The Conditions For The Use Of Medicinal Products Containing Hemp

Original Language Title: podmínky pro používání léčivých přípravků s obsahem konopí

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=84640&nr=236~2F2015~20Sb.&ft=txt

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.