← Ireland

S.I. No. 155/2021 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2021

S.I. No. 155/2021 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2021 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.

  1. ie)Translations (Houses of the Oireachtas) Government Publications for Sale EU Law (EUR-Lex) FAQ Disclaimer Feedback Helpdesk Search Baile Reachtaíocht Achtanna an Oireachtais Ionstraimí Reachtúla Reachtaíocht Réamh-1922 Bunreacht Acmhainní Seachtracha Billí (Tithe an Oireachtais) Iris Oifigiúil Achtanna Athbhreithnithe (CAD) (An Coimisiún um Athchóiriú an Dlí) Liosta Rangaithe Reachtaíochta Aistriúcháin (achtanna.
  2. ie)Aistriúcháin (Tithe an Oireachtais) Foilseacháin Rialtais ar Díol Dlí AE (EUR-Lex) CCanna (Ceisteanna Coitianta) Séanadh Aiseolas Deasc chabhrach Cuardach TitleTeideal Year(
  3. s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2021 S.I. No. 155/2021 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2021 S.I. No. 155/2021 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2021 AmendmentsLeasuithe Download PDF Íoslódáil PDF Notice of the making of this Statutory Instrument was published in “Iris Oifigiúil” of 6th April, 2021. I, STEPHEN DONNELLY, Minister for Health, 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. 6) Regulations 2021.
(2)The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2021” includes these Regulations.
  1. In these Regulations— “Principal Regulations” means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ); “Regulations of 2021” means the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2021 ( S.I. No. 43 of 2021 ).
  2. The Eighth Schedule (as amended by Regulation 3 of the Regulations of 2021) 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 COVID-19 Vaccine Janssen suspension for injection (Ad26.COV2-S [recombinant]). Suspension for injection. Colourless to slightly yellow, clear to very opalescent suspension (pH 6-6.4). Intramuscular (IM) injection only. COVID-19 Vaccine Janssen is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. In accordance with the summary of product characteristics of the product administered and relevant national guidelines. 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. ”.
  3. The Twelfth Schedule (as amended by Regulation 4 of the Regulations of 2021) 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 COVID-19 Vaccine Janssen suspension for injection (Ad26.COV2-S [recombinant]). Suspension for injection. Colourless to slightly yellow, clear to very opalescent suspension (pH 6-6.4). Intramuscular (IM) injection only. COVID-19 Vaccine Janssen is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. In accordance with the summary of product characteristics of the product administered and relevant national guidelines. ”. GIVEN under my Official Seal, 31 March,
  4. 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
  5. The purpose of these Regulations is to add an additional Covid-19 vaccination to the Eighth and Twelfth Schedules to the Regulations of
  6. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations
  7. 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

🔗 To official source

AI explanation based on the official legal text. Indicative, not a substitute for legal advice.