S.I. No. 210/2022 - Misuse of Drugs (Amendment) Regulations 2022


Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 3rd May, 2022.

I, STEPHEN DONNELLY, Minister for Health, in exercise of the powers conferred on me by sections 4 , 5 (amended by section 3 of the Misuse of Drugs (Amendment) Act 2016 (No. 9 of 2016)), 18 and 38 of the Misuse of Drugs Act 1977 (No. 12 of 1977) and section 5 of the Misuse of Drugs Act 1984 (No. 18 of 1984), hereby make the following regulations:

1. These Regulations may be cited as the Misuse of Drugs (Amendment) Regulations 2022.

2. The Misuse of Drugs Regulations 2017 ( S.I. No. 173 of 2017 ) are amended—

(a) by substituting for Schedule 1 to those Regulations the Schedule set out in Schedule 1 to these Regulations, and

(b) by substituting for Schedule 4 to those Regulations the Schedule set out in Schedule 2 to these Regulations.

3. The following are revoked:

(a) the Misuse of Drugs (Amendment) Regulations 2017 ( S.I. No. 532 of 2017 ); and

(b) the Misuse of Drugs (Amendment) Regulations 2021 ( S.I. No. 121 of 2021 ).

(a)

Regulation 2(a)

SCHEDULE 1

New Schedule 1 to Misuse of Drugs Regulations 2017

SCHEDULE 1

1. The following substances and products, namely-

(a) N-(Adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide (otherwise known as Clockwork Orange, 5F AKB48)

N-[(2S)-1-Amino-3,3-dimethyl-1-oxobutan-2yl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (otherwise known as ADB-CHMINACA)

N-(1-Amino-3,3-dimethyl-1-oxobutan-2yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (otherwise known as ADB-FUBINACA)

N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (otherwise known as AB-CHMINACA)

(S)-N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (otherwise known as AB-FUBINACA)

N-[(2S)-1-Amino-3-methyl-1-oxobutan-2yl]-1-pentyl-1H-indazole-3-carboxamide (otherwise known as AB-PINACA)

5-(2-Aminopropyl)indole (otherwise known as 5-IT)

1-(1,3-Benzodioxol-5-yl)-2-(1-pyrrolidinyl)-1-pentanone

N-(1-Benzyl-4-piperidyl)propionanilide

2-(4-Bromo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine (otherwise known as 25B-NBOMe)

1-(4-Bromofuro[2,3-f][1]benzofuran-8-yl)propan-2-amine (otherwise known as BromodragonFLY)

Bufotenine

Cannabinol, except where contained in Cannabis or cannabis resin

Cannabinol derivatives, not being dronabinol or its stereoisomers

Cannabis (not being a preparation specified in paragraph 5 of Part 1 of Schedule 4) or a preparation or product specified in Schedule 1 to the Misuse of Drugs (Prescription and Control of Supply of cannabis for Medical Use) Regulations 2019 ( S.I. No. 262 of 2019 )) and permitted for supply pursuant to those Regulations

Cannabis resin

Cathinone

2-(4-Chloro-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine (otherwise known as 25C-NBOMe)

1-(4-Cyanobutyl)-N-(1-methyl-1-phenylethyl)-1H-indazole-3-carboxamide (otherwise known as CUMYL-4CN-BINACA)

1-Cyclohexyl-4-(1,2-diphenylethyl)piperazine (otherwise known as MT-45)

Coca leaf

Concentrate of poppy straw

3,4-Dichloro-N-[[1-(dimethylamino)cyclohexyl]methyl] benzamide (otherwise known as AH-7921)

3,4-Dichloro-N-(2-dimethylamino-cyclohexyl)-N-methyl-benzamide (otherwise known as U-47700)

[2,3-Dihydro-5-methyl-3-(4-morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin-6-yl]-1-naphthalenylmethanone

N,N-Diethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1H-benzo[d]imidazol-1-yl)ethan-1-amine (otherwise known as Isotonitazene)

N,N-Diethyltryptamine

2,5-Dimethoxy-α,4-dimethylphenethylamine

N,N-Dimethyltryptamine

3-Dimethylheptyl-11-hydroxyhexahydrocannabinol

1-(1,2-Diphenylethyl)piperidine (otherwise known as Diphenidine)

Ethyl phenyl(piperidin-2-yl)acetate (otherwise known as Ethylphenidate)

Eticyclidine

Etryptamine

[1-(5-Fluoropentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (otherwise known as XLR-11)

1-(2-Fluorophenyl)-2-methylaminopropan-1-one

1-(3-Fluorophenyl)-2-methylaminopropan-1-one

1-(4-Fluorophenyl)-2-methylaminopropan-1-one

9-(Hydroxymethyl)-6,6-dimethyl-3-(2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol

