S.I. No. 175/2017 - Misuse of Drugs (Exemption) Order 2017.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 5th May, 2017.

I, CATHERINE BYRNE, Minister of State at the Department of Health, in exercise of the powers conferred on me by section 3 of the Misuse of Drugs Act 1977 (No. 12 of 1977) and the Health (Delegation of Ministerial Functions) (No. 3) Order 2016 ( S.I. No. 511 of 2016 ), hereby order as follows:

1. This Order may be cited as the Misuse of Drugs (Exemption) Order 2017.

2. This Order comes into operation on 4 May 2017.

3. In this Order—

“animal remedy” has the meaning assigned to it by the Animal Remedies Act 1993 (No. 23 of 1993);

“medicinal product” has the meaning assigned to it by Council Directive 2001/83/EC of 6 November 2001¹ , as amended from time to time.

4. Subsection (1) of section 3 of the Misuse of Drugs Act 1977 (No. 12 of 1977) shall not apply to the controlled drugs specified in the Schedule.

SCHEDULE

PART 1

1. Any medicinal product or animal remedy containing one or more of the following substances, their stereoisomeric forms or any salt of any of the said substances or of their stereoisomeric forms:—

Aminorex

Fencamfamin

Fenproporex

Mefenorex

Mesocarb

Propylhexedrine.

Pyrovalerone.

Selegiline.

2. 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.

3. Any plant of any kind or description, which contains 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) where the plant is growing uncultivated.

4. Any plant of any kind or description, which contains 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) or an ester or ether of 7-Hydroxymitragynine where that plant is growing uncultivated.

5. Any plant of any kind or description, which contains 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) where that plant is growing uncultivated.

6. Any fungus containing any proportion of Psilocin or of an ester of Psilocin where that fungus is growing uncultivated.

PART 2

1. (a) Any preparation of one or more of the substances to which this paragraph applies (not being a preparation designed for administration by injection) when compounded with one or more other ingredients and which contains a total of not more than 100 milligrams of the substance or substances (calculated as base) per dosage unit and which in the case of an undivided preparation has a total concentation of not more than 2.5 per cent of the substance or substances (calculated as base).

(b) The substances to which this paragraph applies are acetyldihydrocodeine, codeine, ethylmorphine (3-ethylmorphine), nicocodine, nicodicodine (6-nicotinoyldihydrocodeine), norcodeine, pholcodine and their respective salts.

2. Any preparation of dihydrocodeine (not being a preparation designed for administration by injection) containing, per dosage unit, not more than 10 milligrams of dihydrocodeine (calculated as base) and which in the case of an undivided preparation has a concentration of not more than 1.5 per cent of dihydrocodeine (calculated as base).

3. Any preparation of cocaine containing not more than 0.1 per cent of cocaine (calculated as cocaine base), being a preparation which is compounded with one or more other ingredients in such a way that the cocaine cannot be readily recovered.

4. Any preparation of medicinal opium or of morphine, (not being a preparation designed for administration by injection), containing, in either case, not more than 0.2 per cent of morphine (calculated as anhydrous morphine base), being a preparation which is compounded with one or more other ingredients in such a way that the opium or morphine cannot be readily recovered.

5. Any preparation of dextropropoxyphene, being a preparation designed for oral administration, containing not more than 135 milligrams of dextropropoxyphene (calculated as base) per dosage unit or with a total concentration of not more than 2.5 per cent, (calculated as base) in undivided preparations.

6. Any preparation of difenoxin containing, per dosage unit, not more than 0.5 milligrams of difenoxin and a quantity of atropine sulphate equivalent to at least 5 per cent of the dose of difenoxin.

7. Any preparation of diphenoxylate containing, per dosage unit, not more than 2.5 milligrams of diphenoxylate (calculated as base), and a quantity of atropine sulphate equivalent to at least 1 per cent of the dose of diphenoxylate.

8. Any preparation of propiram containing, per dosage unit, not more than 100 milligrams of propiram (calculated as base) and which is compounded with at least the same amount, by weight, of methylcellulose.

9. Any powder of ipecacuanha and opium comprising 10 per cent powdered opium, 10 per cent powdered ipecacuanha root, both well mixed with the remaining 80 per cent consisting of any other powdered ingredient which contains no controlled drug.

10. Any mixture containing one or more of the preparations specified in this Part of this Schedule, being a mixture of which none of the other ingredients is a controlled drug.

11. Poppy straw.

GIVEN under my Hand,

2 May 2017.

CATHERINE BYRNE,

Minister of State at the Department of Health.

EXPLANATORY NOTE.

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

The effect of this Order is to exempt from the provisions of section 3 (which prohibits the possession of controlled drugs) of the Misuse of Drugs Act, 1977 as amended, the medicinal products, animal remedies and preparations specified in the Schedule. They are essentially preparations in which there are only small quantities of controlled drugs. In addition the order exempts from the provisions of section 3 any fungus containing any proportion of Psilocin, or of an ester of Psilocin, where that fungus is growing uncultivated and any plants containing Salvinorin A, Mitragynine or 7-Hydroxymitragynine where such plants are growing uncultivated.

1 OJ No. L 311, 28.11.2001, p. 67.