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

1. (1) These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations 2025.

(2) The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2025” includes these Regulations.

2. In these Regulations –

“Principal Regulations” means the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (

S.I. No. 540 of 2003

);

“Regulations of 2024” means the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2024 (

S.I. No. 582 of 2024

).

“Regulations of 2025” means the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2025 (

S.I. No. 353 of 2025

).

3. The Eight Schedule (as amended by Regulation 3 of the Regulations of 2024) to the Principal Regulations is amended by removing the Eight Schedule in its entirety and inserting the following entry wherever it appears

“

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 national 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 or less for single administration. In accordance with the summary of product characteristics of the product administered and Immunisation Guidelines for Ireland, as published and updated by the National Immunisation Advisory Committee as approved by the Minister for Health. 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 for Ireland, as published and updated by the National Immunisation Advisory Committee as approved by the Minister for Health. 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 national 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 national 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 re-vaccination as determined by the Immunisation Guidelines for Ireland, as published and updated by the National Immunisation Advisory Committee as approved by the Minister for Health.

The premises of the retail pharmacy business in which the authorised person carries on professional practice

Salbutamol 100 mcg multi-dose 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 national 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 for Ireland, as published and updated by the National Immunisation Advisory Committee as approved by the Minister for Health.

The premises of the retail pharmacy business in which the authorised person carries on professional practice.

Comirnaty KP.2 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 guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

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 KP.2 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 guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

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 KP.2 3 micrograms/dose concentrate for dispersion COVID-19 mRNA Vaccine

Concentrate for 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 to 4 years.

In accordance with the summary of product characteristics and the relevant recommendations or guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

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.

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 guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

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 guidelines issued by the National Immunisation Advisory Committee and approved by the Minister for Health.

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 – 11 years.

In accordance with the summary of product characteristics and the relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and approved by the Minister for Health.

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 3 micrograms/dose concentrate for dispersion COVID-19 mRNA Vaccine

Concentrate for 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 to 4 years.

In accordance with the summary of product characteristics and the relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and approved by the Minister for Health.

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 Twelfth Schedule (as amended by Regulation 2 of the Regulations of 2025) to the Principal Regulations is amended by removing the Twelfth Schedule in its entirety and inserting the following entry wherever it appears

“

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 national 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 or less for a single administration. In accordance with the summary of product characteristics of the product administered and Immunisation Guidelines for Ireland, as published and updated by the National Immunisation Advisory Committee as approved by the Minister for Health.

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 national guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

VARIVAX powder and solvent for suspension for injection in a pre-filled 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 accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

IMVANEX suspension for injection Smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)

Suspension for injection. Light yellow to pale white, milky suspension.

Subcutaneous injection.

Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults.

In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

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 national guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

Tuberculin PPD RT23 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 national guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

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 accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

Priorix - Powder and solvent for solution for injection in a pre-filled syringe Measles, Mumps and Rubella vaccine (live)

Powder and solvent for solution for injection in a pre-filled syringe.

Subcutaneous or intramuscular injection.

Active immunisation against Measles, Mumps and Rubella.

In accordance with the summary of product characteristics of the product administered and/or relevant national guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

Comirnaty KP.2 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 guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

Comirnaty KP.2 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 guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

Comirnaty KP.2 3 micrograms/dose concentrate for dispersion COVID-19 mRNA Vaccine

Concentrate for 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 to 4 years.

In accordance with the summary of product characteristics and the relevant recommendations or guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

Nuvaxovid JN.1 5micrograms/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 guidelines issued by the National Immunisation Advisory Committee as approved by the Minister for Health.

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 guidelines issued by the National Immunisation Advisory Committee and approved by the Minister for Health.

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 – 11 years.

In accordance with the summary of product characteristics and the relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and approved by the Minister for Health.

Comirnaty LP.8.1 3 micrograms/dose concentrate for dispersion COVID-19 mRNA Vaccine

Concentrate for 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 to 4 years.

In accordance with the summary of product characteristics and the relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and approved by the Minister for Health.

Nirsevimab

50mg in 0.5mL pre-filled syringe; 100mg in 1mL pre-filled syringe.

Intramuscular (IM) injection.

Passive immunisation with nirsevimab of all infants who are born during the RSV season.

Passive immunisation with nirsevimab of all *high-risk infants aged ≤12 months at the start of their first RSV season.

Passive immunisation with nirsevimab of all infants who are aged ≤6 months at the start of the RSV season.

Passive immunisation with nirsevimab of all ex-preterm infants under 24 months of age with Chronic Lung Disease in their second RSV season.

In accordance with the summary of product characteristics and the relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and as approved by the Minister for Health.

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.

”.

GIVEN under my Official Seal,

1 September, 2025.

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.

The purpose of these Regulations is to make amendments and additions to the lists of medicinal products in the Eighth and Twelfth Schedules.

These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations 2025.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

5

th September,

2025.

I, JENNIFER CARROLL MACNEILL, 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) and

section 9

of the

Irish Medicines Board (Miscellaneous Provisions) Act 2024

(No. 4 of 2024)) of the

Irish Medicines Board Act 1995

(No. 29 of 1995), hereby make the following regulations