[9-Hydroxy-6-methyl-3-[5-phenylpentan-2-yl]oxy-5,6,6a,7,8,9,10,10a-octahydrophenanthridin-1-yl]acetate

N-Hydroxy-tenamphetamine

2-(4-Iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl] ethanamine (otherwise known as 25I-NBOMe)

Khat (being the leaves of Catha edulis (Celastraceae))

Lysergamide

Lysergide and other N-alkyl derivatives of lysergamide

Mescaline

Methcathinone

1-(1-(3-Methoxyphenyl)cyclohexyl)piperidine (otherwise known as 3-Methoxyphencyclidine)

2-(3-Methoxyphenyl)-2-(ethylamino)cyclohexanone (otherwise known as methoxetamine)

1-(4-Methoxyphenyl)-2-(methylamino)propan-1-one

Methyl (2S,4aR,6aR,7R,10aS,10bR)-9-acetyloxy-2-(furan-3-yl)-6a,10b-dimethyl-4,10-dioxo-2,4a,5,6,7,8,9,10a-octahydro-1H-benzo[f]isochromene-7-carboxylate (otherwise known as Salvinorin A) and any product, whether natural or otherwise, including any plant or plant material of any kind or description, which contains any proportion of the said substance

2-Methylamino-1-(3,4-methylenedioxyphenyl)butan-1-one

2-Methylamino-1-(3,4-methylenedioxyphenyl)propan-1-one

4-Methyl-aminorex

Methyl 2-[[1-(cyclohexylmethyl)indole-3-carbonyl]amino]-3,3-dimethylbutanoate (otherwise known as MDMB CHMICA)

Methyl 3,3-dimethyl-2-(1-(pent-4-en-1-yl)-1H-indazole-3-carboxamido)butanoate (otherwise known as MDMB-4en-PINACA)

Methyl (E)-2-[(2S,3S,7aS,12bS)-3-ethyl-7a-hydroxy-8-methoxy-2,3,4,6,7,12b-hexahydro-1H-indolo[2,3a]quinolizin-2-yl]-3-methoxyprop-2-enoate (otherwise known as 7-Hydroxymitragynine) and any product, whether natural or otherwise, including any plant or plant material of any kind or description, which contains any proportion of the said substance

Methyl (E)-2-[(2S,3S,12bS)-3-ethyl-8-methoxy-1,2,3,4,6,7,12,12b-octahydroindolo[2,3a]quinolizin-2-yl]-3-methoxyprop-2-enoate (otherwise known as Mitragynine) and any product, whether natural or otherwise, including any plant or plant material of any kind or description, which contains any proportion of the said substance

Methyl 2-(1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (otherwise known 4F-MDMB-BINACA)

Methyl 2-({[1-(4-fluorobutyl)-1H-indol-3-yl]carbonyl}amino)-3,3-dimethylbutanoate (otherwise known as 4F-MDMB-BICA)

Methyl (2S)-2-{[1-(5-fluoropentyl)-1H-indazole-3-carbonyl]amino}-3,3-dimethylbutanoate (otherwise known as 5F-MDMB-PINACA)

Methyl (1-(5-fluoropentyl)-1H-indazole-3-carbonyl)valinate (otherwise known as 5F-AMB-PINACA)

Methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (otherwise known as 5F-MDMB-PICA)

Methyl (2S)-2[[1-[(4-fluorophenyl)methyl]indazole-3-carbonyl]amino]-3-methylbutanoate (otherwise known as FUB-AMB)

4-Methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine (otherwise known as 4,4’-DMAR)

α-Methyl-4-(methylthio)phenethylamine

1-(4-Methylphenyl)-2-methylaminopropan-1-one

(1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (otherwise known as UR-144)

5-Pentyl-2-(2-phenylpropan-2-yl)-2,5-dihydro-1H-pyrido[4,3-b]indol-1-one (otherwise known as CUMYL-PEGACLONE)

N-Methyl-1-(thiophen-2-yl)propan-2-amine (otherwise known as Methiopropamine)

Psilocin

Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (otherwise known as Clockwork Orange, PB22)

Raw opium

Rolicyclidine

Tenocyclidine

N-[1-(2-Thenyl)-4-piperidyl]propionanilide

(b) Any substance (not being bupropion, diethylpropion or pyrovalerone) structurally derived from 2-amino-1-phenyl-1-propanone by modification in any of the following ways:

(i) by substitution in the phenyl ring to any extent with alkyl, alkenyl, alkynyl, alkoxy, alkylthio, alkylenedioxy, haloalkyl or halo substituents, whether or not further substituted in the phenyl ring by one or more other univalent substituents;

(ii) by substitution at the 2- or 3-position of the propanone side-chain with an alkyl substituent;

(iii) by substitution at the nitrogen atom with one or more alkyl or dialkyl groups, or by inclusion of the nitrogen atom in a cyclic structure.

