The Misuse of Drugs Regulations 2001

Regulation 3

SCHEDULE 1U.K. CONTROLLED DRUGS SUBJECT TO THE REQUIREMENTS OF REGULATIONS 14, 15, 16, 18, 19, 20, 23, 26 AND 27

1.  The following substances and products, namely -U.K.

  • [F1Adinazolam (1-(8-Chloro-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepin-1-yl)-N,N-dimethylmethanamine)]

  • [F1N-Benzyl-ethylphenidate]

  • [F1 Bromazolam (8-bromo-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)]

  • [F2Brorphine]

  • Bufotenine

  • [F3Butonitazene]

  • Cannabinol

  • [F4Cannabinol derivatives not being—

    (i)

    dronabinol or its stereoisomers; or

    (ii)

    the substance specified in paragraph 10 of Schedule 5]

  • Cannabis [F5(not being the substance specified in paragraph 5 of Part 1 of Schedule 4)] and cannabis resin

  • Cathinone

  • [F64’-Chlorodiazepam (7-Chloro-5-(4-chlorophenyl)-1-methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one)]

  • [F6Clonazolam (6-(2-Chlorophenyl)-1-methyl-8-nitro-4H-[1,2,4]triazolo[4,3-a][1,4] benzodiazepine)]

  • [F7Clonitazene]

  • Coca leaf

  • Concentrate of poppy-straw

  • [F8Cumyl-PeGaClone]

  • [F9Deschloroetizolam (2-Ethyl-9-methyl-4-phenyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4] diazepine)]

  • [F93,4-Dichloroethylphenidate]

  • [F93,4-Dichloromethylphenidate (3,4-DCMP)]

  • [F9Diclazepam (7-Chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one)]

  • [F10[2,3–Dihydro–5–methyl–3–(4–morpholinylmethyl)pyrrolo[1, 2, 3–de]–1,4–benzoxazin–6–yl]–1–naphthalenylmethanone]

  • [F103–Dimethylheptyl–11–hydroxyhexahydrocannabinol]

  • [F11Diphenidine]

  • [F11Ephenidine]

  • [F11Ethyleneoxynitazene]

  • [F12Ethylnaphthidate]

  • [F12Ethylphenidate]

  • Eticyclidine

  • [F13Etizolam]

  • [F14Etodesnitazene (etazene)]

  • [F14Etonitazene]

  • Etryptamine

  • [F15Flualprazolam (8-chloro-6-(2-fluorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)]

  • [F16Flubromazepam (7-Bromo-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one)]

  • [F16Flubromazolam (8-Bromo-6-(2-fluorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4] benzodiazepine)]

  • [F17Flunitazene]

  • [F18Flunitrazolam (6-(2-fluorophenyl)-1-methyl-8-nitro-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)]

  • [F164-Fluoroethylphenidate]

  • [F164-Fluoromethylphenidate]

  • [F16Fonazepam (5-(2-Fluorophenyl)-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-one)]

  • [F19Fungus (of any kind) which contains psilocin or an ester of psilocin]

  • [F20[9–Hydroxy–6–methyl–3–[5–phenylpentan–2–yl] oxy–5, 6, 6a, 7, 8, 9, 10, 10a–octahydrophenanthridin–1–yl] acetate]

  • [F209-(Hydroxymethyl)–6, 6–dimethyl–3–(2–methyloctan–2–yl)–6a, 7, 10, 10a–tetrahydrobenzo[c]chromen–1–ol]

  • [F213-Hydroxyphenazepam (7-Bromo-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-2H-1,4-benzodiazepin-2-one)]

  • [F21Isopropylphenidate (IPP or IPPD)]

  • [F22Isotonitazene]

  • [F23Khat]

  • Lysergamide

  • Lysergide and otherN-alkyl derivatives of lysergamide

  • [F24Meclonazepam (5-(2-Chlorophenyl)-3-methyl-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-one)]

  • Mescaline

  • Methcathinone

  • [F25Methoxyphenidine]

  • [F264-Methylmethylphenidate]

  • [F26Methylmorphenate]

  • [F26Methylnaphthidate (HDMP-28)]

  • [F27N-methyl-1-(thiophen-2-yl)propan-2-amine (methiopropamine or MPA)]

  • [F26Metizolam (4-(2-Chlorophenyl)-2-ethyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]  diazepine)]

  • [F28Metodesnitazene (metazene)]

  • [F28Metonitazene]

  • [F26Nifoxipam (5-(2-Fluorophenyl)-3-hydroxy-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-  one)]

  • [F26Nitrazolam (1-Methyl-8-nitro-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)]

  • [F29Norfludiazepam (7-chloro-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one)]

  • [F26Propylphenidate]

  • [F30Protonitazene]

  • F31...

