236/2015 Sb.
The DECREE
from day 4. September 2015
on the establishment of conditions for prescribing, preparation, distribution, dispensing of and
the use of individually prepared medicines containing
cannabis for medical use
The Ministry of health and Ministry of agriculture, in consultation with the
The Ministry of Defense, Ministry of Interior, Ministry of Justice
and the Ministry of finance pursuant to section 114 of the Act provides for no 378/2007 Coll.
pharmaceuticals and on changes of some related laws (law on medicinal products),
as amended by law No. 50/2013 Coll. and Act No. 70/2013 Coll., to implement section
paragraph 77. 1 (a). (g)), § 79 paragraph. 2, § 79 paragraph. 8 (a). and, Section 79a of the paragraph). 1
and § 80 of the law on medicinal products:
§ 1
The subject of the edit
This Decree regulates the rules of good distribution practice for cannabis
therapeutic use and the conditions of prescription, preparation, issue and use
individually prepared medicinal product containing cannabis for
therapeutic use.
§ 2
Types of cannabis for therapeutic use and determination of quantitative restrictions
(1) For the prescription, preparation, dispensing, and the use of individually
the forthcoming of a medicinal product containing cannabis for medical use
You can only use the types of cannabis for medicinal use, as set out in the annex
No 1 to this Decree, in the aggregate amount of not more than 180 g dried
herbal drugs a month.
(2) for the preparation of individually prepared medicinal product can be
only use cannabis for therapeutic use referred to in paragraph 1, which meets the
the criteria set out in annex 2 to this Decree.
(3) the quality of cannabis for medicinal use for the preparation of medicinal products
must be accompanied by the presentation of a document by checking the quality of medicinal substances
issued in the European Union
and a manufacturer of medicinal products), which is entitled to check the medicinal
substances,
(b) the manufacturer of medicinal substances), which is the holder of a valid certificate
good manufacturing practice in the production of medicinal substances, or
(c)) the laboratory that meets the requirements of good manufacturing practice laid down by
The European Commission and the European Medicines Agency and meet the requirements of
good manufacturing practice, provide proof of a valid certificate of good manufacturing practice
or the Protocol on the control of issued by inspectors of the competent authority of the
of the Member State; such a Protocol on the control must not be older than 3 years.
§ 3
Marking of cannabis for medical use
Cannabis for medicinal use, intended for the preparation of individually
the forthcoming of a medicinal product must be marked on the packaging in accordance with
the characteristics listed in annex 1 to this notice. For the designation of
individually prepared medicinal product containing cannabis for
therapeutic use referred to in section 2 of the Ordinance shall apply to the correct laboratory
practice ^ 1).
§ 4
The prescription of individually prepared medicinal product containing
cannabis for medical use
(1) the Individually prepared medicinal product containing cannabis for
therapeutic use referred to in section 2, in the provision of health services
to prescribe in the indications listed in annex No. 3 to this notice
only a doctor with specialised competence laid down in this annex,
and that only patients who have reached 18 years of age.
(2) the Prescribing physician is obliged to state the General recipe
laid down by a decree on how the prescription of medicinal products ^ 2)
dosage prepared individually for a medicinal product containing
cannabis for therapeutic use referred to in section 2 and the route of administration. The following is veterinarian
required to indicate on the recipe
and the type of cannabis for therapeutic) use,
(b)) the percentage of delta-9-tetrahydrocannabinol and
(c)) the percentage of cannabidiolu.
(3) Prepared medicinal product containing cannabis for medical use
According to § 2 can prescribe for one recipe in quantity
the appropriate dose to ensure one-month treatment for the
the indication.
§ 5
Issue individually prepared medicinal product containing cannabis
for medicinal use
Individually prepared medicinal product containing cannabis for therapeutic
use may be issued only in the event that it is prescribed to a valid
electronic recipe, which contains the elements referred to in section 4, paragraph 4. 2.
§ 6
Final provision
This Decree was notified in accordance with the directive of the European Parliament
and Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision
information in the field of standards and technical regulations and regulations for services
the information society, as amended.
section 7 of the
Cancellation provisions
Decree No. 221/2013, which lays down the conditions for the
prescribing, preparing, dispensing and use of individually prepared
medicinal products containing cannabis for medicinal use, is hereby repealed.
§ 8
The effectiveness of the
This Decree shall enter into force on the thirtieth day after the date of its publication.
Minister of health:
Mudr. Němeček, in r.
Minister of agriculture:
Ing. Abdoul in r.
