S.I. No. 502/2025 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2025

1. (1) These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) 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

);

“Regulation of Retail Pharmacy Businesses Regulations” means the Regulation of Retail Pharmacy Businesses Regulations 2008 to 2025;

“Society” means the Pharmaceutical Society of Ireland.

3. Regulation 4(1) (as amended by Regulation 3 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2023 (

S.I. No. 284 of 2023

)) of the Principal Regulations is amended —

(a) by inserting after the definition of “clinical practice guidelines” the following definitions

“‘Common Conditions Service’ means a service that may be provided by a registered pharmacist practising in a retail pharmacy business, which may include the provision of a prescription for a medicinal product listed in Schedule 13, following appropriate advice and counselling. Delivery of a Common Conditions Service by a registered pharmacist will be subject to that pharmacist adhering to CCSP;

‘Common Conditions Service Protocols (“CCSP”)’ mean the protocols developed by the Health Service Executive and approved by the Minister for Health for use in a Common Conditions Service;”.

(b) by inserting after paragraph (e) in the definition of “prescription” the following paragraph

“(f) a registered pharmacist who is practising in, and operating under the governance of, a retail pharmacy business and is issuing a prescription as part of a Common Conditions Service, which is provided in that retail pharmacy business;”; and

(c) by substituting for the definition of “professional registration number” the following definition

“‘professional registration number’ means—

(a) in the case of a registered medical practitioner, the number attached to the medical practitioner’s registration in accordance with

section 43

(5) of the

Medical Practitioners Act 2007

(No. 25 of 2007),

(b) in the case of a registered nurse, the number attached to the nurse’s registration in accordance with

section 46

(7) of the

Nurses and Midwives Act 2011

(No. 41 of 2011),

(c) in the case of a registered dentist, the number assigned by the Dental Council to the dentist’s registration in the Register of Dentists in accordance with

section 26

of the Dentists Act 1985; or

(d) in the case of a registered pharmacist, the number attached to the pharmacist’s registration in accordance with section 13 of the Pharmacy Act, 2007;”.

4. Regulation 4A of the Principal Regulations (as amended by Regulation 2 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2009 (

S.I. No. 442 of 2009

)) is amended —

(a) by substituting for subparagraph (c) of paragraph (1) the following subparagraph

“(c) Any person, other than a registered medical practitioner or registered dentist, to administer to a patient, in accordance with the directions of a registered medical practitioner or registered dentist or in accordance with a prescription issued by a registered pharmacist, any medicinal product subject to control by virtue of these Regulations.”; and

(b) by inserting after paragraph (2) the following paragraph

“(3) In paragraph (1) a reference to a registered pharmacist shall be construed as a reference to a registered pharmacist acting in the course of his or her practice as a pharmacist.”

5. The Principal Regulations are amended by inserting after Regulation 5B (inserted by Regulation 4 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 (

S.I. No. 201 of 2007

)) the following Regulation

“Prescription by registered pharmacists in the context of a Common Conditions Service

5C. (1) Subject to paragraph (3), a registered pharmacist may only issue a prescription for a medicinal product listed in Schedule 13, where the following conditions are satisfied

(a) the prescription is issued as part of a Common Conditions Service provided in a retail pharmacy business;

(b) the registered pharmacist has satisfactorily completed training as specified by the Society in accordance with education and training rules made by the Society.

(c) the medicinal product is prescribed by the registered pharmacist for the purpose set out in Schedule 13, and in accordance with the CCSP.

(2) Nothing in this Regulation shall be construed as restricting the performance of any function conferred on the

Society under the Pharmacy Act 2007

(No. 20 of 2007); or any other enactment or statutory instrument.”.

6. Regulation 7(1) (as amended by Regulation 4 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2024 (

S.I. No. 73 of 2024

)) of the Principal Regulations is amended –

(a) in subparagraph (c), by substituting for clause (i) the following

“whether he or she is a registered medical practitioner, registered dentist, registered nurse or registered pharmacist; and”; and

(b) in subparagraph (c), by inserting after clause (ii) the following

“(iii) in the case of a registered pharmacist, the registration number assigned to the pharmacist in the register of pharmacists established under section 13 of the Pharmacy Act, 2007; and”.