  • Psilocin

  • [F32Pyrazolam (8-Bromo-1-methyl-6-(2-pyridinyl)-4H-[1,2,4]triazolo[4,3-a][1,4] benzodiazepine)]

  • Raw opium

  • Rolicyclidine

  • Tenocyclidine

  • [F33(6aR,9R)-4-acetyl-N,N-diethyl-7-methyl-4,6,6a,7,8,9-hexahydroindolo[4,3-fg]quinoline-9-carboxamide (ALD-52)]

  • 4-Bromo-2,5-dimethoxy-a-methylphenethylamine

  • [F341-Cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45)]

  • [F35N-Desethyl etonitazene]

  • [F35N-Desethylisotonitazene]

  • [F35N-Desethyl protonitazene]

  • [F363,4-dichloro-N-[[1-(dimethylamino)cyclohexyl]methyl]benzamide (AH-7921)]

  • [F373,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (U-47,700)]

  • [F36(6aR,9R)-N,N-diethyl-7-allyl-4,6,6a,7,8,9-hexahydroindolo[4,3-fg]quinoline-9-carboxamide (AL-LAD)]

  • [F36(6aR,9R)-N,N-diethyl-7-ethyl-4,6,6a,7,8,9-hexahydroindolo[4,3-fg]quinoline-9-carboxamide (ETH-LAD)]

  • [F36(6aR,9R)-N,N-diethyl-7-propyl-4,6,6a,7,8,9-hexahydroindolo[4,3-fg]quinoline-9-carboxamide (PRO-LAD)]

  • N,N-Diethyltryptamine

  • [F382-((Dimethylamino)methyl)-1-(3-hydroxyphenyl)cyclohexanol]

  • [F392,4-dimethylazetidinyl{(6aR,9R)-7-methyl-4,6,6a,7,8,9-hexahydroindolo[4,3-fg]quinolin-9-yl}methanone (LSZ)]

  • N,N-Dimethyltryptamine

  • 2,5-Dimethoxy-a,4-dimethylphenethylamine

  • N-Hydroxy-tenamphetamine

  • 4-Methyl-aminorex

  • [F404-Methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine (4,4’-DMAR)]

  • [F41N-Piperidinyl-etonitazene (etonitazepipne)]

  • [F41N-Pyrrolidino-etonitazene (etoniazepyne)]

  • [F41N-Pyrrolidino protonitazene]

[F42(b)any compound (not being a compound for the time being specified in sub-paragraph (a) above) structurally derived from tryptamine or from a ring-hydroxy tryptamine by modification in any of the following ways, that is to say—

(i)by substitution at the nitrogen atom of the sidechain to any extent with alkyl or alkenyl substituents, or by inclusion of the nitrogen atom of the side chain (and no other atoms of the side chain) in a cyclic structure;

(ii)by substitution at the carbon atom adjacent to the nitrogen atom of the side chain with alkyl or alkenyl substituents;

(iii)by substitution in the 6-membered ring to any extent with alkyl, alkoxy, haloalkyl, thioalkyl, alkylenedioxy, or halide substituents;

(iv)by substitution at the 2-position of the tryptamine ring system with an alkyl substituent;]

