S.I. No. 557/2021 - Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) (Amendment) Regulations 2021

1. These Regulations may be cited as the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) (Amendment) Regulations 2021.

2. The Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (

S.I. No. 262 of 2019

) are amended by substituting for Schedule 1 (as amended by Regulation 2 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) (Amendment) Regulations 2020 (

S.I. No. 505 of 2020

)) the following

“SCHEDULE 1

Regulation 2

Specified Controlled Drugs

Name of Cannabis product or preparation and brand name

Dosage form

Concentration of THC (percentage, weight/weight or weight/volume)

Name of manufacturer

Aurora High CBD Oil Drops

Oral solution

Less than 3% w/v (< 30mg/ml)

This product also contains cannabidiol (CBD) 60% w/v (600mg/ml)

Aurora Cannabis Enterprises Inc.,

4439 Township Road 304,

Cremona, Alberta,

Canada, T0M 0R0

CannEpil ™

Oral solution

0.5% w/v (5mg/ml)

This product also contains cannabidiol (CBD) 10% w/v (100mg/ml)

MGC Pharmaceuticals d.o.o.,

Kamniška ulica 29, 1000, Ljubljana, Slovenia

Tilray Oral Solution THC10:CBD10 25ml

Oral solution

1% w/v (10mg/ml)

This product also contains cannabidiol (CBD) 1% w/v (10mg/ml)

Tilray Canada Ltd., 1100 Maughan Road, Nanaimo, BC, V9X 1J2, Canada

Aurora Sedamen Softgels

Capsules

5mg/capsule

This product also contains cannabidiol (CBD) less than 0.2mg/capsule

Aurora Cannabis Enterprises Inc.

4250 14th Avenue,

Markham, Ontario, Canada

L3R 0J3

Oleo Bedrobinol

Dried Flower

13.5% w/w (135mg/g)

This product also contains cannabidiol (CBD) less than 1.0% w/w (less than 10mg/g)

Bureau voor Medicinale Cannabis Postbus 16114 2500 BC DEN HAAG The Netherlands

Oleo Bedrocan

Dried Flower

22% w/w

(220mg/g)

This product also contains cannabidiol (CBD) less than 1.0% w/w (less than 10mg/g)

Bureau voor Medicinale Cannabis Postbus 16114 2500 BC DEN HAAG The Netherlands

“.

3. The Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) (Amendment) Regulations 2020 are revoked.

GIVEN under my Official Seal,

27 October, 2021.

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 (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 to replace Schedule 1 in order to list certain cannabis products or preparations for medical use as “specified controlled drugs”.

These Regulations may be cited as the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) (Amendment) Regulations 2021.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

29

th October,

2021.

I, STEPHEN DONNELLY, Minister for Health, in exercise of the powers conferred on me by sections 4 and 5 (as amended by

section 3

of the

Misuse of Drugs (Amendment) Act 2016

(No. 9 of 2016)) of the

Misuse of Drugs Act 1977

(No. 12 of 1977), hereby make the following regulations