Decree No. 219 / 2022 Coll.
Decree amending 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, as amended by Decree No. 307 / 2020 Coll.
Valid
Order
Effective from 10.08.2022
Text versions:
10.08.2022
26.07.2022
219
DECLARATION
of 29 June 2022
amending 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, as amended by Decree No. 307 / 2020 Coll.
The Ministry of Health and the Ministry of Agriculture shall determine, pursuant to Article 114 (1) and (2) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll., Act No. 44 / 2019 Coll. and Act No. 262 / 2019 Coll., and pursuant to Section 44c (5) of Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 273 / 2013 Coll.
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, as amended by Decree No. 307 / 2020 Coll., is amended as follows:
1. In Paragraph 1 (1), the words "cannabis extract for therapeutic use 'shall be inserted after the words" therapeutic use and'.
2. In Paragraph 1, the following paragraph 2 is inserted after paragraph 1:
"(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 hemp for therapeutic use for the preparation of an individually prepared medicinal product containing cannabis for therapeutic use. "
Paragraph 2 shall become paragraph 3.
3. In Article 2 (1), the words "or extract of hemp species for therapeutic uses set out in Annex 6 to that decree 'shall be inserted after the words" for the purposes of calculating the quantitative limit' and the sentence "For the purposes of calculating the quantitative limit, 1 g of cannabis extract for therapeutic use is made from 7 g dried plant drugs'.
4. In Article 2, the following paragraph 2 is inserted after paragraph 1:
"(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 drug or 6 / 7 g of cannabis extract for therapeutic use per day. '
Paragraphs 2 and 3 shall become paragraphs 3 and 4.
5. In Article 2, at the end of paragraph 3, the words "or hemp extract for therapeutic use which meets the criteria set out in Annex 5 to this Decree 'shall be added.
6. In Article 2 (4), the words "and cannabis extract for therapeutic use 'are inserted after the words" therapeutic use'.
7. In Article 2 (4), the dot is replaced by a comma at the end of point (c) and the following point (d) is added:
"(d) on the analytical certificate referred to in points (b) and (c), the following particulars shall be provided:
1. the plant drug used (Cannabis sativa / Cannabis indica),
2. the type of extract or, where appropriate, purified extract;
3. declared THC and CBD content,
4. name of solvent used for extraction,
5. the name and quantity of the excipients present in the extract,
6. storage conditions and shelf life. ';
8. The heading of Section 3 reads: "Marking cannabis for therapeutic use and cannabis extract for therapeutic use."
9. In Article 3 (1), the text "§ 2 (3) 'is replaced by the text" § 2 (4)' and at the end of the paragraph the sentence "Cannabinol extract for therapeutic use intended for the preparation of an individually prepared medicinal product containing cannabis for therapeutic use 'shall be replaced by the text" § 2 (4)' and at the end of the paragraph the sentence "Cannabinol extract for therapeutic use for the preparation of an individually prepared medicinal product containing cannabis for therapeutic use 'shall be replaced by the following:
10. in Paragraph 4 (2), the words "highly addictive substance" shall be inserted after the words "electronic recipe," and the words "or the code of cannabis extract for therapeutic use set out in Annex 6 to this Decree shall be added at the end of the text of the paragraph. If the prescriber indicates the code of cannabis extract for therapeutic use, he shall indicate the total quantity of extract used in the preparation of the individually prepared medicinal product containing cannabis for therapeutic use and the type of extract referred to in Annex 5 to this Decree. '
11. In Article 4, the words "with the designation" highly addictive substance "shall be added at the end of paragraph 4."
12. In Article 4, paragraphs 5 and 6 are added:
"(5) 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.
(6) 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). "
13. in Article 5 (1), the words "with the designation" highly addictive substance "shall be inserted after the words" electronic recipe, "and at the end of the text of the paragraph the words" or on a blue stripe request in the framework of the provision of bed health care under the law on addictive substances in accordance with Article 4 (2) and (6) "shall be added.
14. in Article 5 (2), the words "or hemp extract for therapeutic use" shall be inserted after the words "therapeutic use," the word "whose" shall be replaced by "whose" and the words "at least 0,3% and" shall be deleted;
15. Paragraph 5 (3) reads:
"(3) For the preparation and delivery of an individually prepared cannabis-containing medicinal product for therapeutic use based on an electronic recipe marked" highly addictive substance 'or on a blue stripe demand, only cannabis for therapeutic use may be used whose actual percentage of delta- 9-tetrahydrocannabinol and cannadiol corresponds to the code in Annex 1 to this decree, or cannabis extract for therapeutic use, whose actual percentage of delta- 9-tetrahydrocannabinol and cannadiol corresponds to the code in Annex 6 to this decree, and which is indicated by the prescribing doctor on the electronic recipe "highly addictive substance' or on demand with blue stripe. '.
16. in Article 5 (4), the words "with the word" highly addictive substance "or" on demand with a blue stripe "shall be inserted after the words" electronic recipe "and the words" with the word "highly addictive substance" or "on demand with a blue stripe."
