S.I. No. 510/2005 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005

(1)of Regulation 4 of the following definitions - “‘administer’ means administer to a human being, whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not; and any reference in these Regulations to administering a medicinal product is a reference to administering it either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with some other substance used as a vehicle, and cognate words shall be construed accordingly;”; “‘advanced paramedic’, ‘paramedic’ ‘emergency medical technician’ and ‘pre-hospital emergency care provider’ have the same meaning as in the Pre-Hospital Emergency Care Council (Establishment) Order 2000, as amended by the Pre-Hospital Emergency Care Council (Establishment) Order 2000 (Amendment) Order 2004 ( S.I. No. 575 of 2004 );” “ ‘clinical practice guidelines’ or “CPG” means the clinical practice guidelines prepared and published by PHECC;” “‘Opticians Board’ means the Board established by section 5 of the Opticians Act 1956 (No. 17 of 1956);”; “‘PHECC’ means the Pre-Hospital Emergency Care Council established by the Pre-Hospital Emergency Care Council (Establishment) Order 2000 ( S.I. No. 109 of 2000 );”; “‘registered dispensing optician’ means a person registered in the Register of Dispensing Opticians established under the Opticians Acts 1956 and 2003;”; (b) the insertion of the following Regulation after Regulation 4: “4A. It shall not be a contravention of the provisions of these Regulations for - (a) any person to administer to another any medicinal product which is not subject to prescription control by virtue of these Regulations; (b) a registered medical practitioner or registered dentist to administer to a patient any medicinal product subject to control by virtue of these Regulations; (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, any medicinal product subject to control by virtue of these Regulations.”; (c) the substitution of paragraph

(1)of Regulation 5 by the following - “

(1)Subject to the provisions of these Regulations, a person shall not supply a medicinal product of any of the following classes except in accordance with a prescription, namely - (

1. a)any medicinal product which is or which contains a substance specified in Column 1 of the First Schedule; (
2. b)any medicinal product which is intended for parenteral administration; (
3. c)any medicinal product which is or which contains a new chemical molecule; and the supply shall be made by a person keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts 1875 to 1977 and by or under the personal supervision of an authorised person.”; (
4. d)the substitution of paragraph

(2)of Regulation 6 by the following - “

(2)Paragraph

(1)of this Regulation shall not apply to a medicinal product which - (

1. a)contains a substance specified in Part 2 of the Second Schedule, (
2. b)conforms with the requirements specified opposite each such substance in Columns 2, 3 and 4 of the said Part 2, and (
3. c)is not otherwise subject to prescription control by virtue of these Regulations.”; (
4. e)the insertion of the following paragraph in Regulation 7, after paragraph

(8): “

(9)The prescription in the case of a medicinal product, not being a medicinal product for external use, which consists of or contains Isotretinoin, and which is intended for the treatment of a woman of childbearing potential, shall not be dispensed later than seven days after the date on the prescription and the treatment on foot of the said prescription shall not exceed a period of thirty days.”; (f) the substitution in Regulation 10

(1)(d) of the words “regulation 14

(1)(a)” by the words “Regulation 20

(1)(a)”; (g) the substitution of paragraph

(3)of Regulation 10 by the following - “

(3)A person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts 1875 to 1977 shall preserve and keep readily available for inspection at such shop for a period of two years from the relevant date - (a) the register kept under paragraph

(1); (

1. b)in the case of a health prescription, the duplicate copy thereof and in the case of any other prescription, the prescription; and (
2. c)every order or invoice referred to in paragraph

(2)(c).”; (h) the insertion in Regulation 19 of the following paragraph after paragraph

(3)— “

(4)The provisions of this Regulation shall not apply to a medicinal product which by virtue of these Regulations may be supplied otherwise than in accordance with a prescription.”; (i) the substitution of paragraph

(1)(

1. b)of Regulation 20 by the following: “(
2. b)subject to paragraphs

(2)and (2A), the supply of a medicinal product by way of wholesale dealing.”; (j) the substitution in Regulation 20

(2)(b) of the words “Regulation

(5)” by the words “Regulation 5”; (k) the insertion in paragraph

(2)(

1. c)of Regulation 20 of the words “Fluorescein sodium” after the words “Cyclopentolate hydrochloride”; (
2. l)the insertion in Regulation 20 of the following paragraph after paragraph

