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S.I. No. 84/2022 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2022

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 1st March, 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. 3) 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. 2) Regulations 2022 ( S.I. No. 57 of 2022 ).

3. The Eighth Schedule (as amended by Regulation 3 of the Regulations of 2022) to the Principal Regulations is amended, in column 5 of the entry for “Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)”, by substituting “12 years of age” for “16 years of age”.

4. The Twelfth Schedule (as amended by Regulation 4 of the Regulations of 2022) to the Principal Regulations is amended, in column 5 of the entry for “Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)”, by substituting “12 years of age” for “16 years of age”.

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GIVEN under my Official Seal,

24 February, 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 allow for booster doses of the Comirnaty Covid-19 vaccine to be administered to persons between 12 and 15 years of age.

These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2022.