Decree No. 236 / 2015 Coll.
Ordonnance on the conditions for prescription, preparation, distribution, supply and use of individually prepared cannabis-containing medicinal products for therapeutic use
Valid
Order
Effective from 17.10.2015
236
DECLARATION
of 4 September 2015
laying down the conditions for the prescription, preparation, distribution, supply and use of individually prepared cannabis-containing medicinal products for therapeutic use
The Ministry of Health and the Ministry of Agriculture, after consulting the Ministry of Defence, the Ministry of Interior, the Ministry of Justice and the Ministry of Finance, pursuant to § 114 of Act No. 378 / 2007 Coll., on Medicines and on amendments to certain related laws (Act on Medicines), as amended by Act No. 50 / 2013 Coll. and Act No. 70 / 2013 Coll., for the implementation of § 77 (1) (g), § 79 (2), § 79 (8) (a), § 79a (1) and § 80 of the Act on Medicines:
Subject matter
(1) This decree regulates the rules of good distribution practice of cannabis for therapeutic use and cannabis extract for therapeutic use of the conditions of prescription, preparation, dispensation and use of an individually prepared cannabis-containing medicinal product for therapeutic use.
(2) This decree further regulates
(a) methods of producing cannabis extract for therapeutic use;
(b) analytical methods used to test active substances of cannabis extract for therapeutic use;
(c) the conditions for the labelling and storage of cannabis extract for therapeutic use, as well as the manner in which it is processed as a raw material in the preparation of individually prepared medicinal products under the Drug Act; and
(d) the conditions laid down for the use of cannabis for therapeutic use for the preparation of an individually prepared medicinal product containing cannabis for therapeutic use.
(3) This decree also regulates the details, structure, form, manner and time interval of the provision of information on the results of treatment with individually prepared cannabis-containing medicinal products for therapeutic use.
Cannabis for therapeutic use and quantitative restriction
(1) For the prescription, preparation, supply and use of an individually prepared cannabis-containing medicinal product for therapeutic use, only cannabis may be used for therapeutic use of the species Cannabis sativa or cannabis extract for therapeutic use, in aggregate quantities not exceeding 180 g dried plant drugs per month. For the purpose of calculating the quantitative limit, 1 g of cannabis extract for therapeutic use is produced from 3 g dried plant drug.
(2) When using individually prepared cannabis-containing medicinal products for therapeutic use in the framework of the provision of bed-based health care, prepared on the basis of a blue-striped demand, it is the duty of the treating physician to ensure compliance with a quantitative restriction on cannabis for therapeutic use in a hospitalized patient, which is a maximum of 6 g of dried plant drugs or 2 g of cannabis extract for therapeutic use per day.
(3) Only hemp for therapeutic use of the species Cannabis sativa may be used for the preparation of an individually prepared medicinal product, subject to the requirements laid down in the European Pharmacopoeia or hemp extract for therapeutic use which meets the criteria set out in Annex 5 to this Decree.
(4) The quality of cannabis for therapeutic use and cannabis extract for therapeutic use for the preparation of medicinal products shall be documented by the presentation of a proof of verification of the quality of the active substance issued in the European Union.
(a) a manufacturer of medicinal products authorised to control active substances;
(b) a manufacturer of active substances holding a valid certificate of good manufacturing practice in the manufacture of active substances; or
(c) a laboratory which complies with the requirements of good manufacturing practice laid down by the European Commission and the European Medicines Agency and demonstrates compliance with the requirements of good manufacturing practice by a valid certificate of good manufacturing practice or a control protocol issued by inspectors of the competent authority of that Member State; such inspection report shall not be more than 3 years old.
(5) The proof of verification of the quality of the active substance referred to in paragraph 4 shall include the following:
(a) the plant drug (Cannabis sativa) used;
(b) the type of extract or, where appropriate, purified extract;
(c) the declared THC and CBD content;
(d) the name of the solvent used for extraction;
(e) the name and quantity of the excipients present in the extract; and
(f) storage conditions and shelf life.