(2)- “(2A) (a) The exemption provided for in paragraph

(1)(

1. b)shall not apply to the supply of a medicinal product to a registered dispensing optician, who has a Certificate of Entitlement to fit Contact Lenses issued by the Opticians Board, except where the medicinal product - (
2. i)contains fluorescein sodium, (
3. ii)is not intended for parenteral administration, and (iii) is supplied to the said dispensing optician on foot of a signed order given by him or her to the supplier for the purpose of each such supply; (
4. b)The provisions of Regulation 5 shall not apply as respects the administration only of a medicinal product as aforesaid to a patient of his or her by a registered dispensing optician in the course of his or her professional practice.”; (
5. m)the insertion of the following provision after paragraph

(7)of Regulation 20 - “

(8)The provisions of Regulations 5, 6, 13 and 14 shall not apply to the supply to a pre-hospital emergency care provider - (

1. a)of a medicinal product specified in Column 1 of Part 1 of the Seventh Schedule for use by an advanced paramedic in the course of his or her duties as such a person, by a route of administration specified in Column 2 of the said Part 1 and in accordance with the conditions specified opposite in Column 3 and in accordance with the authority to administer as specified opposite in Column 4 of the said Part 1; (
2. b)of a medicinal product specified in Column 1 of Part 2 of the Seventh Schedule for use by a paramedic in the course of his or her duties as such a person, by the route of administration specified in Column 2 of the said Part 2 and in accordance with the conditions specified opposite in Column 3 and in accordance with the authority to administer as specified opposite in Column 4 of the said Part 2; (
3. c)of a medicinal product specified in Column 1 of Part 3 of the Seventh Schedule for use by an emergency medical technician in the course of his or her duties as such a person by the route of administration specified in Column 2 of the said Part 3 and in accordance with the conditions specified opposite in Column 3 and in accordance with the authority to administer as specified opposite in Column 4 of the said Part 3.”; (
4. n)the insertion of the following Regulation after Regulation 20 - “20A. The Seventh Schedule as contained in the Schedule to these Regulations is inserted after the Sixth Schedule.”; (
5. o)the substitution in paragraph

(4)of Regulation 21 of the words “paragraph

(8)” by the words “paragraph

(9)”; (

1. p)the insertion of the following entry in the First Schedule thereto - Circumstances excluding products from prescription-only control Column 1 Column 2 Column 3 Column 4 Column 5 Substance Part in Schedule Maximum strength, pack size or period of treatment Use, pharmaceutical form or manner of administration Maximum Dose and Maximum Daily Dose Methylcobalamine B 25mcg (MS) 25mcg (MDD) Nitrous Oxide A (
2. q)the substitution of the entries in respect of the substances listed in Column 1 of the following Table for the entries in respect of the said substances listed in the First Schedule thereto - Circumstances excluding products from prescription-only control Column 1 Column 2 Column 3 Column 4 Column 5 Substance Part in Schedule Maximum strength, pack size or period of treatment Use, pharmaceutical form or manner of administration Maximum Dose and Maximum Daily Dose Budesonide B Felodipine B Tramadol Hydrochloride A (
3. r)the insertion in Part 1 of the Second Schedule thereto of the substance “Diclofenac Sodium”; (
4. s)the substitution of Part 2 of the Second Schedule thereto by the following: “Part 2 (Regulation 6

(2)) Circumstances in which the substances when contained in non-prescription medicinal products may be supplied in non-pharmacy outlets Column 1 Column 2 Column 3 Column 4 Substance Maximum Strength and/or pack size Use, pharmaceutical form or manner of administration Maximum Dose and Maximum Daily Dose Aspirin Colecalciferol Cyanocobalamin Ergocalciferol Folic Acid Hypericum perforatum L. Ibuprofen 200mg (MS) 12 (MPS) Tablets or capsules for use in adults and children over the age of 12 years only and for the short-term management of mild to moderate pain such as headache, dental pain, period pain, muscular strain and backache and for the management of feverishness and the symptoms of colds and influenza 400mg (MD) 1200mg (MDD) Nicotinic acid Pyridoxine Hydrochloride Retinol Retinol Acetate Retinol Palmitate Sodium Fluoride Sodium Monofluorophosphate Stannous Fluoride ” (t) the insertion in the Fourth Schedule thereto of the substance Isotretinoin. Schedule “Seventh Schedule Part 1 Medicinal products that may be supplied to pre-hospital emergency care providers for use by Advanced Paramedics (Regulation 20

