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S.I. No. 457/2026 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2026

Type Statutory Instrument

Publication 2026-09-08

State In force

Text As published

Source Irish Statute Book

articles 5

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 8th September, 2026.

I, JENNIFER CARROLL MACNEILL, Minister for Health, in exercise of the powers conferred on me by section 32 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) Regulations 2026.

2.

In these Regulations –

“Principal Regulations” means Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 );

“No. 2 Regulations of 2025” means Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2025 ( S.I. No. 418 of 2025 ).

3.

The Principal Regulations are amended by substituting for the Eighth Schedule (inserted by Regulation 3 of the No. 2 Regulations of 2025) the following:

“Eighth Schedule

In this Schedule “Immunisation Guidelines” means Immunisation Guidelines for Ireland, published and updated by the National Immunisation Advisory Committee of the Health Information and Quality Authority.

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

Epinephrine (adrenaline) Injection. Epinephrine (adrenaline) injection presented as a pre-filled syringe or ampoule. Intramuscular or subcutaneous injection. Adults and Children: For the emergency treatment of anaphylactic shock. In accordance with the summary of product characteristics of the product administered and relevant Immunisation Guidelines. Any place.

Glucagon for injection. Glucagon hydrochloride for injection. Intramuscular or subcutaneous injection. Adults and children: For the emergency treatment of hypoglycaemia. In accordance with the summary of product characteristics of the product administered. Any place.

Glyceryl trinitrate aerosol. Glyceryl trinitrate sublingual spray. Sublingual spray. Adults: For the emergency treatment of severe angina attack. In accordance with the summary of product characteristics of the product administered. Any place.

Influenza vaccine of a composition that has been approved for use in the European Union for the season in question. Influenza vaccine suspension for injection presented as a pre-filled syringe. By intramuscular injection only. Prevention of seasonal Influenza. 0.5ml for single administration. In accordance with the summary of product characteristics of the product administered and Immunisation Guidelines. Only to be administered in connection with the carrying on of the registered retail pharmacy business in which the authorised person is employed or engaged. 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.

Influenza vaccine (live attenuated) nasal spray suspension of a composition that has been approved for use in the European Union for the season in question. Influenza vaccine nasal spray, suspension. By intranasal administration only. Prevention of seasonal influenza. Children and adolescents from 2 to 17 years: 0.2 ml (administered as 0.1 ml per nostril). In accordance with the summary of product characteristics of the product administered and Immunisation Guidelines. Only to be administered in connection with the carrying on of the registered retail pharmacy business in which the authorised person is employed or engaged. 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.

Naloxone injection. Naloxone hydrochloride dihydrate pre-filled injection. Intramuscular injection. Adults and children: Respiratory depression secondary to known or suspected narcotic overdose. In accordance with the summary of product characteristics of the product administered or relevant Immunisation Guidelines. Any place.

Naloxone Nasal Spray. Naloxone hydrochloride dihydrate Nasal Spray Solution. Nasal administration. Adults and children: Respiratory depression secondary to known or suspected narcotic overdose. In accordance with the summary of product characteristics of the product administered or relevant Immunisation Guidelines. Any place.

Pneumococcal Polysaccharide Vaccine solution for injection. Pneumococcal Polysaccharide Vaccine solution for injection 25mcg/0.5ml in a pre-filled syringe or vial. By intramuscular or subcutaneous injection. Active immunization against disease caused by the pneumococcal serotypes included in the vaccine. 0.5ml for single administration, in accordance with the summary of product characteristics of the product administered and the specific timing of, and need for revaccination as determined by the Immunisation Guidelines. The premises of the retail pharmacy business in which the authorised person carries on professional practice.

Salbutamol 100 mcg multidose inhaler. Salbutamol pressurised inhalation solution 100mcg multi-dose inhaler. Oral inhalation. Adults and children: For the emergency treatment of acute asthmatic attack. In accordance with the summary of product characteristics of the product administered or relevant guidelines. Any place.

Shingrix powder and suspension for suspension for injection. Herpes zoster vaccine (recombinant, adjuvanted). Adjuvanted recombinant Varicella Zoster Virus glycoprotein E antigen. Powder and suspension for suspension for injection. Intramuscular (IM) injection only. Prevention of zoster and zoster-related post-herpetic neuralgia. Two doses of 0.5 mL each in accordance with the summary of product characteristics of the product administered and Immunisation Guidelines. The premises of the retail pharmacy business in which the authorised person carries on professional practice.

Nuvaxovid JN.1 5 micrograms/do se dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted). Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.

Comirnaty LP.8.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine. Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.

Comirnaty LP.8.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine. Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.

