S.I. No. 105/2023 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2023 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.
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- s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2023 S.I. No. 105/2023 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2023 S.I. No. 105/2023 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2023 AmendmentsLeasuithe Download PDF Íoslódáil PDF Notice of the making of this Statutory Instrument was published in “Iris Oifigiúil” of 10th March, 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:
(1)These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2023.
(2)The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2023” includes these Regulations. In these Regulations— “Principal Regulations” means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ); “Regulations of 2023” means the Medicinal Products (Prescription and Control of Supply (Amendment) Regulations 2023 ( S.I. No. 11 of 2023 ). The Eighth Schedule (as amended by Regulation 3 of the Regulations of 2023) to the Principal Regulations is amended— (
- a)in the entry for “Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)”— (
- i)in column 4, by deleting “and who have previously received at least a primary vaccination course against COVID-19”, and (
- ii)in column 5— (I) by deleting “and have previously received at least a primary vaccination course against COVID-19”, and (II) by deleting “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)in the entry for “Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for injection COVID-19 mRNA Vaccine (nucleoside modified)”— (
- i)in column 4, by deleting “who have previously received at least a primary vaccination course against COVID-19”, and (
- ii)in column 5, by deleting “and have previously received at least a primary vaccination course against COVID-19”. 3. The Twelfth Schedule (as amended by Regulation 4 of the Regulations of 2023) to the Principal Regulations is amended— (
- a)in the entry for “Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)”— (
- i)in column 4, by deleting “and who have previously received at least a primary vaccination course against COVID-19”, and (
- ii)in column 5— (I) by deleting “and have previously received at least a primary vaccination course against COVID-19”, and (II) by deleting “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)in the entry for “Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for injection COVID-19 mRNA Vaccine (nucleoside modified)”— (
- i)in column 4, by deleting “who have previously received at least a primary vaccination course against COVID-19”, and (
- ii)in column 5, by deleting “and have previously received at least a primary vaccination course against COVID-19”. GIVEN under my Official Seal, 7 March, 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 allow for certain bivalent COVID-19 vaccines to be used as the primary vaccination course. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2023. Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government of Ireland. Oireachtas Copyright Material is reproduced with the permission of the Houses of the Oireachtas © Rialtas na hÉireann. Atáirgtear ábhar faoi Chóipcheart le cead ó Thithe an Oireachtais