Medicinal Products (Prescription and Control of Supply) Regulations ...

Medicinal Products (Prescription and Control of Supply) 

Regulations, 2003 (S.I. No. 540 of 2003) 

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 2005 

(S.I. No. 510 of 2005) 

Sections 37-39 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 

(No. 3 of 2006) 



Regulations 20-24 of the Medicinal Products (Control of Placing on the Market) 








SF 2012-13 Medicinal Products (Prescription & Control of Supply) Regulations 1 

Medicinal Product: definition 

(a) 

Any substance or combination of substances presented as having properties 

for treating or preventing disease in human beings; or 

(b) 

Any substance or combination of substances which may be used in or 

administered to human beings either with a view to restoring, correcting or 

modifying physiological functions by exerting a pharmacological, 

immunological or metabolic action, or to making a medical diagnosis. 

SF 2012-13 

Medicinal Products (Prescription & Control of Supply) Regulations 

2 

1

Structure and content 

• 23 Regulations + 7 Schedules (1-5 & 7-8) [updated: 2011 amendment] 

• Regulations 

Reg. 1 Citation 

Reg. 2 Commencement 

Reg. 3 Revocations 

Reg. 4 Definitions 

Reg. 5 Medicinal products on R x 

only; exemptions. 

NB - Regs. 5A and 5B: Nurse prescribing [2007 amendment] 

Reg. 6 Sales supervised by pharmacist. 

Reg. 7 R x 

requirements; restrictions on dispensing. 

Reg. 8 Emergency supply. 

Reg. 9 

Labelling 

Reg. 10 Records 

Reg. 11 Mifepristone register 

Regs. 12-16 Paracetamol 

Regs. 17-19 Miscellaneous provisions (vending machines, expiry date, mail order) 

Reg. 20 Exemptions 

Regs. 21-23 Enforcement, evidence from analysis, transitional provisions 

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Structure and content (contd.) 

• Schedules 

Sch. 1 Column 1 List of R x 

-controlled drugs 

Column 2 Drug class (S1A, S1B or S1C) 

Columns 3-5 Exemptions from R x 

control, if any. 

Sch. 2 Part 1 R x 

-exempt drugs to be sold in manufacturers' packs. 

Part 2 Deleted in 2008. Was formerly R x 

-exempt drugs available from nonpharmacy 

outlets. 

Part 3 R x 

-exempt homoeopathic products (when < 1 ppm), available from 

non-pharmacy outlets. 

Part 4 R x 

-exempt extemporaneous herbal products available from nonpharmacy 

outlets (limited circumstances). 

Sch. 3 Steroids treated as S1B when presented in particular form 

i.e. external use (Part 1) or oral contraceptives (Part 2). 

Sch. 4 Substances whose emergency supply at patient's request is banned. 

Sch. 5 Cautionary labels for dispensed products. 

Sch. 6 Deleted in 2006 - was formerly format of certificate of analysis 

Sch. 7 Med prods that may be supplied to pre-hospital emergency care providers 

Sch. 8 Med prods that may be administered in community pharmacies (vaccination) 

[added 2011] 

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2

Sample definitions 

• ‘External use' means application to the skin, hair, teeth, mucosa of the mouth, 

throat, nose, ear, eye, vagina or anal canal where a local action only is 

intended and extensive systemic absorption is unlikely to occur and references 

to medicinal products for external use shall be read accordingly gy except that 

such references shall not include transdermal delivery systems, throat sprays, 

throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal 

inhalations or teething products. 

• ‘New chemical molecule' means a substance, not being a substance specified 

in any of the Schedules to these Regulations, which was not contained in a 

medicinal product, as one of its active ingredients, which was lawfully in the 

market in the State on, or immediately before, the 19 th day of January 1987. 

• ‘Supply' includes sell, distribute or offer or keep for sale or distribution 

notwithstanding that the person supplied may be in another Member State of 

the European Community and cognate words shall be construed accordingly. 