Comirnaty XFG 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine. Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.

Comirnaty XFG 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine. Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months – 11 years. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.

”.


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
Epinephrine (adrenaline) Injection.	Epinephrine (adrenaline) injection presented as a pre-filled syringe or ampoule.	Intramuscular or subcutaneous injection.	Adults and Children: For the emergency treatment of anaphylactic shock.	In accordance with the summary of product characteristics of the product administered and relevant Immunisation Guidelines.	Any place.
Glucagon for injection.	Glucagon hydrochloride for injection.	Intramuscular or subcutaneous injection.	Adults and children: For the emergency treatment of hypoglycaemia.	In accordance with the summary of product characteristics of the product administered.	Any place.
Glyceryl trinitrate aerosol.	Glyceryl trinitrate sublingual spray.	Sublingual spray.	Adults: For the emergency treatment of severe angina attack.	In accordance with the summary of product characteristics of the product administered.	Any place.
Influenza vaccine of a composition that has been approved for use in the European Union for the season in question.	Influenza vaccine suspension for injection presented as a pre-filled syringe.	By intramuscular injection only.	Prevention of seasonal Influenza.	0.5ml for single administration. In accordance with the summary of product characteristics of the product administered and Immunisation Guidelines. Only to be administered in connection with the carrying on of the registered retail pharmacy business in which the authorised person is employed or engaged.	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.
Influenza vaccine (live attenuated) nasal spray suspension of a composition that has been approved for use in the European Union for the season in question.	Influenza vaccine nasal spray, suspension.	By intranasal administration only.	Prevention of seasonal influenza.	Children and adolescents from 2 to 17 years: 0.2 ml (administered as 0.1 ml per nostril). In accordance with the summary of product characteristics of the product administered and Immunisation Guidelines. Only to be administered in connection with the carrying on of the registered retail pharmacy business in which the authorised person is employed or engaged.	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.
Naloxone injection.	Naloxone hydrochloride dihydrate pre-filled injection.	Intramuscular injection.	Adults and children: Respiratory depression secondary to known or suspected narcotic overdose.	In accordance with the summary of product characteristics of the product administered or relevant Immunisation Guidelines.	Any place.
Naloxone Nasal Spray.	Naloxone hydrochloride dihydrate Nasal Spray Solution.	Nasal administration.	Adults and children: Respiratory depression secondary to known or suspected narcotic overdose.	In accordance with the summary of product characteristics of the product administered or relevant Immunisation Guidelines.	Any place.
Pneumococcal Polysaccharide Vaccine solution for injection.	Pneumococcal Polysaccharide Vaccine solution for injection 25mcg/0.5ml in a pre-filled syringe or vial.	By intramuscular or subcutaneous injection.	Active immunization against disease caused by the pneumococcal serotypes included in the vaccine.	0.5ml for single administration, in accordance with the summary of product characteristics of the product administered and the specific timing of, and need for revaccination as determined by the Immunisation Guidelines.	The premises of the retail pharmacy business in which the authorised person carries on professional practice.
Salbutamol 100 mcg multidose inhaler.	Salbutamol pressurised inhalation solution 100mcg multi-dose inhaler.	Oral inhalation.	Adults and children: For the emergency treatment of acute asthmatic attack.	In accordance with the summary of product characteristics of the product administered or relevant guidelines.	Any place.
Shingrix powder and suspension for suspension for injection. Herpes zoster vaccine (recombinant, adjuvanted).	Adjuvanted recombinant Varicella Zoster Virus glycoprotein E antigen. Powder and suspension for suspension for injection.	Intramuscular (IM) injection only.	Prevention of zoster and zoster-related post-herpetic neuralgia.	Two doses of 0.5 mL each in accordance with the summary of product characteristics of the product administered and Immunisation Guidelines.	The premises of the retail pharmacy business in which the authorised person carries on professional practice.
Nuvaxovid JN.1 5 micrograms/do se dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted).	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.
Comirnaty LP.8.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine.	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.
Comirnaty LP.8.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine.	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.
Comirnaty XFG 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine.	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.
Comirnaty XFG 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine.	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months – 11 years.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation 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.

4.

The Principal Regulations are amended by substituting for the Twelfth Schedule (inserted by Regulation 4 of the No. 2 Regulations of 2025) the following:

“Twelfth Schedule

In this Schedule “Immunisation Guidelines” means Immunisation Guidelines for Ireland, published and updated by the National Immunisation Advisory Committee of the Health Information and Quality Authority.

