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European Union

Dáil Éireann Debate, Tuesday - 30 April 2024

Tuesday, 30 April 2024

Questions (701)

John Paul Phelan

Question:

701. Deputy John Paul Phelan asked the Minister for Health to list all Acts and Statutory Instruments sponsored by his Department which became law from 20 February 2020 to date in 2024 and which were necessitated, either in whole or in part, to transpose or give effect to regulations, directives or other measures passed at European Union level. [19168/24]

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Written answers

Given the scope of the Deputy's request, it was necessary to canvass all areas of my Department as that was considered to be the most efficient way to gather the information required. As such, the information set out below, regarding a reviews of all Acts and Statutory Instruments sponsored by this Department which became law from 20 February 2020 to date in 2024 and which were necessitated, either in whole or in part, to transpose or give effect to regulations, directives or other measures passed at European Union level, is as accurate as can be provided in the absence of a systematic examination of all Acts & Statutory Instruments enacted by this Department in the last 4 years.

There is one Act which falls within the scope of the question posed by the Deputy, the Regulated Professions (Health and Social Care) (Amendment) Act 2020 which was enacted on the 14th of October 2020. This Act was necessitated in part to give further effect to Directive 2005/36/EC (as amended) of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications.

There are a number of Statutory Instruments which fall within the scope of the question posed by the Deputy and they are listed as follows by year:

2020

• S.I. No. 47 of 2020 European Communities (Hygiene of Foodstuffs) (Amendment) Regulations 2020     

• S.I. No. 55 of 2020 European Union (Natural Mineral Waters, Spring Waters and Other Waters in Bottles or Containers) (Amendment) Regulations 2020

• S.I. No. 79 of 2020 European Union (Official Controls in Relation to Food Legislation) Regulations 2020

• S.I. No. 144 of 2020 European Communities (Medical Devices) (Amendment) Regulations 2020

• S.I. No. 145 of 2020 European Communities (In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2020

• S.I. No. 300 of 2020 European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2020

• S.I. No. 301 of 2020 European Communities (Medical Devices) (Amendment) (No. 2) Regulations 2020

• S.I. No. 302 of 2020 European Communities (In Vitro Diagnostic Medical Devices) (Amendment) (No. 2) Regulations 2020

• S.I. No. 324 of 2020 European Union (Protection of Animals used for Scientific Purposes) (Amendment) Regulations 2020

• S.I. No. 425 of 2020 - European Union (Microbiological Criteria for Foodstuffs) (Amendment) Regulations 2020

• S.I. No. 575 of 2020 European Union (Official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal origin) Regulations 2020

• S.I. No. 700 of 2020 Withdrawal of The United Kingdom From The European Union (Consequential Provisions) Act 2020 (Part 2) (Commencement) order 2020

2021

• S.I. No. 1 of 2021 Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2021

• S.I. No. 82 of 2021 Misuse of Drugs Act 1977 (Controlled Drugs) (Declaration) order 2021

• S.I. No. 121 of 2021 Misuse of Drugs (Amendment) Regulations 2021

• S.I. No. 122 of 2021 Misuse of Drugs (Controlled Drugs) (Designation) order 2021

• S.I. No. 243 of 2021 European Union (Nutrition and Health Claims Made on Foods) (Amendment) Regulations 2021

• S.I. No. 244 of 2021 European Union (Official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal Origin) (Amendment) Regulations 2021

• S.I. No. 260 of 2021 European Union (National Research Ethics Committee for Clinical investigations of Medical Devices) Regulations 2021

• S.I. No. 261 of 2021 Medical Devices Regulations 2021

• S.I. No. 317 of 2021 (Health Act 1947 (Section 31a – EU Digital Covid Certificates) Regulations 2021). Revoked Under S.I. 140 of 2022.

