plant operated by him is a uniform, secure complex
(a) more than one site; or
(b) more space within one building.
(2) The complex referred to in paragraph 1 must be provided at least
(a) continuous surveillance with the possibility of immediate response to security breaches;
(b) electronic security equipment with a central security counter outlet;
(c) by a camera system,
(d) by means of a security entrance into the various parts of the growing plant; and
(e) fencing fitted with razor blades.
(3) The grow room must be constructed from materials which make penetration difficult.
(4) The camera system referred to in paragraph 2 (c) must be set to:
(a) allow live output, with sufficient resolution of camera transmission for identification of persons, at the disposal of the supervising person or the person authorised on behalf of the grower to verify the safety of the growing plant;
(b) allow the retention of a camera record with sufficient resolution to identify persons for at least 40 days; and
(c) at least the camera records are secured
1. entry into the complex,
2. entry into the grow house,
3. growing areas,
4. processing premises; and
5. the area where cannabis intermediates are stored for therapeutic use.
(5) The security access conditions referred to in paragraph 2 (d) shall be fulfilled by:
(a) doors locked by a safety lock made of a material which makes penetration difficult; and
(b) the issue of keys, magnetic cards or other means of entry only to designated persons.
(6) The breeder shall draw up an internal regulation governing the security system for each individual growing plant; the internal regulation in addition to the specification of the individual safety features referred to in paragraphs 1 to 5 shall also contain:
(a) the identification of persons who have access to the growing plant and under what conditions;
(b) the method of access to the growing plant;
(c) the method of recording the entry into the grow house; and
(d) the way in which keys, magnetic cards or other means of access to the grow house are handled.
Technical Regulation
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Efficacy
This decree shall take effect on the 15th day following its publication.
Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
1) Article 58 of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Related Acts, as amended. Act No. 18 / 2004 Coll., on the Recognition of Professional Qualifications, as amended.
(2) Regulation (EC) No 1107 / 2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79 / 117 / EEC and 91 / 414 / EEC.
3) Act No. 156 / 1998 Coll., on fertilisers, soil aids, plant biostimulants and substrates and on agrochemical testing of agricultural soils (Fertilisers Act), as amended.
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Regulation Information
| Citation | Decree No. 235 / 2022 Coll., on the cultivation and processing of cannabis plants for therapeutic use |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 12.08.2022 |
|---|---|
| Effective from | 27.08.2022 |
| Effective until | - |
| Status | Valid |
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