(c)the following phenethylamine derivatives, namely—

  • Allyl(a-methyl-3,4-methylenedioxyphenethyl)amine

  • 2-Amino-1-(2,5-dimethoxy-4-methylphenyl)ethanol

  • 2-Amino-1-(3,4-dimethoxyphenyl)ethanol

  • Benzyl(a-methyl-3,4-methylenedioxyphenethyl)amine

  • 4-Bromo-b,2,5-trimethoxyphenethylamine

  • N-(4-sec-Butylthio-2,5-dimethoxyphenethyl)hydroxylamine

  • Cyclopropylmethyl(a-methyl-3,4-methylenedioxyphenethyl)amine

  • 2-(4,7-Dimethoxy-2,3-dihydro-1H-indan-5-yl)ethylamine

  • 2-(4,7-Dimethoxy-2,3-dihydro-1H-indan-5-yl)-1-methylethylamine

  • 2-(2,5-Dimethoxy-4-methylphenyl)cyclopropylamine

  • 2-(1,4-Dimethoxy-2-naphthyl)ethylamine

  • 2-(1,4-Dimethoxy-2-naphthyl)-1-methylethylamine

  • N-(2,5-Dimethoxy-4-propylthiophenethyl)hydroxylamine

  • 2-(1,4-Dimethoxy-5,6,7,8-tetrahydro-2-naphthyl)ethylamine

  • 2-(1,4-Dimethoxy-5,6,7,8-tetrahydro-2-naphthyl)-1-methylethylamine

  • a,a-Dimethyl-3,4-methylenedioxyphenethylamine

  • a,a-Dimethyl-3,4-methylenedioxyphenethyl(methyl)amine

  • Dimethyl(a-methyl-3,4-methylenedioxyphenethyl)amine

  • N-(4-Ethylthio-2,5-dimethoxyphenethyl)hydroxylamine

  • 4-Iodo-2,5-dimethoxy-a-methylphenethyl(dimethyl)amine

  • 2-(1,4-Methano-5,8-dimethoxy-1,2,3,4-tetrahydro-6-naphthyl)ethylamine

  • 2-(1,4-Methano-5,8-dimethoxy-1,2,3,4-tetrahydro-6-naphthyl)-1-methylethylamine

  • 2-(5-Methoxy-2,2-dimethyl-2,3-dihydrobenzo[b]furan-6-yl)-1-methylethylamine

  • 2-Methoxyethyl(a-methyl-3,4-methylenedioxyphenethyl)amine

  • 2-(5-Methoxy-2-methyl-2,3-dihydrobenzo[b]furan-6-yl)-1-methylethylamine

  • b-Methoxy-3,4-methylenedioxyphenethylamine

  • 1-(3,4-Methylenedioxybenzyl)butyl(ethyl)amine

  • 1-(3,4-Methylenedioxybenzyl)butyl(methyl)amine

  • 2-(a-Methyl-3,4-methylenedioxyphenethylamino)ethanol

  • a-Methyl-3,4-methylenedioxyphenethyl(prop-2-ynyl)amine

  • N-Methyl-N-(a-methyl-3,4-methylenedioxyphenethyl)hydroxylamine

  • O-Methyl-N-(a-methyl-3,4-methylenedioxyphenethyl)hydroxylamine

  • a-Methyl-4-(methylthio)phenethylamine

  • b,3,4,5-Tetramethoxyphenethylamine

  • b,2,5-Trimethoxy-4-methylphenethylamine

(d)any compound (not being methoxyphenamine or a compound for the time being specified in sub-paragraph (a) above) structurally derived from phenethylamine, anN-alkylphenethylamine,a-methylphenethylamine, anN-alkyl-a-methylphenethylamine,a-ethylphenethylamine, or anN-alkyl-a-ethylphenethylamine by substitution in the ring to any extent with alkyl, alkoxy, alkylenedioxy or halide substitutents, whether or not further substituted in the ring by one or more other univalent substituents;

(e)any compound (not being a compound for the time being specified in Schedule 2) structurally derived from fentanyl by modification in any 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, halogeno, 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, halogeno 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 theN-propionyl group by another acyl group;

(f)any compound (not being a compound for the time being specified in Schedule 2) structurally derived from pethidine by modification in any of the following ways, that is to say—

(i)by replacement of the l-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, halogeno 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.

[F43(g)1–benzylpiperazine or any compound (not being a compound for the time being specified in Schedule 4) 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, halide or haloalkyl groups;

[F44(h)Any compound structurally derived from 3–(1–naphthoyl)indole, 3-(2-naphthoyl)indole, 1H–indol–3–yl–(1–naphthyl)methane or 1H-indol-3-yl-(2-naphthyl)methane by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl 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 compound structurally derived from 3–(1–naphthoyl)pyrrole or 3-(2-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl 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 compound structurally derived from 1–(1–naphthylmethylene)indene or 1-(2-naphthylmethylene)indene by substitution at the 3–position of the indene ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl 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 compound structurally derived from 3–phenylacetylindole by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl 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.]

(l)any compound 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.]

[F45(la)Any compound structurally derived from 3-benzoylindole by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl 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.

(lb)Any compound structurally derived from 3-(1-adamantoyl)indole or 3-(2-adamantoyl)indole by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl or 2–(4–morpholinyl)ethyl, whether or not further substituted in the indole ring to any extent and whether or not substituted in the adamantyl ring to any extent.

(lc)Any compound structurally derived from 3-(2,2,3,3-tetramethylcyclopropylcarbonyl)indole by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl or 2–(4–morpholinyl)ethyl, whether or not further substituted in the indole ring to any extent.]