(c) Any substance structurally derived from 2-amino-1-propanone by substitution at the 1-position with any monocyclic, or fused-polycyclic ring system (not being a phenyl ring or alkylenedioxyphenyl ring system), whether or not the substance is further modified in any of the following ways:

(i) by substitution in the ring system to any extent with alkyl, alkenyl, alkynyl, alkoxy, alkylthio, haloalkyl or halo substituents, whether or not further substituted in the ring system by one or more other univalent substituents;

(ii) by substitution at the 3-position with an alkyl substituent;

(iii) by substitution at the 2-amino nitrogen atom with one or more alkyl or dialkyl groups, or by inclusion of the 2-amino nitrogen atom in a cyclic structure.

(d) Any substance structurally derived from 3-(1-benzoyl)indole or 3-(1-naphthoyl)indole by modification in any of the following ways:

(i) by substitution at the nitrogen atom of the indole ring by alkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl or 2-(4-morpholinyl)ethyl;

(ii) by replacement of one or more hydrogen atoms of any of the substituents referred to in clause (i), with a halo substituent;

whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl or naphthyl ring to any extent.

(e) 1-Benzylpiperazine or any substance (not being a substance specified in Schedule 3) structurally derived from 1-benzylpiperazine or 1-phenylpiperazine by modification in any of the following ways:

(i) by substitution at the second nitrogen atom of the piperazine ring with alkyl, benzyl, haloalkyl or phenyl groups;

(ii) by substitution in the aromatic ring to any extent with alkyl, alkoxy, alkylenedioxy, halo or haloalkyl groups.

(f) Any substance (not being a substance specified in Schedule 2) structurally derived from fentanyl by modification in one or more of the following ways, that is to say:

(i) by replacement of the phenyl portion of the phenethyl group by any heteromonocycle whether or not further substituted in the heterocycle;

(ii) by substitution in the phenethyl group with alkyl, alkenyl, alkoxy, hydroxy, halo, haloalkyl, amino or nitro groups;

(iii) by substitution in the piperidine ring with alkyl or alkenyl groups;

(iv) by substitution in the aniline ring with alkyl, alkoxy, alkylenedioxy, halo or haloalkyl groups;

(v) by substitution at the 4-position of the piperidine ring with any alkoxycarbonyl or alkoxyalkyl or acyloxy group;

(vi) by replacement of the N-propionyl group by another acyl group.

(g) Any substance structurally derived from 2-(3-hydroxycyclohexyl)phenol by substitution at the 5-position of the phenolic ring by alkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl or 2-(4-morpholinyl)ethyl, whether or not further substituted in the cyclohexyl ring to any extent.

(h) Any substance structurally derived from 3-(1-naphthoyl)indole or 1H-indol-3-yl-(1-naphthyl)methane by substitution at the nitrogen atom of the indole ring by alkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl or 2-(4-morpholinyl)ethyl, whether or not further substituted in the indole ring to any extent and whether or not substituted in the naphthyl ring to any extent.

(i) Any substance structurally derived from 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring by alkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl or 2-(4-morpholinyl)ethyl, whether or not further substituted in the pyrrole ring to any extent and whether or not substituted in the naphthyl ring to any extent.

(j) Any substance structurally derived from 1-(1-naphthylmethyl)indene by substitution at the 3-position of the indene ring by alkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl or 2-(4-morpholinyl)ethyl, whether or not further substituted in the indene ring to any extent and whether or not substituted in the naphthyl ring to any extent.

(k) Any substance (not being a substance specified in Schedule 2) structurally derived from pethidine by modification in one or more of the following ways, that is to say:

(i) by replacement of the 1-methyl group by an acyl, alkyl (whether or not unsaturated), benzyl or phenethyl group, whether or not further substituted;

(ii) by substitution in the piperidine ring with alkyl or alkenyl groups or with a propano bridge, whether or not further substituted;

(iii) by substitution in the 4-phenyl ring with alkyl, alkoxy, aryloxy, halo or haloalkyl groups;

(iv) by replacement of the 4-ethoxycarbonyl by any other alkoxycarbonyl or any alkoxyalkyl or acyloxy group;

(v) by formation of an N-oxide or of a quaternary base.

(l) Any substance (not being methoxyphenamine) structurally derived from phenethylamine, an N-alkyl-phenethylamine, α-methylphenethylamine, an N-alkyl- α-methylphenethylamine, α-ethylphenethylamine, or an N-alkyl-α-ethylphenethylamine by substitution in the ring to any extent with alkyl, alkoxy, alkylenedioxy or halo substituents, whether or not further substituted in the ring by one or more other univalent substituents.

