S.I. No. 401/2020 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2020 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.
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- s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2020 S.I. No. 401/2020 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2020 S.I. No. 401/2020 - Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2020 AmendmentsLeasuithe Download PDF Íoslódáil PDF Notice of the making of this Statutory Instrument was published in “Iris Oifigiúil” of 6th October, 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. 5) Regulations 2020.
(2)The citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2020” 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 ). 3. The Principal Regulations are amended by substituting for Regulation 4B (inserted by Regulation 4 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015 ( S.I. No. 449 of 2015 )) the following: “Supply and administration of certain medicinal products by authorised persons 4B. It shall not be a contravention of a provision of these Regulations for an authorised person, in the course of his or her professional practice as an authorised person, to supply a person with, and to administer to the person, a medicinal product specified in column 1 of the Eighth Schedule if, and only if— (
- a)a body recognised by the Council of the Pharmaceutical Society of Ireland has issued to the authorised person a certificate stating that he or she has satisfactorily completed a course of training approved by the Registrar of the Pharmaceutical Society of Ireland relating to the supply and administration of the product and the management of any immediate adverse reaction that may follow from such administration, (
- b)the product is administered in accordance with the requirements specified in columns 2 to 5 of the Eighth Schedule opposite the mention of the product specified in column 1 of that Schedule, and (
- c)the product is administered at the place specified in column 6 of the Eighth Schedule opposite the mention of the product specified in column 1 of that Schedule.”. 4. The Principal Regulations are amended by substituting for the Eighth Schedule (as amended by Regulation 2 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2020 ( S.I. No. 241 of 2020 )) the following: “EIGHTH SCHEDULE MEDICINAL PRODUCTS WHICH MAY BE SUPPLIED AND ADMINISTERED BY AUTHORISED PERSONS PURSUANT TO REGULATION 4B 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 Herpes zoster vaccine for injection Live, attenuated, varicella-zoster virus powder and solvent for the suspension for injection By intramuscular or subcutaneous injection Prevention of zoster and zoster-related post-herpetic neuralgia 0.65ml 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 of the Royal College of Physicians of Ireland The premises of the retail pharmacy business in which the authorised person carries on professional practice 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 of the Royal College of Physicians of Ireland. 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 24 months: 0.2 ml (administered as 0.1 ml per nostril). For children who have not previously been vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks. 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. 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 1mg/ml 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 and relevant national guidelines Any place Naloxone Nasal Spray Naloxone hydrochloride dihydrate 1.8 mg 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 of the Royal College of Physicians of Ireland 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 ”. GIVEN under my Official Seal, 30 September, 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 allow for influenza vaccination to be administered by registered pharmacists in places other than the premises of the retail pharmacy business in which they carry on their professional practice. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations 2020. Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government of Ireland. Oireachtas Copyright Material is reproduced with the permission of the Houses of the Oireachtas © Rialtas na hÉireann. 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