Government Decree No. 534 / 2025 Coll.
Government Regulation amending Government Regulation No. 463 / 2013 Coll., on substance lists, as amended, and Government Regulation No. 11 / 2025 Coll., on the List of classified psychoactive substances
Valid
Regulation
Effective from 16.12.2025
534
GOVERNMENT REGULATION
of 27 November 2025
amending Government Regulation No 463 / 2013 Coll., on substance lists, as amended, and Government Regulation No 11 / 2025 Coll., on the list of classified psychoactive substances
The Government orders pursuant to § 44c (1) to (3) and to implement § 33k (6) (b) of Act No. 167 / 1998 Coll., on addictive substances and on amending certain other laws, as amended by Act No. 273 / 2013 Coll., Act No. 366 / 2021 Coll. and Act No. 321 / 2024 Coll.:
Amendment of the Government Regulation on substance lists
Government Regulation No. 463 / 2013 Coll., on substance lists, as amended by Government Regulation No. 243 / 2015 Coll., Government Regulation No. 46 / 2017 Coll., Government Regulation No. 30 / 2018 Coll., Government Regulation No. 242 / 2018 Coll., Government Regulation No. 184 / 2021 Coll., Government Regulation No. 159 / 2022 Coll., Government Regulation No. 228 / 2023 Coll., Government Regulation No. 52 / 2024 Coll., Government Regulation No. 176 / 2024 Coll., Government Regulation No. 419 / 2024 Coll., is amended as follows:
1. In the table in Annex No 3, the word "Acetylbenzylfentanyl 'is inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / common name', and in the column entitled "Chemical name according to IUPAC ', the word" [4- [[1- [2- (diethylamino) ethyl] -5-nitrobenzimidazole-2-yl] methyl] phenyl] acetate' is inserted.
2. In the table in Annex No 3, the word "Brorfin 'is inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / general name', and in the column entitled "Chemical name according to IUPAC ', the word" 2- [2- [(4-bromophenyl) methyl] -5-nitrobenzimidazol-1-yl] -N, N, N-diethyl lethanamine' is inserted.
3. In the table of Annex 3, the word "Desomorphine 'is inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / general name', and in the column entitled "Chemical name according to IUPAC ', the word" 1-diethylaminoethyl-2-benzyl-benzimidazole' is inserted.
4. In the table in Annex No 3, the word "Dipyanone 'is inserted above the line in the column entitled" International non-proprietary name (INN) in the Czech language / common name', the word "Dipyanone 'is inserted, the word" dimethonitazene' in the column entitled "International non-proprietary name (INN) in the Czech language / common name is inserted, the word" Dimethoxynitazen 'is inserted, the word "dimethonitazene' in the column entitled" International non-proprietary name (INN) in the Czech language / common name 'is inserted, the word "Dimethoxynitazene' in the column" Additional non-nitrobenz- imidazol-1-yl] -N, N- Diethyl lethanamine '.
5. In the table in Annex No 3, the word "Ethylenoxynitazene 'is inserted under the line in the column headed" International non-proprietary name (INN) in the Czech language / common name' and the word "Ethylthionitazen 'in the column entitled" IUPAC chemical name' contains the word "2- [2- [2- [(4-ethylsulfanylphenyl) methyl] -5-nitrobenzimidazole-1-yl] -N, N-diethyl-ethanamine '.
6. In the table in Annex No 3, under the line in which the word "Ethylthionitazen 'is inserted in the column headed" International non-proprietary name (INN) in the Czech language / common name', the word "Etodesnitazepine 'in the column entitled" Ethylthionitazen or the other common name' is inserted, the words "ethodesnitazene pyrrolidine analogue 'in the column entitled" Etodesnitazepine' in the column entitled "IUPAC 'in the column entitled" 2- [((4-ethoxyphenyl) methyl] -1- (2-pyrrolidin-1-ylethyl) - benzimidazole'.
7. In the table in Annex No 3, under the row in the column headed "International non-proprietary name (INN) in the Czech language / common name ', the word" Etodesnitazepine' is inserted, in which the word "Etodesnitazepine 'is inserted in the column headed" International non-proprietary name (INN) in the Czech language / common name', and in the column entitled "Chemical name according to IUPAC 'the word" 2- [2- [2- [[[4- (2-ethoxyethoxy) phenyl] methyl] -5-nitro- benzimidazol-1-yl] -N, N- diethyl ethanamine'.
8. In the table in Annex No 3, the word "Flunitazen 'is inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / common name', the word "Flunitazen 'in the column headed" International non-proprietary name (INN) in the Czech language / common name', and the word "Fluetonitazepine 'in the column entitled" Chemical name according to IUPAC' in the column entitled "2- [[[4- (2-fluoroethoxy) phenyl] methyl] -5-nitro-1- (2-pyrrolidin-1-ylethyl) benzimidazole '.