Marking of cannabis for therapeutic use and cannabis extract for therapeutic use
(1) Cannabidiol for therapeutic use intended for the preparation of an individually prepared medicinal product must bear on the packaging the content of delta- 9-tetrahydrocannabinol and cannadiol, as indicated in the proof of verification of the quality of the active substance referred to in Article 2 (4). Cannabis extract for therapeutic use for the preparation of an individually prepared medicinal product containing cannabis for therapeutic use shall bear on the packaging the content of delta- 9-tetrahydrocannabinol and cannadiol, as indicated in the document of verification of the quality of the active substance referred to in Section 2 (4), the type of extract referred to in Annex 5 to this Regulation, the name of the solvent used for the extraction, the name and quantity of the excipients present in the extract, information on storage conditions and shelf life.
(2) For the designation of the individually prepared cannabis-containing medicinal product for therapeutic use provided for in Article 2, the Ordinance on the correct pharmaceutical praxi1 shall apply).
Prescription of an individually prepared cannabis-containing medicinal product for therapeutic use
(1) Individually prepared cannabis-containing medicinal product for therapeutic use as referred to in Article 2 may prescribe when providing health services:
(a) to a patient from 18 years of age in the indications listed in Annex 3 to this Regulation, only a physician with specialised competence as set out in that Annex;
(b) to a patient under 18 years of age only a doctor
1. with special specialised competence in palliative medicine in providing palliative care; or
2. providing medical care to such a patient in the centre of highly specialised care (3) in the field of haematooncological care for children or oncological care for children.
(2) The prescribing physician shall indicate on the electronic recipe "Highly addictive ', except for the general requirements laid down in the Regulation on the Prescription of Medicinal Products (2), the dosage of the individually prepared medicinal product containing cannabis for therapeutic use as provided for in § 2, the route of administration code 9190000 for medicinal use or 9390000 for cannabis extract for therapeutic use, and in the note of the electronic recipe" Highly addictive substance', or the blue stripe demand, the required percentage of delta- 9-tetrahydrocanabinol and cannadiol prescribed for therapeutic use of delta- 9-tetrahydrocanabinol and cannadiol or a cannabis extract code for therapeutic use. If the prescriber prescribes cannabis extract for therapeutic use, he shall indicate the total amount of extract used in the preparation of the individually prepared cannabis medicinal product for therapeutic use and the type of extract referred to in Annex 5 to this Decree.
(3) A preparation of a cannabis-containing medicinal product for therapeutic use as provided for in Section 2 may be prescribed for one recipe at a maximum of the equivalent dose to provide three months of treatment for the indication.
(4) When providing bed care, the treating physician may indicate the use of a cannabis-containing medicinal product for a hospitalized patient by means of a written entry in the patient's medical file in accordance with § 2 (2). The condition for this indication is the specialised fitness of the treating physician as set out in Annex 3 to this Regulation, or the written recommendation of a doctor with specialised competence as set out in Annex 3 to this Regulation, which provided the patient with specialised outpatient care prior to hospitalisation, under which he prescribed an individually prepared cannabis-containing medicinal product for therapeutic use in accordance with this Decree, or on the basis of a written recommendation from the consulting doctor with specialised competence as set out in Annex 3 to this Regulation during hospitalisation. The recommendation of a doctor with specialised competence shall be based on the patient's medical documentation at the latest on the day of issue of the blue stripe application.
(5) An individually prepared cannabis-containing medicinal product for therapeutic use for a hospitalised patient can only be prepared in a pharmacy on the basis of a blue stripe demand, provided that the amount of cannabis for therapeutic use in one unit of the prescribed pharmaceutical form does not exceed the quantitative limit provided for in Article 2 (2).