(8)(a)) Medicinal Product Route of Administration Conditions of Administration Authority to Administer Column 1 Column 2 Column 3 Column 4 Amiodarone injection Intravenous Intraosseous Adults and children: Cardiac arrest According to CPG or on registered medical practitioner's instructions Atropine injection - prefilled disposable syringe Intravenous Endotracheal Intraosseous Adults: Cardiac arrest, Bradycardia. Children: Bradycardia According to CPG or on registered medical practitioner's instructions Benzylpenicillin injection Intravenous Intraosseous Intramuscular Adults and children: Suspected or confirmed meningococcal sepsis According to CPG or on registered medical practitioner's instructions Cyclizine injection Intravenous Adults and children: To prevent or treat opiate induced nausea and vomiting According to CPG or on registered medical practitioner's instructions Dextrose 10% Solution for infusion Intravenous Adults and children: Hypoglycaemia According to CPG or on registered medical practitioner's instructions Diazepam injection Intravenous Intraosseous Adults and children: Seizures According to CPG or on registered medical practitioner's instructions Diazepam rectal solution Per Rectum Adults and children: Seizures According to CPG or on registered medical practitioner's instructions Epinephrine (Adrenaline) 1 mg/1ml (1:1 000) - prefilled disposable syringe Intramuscular Adults and children: Anaphylaxis According to CPG or According to CPG or on registered medical practitioner's instructions Epinephrine (Adrenaline) injection - prefilled disposable syringe (auto) Intramuscular Adults and children: Anaphylaxis According to CPG or on registered medical practitioner's instructions Epinephrine (Adrenaline) 1 mg/10ml (1:10 000) - prefilled disposable syringe Intravenous Endotracheal Intraosseous Adults and children: Cardiac arrest, Bradycardia, Anaphylaxis According to CPG or on registered medical practitioner's instructions Glucagon for injection Intramuscular Subcutaneous Adults and children: Hypoglycaemia According to CPG or on registered medical practitioner's instructions Glyceryl trinitrate aerosol Sublingual Adults: Cardiac chest pain According to CPG or on registered medical practitioner's instructions Hartmann's Solution for infusion Intravenous Intraosseous Adults and children: Hypovolaemic shock, Anaphylaxis According to CPG or on registered medical practitioner's instructions Ibuprofen Tablets or Capsules Orally Children: Pain According to CPG or on registered medical practitioner's instructions Lidocaine Hydrochloride Injection Intravenous Endotracheal Adults: Cardiac arrest According to CPG or on registered medical practitioner's instructions Lorazepam Injection Intravenous Intramuscular Adults and children: Seizures According to CPG or on registered medical practitioner's instructions Morphine Injection Intravenous Intramuscular Adults and Children: Moderate to severe pain According to CPG or on registered medical practitioner's instructions Naloxone for injection Intravenous Intramuscular Subcutaneous Adults: Respiratory depression secondary to known or suspected narcotic overdose According to CPG or on registered medical practitioner's instructions Nitrous oxide - Oxygen mixture - medical gas By Inhalation Adults and children: Pain relief for medical, surgical or trauma conditions According to CPG or on registered medical practitioner's instructions Ondansetron Hydrochloride Injection Intravenous Adults and children: To prevent or treat opiate induced nausea and vomiting According to CPG or on registered medical practitioner's instructions Paracetamol suppositories Per rectum Children: Pyrexia According to CPG or on registered medical practitioner's instructions Salbutamol for nebulisation Inhalation Adults and children: Bronchospasm in anaphylaxis, and acute asthma According to CPG or on registered medical practitioner's instructions Salbutamol inhaled aerosol Inhalation Adults and children: Bronchospasm in anaphylaxis, and acute asthma According to CPG or on registered medical practitioner's instructions Sodium Chloride 0.9% for infusion Intravenous Adults: Hyperglycaemia Adults and children: To keep vein open, Cannula flush According to CPG or on registered medical practitioner's instructions Tetracaine Gel 4% Topical Adults and children: Anaesthesia prior to venepuncture According to CPG or on registered medical practitioner's instructions PART 2 Medicinal products that may be supplied to pre-hospital emergency care providers for use by Paramedics (Regulation 20