Annex 1
Types of cannabis for medical use
+------------------------------+-------------------------------------------------+
| Referenced information is compulsory | Characteristics/permissible values |
+------------------------------+-------------------------------------------------+
| Kind of hemp | Cannabis indica |
| | or |
| | Cannabis sativa L. |
+------------------------------+-------------------------------------------------+
| The content of DELTA-9-THC (delta-9-| Expressed as a percentage of content in the range 0.3%-|
| tetrahydrocannabinol) | 21.0%. The actual content of DELTA-9-THC in hemp |
| | for therapeutic use shall not deviate by more |
| | than +-20% of the values given by the breeder. |
+------------------------------+-------------------------------------------------+
| The contents of the CBD (cannabidiol) | Expressed as a percentage of content in the range of 0.1% |
| | 19.0%. The actual content of the CBD in the cannabis for therapeutic |
| | the use shall not deviate by more than +-20% |
| | by the given values. |
+------------------------------+-------------------------------------------------+
Annex 2
Criteria for cannabis for medical use
+--------------------------------------------------------------------------------------------------------------+
| Parameter | Method | Limit |
+--------------------------------+------------------------+----------------------------------------------------+
| Identity |
+--------------------------------+------------------------+----------------------------------------------------+
| Macroscopic description | Visual | Whole or in fine slices dried vrcholičnatá flowers |
| | | dark green, grey-green to or colors |
| | | the compound into the thick ear. The tiny flowers are |
| | | packed with bracts, with parties from the top |
| | | žláznatými hair. |
+--------------------------------+------------------------+----------------------------------------------------+
| TLC^a) | ARTICLE ^ b) 2.2.27 | Visual assessment |
+--------------------------------+------------------------+----------------------------------------------------+
| Purity tests |
+--------------------------------+------------------------+----------------------------------------------------+
| Foreign matter | ARTICLE 2.8.2 | Max. 2 % |
+--------------------------------+------------------------+----------------------------------------------------+
| Loss on drying | ARTICLE 2.2.32 | Max. 10,0 % |
+--------------------------------+------------------------+----------------------------------------------------+
| Pesticide residues | ARTICLE 2.8.13 | ODP. the limits referred to in the ARTICLE. 2.8.13 |
+--------------------------------+------------------------+----------------------------------------------------+
| Heavy metals | ARTICLE 2.4.27 | PB-max. 5,0 µg/g |
| | | CD-max. 1,0 µg/g |
| | | Hg-max. 0,1 µg/g |
+--------------------------------+------------------------+----------------------------------------------------+
| Aflatoxins | ARTICLE 2.8.18 | Max. 2 µ g/kg |
| -Aflatoxin B1 | | Max. 4 µ g/kg |
| -The total aflatoxin content | | |
| B1, B2, G1 and G2 | | |
+--------------------------------+------------------------+----------------------------------------------------+
| Microbiological quality | 2.6.12 and 2.6.13 ARTICLE | |
| ARTICLE 5.1.4 | | Max. 103 CFU/g ^ e) |
| -TAMC ^ c) | | Max. 102 CFU/g |
| TYMC-^ d) | | |
+--------------------------------+------------------------+----------------------------------------------------+
| Decomposition products | HPLC ^ f)-ARTICLE 2.2.29 | Max. 1 % |
| -cannabinol | | |
+--------------------------------+------------------------+----------------------------------------------------+
| Content |
+--------------------------------+------------------------+----------------------------------------------------+
| -THC (DELTA-9-| HPLC-ARTICLE 2.2.29 | +-20% of the declared content of THC or CBD |
| tetrahydrocannabinol) | | |
| -CBD (cannabidiol) | | |
+--------------------------------+------------------------+----------------------------------------------------+
and) chromatography.
(b)) the Czech pharmacopoeia.
(c)), the total number of aerobic micro-organisms.
(d)), the total number of yeast/fungus.
(e)) of the colony forming unit/s.
f) high performance liquid chromatologie.
Annex 3
Indication of the prescribing physician and specialist competence
+-------------------------------------------------------+-----------------------------------+
| Indications | The specialized competence of the doctor |
+-------------------------------------------------------+-----------------------------------+
| chronic neutišitelná pain (especially Clinical Oncology pain | |
| in the context of cancer patients, pain | Radiation Oncology |
| associated with degenerative diseases | Neurology |
| system, System Binder and disease | Palliative Medicine |
| imunopatologickými conditions, neuropathic pain, pain | pain treatment |
| When glaucoma) | Rheumatology |
| | Orthopedics |
| | infectious medicine |
| | internal medicine |
| | Ophthalmology |
| | Hyperhidrosis |
| | Geriatrics |
+-------------------------------------------------------+-----------------------------------+
| spasticita and the pain associated with it at the scattered | Neurology |
| multiple sclerosis or spinal cord injury, painless Royal | Geriatrics |
| spasticita fundamentally limiting the movement and | |
| mobility, or the patient's breathing, involuntary kinézy | |
| caused by a neurological disease and other health | |
| complications, resulting in neurological disease | |
| or injury of the spine with spinal cord damage, or injury of the brain | |
| Neurological tremor caused by the disease and the Parinsonovou | |
| other neurological problems by considering health care | |
| lékaře | |
+-------------------------------------------------------+-----------------------------------+
| nausea, vomiting, stimulating appetite in context | Clinical Oncology |
| with the treatment of oncological diseases or with treatment | Radiation Oncology |
| HIV | infectious medicine |
| | Hyperhidrosis |
| | Geriatrics |
+-------------------------------------------------------+-----------------------------------+
| Gilles de la Tourette's syndrome | Psychiatry |
+-------------------------------------------------------+-----------------------------------+
| surface treatment of dermatoses and mucosal lesions | Hyperhidrosis |
| | infectious medicine |
| | Geriatrics |
+-------------------------------------------------------+-----------------------------------+
1) Decree No. 84/2008 Coll., on good laboratory practice, closer
the conditions of treatment with the drugs in pharmacies, health establishments and
for other operators and devices producing medicinal products in
the texts of Decree No. 254/2013 Sb.
2) Decree No. 54/2008 Coll., about how the prescription of medicinal products,
the data placed on medical prescription and the rules of use
medical regulations, as amended.