Preparation and delivery of an individually prepared cannabis-containing medicinal product for therapeutic use
(1) An individually prepared cannabis-containing medicinal product for therapeutic use may be issued only if it is prescribed for a valid electronic prescription with the designation "highly addictive substance," containing the particulars referred to in § 4 (2) or for a blue stripe requisition in the framework of the provision of bed health care under the law on addictive substances in accordance with § 4 (2) and (6).
(2) For the preparation of an individually prepared medicinal product with a cannabis content for therapeutic use or a cannabis extract for therapeutic use, only hemp for therapeutic use or hemp extract for therapeutic use may be used, with a percentage of delta- 9-tetrahydrocannabinol of not more than 25,0% and a percentage of cannadiol of not more than 23,0%.
(3) For the preparation and delivery of an individually prepared cannabis-containing medicinal product for therapeutic use on the basis of an electronic recipe marked "highly addictive substance 'or on the basis of a blue stripe demand, only cannabis for therapeutic use or cannabis extract for therapeutic use may be used, which corresponds to prescribing physicians with a tolerance of 10%.
Manufacture of cannabis extract for therapeutic use
(1) For the manufacture of cannabis extract for therapeutic use, only hemp for therapeutic use may be used for the preparation of an individually prepared medicinal product.
(2) The analytical methods used for testing active substances in cannabis extract for therapeutic use are set out in Annex 5 to this Decree.
Final provision
This Decree was notified in accordance with Directive 98 / 34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services, as amended.
Repeal
Decree No. 221 / 2013 Coll., laying down the conditions for the prescription, preparation, supply and use of individually prepared cannabis-containing medicinal products for therapeutic use, is hereby repealed.
Efficacy
This Decree shall take effect on the 30th day following its publication.
Minister for Health:
MUDr.
Minister for Agriculture:
Ing. Jurečka v. r.
Příloha č. 3
Annex No. 3 to Decree No. 236 / 2015 Coll.
Indication and specialist competence of prescribing physician
| Indikace | Specializovaná způsobilost lékaře |
|---|---|
| chronická neutišitelná bolest (zejména bolest v souvislosti s onkologickým onemocněním, bolest spojená s degenerativním onemocněním pohybového systému, systémovým onemocněním pojiva a imunopatologickými stavy, neuropatická bolest, bolest při glaukomu) | klinická onkologie |
| radiační onkologie | |
| neurologie | |
| paliativní medicína | |
| léčba bolesti | |
| revmatologie | |
| ortopedie | |
| infekční lékařství | |
| vnitřní lékařství | |
| oftalmologie | |
| dermatovenerologie | |
| geriatrie | |
| všeobecné lékařství | |
| spasticita a s ní spojená bolest u roztroušené sklerózy nebo při poranění míchy, nebolestivá úporná spasticita zásadním způsobem omezující pohyb a mobilitu, nebo dýchání pacienta, mimovolné kinézy způsobené neurologickým onemocněním a další zdravotní komplikace, mající původ v neurologickém onemocnění, nebo úrazu páteře s poškozením míchy, či úrazu mozku, neurologický třes způsobený Parkinsonovou chorobou a další neurologické potíže dle zvážení ošetřujícího lékaře | neurologie |
| geriatrie | |
| nauzea, zvracení, stimulace apetitu v souvislosti s léčbou onkologického onemocnění nebo s léčbou onemocnění HIV | klinická onkologie |
| radiační onkologie | |
| infekční lékařství | |
| dermatovenerologie | |
| geriatrie | |
| Gilles de la Tourette syndrom | psychiatrie |
| povrchová léčba dermatóz a slizničních lézí | dermatovenerologie |
| infekční lékařství | |
| geriatrie |
Příloha č. 5
Annex No 5 to Decree No. 236 / 2015 Coll.
