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Notice of the making of this Statutory Instrument was published in
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“Iris Oifigiúil” of 19th September, 2023.
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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:
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1. (1) These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023.
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(2) The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2023” includes these Regulations.
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2. In these Regulations “Principal Regulations” means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (
S.I. No. 540 of 2003
).
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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:
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“
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Medicinal Product
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Form and presentation of product administered
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Route of administration
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Indication for which the medicinal product may be administered
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Dosage and conditions of administration
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Place of administration
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Column 1
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Column 2
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Column 3
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Column 4
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Column 5
|
Column 6
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COMIRNATY Omicron XBB.1.5 30 mcg/dose
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Dispersion for injection
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Intramuscular injection
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Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older
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In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee
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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.
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COMIRNATY Omicron XBB.1.5 10 mcg/dose
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Concentrate for dispersion for injection
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Intramuscular injection
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Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in children aged 5 to 11 years.
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In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee
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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.
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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
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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.
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”.
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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:
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“
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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
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|
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.
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In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee
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”.
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GIVEN under my Official Seal,
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14 September, 2023.
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STEPHEN DONNELLY,
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Minister for Health.
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EXPLANATORY NOTE
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(This note is not part of the Instrument and does not purport to be a legal interpretation.)
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These Regulations amend the Medicinal Products (Prescription and Control of Supply) Regulations 2003.
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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.
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These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023.
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