9. In the table in Annex No 3, the word "Isotonitazen 'is inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / common name', and in the column entitled "IUPAC chemical name ', the word" 2- [2- [(4-propan-2-yloxyphenyl) methyl] benzimidazol-1-yl] -N, N- diethyl-ethanamine' is inserted.
10. In the table in Annex No 3, the word "Isotonitazen 'is inserted below the line in the column headed" International non-proprietary name (INN) in the Czech language / common name', and in the column entitled "IUPAC chemical name 'the word" 2- [4- (2-propoxy) benzyl] -5-nitro-1- [2- (pyrrolidin-1-yl) ethyl] -1H-benzimidazole' is inserted.
11. In the table in Annex No 3, the word "Carbonyl-bromadol 'is inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / common name', and in the column entitled "Chemical name according to IUPAC ', the word" 2- [4- (2-propoxy) benzyl] -5-nitro-1- [2- (piperidin-1-yl) ethyl] -1H-benzimidazole' is inserted.
12. In the table of Annex 3, the word "3,4-Methylenedioxy-U-47700 'is inserted above the line in the column headed" International Non-Proprietary Name (INN) in the Czech language / common name' and the word "Methylenedioxynitazen 'in the column entitled" Chemical name according to IUPAC' contains the word "2- ((2) ((1,3-benzodioxol-5-yl) methyl) -5-nitro-1H-benzimidazol-1-1-yl) -N, N-diethylethan-1-amine '.
13. In the table in Annex No 3, under the line in the column headed "International non-proprietary name (INN) in the Czech language / common name ', the word" 3- Methylcrotonylfentanyl' is inserted under the heading "International non-proprietary name (INN) in the Czech language / common name ', the word" Methylnitazen' is inserted, the word "Additional international non-proprietary name or other generic name 'is entered in the column headed" Menitazene' and the word "Chemical name according to IUPAC 'is entered in the column entitled" 2- [2- [2- [(4-methylphenyl) methyl] -5-nitrobenzimidazol-1-yl] -N, N-diethyl lethanamine'.
14. In the table in Annex No 3, the word "Metodesnitazen 'is inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / common name', and in the column entitled "IUPAC chemical name ', the word" 2- [2- [(4-methylsulfanylphenyl) methyl] -5-nitrobenzimidazole-1-yl] -N, N-diethyl-ethanamine' is inserted.
15. In the table in Annex No 3, the word "Metonitazen 'is inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / common name', and in the column entitled "Chemical name according to IUPAC ', the word" 2- (4-methoxybenzyl) -1- (2- (pyrrolidin-1-yl) ethyl) -1H-benzimidazole' is inserted.
16. In the table in Annex No 3, the word "Metonitazepine 'is inserted under the line in the column headed" International non-proprietary name (INN) in the Czech language / common name', the word "Metonitazepine 'in the column headed" International non-proprietary name (INN) in the Czech language / common name' and the word "Metonitazepippe 'in the column entitled" Chemical name according to IUPAC' in the column entitled "2- (4-methoxybenzyl) -5-nitro-1- (2- (piperidinyl) ethyl) -1H-benzimidazole '.
17. In the table of Annex 3, under the line in which the word "N-methyl-U-47931E 'is inserted under the column headed" International non-proprietary name (INN) in the Czech language / common name', the word "N, N-dimethylamino etonitazene 'and the column headed" Chemical name according to IUPAC' contains the word "2- [2- [(4-ethoxyphenyl) methyl] -5-nitrobenzimidazol-1-yl] -N, N, N-dimethylethanamine '.
18. In the table in Annex No 3, the word "Nortilidine 'is inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / general name', the word "Nortilidine 'is inserted, in the column headed" International non-proprietary name (INN) in the Czech language / common name', and in the column entitled "Chemical name according to IUPAC ', the word" 2- (2-benzyl-5-nitro- 1H-benzimidazol-1-1-yl) -N, N-diethyl lethanamine' is inserted.
19. In the table in Annex No 3, the words "Cannabis resin 'are inserted above the line in the column headed" International non-proprietary name (INN) in the Czech language / common name', and in the column entitled "Chemical name according to IUPAC ', the words" 2- [(4-propoxyphenyl) methyl] 5-nitro-1- (2-piperidin-1-ylethyl) benzimidazole' are inserted.
20. In the table in Annex No 3, the word "Tetrahydrofuranfentanyl 'is inserted above the line in the column headed" International non-proprietary name (INN)', the word "Spirochlorfin 'is inserted above the column headed" International non-proprietary name (INN) in the Czech language / common name', the word "Spirochlorfin 'in the column headed" Other international non-proprietary name or other common name' is inserted, the text "R6890 'and the column headed" Chemical name according to IUPAC' is entered in the column headed "8- [1- (4-chlorophenyl) ethyl] -1-phenyl-1,3,8-triazaspiro [4.5] decan -4-on '.