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

Epinephrine (adrenaline) injection. Epinephrine (adrenaline) injection presented as a pre-filled syringe or ampoule. Intramuscular or subcutaneous Injection. Adults and Children: For the emergency treatment of anaphylactic shock. In accordance with the summary of product characteristics of the product administered and relevant Immunisation Guidelines.

Influenza vaccine of a composition that has been approved for use in the European Union for the season in question. Influenza vaccine suspension for injection presented as a pre-filled syringe. By intramuscular injection only. Prevention of seasonal influenza. 0.5ml for a single administration. In accordance with the summary of product characteristics of the product administered and Immunisation Guidelines.

Influenza vaccine (live attenuated) nasal spray suspension of a composition that has been approved for use in the European Union for the season in question. Influenza vaccine nasal spray, suspension. By intranasal administration only. Prevention of seasonal influenza. Children and adolescents from 2 to 17 years: 0.2 ml (administered as 0.1 ml per nostril). In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.

VARIVAX powder and solvent for suspension for injection in a prefilled syringe. Varicella Vaccine (live). Powder and solvent for suspension for injection. White to off-white powder and clear, colourless liquid solvent. Intramuscular or subcutaneous injection. Vaccination against varicella in individuals from 12 months of age. In accordance with the summary of product characteristics of the product administered and/or Immunisation Guidelines.

IMVANEX suspension for injection Smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara). Suspension for injection. Light yellow to pale white coloured, clear to milky suspension. Subcutaneous injection. Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus. In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.

BCG VACCINE AJV. Powder and solvent for suspension for injection. White crystalline powder (might be difficult to see due to the small amount of powder in the vial). The solvent is a colourless solution without any visible particles. Intradermal injection. Active immunisation against tuberculosis. In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.

Tuberculin PPD RT23 AJV 2 T.U./0.1 mL. Solution for injection (injection). Clear, colourless to pale-yellow solution. Intradermal injection. Used for Mantoux tuberculin skin testing. In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.

M-M-RvaxPro powder and solvent for suspension for injection Measles, Mumps and Rubella vaccine (live). Powder and solvent for suspension for injection. Before reconstitution, the powder is a light yellow compact crystalline cake and the solvent is a clear colourless liquid. Intramuscular or subcutaneous injection. Vaccination against measles, mumps and rubella in individuals from 12 months of age. Can be administered to infants from 6 months of age in the event of measles outbreak. In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.

Priorix - Powder and solvent for solution for injection in a prefilled syringe Measles, Mumps and Rubella vaccine (live). Powder and solvent for solution for injection in a prefilled syringe. Subcutaneous or intramuscular injection. Active immunisation against Measles, Mumps and Rubella from 12 months of age. Can be administered to infants from 6 months of age in the event of measles outbreak. In accordance with the summary of product characteristics of the product. administered and/or relevant Immunisation Guidelines.

Nuvaxovid JN.1 5 micrograms/dose dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted). Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

Comirnaty LP.8.1 30 micrograms /dose dispersion for injection COVID-19 mRNA Vaccine. Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

Comirnaty LP.8.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine. Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

Beyfortus 50mg solution for injection in pre-filled syringe and Beyfortus 100mg solution for injection in pre-filled syringe. Solution for injection (injection). Intramuscular (IM) injection. Passive immunisation of all infants who are born during the RSV season. Passive immunisation of all high-risk infants aged ≤ 12 months at the start of their first RSV season. Passive immunisation of all infants who are aged ≤6 months at the start of the RSV season. Passive immunisation of all ex-preterm infants under 24 months of age with Chronic Lung Disease in their second RSV season, and those severely immunocompromised in their second RSV season after discussion with their specialist. An additional dose may be administered to individuals after cardiac surgery involving cardiopulmonary bypass. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines. Infants weight<5kg: A single dose of 50mg (0.5ml) administered intramuscularly. Infants weight ≥ 5kg: A single dose of 100mg (1.0ml) administered intramuscularly. Children up to 24 months entering their second season: 200 mg given as 2 x 100 mg intramuscular injections.

Comirnaty XFG 30 micrograms /dose dispersion for injection COVID-19 mRNA Vaccine. Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

Comirnaty XFG 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine. Dispersion for injection. Intramuscular injection. Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months – 11 years. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

Tetravac suspension for injection in prefilled syringe diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine, (adsorbed). Suspension for injection in prefilled syringe. Intramuscular injection. Indicated for primary and booster vaccination of infants and children from 2 months of age against diphtheria, tetanus, pertussis and poliomyelitis. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

Boostrix suspension for injection in pre-filled syringe diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content). Suspension for injection in pre-filled syringe. Intramuscular injection. Indicated for active immunisation of individuals from the age of 4 years against Diphtheria, tetanus, pertussis and passive protection against pertussis in early infancy following maternal immunisation during pregnancy. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine. Nimenrix powder and solvent for solution for injection in pre-filled syringe. Intramuscular injection. Indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY. MenQuadfi solution for injection. Intramuscular injection. Indicated for active immunisation of individuals from the age of 6 weeks and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

Gardasil 9 suspension for injection. Gardasil 9 suspension for injection in a pre-filled syringe. Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed). Gardasil 9 suspension for injection in pre-filled syringe. Intramuscular injection. Indicated for active immunisation of individuals from the age of 9 years against some HPV diseases caused by specific HPV types. In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

”.