7. The Principal Regulations are amended by inserting after Regulation 10E (as inserted by Regulation 5 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2024 (

S.I. No. 73 of 2024

)) the following regulations

“Keeping of records in relation to a Common Conditions Service

8. The Principal Regulations are amended by inserting after the Twelfth Schedule (as amended by Regulation 4 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2025 (

S.I. No. 418 of 2025

)) the following Schedule

THIRTEENTH SCHEDULE

Regulation 5C

Medicinal products which may be prescribed by registered pharmacists

Medicinal Product

Strength

Pharmaceutical Form

Purpose

Column 1

Column 2

Column 3

Column 4

Chloramphenico 1

0.5% w/v

Eye drops, solution

For the treatment of symptoms consistent with conjunctivitis, in accordance with the relevant protocol approved by the Minister for Health

1% w/w

Ointment

Fusidic Acid

10mg/g

Eye drops, suspension

Aciclovir

5% w/w

Cream

For the treatment of symptoms consistent with cold sores, in accordance with the relevant protocol approved by the Minister for Health

Fusidic Acid

20mg/g

Cream

For the treatment of symptoms consistent with impetigo, in accordance with the relevant protocol approved by the Minister for Health

Sodium Fusidate

20mg/g

Ointment

Nystatin

100,000 units/ml

Oral suspension

For the treatment of symptoms consistent with oral thrush, in accordance with the relevant protocol approved by the Minister for Health

Miconazole

20mg/g

Oral gel

2% w/w

Cream

For the treatment of breastfeeding mothers if a breast-fed baby has oral thrush, in accordance with the relevant protocol approved by the Minister for Health

Valaciclovir

250mg or 500mg

Tablets

For the treatment of symptoms consistent with shingles, in accordance with the relevant protocol approved by the Minister for Health

Aciclovir

200mg or 800mg

Dispersible Tablets

200mg/5ml or 400mg/5ml

Oral Suspension

Famciclovir

125mg, 250mg or 500mg

Tablets

Clotrimazole

1% w/w or 2% w/w

Cream

For the treatment of symptoms consistent with vulvovaginal thrush, in accordance with the relevant protocol approved by the Minister for Health

100mg, 200mg or 500mg

Pessary

Econazole nitrate

150mg

Pessary

Clotrimazole and Hydrocortisone

1% w/w and 1% w/w

Cream

Fluticasone furoate

27.5 micrograms/spray

Nasal spray, suspension

For the treatment of symptoms consistent with allergic rhinitis or allergic conjunctivitis, in accordance with the relevant protocol approved by the Minister for Health

Fluticasone propionate

50 micrograms/spray

Nasal spray, suspension

Mometasone furoate

50 micrograms/spray

Nasal spray, suspension

Azelastine hydrochloride and fluticasone propionate

137 micrograms and 50 micrograms per actuation

Nasal spray, suspension

Mometasone furoate and Olopatadine

25 micrograms/actuation and 600 micrograms/actuation nasal spray

Nasal spray, suspension

Beclometasone Dipropionate

50 micrograms/spray

Nasal spray, suspension

Triamcinolone acetonide

55 micrograms/ dose

Nasal spray, suspension

Azelastine Hydrochloride

140 micrograms/spray

Nasal spray, solution

Cetirizine dihydrochloride

10mg

Tablets

1mg/ml

Oral solution

Loratadine

10mg

Tablets

Bilastine

10mg

Orodispersible tablet

20mg

Tablets

2.5mg/ml

Oral solution

Desloratadine

5mg

Tablets

0.5mg/ml

Oral solution

Fexofenadine hydrochloride

120mg

Tablets

Levocetirizine dihydrochloride

5mg

Tablets

0.5mg/ml

Oral solution

Sodium cromoglicate

2% w/v

Eye drops, solution

Ketotifen

0.25mg/mL

Eye drops, solution

Olopatadine

1mg/mL

Eye drops, solution

Nitrofurantoin

100mg

Prolonged-release Capsule, hard

For the treatment of symptoms consistent with uncomplicated lower urinary tract infection (cystitis), in accordance with the relevant protocol approved by the Minister for Health

50mg

Capsule, hard

Trimethoprim

100mg

Tablets

GIVEN under my Official Seal,

22 October, 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 provide for prescribing by registered pharmacists of certain medicinal products, in accordance with specific protocols, as part of a Common Conditions Service.

These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations 2025.

10F. A registered pharmacist who makes a decision to issue a prescription for a medicinal product listed in Schedule 13 pursuant to Regulation 5C(1), shall, on the making of such decision in relation to a prescription, make an entry, in the register kept in accordance with Regulation 10(1), recording the following particulars

(a) the date of the decision;

(b) the name and registration number of the registered pharmacist who made the decision to issue the prescription; and

(c) details of the prescription.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

28

th October,

2025.

I, JENNIFER CARROLL MACNEILL, Minister for Health, in exercise of the powers conferred on me by

section 32

(as amended by

section 9

of the

Health (Miscellaneous Provisions) Act 2024

(No. 23 of 2024)) of the

Irish Medicines Board Act 1995

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