S.I. No. 451/2023 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023

1. (1) These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023.

(2) The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2023” includes these Regulations.

2. In these Regulations “Principal Regulations” means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (

S.I. No. 540 of 2003

).

3. The Eighth Schedule (as amended by Regulation 8 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2023 (

S.I. No. 284 of 2023

)) to the Principal Regulations is amended by inserting the following entry

“

Medicinal Product

Form and presentation of product administered

Route of administration

Indication for which the medicinal product may be administered

Dosage and conditions of administration

Place of administration

Column 1

Column 2

Column 3

Column 4

Column 5

Column 6

COMIRNATY Omicron XBB.1.5 30 mcg/dose

Dispersion for injection

Intramuscular injection

Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older

In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee

Any suitable and appropriate place, having regard to public convenience and the need to protect the health and safety of the public and safely administer the product.

COMIRNATY Omicron XBB.1.5 10 mcg/dose

Concentrate for dispersion for injection

Intramuscular injection

Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in children aged 5 to 11 years.

In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee

Any suitable and appropriate place, having regard to public convenience and the need to protect the health and safety of the public and safely administer the product.

COMIRNATY Omicron XBB.1.5 10 mcg/dose

Dispersion for injection

Intramuscular injection

Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in children aged 5 to 11 years.

In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee

Any suitable and appropriate place, having regard to public convenience and the need to protect the health and safety of the public and safely administer the product.

”.

4. The Twelfth Schedule (as amended by Regulation 6 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2023 (

S.I. No. 422 of 2023

)) to the Principal Regulations is amended by inserting the following entry

“

Medicinal product

Form and presentation of product administered

Route of administration

Indication for which the medicinal product may be administered

Dosage and conditions of administration

Column 1

Column 2

Column 3

Column 4

Column 5

COMIRNATY Omicron XBB.1.5 30 mcg/dose

Dispersion for injection

Intramuscular injection

Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee.

COMIRNATY Omicron XBB.1.5 10 mcg/dose

Concentrate for dispersion for injection

Intramuscular injection

Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in children aged 5 to 11 years.

In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee

COMIRNATY Omicron XBB.1.5 10 mcg/dose

Dispersion for injection

Intramuscular injection

Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in children aged 5 to 11 years.

In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee

”.

GIVEN under my Official Seal,

14 September, 2023.

STEPHEN DONNELLY,

Minister for Health.

EXPLANATORY NOTE

(

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

)

These Regulations amend the Medicinal Products (Prescription and Control of Supply) Regulations 2003.

The purpose of these Regulations is to update the relevant schedules in relation to the COVID-19 vaccines to include the COMIRNATY Omicron XBB.1.5 vaccine.

These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

19

th September,

2023.

I, STEPHEN DONNELLY, in exercise of the powers conferred on me by

section 32

(as amended by

section 16

of the

Irish Medicines Board (Miscellaneous Provisions) Act 2006

(No. 3 of 2006)) of the

Irish Medicines Board Act 1995

(No. 29 of 1995), hereby make the following regulations