S.I. No. 241/2020 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2020

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 10th July, 2020.

I, STEPHEN DONNELLY, 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)) of the Irish Medicines Board Act 1995 (No. 29 of 1995), hereby make the following regulations:

1. (1) These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2020.

(2) The citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2020” includes these Regulations.

2. The Eighth Schedule (as amended by Regulation 5 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2018 ( S.I. No. 530 of 2018 )) to the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ) is amended by inserting after the entry for “Influenza vaccine of a composition that has been approved for use in the European Union for the season in question” the following entry:

“

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 24 months:

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 of the Royal College of Physicians of Ireland.

”.

/images/ls

GIVEN under the Official Seal,

3 July, 2020.

STEPHEN DONNELLY,

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 amend the Eighth Schedule to insert an entry for Intranasal Influenza Vaccination.

These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2020.