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
Epinephrine (adrenaline) injection.	Epinephrine (adrenaline) injection presented as a pre-filled syringe or ampoule.	Intramuscular or subcutaneous Injection.	Adults and Children: For the emergency treatment of anaphylactic shock.	In accordance with the summary of product characteristics of the product administered and relevant Immunisation Guidelines.
Influenza vaccine of a composition that has been approved for use in the European Union for the season in question.	Influenza vaccine suspension for injection presented as a pre-filled syringe.	By intramuscular injection only.	Prevention of seasonal influenza.	0.5ml for a single administration. In accordance with the summary of product characteristics of the product administered and Immunisation Guidelines.
Influenza vaccine (live attenuated) nasal spray suspension of a composition that has been approved for use in the European Union for the season in question.	Influenza vaccine nasal spray, suspension.	By intranasal administration only.	Prevention of seasonal influenza.	Children and adolescents from 2 to 17 years: 0.2 ml (administered as 0.1 ml per nostril). In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.
VARIVAX powder and solvent for suspension for injection in a prefilled syringe. Varicella Vaccine (live).	Powder and solvent for suspension for injection. White to off-white powder and clear, colourless liquid solvent.	Intramuscular or subcutaneous injection.	Vaccination against varicella in individuals from 12 months of age.	In accordance with the summary of product characteristics of the product administered and/or Immunisation Guidelines.
IMVANEX suspension for injection Smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara).	Suspension for injection. Light yellow to pale white coloured, clear to milky suspension.	Subcutaneous injection.	Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus.	In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.
BCG VACCINE AJV.	Powder and solvent for suspension for injection. White crystalline powder (might be difficult to see due to the small amount of powder in the vial). The solvent is a colourless solution without any visible particles.	Intradermal injection.	Active immunisation against tuberculosis.	In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.
Tuberculin PPD RT23 AJV 2 T.U./0.1 mL.	Solution for injection (injection). Clear, colourless to pale-yellow solution.	Intradermal injection.	Used for Mantoux tuberculin skin testing.	In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.
M-M-RvaxPro powder and solvent for suspension for injection Measles, Mumps and Rubella vaccine (live).	Powder and solvent for suspension for injection. Before reconstitution, the powder is a light yellow compact crystalline cake and the solvent is a clear colourless liquid.	Intramuscular or subcutaneous injection.	Vaccination against measles, mumps and rubella in individuals from 12 months of age. Can be administered to infants from 6 months of age in the event of measles outbreak.	In accordance with the summary of product characteristics of the product administered and/or relevant Immunisation Guidelines.
Priorix - Powder and solvent for solution for injection in a prefilled syringe Measles, Mumps and Rubella vaccine (live).	Powder and solvent for solution for injection in a prefilled syringe.	Subcutaneous or intramuscular injection.	Active immunisation against Measles, Mumps and Rubella from 12 months of age. Can be administered to infants from 6 months of age in the event of measles outbreak.	In accordance with the summary of product characteristics of the product. administered and/or relevant Immunisation Guidelines.
Nuvaxovid JN.1 5 micrograms/dose dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted).	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.
Comirnaty LP.8.1 30 micrograms /dose dispersion for injection COVID-19 mRNA Vaccine.	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.
Comirnaty LP.8.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine.	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.
Beyfortus 50mg solution for injection in pre-filled syringe and Beyfortus 100mg solution for injection in pre-filled syringe.	Solution for injection (injection).	Intramuscular (IM) injection.	Passive immunisation of all infants who are born during the RSV season. Passive immunisation of all high-risk infants aged ≤ 12 months at the start of their first RSV season. Passive immunisation of all infants who are aged ≤6 months at the start of the RSV season. Passive immunisation of all ex-preterm infants under 24 months of age with Chronic Lung Disease in their second RSV season, and those severely immunocompromised in their second RSV season after discussion with their specialist. An additional dose may be administered to individuals after cardiac surgery involving cardiopulmonary bypass.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines. Infants weight<5kg: A single dose of 50mg (0.5ml) administered intramuscularly. Infants weight ≥ 5kg: A single dose of 100mg (1.0ml) administered intramuscularly. Children up to 24 months entering their second season: 200 mg given as 2 x 100 mg intramuscular injections.
Comirnaty XFG 30 micrograms /dose dispersion for injection COVID-19 mRNA Vaccine.	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.
Comirnaty XFG 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine.	Dispersion for injection.	Intramuscular injection.	Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months – 11 years.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.
Tetravac suspension for injection in prefilled syringe diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine, (adsorbed).	Suspension for injection in prefilled syringe.	Intramuscular injection.	Indicated for primary and booster vaccination of infants and children from 2 months of age against diphtheria, tetanus, pertussis and poliomyelitis.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.
Boostrix suspension for injection in pre-filled syringe diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content).	Suspension for injection in pre-filled syringe.	Intramuscular injection.	Indicated for active immunisation of individuals from the age of 4 years against Diphtheria, tetanus, pertussis and passive protection against pertussis in early infancy following maternal immunisation during pregnancy.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.
Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine.	Nimenrix powder and solvent for solution for injection in pre-filled syringe.	Intramuscular injection.	Indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.
MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine MenACWY.	MenQuadfi solution for injection.	Intramuscular injection.	Indicated for active immunisation of individuals from the age of 6 weeks and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.
Gardasil 9 suspension for injection. Gardasil 9 suspension for injection in a pre-filled syringe. Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed).	Gardasil 9 suspension for injection in pre-filled syringe.	Intramuscular injection.	Indicated for active immunisation of individuals from the age of 9 years against some HPV diseases caused by specific HPV types.	In accordance with the summary of product characteristics and the relevant recommendations or Immunisation Guidelines.