(m) Any substance structurally derived from 3-phenylacetylindole by substitution at the nitrogen atom of the indole ring with alkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl or 2-(4-morpholinyl)ethyl, whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent.

(n) Any fungus containing any proportion of Psilocin or of an ester of Psilocin.

(o) 1,2,3,4-Tetrahydronaphthalen-2-amine, 1,2-dihydronaphthalen-2-amine or 2,3-dihydro-1H-inden-2-amine or any substance structurally derived from 1,2,3,4-tetrahydronaphthalen-2-amine, 1,2-dihydronaphthalen-2-amine or 2,3-dihydro-1H-inden-2-amine by modification in any of the following ways:

(i) by substitution in the phenyl ring to any extent with alkyl, alkoxy, alkenyl, alkynyl, alkylthio, alkylenedioxy, haloalkyl, hydroxy or halo substituents, whether or not further substituted by one or more other univalent substituents;

(ii) by mono- or di-substitution at the nitrogen atom with alkyl, alkenyl, alkynyl or haloalkyl groups or by inclusion of the nitrogen atom in a cyclic structure.

(p) Any substance structurally derived from tryptamine or from a ring-hydroxy tryptamine by substitution at the nitrogen atom of the side-chain with one or more alkyl substituents but no other substituent.

2. Any stereoisomeric form of a substance specified in paragraph 1.

3. Any ester or ether of a substance specified in paragraph 1 or 2.

4. Any salt of a substance specified in any of paragraphs 1, 2 or 3.

5. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 1, 2, 3 or 4, not being a preparation specified in Schedule 5.”

Regulation 2(b)

SCHEDULE 2

New Schedule 4 to Misuse of Drugs Regulations 2017

SCHEDULE 4

PART 1

1. The following substances, namely:—

Alprazolam

Bromazepam

Brotizolam

Camazepam

Chlordiazepoxide

Clobazam

Clonazepam

Clonazolam

Clorazepic Acid (clorazepate)

Clotiazepam

Cloxazolam

Delorazepam

Diazepam

Diclazepam

Estazolam

Ethyl loflazepate

Etizolam

Flualprazolam

Flubromazolam

Fludiazepam

Flurazepam

Halazepam

Haloxazolam

Ketazolam

Loprazolam

Lorazepam

Lormetazepam

Medazepam

Midazolam

Nimetazepam

Nitrazepam

Nordazepam

Oxazepam

Oxazolam

Phenazepam

Pinazepam

Prazepam

Tetrazepam

Triazolam

Zaleplon

Zolpidem

Zopiclone.

2. Any stereoisomeric form of a substance specified in paragraph 1.

3. Any salt of a substance specified in paragraphs 1 or 2.

4. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 1 to 3, not being a preparation specified in Schedule 5.

5. An extract of Cannabis which—

(a) is a medicinal product for human use which has been granted a marketing authorisation and which is presented as a liquid formulation for administration to a person through a meter dose pump as a mucosal mouth spray, and

(b) has a concentration of not more than 30 milligrams of cannabidiol per millilitre, and not more than 30 milligrams of delta-9-tetrahydrocannabinol per millilitre, where the ratio of cannabidiol to delta-9-tetrahydrocannabinol is between 0.7 to 1.3.

6. Any stereoisomeric form of a substance specified in paragraph 5.

7. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 5 or 6, not being a preparation specified in Schedule 5.

PART 2

1. The following substances namely:-

Aminorex

Fencamfamin

Fenproporex

Mefenorex

Mesocarb

Propylhexedrine

Pyrovalerone

Selegiline

2. Any stereoisomeric form of a substance specified in paragraph 1.

3. Any salt of a substance specified in paragraphs 1 or 2.

4. Any preparation or other product containing any proportion of a substance or product specified in any of paragraphs 1 to 3, not being a preparation specified in Schedule 5.

5. Any preparation containing not more than 100 milligrams of methylphenobarbitone or of phenobarbitone (calculated in either case in terms of base) per dosage unit and no other controlled drug and which in the case of an undivided preparation has a concentration of not more than 0.5 per cent of phenobarbitone (calculated as base) and no other controlled drug.”

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GIVEN under my Official Seal,

27 April, 2022.

STEPHEN DONNELLY,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

The purpose of these Regulations is to amend the Misuse of Drugs Regulations 2017 by adding certain additional substances to Schedules 1 and 4 of those Regulations.

These Regulations may be cited as the Misuse of Drugs (Amendment) Regulations 2022.