17. in Article 5 (5), the words "highly addictive substance" or "highly addictive substance" shall be inserted after "electronic recipe," and "highly addictive substance" or "blue stripe" shall be inserted after the words "Annex No 6"; the words "highly addictive substance" or "blue stripe" shall be inserted after the words "on electronic recipe";
18. in Paragraph 5a (2) (b), at the end of the text in point 1, the words "and the code of cannabis extract for therapeutic use as set out in Annex 6 to this Decree" shall be added.
19. in Paragraph 5a (2) (b), at the end of the text in point 3, the words "and the total quantity of cannabis extract prescribed for therapeutic use for the period referred to in Annex 6 to this Decree" shall be added.
20. After Paragraph 5a, the following Section 5b is inserted:
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 Regulation. '
21. In Annex 1, "THC 0,3% ≤ 4% 'is replaced by" THC ≤ 4%' and "0,3% THC ≤ 4% 'is replaced by" THC ≤ 4%'.
22. The following Annexes 5 and 6 are added:
"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 ČL/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 | dle kódu extraktu z konopí pro léčebné použití |
* * testing is not necessary if the default drug used to produce the extract meets the requirements of Decree 236 / 2015 Coll.
Explanatory notes:
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
Příloha č. 6
Annex No 6 to Decree No. 236 / 2015 Coll.
Types of cannabis extract for therapeutic use
| Kód | Druh extraktu | Rozmezí THCa) | Rozmezí CBDb) |
|---|---|---|---|
| 9311000 | Cannabis sativae extractum | 25 % ≥ THC > 21 % | CBD < 1 % |
| 9312000 | Cannabis sativae extractum | 25 % ≥ THC > 21 % | 1 % ≤ CBD < 5 % |
| 9313000 | Cannabis sativae extractum | 25 % ≥ THC > 21 % | 5 % ≤ CBD < 7,5 % |
| 9314000 | Cannabis sativae extractum | 25 % ≥ THC > 21 % | 7,5 % ≤ CBD < 23 % |
| 9321000 | Cannabis sativae extractum | 21 % ≥ THC > 18 % | CBD < 1 % |
| 9322000 | Cannabis sativae extractum | 21 % ≥ THC > 18 % | 1 % ≤ CBD < 5 % |
| 9323000 | Cannabis sativae extractum | 21 % ≥ THC > 18 % | 5 % ≤ CBD < 7,5 % |
| 9324000 | Cannabis sativae extractum | 21 % ≥ THC > 18 % | 7,5 % ≤ CBD ≤ 23 % |
| 9331000 | Cannabis sativae extractum | 18 % ≥ THC > 15 % | CBD < 1 % |
| 9332000 | Cannabis sativae extractum | 18 % ≥ THC > 15 % | 1 % ≤ CBD < 5 % |
| 9333000 | Cannabis sativae extractum | 18 % ≥ THC > 15 % | 5 % ≤ CBD < 7,5 % |
| 9334000 | Cannabis sativae extractum | 18 % ≥ THC > 15 % | 7,5 % ≤ CBD ≤ 23 % |
| 9341000 | Cannabis sativae extractum | 15 % ≥ THC > 12 % | CBD < 1 % |
| 9342000 | Cannabis sativae extractum | 15 % ≥ THC > 12 % | 1 % ≤ CBD < 5 % |
| 9343000 | Cannabis sativae extractum | 15 % ≥ THC > 12 % | 5 % ≤ CBD < 7,5 % |
| 9344000 | Cannabis sativae extractum | 15 % ≥ THC > 12 % | 7,5 % ≤ CBD ≤ 23 % |
| 9351000 | Cannabis sativae extractum | 12 % ≥ THC > 9 % | CBD < 1 % |
| 9352000 | Cannabis sativae extractum | 12 % ≥ THC > 9 % | 1 % ≤ CBD < 5 % |
| 9353000 | Cannabis sativae extractum | 12 % ≥ THC > 9 % | 5 % ≤ CBD < 7,5 % |
| 9354000 | Cannabis sativae extractum | 12 % ≥ THC > 9 % | 7,5 % ≤ CBD ≤ 23 % |
| 9361000 | Cannabis sativae extractum | 9 % ≥ THC > 7 % | CBD < 1 % |
| 9362000 | Cannabis sativae extractum | 9 % ≥ THC > 7 % | 1 % ≤ CBD < 5 % |
| 9363000 | Cannabis sativae extractum | 9 % ≥ THC > 7 % | 5 % ≤ CBD < 7,5 % |
| 9364000 | Cannabis sativae extractum | 9 % ≥ THC > 7 % | 7,5 % ≤ CBD ≤ 23 % |
| 9371000 | Cannabis sativae extractum | 7 % ≥ THC > 4 % | CBD < 1 % |
| 9372000 | Cannabis sativae extractum | 7 % ≥ THC > 4 % | 1 % ≤ CBD < 5 % |
| 9373000 | Cannabis sativae extractum | 7 % ≥ THC > 4 % | 5 % ≤ CBD < 7,5 % |