[F46(ld)[F47Any compound (not being a compound for the time being specified in sub-paragraphs (h) to (lc) above) structurally related to 1-pentyl-3-(1-naphthoyl)indole (JWH-018), in that the four sub-structures, that is to say the indole ring, the pentyl substituent, the methanone linking group and the naphthyl ring, are linked together in a similar manner, whether or not any of the sub-structures have been modified, and whether or not substituted in any of the linked sub-structures with a benzyl or phenyl group and whether or not such compound is further substituted to any extent with alkyl, alkenyl, alkoxy, halide, haloalkyl or cyano substituents and, where any of the sub-structures have been modified, the modifications of the sub-structures are limited to any of the following, that is to say—]

(i)replacement of the indole ring with indane, indene, indazole, pyrrole, pyrazole, imidazole, benzimidazole, pyrrolo[2,3-b]pyridine, pyrrolo[3,2-c]pyridine or pyrazolo[3,4‑b]pyridine;

(ii)replacement of the pentyl substituent with alkyl, alkenyl, benzyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)methyl, 2-(4-morpholinyl)ethyl or (tetrahydropyran-4-yl)methyl;

(iii)replacement of the methanone linking group with an ethanone, carboxamide, carboxylate, methylene bridge or methine group;

(iv)replacement of the 1-naphthyl ring with 2-naphthyl, phenyl, benzyl, adamantyl, cycloalkyl, cycloalkylmethyl, cycloalkylethyl, bicyclo[2.2.1]heptanyl, 1,2,3,4-tetrahydronaphthyl, quinolinyl, isoquinolinyl, 1-amino-1-oxopropan-2-yl, 1‑hydroxy-1-oxopropan-2-yl, piperidinyl, morpholinyl, pyrrolidinyl, tetrahydropyranyl or piperazinyl;]

[F48(m)Any compound (not being bupropion, diethylpropion, pyrovalerone or a compound for the time being specified in sub–paragraph (a) above) structurally derived from 2–amino–1–phenyl–1–propanone by modification in any of the following ways, that is to say—

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

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

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

[F49(n)Any compound structurally derived from 2–aminopropan–1–one 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 compound is further modified in any of the following ways, that is to say—

(i)by substitution in the ring system to any extent with alkyl, alkoxy, haloalkyl or halide 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 alkyl or dialkyl groups, or by inclusion of the 2‑amino nitrogen atom in a cyclic structure.]

[F50(o)Any compound (not being pipradrol) structurally derived from piperidine, pyrrolidine, azepane, morpholine or pyridine by substitution at a ring carbon atom with a diphenylmethyl group, whether or not the compound is further modified in any of the following ways, that is to say,

(i)by substitution in any of the phenyl rings to any extent with alkyl, alkoxy, haloalkyl or halide groups;

(ii)by substitution at the methyl carbon atom with an alkyl, hydroxyalkyl or hydroxy group;

(iii)by substitution at the ring nitrogen atom with an alkyl, alkenyl, haloalkyl or hydroxyalkyl group.]

[F51(p)1-Phenylcyclohexylamine or any compound (not being eticyclidine, ketamine, phencyclidine, rolicyclidine, tenocyclidine or tiletamine) structurally derived from 1-phenylcyclohexylamine or 2-amino-2-phenylcyclohexanone by modification in any of the following ways, that is to say,

(i)by substitution at the nitrogen atom to any extent by alkyl, alkenyl or hydroxyalkyl groups, or replacement of the amino group with a 1-piperidyl, 1-pyrrolidyl or 1-azepyl group, whether or not the nitrogen containing ring is further substituted by one or more alkyl groups;

(ii)by substitution in the phenyl ring to any extent by amino, alkyl, hydroxy, alkoxy or halide substituents, whether or not further substituted in the phenyl ring to any extent;

(iii)by substitution in the cyclohexyl or cyclohexanone ring by one or more alkyl substituents;

(iv)by replacement of the phenyl ring with a thienyl ring.]

[F52(q)Any compound (not being benzyl(α-methyl-3,4-methylenedioxyphenethyl)amine) structurally derived from mescaline, 4-bromo-2,5-dimethoxy-α-methylphenethylamine, 2,5-dimethoxy-α,4-dimethylphenethylamine, N-hydroxytenamphetamine, or a compound specified in sub-paragraph (c) or (d) above, by substitution at the nitrogen atom of the amino group with a benzyl substituent, whether or not substituted in the phenyl ring of the benzyl group to any extent;

(r)Any compound (not being a compound for the time being specified in sub- paragraph (c) above) structurally derived from 1-benzofuran, 2,3-dihydro-1-benzofuran, 1H-indole, indoline, 1H-indene, or indane by substitution in the 6-membered ring with a 2-ethylamino substituent whether or not further substituted in the ring system to any extent with alkyl, alkoxy, halide or haloalkyl substituents and whether or not substituted in the ethylamino side-chain with one or more alkyl substituents.]

Textual Amendments

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

[F533.  Any ester or ether of a substance specified in paragraph 1 (not being 2-((dimethylamino)methyl)-1-(3-hydroxyphenyl)cyclohexanol) or paragraph 2.]U.K.

4.  Any salt of a substance specified in any of paragraphs 1 to 3.U.K.

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

[F546.  But paragraphs 1 to 5 do not include a cannabis-based product for medicinal use in humans.]U.K.