21. In the table in Annex No 4, the word "ADB-FUBINACA 'is inserted above the line in the column headed" Additional International Non-Proprietary Name or Other General Name', and in the column entitled "Chemical name according to IUPAC ', the word" N- (1-amino-3,3-dimethyl-1-oxobutan-2-yl) -1-butyl-1H-indazol-3-carboxamide' is inserted.
22. In the table of Annex 5, a new line is inserted above the line in the column headed "International non-proprietary name (INN) in the Czech language ', containing the word" Secobarbital' in the column entitled "International non-proprietary name (INN) in the Czech language ', the words" Psilocybin for therapeutic use' in the column entitled "Chemical name according to IUPAC 'in the column entitled" [3- [2- (dimethylamino) ethyl] -1H-indol-4-yl] dihydrogen phosphate' and the column entitled "Chemical name according to IUPAC 'in the column entitled" Active substance according to Act No 378 / 2007 Coll., on Medicines and amending certain related laws (the Law on Medicines).'.
23. In Annex 6, the words "gamma-butyrolactone 'are replaced by the words" Except for preparations containing GBL from which GBL cannot be obtained in an economically acceptable way and whose oral or other administration is excluded for reasons of health or taste'.
24. In the table in Annex No 7, the word "Ketamine 'is inserted above the line in the column headed" Karioprodol' and in the column entitled "Chemical name according to IUPAC ', the word" (RS) -2- {[(aminocarbonyl) oxy] methyl} -2-methylpentyl isopropylcarbamate' is inserted above the row in the table in Annex No 7.
Amendment of the Government Decree on the list of classified psychoactive substances
Government Regulation No 11 / 2025 Coll., on the list of classified psychoactive substances, is amended as follows:
1. In the table below, the words "quantities less than 0,3% 'are replaced by the words" inevitably occurring natural trace quantities'.
2. In the table in the Annex, the word "ADB-BUTINACA 'is deleted from the column entitled" International non-proprietary name (INN) in Czech language'.
3. In the Annex, under the table under the line in which the word "FUBIAT 'is entered in the column entitled" International non-proprietary name (INN) in the Czech language', the word "FUBIAT 'is inserted in the column entitled" International non-proprietary name (INN) in the Czech language', and the word "10- hydroxy- HHC 'in the column entitled" Chemical name according to IUPAC' is inserted "(6aR, 10R, 10aR) -6,6,9-trimethyl-3-pentyl-6a, 7,10,10a-hexahydro-6H-dibenzo [b, d] pyran-1,10-diol '.
4. In the Annex, in the table above, in the column headed "International Non-Proprietary Name (INN) in the Czech language ', the word" CH-FUBBMPDORA' is inserted, the word "(6aR, 10R, 10aR) -6,6,9-trimethyl-3-pentyl-6a, 7,10,10a-tetrahydro- benzo [c] chromen- 1,10- diol 'is inserted in the column headed" International Non-Proprietary Name (INN) in the Czech language'.
5. In the Annex, under the table under the line in which the word "MDMB-INACA 'is entered in the column entitled" International non-proprietary name (INN) in the Czech language', the word "MDMB-INACA 'is inserted in the table, and in the column entitled" Chemical name according to IUPAC' is inserted the word "methyl 3,3-dimethyl-2- [(1-pentyl-1H-indazol-3-carbonyl) amino] butanoate '.
6. In the Annex, the word "NMDMSB 'is inserted in the table above the line in the column headed" International non-proprietary name (INN) in the Czech language', the word "NMDMSB 'is inserted in the column headed" International non-proprietary name (INN) in the Czech language', the word "Muscimol 'in the column entitled" Chemical name according to IUPAC' is inserted, the word "5- (aminomethyl) -3 (2H) -isoxazolone 'is inserted in the column headed" Note', the phrase "With the exception of unprocessed mushrooms in which the muscimol occurs naturally '.
TECHNICAL REGULATION
This Regulation has been 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.
EFFECTIVE
This Regulation shall be binding in its entirety and directly applicable in all Member States. I, point 22, which shall take effect on 1 January 2026.
Prime Minister:
Prof. PhDr. Fiala, Ph.D., LL.M., v. r.
Deputy Prime Minister and Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
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Regulation Information
| Citation | Government Regulation No. 534 / 2025 Coll., amending Government Regulation No. 463 / 2013 Coll., on substance lists, as amended, and Government Decree No. 11 / 2025 Coll., on the List of Listed Psychoactive Substances |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.12.2025 |
|---|---|
| Effective from | 16.12.2025 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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