• S.I. No. 318 of 2021 European Union (EU Digital Covid Certificates) Regulations 2021

• S.I. No. 510 of 2021 Medical Devices (Amendment) Regulations 2021 

• S.I. No. 540 of 2021 European Communities (Food Supplements) (Amendment) Regulations 2021

• S.I. No. 541 of 2021 European Union (Addition of Vitamins and Minerals and of Certain Other Substances to Foods) (Amendment) Regulations 2021

• S.I. No. 542 of 2021 European Union (Provision of Food information to Consumers) (Amendment) Regulations 2021

• S.I. No. 614 of 2021 European Union (Manufacture, Presentation and Sale of tobacco and Related Products) (Amendment) Regulations 2021

• S.I. No. 638 of 2021 European Union (official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal origin) (Amendment) (No. 2) Regulations 2021

• S.I. No. 691 of 2021 Medical Devices (Registration) Regulations 2021

2022

• S.I. No. 5 of 2022 European Union (official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal origin) (Amendment) Regulations 2022

• S.I. No. 9 of 2022 European Union (official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal origin) (Amendment) (No. 2) Regulations 2022

• S.I. No. 40 of 2022 European Union (Clinical Trials on Medicinal Products for Human Use) Regulations 2022

• S.I. No. 41 of 2022 European Union (Clinical Trials on Medicinal Products for Human Use) (National Research Ethics Committees) Regulations 2022

• S.I. No. 99 of 2022 European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022

• S.I. No. 111 of 2022 European Union (Food intended for infants and Young Children, Food for Special Medical Purposes, and total Diet Replacement for Weight Control) (Amendment) Regulations 2022

• S.I. 139 of 2022 Infectious Diseases (EU Digital Covid Certificates) Regulations 2022. Amended Under S.I. 181 2022. Revoked Under S.I. 416/23.

• S.I. No. 140 of 2022 Health Act 1947 (Section 31a – EU Digital Covid Certificates) (Revocation) Regulations 2022

• S.I. No. 176 of 2022 Misuse of Drugs Act 1977 (Controlled Drugs) (Declaration) Order 2022

• S.I. No. 181 of 2022 Infectious Diseases (EU Digital Covid Certificates) (Amendment) Regulations 2022

• S.I. No. 182 of 2022 European Union (EU Digital Covid Certificates) (Amendment) Regulations 2022

• S.I. No. 189 of 2022 Infectious Diseases (EU Digital Covid Certificates) Regulations 2022

• S.I. No. 205 of 2022 European Union (Protection of Animals used for Scientific Purposes) (Amendment) Regulations 2022

• S.I. No. 210 of 2022 Misuse of Drugs (Amendment) Regulations 2022

• S.I. No. 211 of 2022 Misuse of Drugs Act 1977 (Controlled Drugs) (Designation) Order 2022

• S.I. No. 239 of 2022 Infectious Diseases (EU Digital Covid Certificates) (Revocation) Regulations 2022

• S.I. No. 253 of 2022 European Union (Novel Foods) Regulations 2022

• S.I. No. 254 of 2022 European Communities (Hygiene of Foodstuffs) (Amendment) Regulations 2022

• S.I. No. 256 of 2022 In Vitro Diagnostic Medical Devices Regulations 2022

• S.I. No. 257 of 2022 European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022

• S.I. No. 270 of 2022 Medicinal Products (Safety Features on Packaging) Regulations 2022

• S.I. No. 328 of 2022 European Union (official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal origin) (Amendment) (No. 3) Regulations 2022

• S.I. No. 329 of 2022 Designation Under Regulation 17 of The European Union (official Controls in Relation to Food Legislation) Regulations 2020 (S.I. No. 79 of 2020)

• S.I. No. 365 of 2022 In Vitro Diagnostic Medical Devices (Registration) Regulations 2022

• S.I. No. 403 of 2022 European Union (official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal origin) (Amendment) (No. 4) Regulations 2022

• S.I.  414 of 2022 Medicinal Products (Control of Manufacture) (Amendment) (No.2) Regulations 2022 