Analytical methods for testing active substances in cannabis extract for therapeutic use
Cannabis extract for therapeutic use
(EXTRACT FROM THE CONTACT FLOW STANDARDISED *, Cannabis floris extractum normum)
* For a particular extract the name must be further extended by the type of extract (liquid extract, tincture, thick extract, dry extract)
It complies with the requirements of the general article of Article L / Ph.Eur. Extracts from plant drugs (Plantarum medicinalia extract) for a given type of extract which is liquid extract, tincture, dense extract, or dry extract and other tests:
| Parametr | Metoda | Limit |
|---|---|---|
| Vzhled | vizuálně | podle specifikace daného extraktu |
| Totožnost | HPLC1) - ČL2) / Ph.Eur3). 2.2.27, 2.2.29 | |
| Zkoušky na čistotu | ||
| Zkoušky dle požadavků ČL/Ph.Eur. pro daný typ extraktu | ČL/Ph.Eur. 0765 | |
| Zbytky pesticidů** | ČL/Ph.Eur. 2.8.13 | odpovídá limitům uvedeným v Ph.Eur. 2.8.13 |
| Těžké kovy** | ČL 2.4.27 | Pb - max. 5,0 μg/g Cd - max. 1,0 μg/g Hg - max. 0,1 μg/g |
| Aflatoxiny**- Aflatoxin B1 - celkový obsah aflatoxinů B1, B2, G1 a G2 | ČL/Ph.Eur. 2.8.18 | max. 2 μg/kg max. 4 μg/kg |
| Mikrobiologická jakost CL/Ph.Eur. 5.1.4 - TAMC4) - TYMC5) - Escherichia coli - Staphylococcus aureus - Pseudomonas aeruginosa - Žluč tolerující gramnegativní bakterie - Salmonella | ČL/Ph.Eur 2.6.12 a 2.6.13 | max. 102 CFU6)/1 g nebo v 1 ml max. 101 CFU/1 g nebo v 1 ml nepřítomnost (v 1 g nebo v 1 ml) nepřítomnost (v 1 g nebo v 1 ml) nepřítomnost (v 1 g nebo v 1 ml) nepřítomnost (v 1 g nebo v 1 ml) nepřítomnost (v 10 g nebo v 10 ml) |
| Rozkladné produkty- Kanabinol / Cannabinol | HPLC - ČL / Ph.Eur. 2.2.29 | max. 2,5 % |
| Olejové extrakty nebo extrakty s obsahem oleje - Číslo kyselosti - Číslo peroxidové | ČL/Ph.Eur. 2.5.1 ČL/Ph.Eur. 2.5.5 | dle charakteru použitého oleje |
| Obsah- THC 7) - CBD 8) | HPLC - ČL/Ph.Eur. 2.2.29 | max. 25 % max. 23 % |
Explanatory notes:
* * testing is not necessary if the default drug used to produce the extract meets the requirements of Decree 236 / 2015 Coll.
1) High performance liquid chromatography
2) Czech Pharmacopoeia
3) European Pharmacopoeia
4) Total number of aerobic micro-organisms
5) Total number of yeast / mold
6) Colonies forming unit (s)
7) Tetrahydrocanabinol / tetrahydrocannabinol
8) Canabidiol / Cannabidiol
1) Decree No. 84 / 2008 Coll., on the correct practice of pharmaceuticals, closer treatment conditions for medicinal products in pharmacies, medical devices and for other operators and devices issuing medicinal products, as amended by Decree No. 254 / 2013 Coll.
2) Decree No. 329 / 2019 Coll., on the prescription of medicinal products for the provision of health services.
3) Section 112 of Act No. 372 / 2011 Coll., on Health Services and the Conditions for Their Provision (Health Services Act), as amended.
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Regulation Information
| Citation | Decree No. 236 / 2015 Coll., laying down the conditions for the prescription, preparation, distribution, supply and use of individually prepared cannabis-containing medicinal products for therapeutic use |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.09.2015 |
|---|---|
| Effective from | 17.10.2015 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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