Decree No. 12 / 2025 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
Valid
Effective from 01.04.2025
12
DECLARATION
of 8 January 2025
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
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., Act No. 262 / 2019 Coll., Act No. 366 / 2021 Coll., as amended by Act No. 314 / 2022 and Act No. 456 / 2023 Coll., and § 44c (5) of Act No. 167 / 1998 Coll., § 79 (a), § 79 (a), § 79 (a) and § 80 (5) of the Act on medicinal products and § 2 (2) (2) and § 24a Act on addictive substances:
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. and Decree No. 219 / 2022 Coll., is amended as follows:
1. In Section 2, the words "hemp species' are replaced by the words" Cannabis'.
2. In Paragraph 2 (1), the word "species' is deleted, the words" set out in Annex 1 to this decree 'are replaced by "species Cannabis sativa', the word" species' is deleted, the words "set out in Annex 6 to this decree 'are deleted and the number" 7' is replaced by "3 '.
3. In Paragraph 2 (2), "6 / 7 'is replaced by" 2'.
4. In Paragraph 2 (3), the words "as referred to in paragraph 1, meeting the criteria set out in Annex 2 to this Decree 'are replaced by the words" Cannabis sativa species, subject to the requirements laid down in the European Pharmacopoeia'.
5. In Paragraph 2 (4), at the end of point (c), the comma is replaced by a dot and point (d) is deleted.
6. In Article 2, the following paragraph 5 is added:
"(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. ';
7. In the first sentence of Article 3 (1), the word "be 'is replaced by the word" have', the words "indicated by a code in Annex 1 to this Decree corresponding to the percentage content 'are replaced by the words" content' and the word "mentioned 'is replaced by the words" which is given'.
8. In the second sentence of Article 3 (1), the word "be 'is replaced by" have', the word "type 'is replaced by the word" type', the word "name 'is replaced by the word" name', the word "quantity 'is replaced by the word" quantity', the word "information 'is replaced by the word" information' and the word "time 'is replaced by" period'.
9. Paragraph 4 (1), including footnote 3, reads:
"(1) An individually prepared cannabis-containing medicinal product for therapeutic use as referred to in Section 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.
3) Article 112 of Act No. 372 / 2011 Coll., on Health Services and the Conditions for Their Provision (Health Services Act), as amended. '
10. in Article 4 (2), the words "and code" shall be replaced by the words "code 9190000 for cannabis for therapeutic use or code 9390000 for cannabis extract for therapeutic use," and the words "listed in Annex 1 to this Decree" shall be replaced by the words "percentage of delta- 9-tetrahydrocanabinol and cannadiol"; the words "Annex 6 to this Decree" shall be deleted; and the words "extract code" shall be replaced by the words "prescribe extract."
11. in Article 4 (3), "one month" is replaced by "three months."
12. in Paragraph 4, paragraph 4 is deleted;
Paragraphs 5 and 6 shall be renumbered paragraphs 4 and 5.
13. in Article 5 (3), the words "whose actual percentage of delta- 9- tetrahydrocannabinol and cannadiol corresponds to the code set out in Annex 1 to this Regulation," shall be deleted and the words "whose actual percentage of delta- 9- tetrahydrocannabinol and cannadiol corresponds to the code set out in Annex 6 to this Regulation, which is given by the prescribing doctor at the electronic recipe marked" highly addictive substance "or blue stripe applications," shall be replaced by the words "corresponding to the prescribing physician at 10% tolerance."
14. in Article 5, paragraphs 4 and 5 are deleted;
15. Article 5a is deleted.
16. Annexes 1, 2, 4 and 6 are deleted.
17. In Annex 3, in the first row of the table, the words "general medicine 'are added in the column entitled" Specialised medical fitness'.
18. In Annex 5, in the 11th column of the third column of the table, the words "by the code of cannabis extract for therapeutic use 'are replaced by the words" max. 25% max. 23%'.
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.
Transitional provisions
1. Cannabis for therapeutic use and cannabis extract for therapeutic use produced and released in accordance with Decree No. 236 / 2015 Coll., as effective before the date of entry into force of this Order, may be used in accordance with Decree No. 236 / 2015 Coll., as effective before the date of entry into force of the Decree.
2. If an individually prepared cannabis-containing medicinal product for therapeutic use has been prescribed for a prescription issued before the date of entry into force of this Decree and has not been issued by the date of entry into force of this Decree, the validity of such a prescription shall be assessed in accordance with Decree No. 236 / 2015 Coll., as effective before the date of entry into force of this Decree.
Efficacy
This Decree shall take effect on 1 April 2025.
Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
Minister for Agriculture:
Mgr. Excellent v. r.
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Regulation Information
| Citation | Decree No. 12 / 2025 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 |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 16.01.2025 |
|---|---|
| Effective from | 01.04.2025 |
| Effective until | - |
| Status | Valid |
Public Contracts 2
PŘÍKAZNÍ SMLOUVA O ZAJIŠTĚNÍ VÝKONU ČINNOSTI
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Notifications
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The regulation text is for informational purposes only.
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