Legislation for medicines for human use
Below are links to the legislation relevant to the regulation of medicines for human use.
Clinical trials
- Control of Clinical Trials Act 1987
- Control of Clinical Trials and Drugs Act 1990
- European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (SI 190/2004)
- European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2004 (SI 878/2004)
- European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment No. 2) Regulations 2006 (SI 374/2006)
- Medicinal Products (Control of Manufacture) Regulations 2007 (SI 539/2007)
- European Communities (Control of Placing on the Market) Regulations 2007 (SI 540/2007)
- European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2009 (SI 1/2009)
- European Union (Clinical Trials on Medicinal Products for Human Use) Regulations 2022 (SI 40/2022)
- European Union (Clinical Trials on Medicinal Products for Human Use) (National Research Ethics Committees) Regulations 2022 (SI 41/2022)
- European Union (Clinical Trials on Medicinal Products for Human Use) (Principal Regulations) 2022 (SI 99/2022)
- European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2022 (SI
- European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) (Amendment) Regulations 2022 (SI 418/2022)
- European Union (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2024 (SI 3/2024)
Manufacture
- Medicinal Products (Control of Manufacture) Regulations 2007 (SI 539/2007)
- Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2009 (SI 4/2009)
- Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2010 (SI 288/2010)
- Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012 (SI 273/2012)
- Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013 (SI 163/2013)
- Medicinal Products (Safety Features on Packaging) Regulations 2019 (SI 36/2019)
- Medicinal Products (Control of Manufacture) (Amendment) Regulations 2019 (SI 219/2019)
- Medicinal Products (Control of Manufacture) (Amendment) Regulations 2022 (SI 43/2022)
- Medicinal Products (Safety Features on Packaging) Regulations 2022 (SI 270/2022)
- Medicinal Products (Control of Manufacture) (Amendment) (No 2) Regulations 2022 (SI 414/2022)
Prescription and control of supply
- Medicinal Products (Prescription and Control of Supply) Regulations 2003 (SI 540/2003)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 (SI 510/2005)
- Irish Medicines Board (Miscellaneous Provisions) Act 2006
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 (SI 201/2007)
- Medicinal Products (Control of Placing on the Market) Regulations 2007 (SI 540/2007)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2008 (SI 512/2008)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2009 (SI 442/2009)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011 (SI 525/2011)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2014 (SI 300/2014)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations 2014 (SI 504/2014)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015 (SI 87/2015)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015 (SI 449/2015)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2018 (SI 530/2018)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020 (SI 98/2020)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations 2020 (SI 177/2020)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.3) Regulations 2020 (SI 204/2020)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.4) Regulations 2020 (SI 241/2020)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.5) Regulations 2020 (SI 401/2020)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.6) Regulations 2020 (SI 614/2020)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.7) Regulations 2020 (SI 698/2020)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2021 (SI 2/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2021 (SI 8/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2021 (SI 43/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.4) Regulations 2021 (SI 81/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2021 (SI 130/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2021 (SI 155/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.7) Regulations 2021 (SI 245/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.8) Regulations 2021 (SI 411/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.9) Regulations 2021 (SI 492/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.10) Regulations 2021 (SI 511/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.11) Regulations 2021 (SI 558/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.12) Regulations 2021 (SI 578/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.13) Regulations 2021 (SI 605/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.14) Regulations 2021 (SI 692/2021)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.15) Regulations 2021 (SI 718/2021)
- Medicinal Products (Prescription and Control of Supply) Regulations 2022 (SI 32/2022)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations 2022 (SI 57/2022)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No.3) Regulations 2022 (SI 84/2022)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2022 (SI 402/2022)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No 5) Regulations 2022 (SI 467/2022)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2023 (SI 11/2023)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2023 (SI 105/2023)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2023 (SI 238/2023)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2023 (SI 284/2023)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No 5) Regulations 2023 (SI 422/2023)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No 6) Regulations 2023 (SI 451/2023)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No 7) Regulations 2023 (SI 584/2023)
- Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2024 (SI 72/2024)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No 2) Regulations 2024 (SI 73/2024)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No 3) Regulations 2024 (SI 162/2024)
- Medicinal Products (Prescription and Control of Supply) (Amendment) (No 4) Regulations 2024 (SI 458/2024)
Placing on the market
- Medicinal Products (Control of Placing on the Market) Regulations 2007 (SI 540/2007)
- Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2009 (SI 3/2009)
- Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) (No. 2) Regulations 2009 (SI 553/2009)
- Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2010 (SI 287/2010)
- Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2011 (SI 722/2011)
- Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012 (SI 272/2012)
- Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 (SI 162/2013)
- Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2014 (SI 151/2014)
- Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2018 (SI 529/2018)
- Medicinal Products (Safety Features on Packaging) (Amendment) Regulations 2019 (SI 36/2019)
- Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2019 (SI 218/2019)
- Medicinal Products (Safety Features on Packaging) Regulations 2022 (SI 270/2022)
- Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2022 (SI 416/2022)
Wholesale distribution
- Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (SI 538/2007)
- Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2009 (SI 2/2009)
- Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2010 (SI 286/2010)
- Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012 (SI 274/2012)
- Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 (SI 164/2013)
- Medicinal Products (Safety Features on Packaging) Regulations 2019 (SI 36/2019)
- Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2019 (SI 217/2019)
- Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2021 (SI 1/2021)
- Medicinal Products (Safety Features on Packaging) Regulations 2022 (SI 270/2022)
- Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2022 (SI 415/2022)