| |
Notice of the making of this Statutory Instrument was published in
|
| |
“Iris Oifigiúil” of 23rd September, 2022.
|
| |
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:
|
| |
1. (1) These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2022.
|
| |
(2) The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2022” 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
);
|
| |
“Regulations of 2022” means the Medicinal Products (Prescription and Control of Supply (Amendment) (No. 4) Regulations 2022 (
S.I. No. 402 of 2022
).
|
| |
3. The Eighth Schedule (as amended by Regulation 3 of the Regulations of 2022) to the Principal Regulations is amended—
|
| |
(a) by inserting after the entry for “Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)” the following entries:
|
| |
“
|
| | |
Medicinal product
|
Form and presentation of the 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 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
|
Ready to use dispersion for injection in a multidose vial One dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine.
|
Intramuscular injection
|
Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older
|
In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any directions to the contrary in the summary of product characteristics—
(a) an additional dose may be administered to immunocompromised persons who are 12 years of age or older and have already received a primary vaccine course against Covid-19, and
(b) a booster dose may be administered to—
(i) persons who are 12 years of age or older and have already received a primary vaccine course against Covid-19, and
(ii) immunocompromised persons who are 12 years of age or older and have already received an additional dose of a Covid-19 vaccine, in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy, living arrangements or otherwise), as may be specified in such recommendations or guidelines, and subject to informed consent being obtained
|
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 Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
|
Dispersion for injection in a multidose vial
|
Intramuscular injection
|
Active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19
|
In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
The product is to be given to eligible individuals who are 12 years of age or older and have previously received at least a primary vaccination course against COVID-19.
The product is to be administered in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy, living arrangements or otherwise), as may be specified in such recommendations or guidelines with an interval of not less than 4 months, or 3 months in exceptional circumstances, between administration of the product and the last prior dose of a COVID-19 vaccine, or confirmed SARS-CoV-2 infection.
|
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 Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
|
Dispersion for injection in a multidose vial
|
Intramuscular injection
|
Active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19
|
In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health
The product is to be given to eligible individuals who are 12 years of age or older and have previously received at least a primary vaccination course against COVID-19.
The product is to be administered in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy, living arrangements or otherwise), as may be specified in such recommendations or guidelines with an interval of not less than 4 months, or 3 months in exceptional circumstances, between administration of the product and the last prior dose of a COVID-19 vaccine, or confirmed SARS-CoV-2 infection.
|
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.
|
|
| |
”, and
|
| |
(b) by inserting after the entry for “Spikevax (previously Covid-19 Vaccine Moderna) dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)” the following entry:
|
| |
“
|
| | |
Medicinal product
|
Form and presentation of the 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
|
|
Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
|
Dispersion for injection in a multidose vial
|
Intramuscular injection.
|
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 30 years of age and older who have previously received at least a primary vaccination course against COVID-19
|
In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any directions to the contrary in the summary of product characteristics, the product shall only be administered to eligible individuals who are 30 years of age or older and have previously received at least a primary vaccination course against COVID-19.
The product is to be administered in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy, living arrangements or otherwise), as may be specified in such recommendations or guidelines with an interval of not less than 4 months, or 3 months in exceptional circumstances, between administration of the product and the last prior dose of a COVID-19 vaccine, or confirmed SARS-CoV-2 infection.
|
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 4 of the Regulations of 2022) to the Principal Regulations is amended—
|
| |
(a) by inserting after the entry for “Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)” the following entries:
|
| |
“
|
| | |
Medicinal product
|
Form and presentation of the 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 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
|
Ready for use dispersion for injection in a multidose vial One dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine.
|
Intramuscular Injection
|
Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older
|
In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any directions to the contrary in the summary of product characteristics—
(a) an additional dose may be administered to immunocompromised persons who are 12 years of age or older and have already received a primary vaccine course against Covid-19, and
(b) a booster dose may be administered to—
(i) persons who are 12 years of age or older and have already received a primary vaccine course against Covid-19, and
(ii) immunocompromised persons who are 12 years of age or older and have already received an additional dose of a Covid-19 vaccine, in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy, living arrangements or otherwise), as may be specified in such recommendations or guidelines, and subject to informed consent being obtained.
|
|
Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
|
Dispersion for injection in a multidose vial
|
Intramuscular injection
|
Active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19
|
In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health
The product is to be given (as a booster dose) to eligible individuals who are 12 years of age or older and have previously received at least a primary vaccination course against COVID-19.
The product is to be administered in such volumes, at such intervals, in such manner and in such order of eligibility and prioritisation (whether by reference to age, employment sector, pregnancy, living arrangements or otherwise), as may be specified in such recommendations or guidelines with an interval of not less than 4 months, or 3 months in exceptional circumstances between administration of the product and the last prior dose of a COVID-19 vaccine, or confirmed SARS-CoV-2 infection.
|
|
Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
|
Dispersion for injection in a multidose vial
|
Intramuscular injection
|
Active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19
|
In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health
The product is to be given to eligible individuals who are 12 years of age or older and have previously received at least a primary vaccination course against COVID-19.
The product is to be administered in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy, living arrangements or otherwise), as may be specified in such recommendations or guidelines with an interval of not less than 4 months or 3 months in exceptional circumstances, between administration of the product and the last prior dose of a COVID-19 vaccine, or confirmed SARS-CoV-2 infection.
|
|
| |
”, and
|
| |
(b) by inserting after the entry for “Spikevax (previously Covid-19 Vaccine Moderna) dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)” the following entry:
|
| |
“
|
| | |
Medicinal product
|
Form and presentation of the 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
|
|
Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
|
Dispersion for injection in a multidose vial
|
Intramuscular injection
|
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 30 years of age and older who have previously received at least a primary vaccination course against COVID-19
|
In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any directions to the contrary in the summary of product characteristics, the product shall only be administered to eligible individuals who are 30 years of age or older and have previously received at least a primary vaccination course against COVID-19.
The product is to be administered in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy, living arrangements or otherwise), as may be specified in such recommendations or guidelines with an interval of not less than 4 months, or 3 months in exceptional circumstances, between administration of the product and the last prior dose of a COVID-19 vaccine, or confirmed SARS-CoV-2 infection.
|
|
| |
”.
|
| |
|
| |
GIVEN under my Official Seal,
|
| |
20 September, 2022.
|
| |
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 amend the relevant schedules in relation to the COVID-19 vaccines to provide for the administration of bivalent adapted Covid vaccines as booster doses, and to add an additional product formulation of the original Comirnaty product.
|
| |
These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2022.
|