| 9374000 | Cannabis sativae extractum | 7 % ≥ THC > 4 % | 7,5 % ≤ CBD ≤ 23 % |
| 9381000 | Cannabis sativae extractum | THC ≤ 4 % | CBD < 1 % |
| 9382000 | Cannabis sativae extractum | THC ≤ 4 % | 1 % ≤ CBD < 5 % |
| 9383000 | Cannabis sativae extractum | THC ≤ 4 % | 5 % ≤ CBD < 7,5 % |
| 9384000 | Cannabis sativae extractum | THC ≤ 4 % | 7,5 % ≤ CBD ≤ 23 % |
| 9411000 | Cannabis indicae extractum | 25 % ≥ THC > 21 % | CBD < 1 % |
| 9412000 | Cannabis indicae extractum | 25 % ≥ THC > 21 % | 1 % ≤ CBD < 5 % |
| 9413000 | Cannabis indicae extractum | 25 % ≥ THC > 21 % | 5 % ≤ CBD < 7,5 % |
| 9414000 | Cannabis indicae extractum | 25 % ≥ THC > 21 % | 7,5 % ≤ CBD ≤ 23 % |
| 9421000 | Cannabis indicae extractum | 21 % ≥ THC > 18 % | CBD < 1 % |
| 9422000 | Cannabis indicae extractum | 21 % ≥ THC > 18 % | 1 % ≤ CBD < 5 % |
| 9423000 | Cannabis indicae extractum | 21 % ≥ THC > 18 % | 5 % ≤ CBD < 7,5 % |
| 9424000 | Cannabis indicae extractum | 21 % ≥ THC > 18 % | 7,5 % ≤ CBD ≤ 23 % |
| 9431000 | Cannabis indicae extractum | 18 % ≥ THC > 15 % | CBD < 1 % |
| 9432000 | Cannabis indicae extractum | 18 % ≥ THC > 15 % | 1 % ≤ CBD < 5 % |
| 9433000 | Cannabis indicae extractum | 18 % ≥ THC > 15 % | 5 % ≤ CBD < 7,5 % |
| 9434000 | Cannabis indicae extractum | 18 % ≥ THC > 15 % | 7,5 % ≤ CBD ≤ 23 % |
| 9441000 | Cannabis indicae extractum | 15 % ≥ THC > 12 % | CBD < 1 % |
| 9442000 | Cannabis indicae extractum | 15 % ≥ THC > 12 % | 1 % ≤ CBD < 5 % |
| 9443000 | Cannabis indicae extractum | 15 % ≥ THC > 12 % | 5 % ≤ CBD < 7,5 % |
| 9444000 | Cannabis indicae extractum | 15 % ≥ THC > 12 % | 7,5 % ≤ CBD ≤ 23 % |
| 9451000 | Cannabis indicae extractum | 12 % ≥ THC > 9 % | CBD < 1 % |
| 9452000 | Cannabis indicae extractum | 12 % ≥ THC > 9 % | 1 % ≤ CBD < 5 % |
| 9453000 | Cannabis indicae extractum | 12 % ≥ THC > 9 % | 5 % ≤ CBD < 7,5 % |
| 9454000 | Cannabis indicae extractum | 12 % ≥ THC > 9 % | 7,5 % ≤ CBD ≤ 23 % |
| 9461000 | Cannabis indicae extractum | 9 % ≥ THC > 7 % | CBD < 1 % |
| 9462000 | Cannabis indicae extractum | 9 % ≥ THC > 7 % | 1 % ≤ CBD < 5 % |
| 9463000 | Cannabis indicae extractum | 9 % ≥ THC > 7 % | 5 % ≤ CBD < 7,5 % |
| 9464000 | Cannabis indicae extractum | 9 % ≥ THC > 7 % | 7,5 % ≤ CBD ≤ 23 % |
| 9471000 | Cannabis indicae extractum | 7 % ≥ THC > 4 % | CBD < 1 % |
| 9472000 | Cannabis indicae extractum | 7 % ≥ THC > 4 % | 1 % ≤ CBD < 5 % |
| 9473000 | Cannabis indicae extractum | 7 % ≥ THC > 4 % | 5 % ≤ CBD < 7,5 % |
| 9474000 | Cannabis indicae extractum | 7 % ≥ THC > 4 % | 7 % ≥ THC > 4 % |
| 9481000 | Cannabis indicae extractum | THC ≤ 4 % | CBD < 1 % |
| 9482000 | Cannabis indicae extractum | THC ≤ 4 % | 1 % ≤ CBD < 5 % |
| 9483000 | Cannabis indicae extractum | THC ≤ 4 % | 5 % ≤ CBD < 7,5 % |
| 9484000 | Cannabis indicae extractum | THC ≤ 4 % | 7,5 % ≤ CBD ≤ 23 % |
Explanatory notes:
(a) The percentage range of delta- 9-tetrahydrocannabinol for that code.
(b) The percentage range of cannadiol for the code. ';
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.
Minister for Agriculture:
Ing. Nekula v. r.
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Regulation Information
| Citation | Decree No. 219 / 2022 Coll., amending 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, as amended by Decree No. 307 / 2020 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 26.07.2022 |
|---|---|
| Effective from | 10.08.2022 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
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Kupní smlouva č. 87/2022, k.ú. Dyjákovičky, schválena MF dne 17.6.2022
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