• S.I.  415 of 2022 Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 

• S.I.  416 of 2022 Medicinal Products (Control of Placing on The Market) (Amendment) Regulations 2022 

• S.I. No. 417 of 2022 European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2022

• S.I. No. 418 of 2022 European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) (Amendment) Regulations 2022

• S.I. No. 528 of 2022 European Union (Basic Safety Standards for Protection Against Dangers Arising From Medical Exposure to Ionising Radiation) (Amendment) Regulations 2022

• S.I. No. 555 of 2022 European Communities (Control of Drug Precursors) (Amendment) Regulations 2022

• S.I. No. 586 of 2022 Designation Under Regulation 17 of The European Union (official Controls in Relation to Food Legislation) Regulations 2020 (S.I. No. 79 of 2020)

• S.I. No. 689 of 2022 European Union (Nutrition and Health Claims Made on Foods) (Amendment) Regulations 2022

• S.I. No. 691 of 2022 European Union (Natural Mineral Waters, Spring Waters and Other Waters in Bottles or Containers) (Amendment) Regulations 2022

• S.I. No. 725 of 2022 European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2022

• S.I. No. 726 of 2022 European Union (National Research Ethics Committee for Clinical investigations of Medical Devices) (Amendment) Regulations 2022

• S.I. No. 727 of 2022 European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) (Amendment) Regulations 2022

2023

• S.I. No. 29 of 2023 European Union (Basic Safety Standards for Protection Against Dangers Arising From Medical Exposure to Ionising Radiation) (Amendment) Regulations 2023

• S.I. No. 50 of 2023 European Union (official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal origin) (Amendment) Regulations 2023

• S.I. No. 150 of 2023 Misuse of Drugs (Amendment) Regulations 2023

• S.I. No. 156 of 2023 Misuse of Drugs (Amendment) (No. 2) Regulations 2023

• S.I. No. 222 of 2023 Food Safety Authority of Ireland Act 1998 (Amendment of First Schedule) order 2023

• S.I. No. 237 of 2023 Misuse of Drugs Act 1977 (Controlled Drugs) (Designation) (Amendment) Order 2023

• S.I. No. 265 of 2023 European Union (Addition of Vitamins and Minerals and of Certain Other Substances to Foods) (Amendment) Regulations 2023

• S.I. No. 335 of 2023 European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) (Amendment) Regulations 2023

• S.I. No. 338 of 2023 European Union (Official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal origin) (Amendment) (No. 2) Regulations 2023

• S.I. No. 400 of 2023 Food Safety Authority of Ireland Act 1998 (Amendment of First Schedule) (No. 2) Order 2023

• S.I. No. 415 of 2023 European Union (EU Digital Covid Certificates) (Revocation) Regulations 2023

• S.I. No. 416 of 2023 Infectious Diseases (EU Digital Covid Certificates) (Revocation) Regulations 2023

• S.I. No. 490 of 2023 European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and total Diet Replacement for Weight Control) (Amendment) Regulations 2023

• S.I. No. 670 of 2023 European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2023

• S.I. No. 671 of 2023 European Union (National Research Ethics Committees for Clinical investigations of Medical Devices) Regulations 2023

• S.I. No. 697 of 2023 Health Products Regulatory Authority (Fees) Regulations 2023

2024

• S.I. No. 3 of 2024 European Union (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2024

• S.I. No. 9 of 2024 European Union (Official Controls in Relation to Food Legislation) (Amendment) Regulations 2024

• S.I. No. 51 of 2024 European Union (Official Controls in Relation to Food Legislation) (Imports of Food of Non-Animal origin) (Amendment) Regulations 2024

• S.I. No. 106 of 2024 European Union (Official Controls in Relation to Food Legislation) (Amendment) (No. 2) Regulations 2024

• S.I. No. 159 of 2024 European Union (Novel Foods) (Amendment) Regulations 2024

I hope the above information is of assistance.

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