Citation, commencement and extent

1.—(1) These Regulations may be cited as the Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment and Revocation) Regulations 2024.

(2) These Regulations come into force as follows—

(a) this regulation and regulation 4 come into force on 19th March 2024; and

(b) the remaining regulations come into force on 20th March 2024.

(3) These Regulations extend to England and Wales and Scotland.

Amendment of the Misuse of Drugs Regulations 2001

2.—(1) The following amendments are made to the Misuse of Drugs Regulations 2001( 2).

(2) In paragraph 1(a) of Schedule 1 (which specifies controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 19, 20, 23, 26 and 27)—

(a) after “Bromazolam (8-bromo-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)” insert “Brorphine”;

(b) after “Bufotenine” insert “Butonitazene”;

(c) after “Clonazolam (6-(2-Chlorophenyl)-1-methyl-8-nitro-4H-[1,2,4]triazolo[4,3-a][1,4] benzodiazepine)” insert “Clonitazene”;

(d) after “Concentrate of poppy-straw” insert “Cumyl-PeGaClone”;

(e) after “3-Dimethylheptyl-11-hydroxyhexahydrocannabinol” insert—

“Diphenidine

Ephenidine

Ethyleneoxynitazene ”;

(f) after “Etizolam” insert—

“Etodesnitazene (etazene)

Etonitazene ”;

(g) after “Flubromazolam (8-Bromo-6-(2-fluorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4] benzodiazepine)” insert “Flunitazene”;

(h) after “Isopropylphenidate (IPP or IPPD)” insert “Isotonitazene”;

(i) after “Methcathinone” insert “Methoxyphenidine”;

(j) after “Metizolam (4-(2-Chlorophenyl)-2-ethyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4] diazepine)” insert—

“Metodesnitazene (metazene)

Metonitazene ”;

(k) after “Propylphenidate” insert “Protonitazene”;

(l) after “1-Cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45)” insert—

“N -Desethyl etonitazene

N -Desethylisotonitazene

N -Desethyl protonitazene ”;

(m) after “4-Methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine (4,4’-DMAR)” insert—

“N -Piperidinyl-etonitazene (etonitazepipne)

N -Pyrrolidino-etonitazene (etoniazepyne)

N -Pyrrolidino protonitazene ”.

(3) In paragraph 1 of Schedule 2 (which specifies controlled drugs subject to the requirements of regulations 14, 15, 16, 16A, 18, 19, 20, 21, 23, 26 and 27) omit “Clonitazene” and “Etonitazene”.

(4) In paragraph 1 of Part 1 of Schedule 4 (which specifies controlled drugs subject to the requirements of regulations 22, 23, 26 and 27) after “Pyrovalerone” insert “Remimazolam”.

Amendment of the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015

3.—(1) The following amendments are made to Schedule 1 to the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015( 3) (which specifies controlled drugs to which section 7(4) of the Misuse of Drugs Act 1971 applies).

(2) In paragraph 1(a)—

(a) after “Bromazolam (8-bromo-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine)” insert “Brorphine”;

(b) after “1,4-Butanediol” insert “Butonitazene”;

(c) after “Clonazolam (6-(2-Chlorophenyl)-1-methyl-8-nitro-4H-[1,2,4]triazolo[4,3-a][1,4] benzodiazepine)” insert “Clonitazene”;

(d) after “Concentrate of poppy-straw” insert “Cumyl-PeGaClone”;

(e) after “Diclazepam (7-Chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one)” insert—

“Diphenidine

Ephenidine

Ethyleneoxynitazene ”;

(f) after “Etizolam” insert—

“Etodesnitazene (etazene)

Etonitazene ”;

(g) after “Flubromazolam (8-Bromo-6-(2-fluorophenyl)-1-methyl-4H-[1,2,4]triazolo[4,3-a][1,4] benzodiazepine)” insert “Flunitazene”;

(h) after “Isopropylphenidate (IPP or IPPD)” insert “Isotonitazene”;

(i) after “Methcathinone” insert “Methoxyphenidine”;

(j) after “Metizolam (4-(2-Chlorophenyl)-2-ethyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4] diazepine)” insert—

“Metodesnitazene (metazene)

Metonitazene ”;

(k) after “Propylphenidate” insert “Protonitazene”;

(l) after “1-Cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45)” insert—

“N -Desethyl etonitazene

N -Desethylisotonitazene

N -Desethyl protonitazene ”;

(m) after “4-Methyl-5-(4-methylphenyl)-4,5-dihydrooxazol-2-amine (4,4’-DMAR)” insert—

“N -Piperidinyl-etonitazene (etonitazepipne)

N -Pyrrolidino-etonitazene (etoniazepyne)

N -Pyrrolidino protonitazene ”.

Revocation of the Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) Regulations 2024

4.  The Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) Regulations 2024( 4) are revoked.

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Misuse of Drugs Regulations 2001 ( S.I. 2001/3998) (“ the 2001 Regulations”) and the Misuse of Drugs (Designation) (England, Wales and Scotland) Order 2015 ( S.I. 2015/704) (“ the 2015 Order”) and revoke the Misuse of Drugs and Misuse of Drugs (Designation) (England and Wales and Scotland) (Amendment) Regulations 2024 ( S.I. 2024/239) (“ the initial 2024 Regulations”).

Regulation 2(2) adds twenty-one substances (including seventeen synthetic opioids, sixteen of which are nitazenes) to Schedule 1 to the 2001 Regulations. Regulation 2(3) removes two synthetic opioids, both of which are nitazenes (clonitazene and etonitazene), from Schedule 2 to the 2001 Regulations, following their insertion into Schedule 1 to the 2001 Regulations by regulation 2(2)(c) and (f). Regulation 2(4) adds remimazolam to Part 1 of Schedule 4 to the 2001 Regulations. The Schedule in which a controlled drug is placed affects the extent to which the drug can be lawfully imported, exported, produced, supplied or possessed and dictates the controls that the drug is subject to, such as the record-keeping, labelling and destruction requirements in relation to that drug.

Regulation 3 adds the twenty-one substances added to Schedule 1 of the 2001 Regulations to Schedule 1 to the 2015 Order. Section 7(3) of the Misuse of Drugs Act 1971 (c. 38)requires the Secretary of State to make regulations to allow drugs controlled under that Act to be used for medicinal purposes. Section 7(3), however, does not apply to any drug which is designated by order under section 7(4) of that Act. Controlled drugs are designated where the Secretary of State is of the opinion that it is in the public interest for production, supply and possession of that drug to be either wholly unlawful or unlawful except for research or other special purposes, or for medicinal use of the drug to be unlawful except under licence. Schedule 1 to the 2015 Order specifies the list of controlled drugs to which section 7(4) applies.

Regulation 4 revokes the initial 2024 Regulations, which were made in error on 20th February 2024 and, if not revoked by these Regulations, would have come into force on 20th March 2024. Regulations 2 and 3 reflect, and replace, the amendments made by the initial 2024 Regulations.

A full impact assessment and an economic note of the effect that this instrument will have on the costs of business and the voluntary sector and community bodies are available with the Explanatory Memorandum alongside this instrument onwww.legislation.gov.uk. Copies may be obtained from the Drug Misuse Unit of the Home Office at 2 Marsham Street, London, SW1P 4DF.