(8)(b)) Medicinal Product Route of Administration Conditions of Administration Authority to Administer Column 1 Column 2 Column 3 Column 4 Cyclizine Injection Intramuscular Adults and children: To prevent or treat opiate induced nausea and vomiting On registered medical practitioner's instructions Diazepam rectal solution Per Rectum Adults and children: Seizures On registered medical practitioner's instructions Epinephrine (Adrenaline) 1mg/1ml (1:1 000) - prefilled disposable syringe Intramuscular Adults and children: Anaphylaxis According to CPG or on registered medical practitioner's instructions Epinephrine (Adrenaline Injection - prefilled disposable syringe (auto) Intramuscular Adults and children: Anaphylaxis According to CPG or on registered medical practitioner's instructions Glucagon for injection Intramuscular Subcutaneous Adults and children: Hypoglycaemia According to CPG or on registered medical practitioner's instructions Glyceryl trinitrate aerosol Sublingual Adults: Cardiac chest pain According to CPG or on registered medical practitioner's instructions Hartmann's Solution for infusion Intravenous Adults and children: Hypovolaemic shock, Anaphylaxis On registered medical practitioner's instructions Morphine Injection Intravenous Intramuscular Adults and Children: Moderate to severe pain On registered medical practitioner's instructions Naloxone for injection Intramuscular Subcutaneous Adults: Respiratory depression secondary to known or suspected narcotic overdose On registered medical practitioner's instructions Nitrous oxide - Oxygen mixture - medical gas By Inhalation Adults and children: Pain relief for medical, surgical or trauma conditions According to CPG or on registered medical practitioner's instructions Paracetamol suppositories Per rectum Children: Pyrexia On registered medical practitioner's instructions Salbutamol for nebulisation Inhalation Adults and children: Bronchospasm in anaphylaxis, and acute asthma According to CPG or on registered medical practitioner's instructions Salbutamol inhaled aerosol Inhalation Adults and children: Bronchospasm in anaphylaxis, and acute asthma According to CPG or on registered medical practitioner's instructions Sodium Chloride 0.9% for infusion Intravenous Adults: Hyperglycaemia Adults and children: To keep vein open, Cannula flush On registered medical practitioner's instructions Tetracaine Gel 4% Topical Adults and children: Anaesthesia prior to venepuncture On registered medical practitioner's instructions PART 3 Medicinal products that may be supplied to pre-hospital emergency care providers for use by Emergency Medical Technicians (Regulation 20

(8)(c)) Medicinal Product Route of Administration Conditions of Administration Authority to Administer Column 1 Column 2 Column 3 Column 4 Cyclizine Injection Intramuscular Adults and children: To prevent or treat opiate induced nausea and vomiting On registered medical practitioner's instructions Epinephrine (Adrenaline) injection - prefilled disposable syringe (auto) Intramuscular Adults and children: Anaphylaxis According to CPG or on registered medical practitioner's instructions Glyceryl trinitrate aerosol Sublingual Adults: Cardiac chest pain According to CPG or on registered medical practitioner's instructions Morphine Injection Intravenous Intramuscular Adults and Children: Moderate to severe pain On registered medical practitioner's instructions Naloxone for injection Intramuscular Subcutaneous Adults: Respiratory depression secondary to known or suspected narcotic overdose On registered medical practitioner's instructions Nitrous oxide - Oxygen mixture - medical gas By Inhalation Adults and children: Pain relief for medical, surgical or trauma conditions According to CPG or on registered medical practitioner's instructions Salbutamol inhaled aerosol Inhalation Adults and children: Bronchospasm in anaphylaxis, and acute asthma According to CPG or on registered medical practitioner's instructions Given under my hand this 9th day of August, 2005. SEAN POWER Minister of State at the Department of Health and Children EXPLANATORY NOTE (This note is not part of the Instrument and does not purport to be a legal interpretation.) The purpose of these Regulations is to update the controls in respect of the supply of medicinal products as set out in the Medicinal Products (Prescription and Control of Supply Regulations 2003 ( S.I. No. 540 of 2003 ). The Regulations provide for: (

1. a)clarification with regard to the administration of medicinal products; (
2. b)clarification of the role of authorised persons with regard to supervision of the supply of prescription - only medicinal products; (
3. c)the availability of certain medicinal products in non - pharmacy outlets; (
4. d)further restrictions on certain medicinal products containing Isotretinoin; (
5. e)clarification on the record keeping requirements in respect of pharmacies; (
6. f)the exemption of non - prescription medicinal products from the prohibition on the sale of medicinal products by mail order; (
7. g)the extension of the availability of fluorescein sodium to optometrists and dispensing opticians for professional use; (
8. h)the availability and use of certain medicinal products by various grades of ambulance personnel; (
9. i)the addition of certain products to the schedules of prescription only medicinal products; (
10. j)the correction of certain minor errors and omissions which have come to light since publication of the principal Regulations. 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. Atáirgtear ábhar faoi Chóipcheart le cead ó Thithe an Oireachtais