5.

The following are revoked:

(a) Regulation 8 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2011 ( S.I. No. 525 of 2011 );

(b) Regulation 12 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015 ( S.I. No. 449 of 2015 );

(c) Regulation 5 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2018 ( S.I. No. 530 of 2018 );

(d) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2020 ( S.I. No. 241 of 2020 );

(e) Regulation 4 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2020 ( S.I. No. 401 of 2020 );

(f) Regulations 5 and 6 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2020 ( S.I. No. 698 of 2020 );

(g) Regulations 4 and 5 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2021 ( S.I. No. 2 of 2021 );

(h) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2021 ( S.I. No. 8 of 2021 );

(i) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2021 ( S.I. No. 155 of 2021 );

(j) Regulations 6 and 7 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2021 ( S.I. No. 245 of 2021 );

(k) the Medicinal Products (Prescription and Control of Supply) (Amendment) No. 8 Regulations 2021 ( S.I. No. 411 of 2021 );

(l) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 9) Regulations 2021 ( S.I. No. 492 of 2021 );

(m) Regulation 5 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 10) Regulations 2021 ( S.I. No. 511 of 2021 );

(n) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 12) Regulations 2021 ( S.I. No. 578 of 2021 );

(o) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 13) Regulations 2021 ( S.I. No. 605 of 2021 );

(p) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 15) Regulations 2021 ( S.I. No. 718 of 2021 );

(q) the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2022 ( S.I. No. 32 of 2022 );

(u) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2022 ( S.I. No. 57 of 2022 );

(v) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2022 ( S.I. No. 84 of 2022 );

(w) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2022 ( S.I. No. 402 of 2022 );

(x) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2022 ( S.I. No. 467 of 2022 );

(y) the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2023 ( S.I. No. 11 of 2023 );

(z) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2023 ( S.I. No. 105 of 2023 );

(aa) Regulations 8 and 9 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2023 ( S.I. No. 284 of 2023 );

(ab) Regulation 6 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2023 ( S.I. No. 422 of 2023 );

(ac) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations 2023 ( S.I. No. 451 of 2023 );

(ad) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 7) Regulations 2023 ( S.I. No. 584 of 2023 );

(ae) Regulations 3 and 5 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2024 ( S.I. No. 162 of 2024 );

(af) Regulations 7 and 8 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2024 ( S.I. No. 458 of 2024 );

(ag) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2024 ( S.I. No. 582 of 2024 );

(ah) the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2025 ( S.I. No. 353 of 2025 );

(ai) the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2025 ( S.I. No. 418 of 2025 ).

GIVEN under my Official Seal,

3 September, 2026.

JENNIFER CARROLL MACNEILL,

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 by replacing the Eighth and Twelfth Schedules.

This document does not substitute the official text published in the Irish Statute Book. We accept no responsibility for any inaccuracies arising from the transcription of the original into this format.

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