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Schedule 1: selected entries 

Circumstances excluding medicinal products from 

prescription control 

Column 1 Column 2 Column 3 Column 4 Column 5 

Substance 

Part in 

Maximum strength, 

th Use, pharmaceutical lform or manner of 

Maximum dose 

Schedule pack size or period 

of treatment 

administration 

and maximum 

daily dose 

Amoxycillin A 

Amylocaine A 

Any use except local ophthalmic use 

hydrochloride 

Aspirin B (1) Internal: any use (except for children 

under 12 years of age) 

(2) External 

Naproxen 

sodium 

B 

5% (MS) 

30.0 g (MPS) 

7 days (MPT) 

External 

For local symptomatic relief of pain and 

inflammation in the trauma of the tendons, 

ligaments, muscles and joints and in 

localised forms of soft tissue rheumatism 

For use in adults and children not under 

12 years 

(1) 650 mg (MD) 

4.0 g (MDD) 

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3

Schedule 2 Part 1 

Substances which when contained in certain non-prescription medicinal products 

may only be supplied in the manufacturer’s original container showing the legal 

classification for supply 

Acyclovir 

Diclofenac diethylammonium 

Diclofenac sodium 

Famotidine 

Hydrocortisone 

Hydrocortisone acetate 

Ibuprofen 

Flurbiprofen 

Ketoprofen 

Minoxidil 

Naproxen 

Nicotine 

Nicotine resinate 

Oxethazine 

Piroxicam 

SF 2012-13 


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Schedule 2 Part 2: non-pharmacy products - now deleted [2008 amendment] 

Availability outside pharmacies is now by designating ‘general sale’ in marketing authorisation. 

Circumstances in which substances, when in non-Rx medicinal products, may be 

supplied in non-pharmacy outlets 

Column 1 Column 2 Column 3 Column 4 

Substance 

Maximum strength 

Use, pharmaceutical form or manner of 

Maximum dose and 

&/or pack size administration 

maximum daily dose 

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) 

Complete list of substances in Schedule 2 Part 2: 

Aspirin 

Colecalciferol 

Cyanocobalamin 

Ergocalciferol 

Folic acid 

Hypericum perforatum L. 

Ibuprofen [added 2005, as above] 

Nicotinic acid 

Pyridoxine hydrochloride 

Retinol 

Retinol acetate 

Retinol palmitate 

Sodium fluoride 

Sodium monofluorophosphate 

Stannous fluoride 

Only ibuprofen has entries in Columns 2-4; others have no limitations on strength/pack size/use/dose. 

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4


Substances which when contained in certain homeopathic medicinal products may 

be supplied without a prescription and in non-pharmacy outlets 

Aconitum napellus L. 

Mandragora autumnalis Bertol. 

Anamirta cocculus (L.) Wight & Arn 

Arsenic 

Atropa belladonna L. 

Caulophyllum thalictorides (L.) Mich. 

Conium maculatum L. 

Cytisus scoparium L. 

Digitalis purpurea L. 

Ephedra vulgaris Rich. 

Gelenium nitidum L. 

Ginkgo biloba L. 


Phytolacca species 

Podophyllum species 

Rauwolfia serpentine (L.) Benth. ex Kurtz 

Schoenocaulon officinale (Schlect & Cham) 

A. Gray 

Snake venoms 

Strychnos ignatii Berg. 

Strychnos nux vomica L. 

Symphytum species 

Veratrum album L. 

Viscum album L. 

Product must be licensed (i.e. have product authorisation or certificate of registration) 

and strength must be no more than 1 part per million. 

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Herbal substances which when contained in extemporaneously prepared medicinal 

products may be supplied without a prescription in certain limited circumstances 

Ginkgo biloba L. 


Intention of legislation - to allow supply by herbalists to their patients. 

• Supplier must be the occupier of the premises on which the product has been 

extemporaneously compounded. 

• Premises must not be shop/retail outlet, and occupier must be able to close 

premises to exclude public (e.g. g not street stall). 

• Product must be extemporaneously compounded on the premises (i.e. not 

commercially manufactured preparation). 

• Product must be supplied on the premises for administration to a particular 

patient, following a request by (or on behalf of) that patient, and in the 

patient’s presence, for the supplier to use his professional judgement as to 

the treatment required. 

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5

Conditions for nurse prescribing 

(a) The nurse is employed by a health service provider in a hospital, nursing home, 

clinic or other health service setting (including any case where the health service 

is provided in a private home); 

(b) The medicinal product is a medicinal product which would be given in the usual 

course of the provision of the health service provided in the health service 

setting in which the nurse is employed; and 

(c) The prescription is in fact issued in the usual course of the provision of that 

health service. 

• Pharmacist may refuse to supply a medicinal product prescribed by a registered 

nurse if reasonable cause to believe that the conditions above have not been 

satisfied. 

• Prescription must clearly indicate prescriber’s name and state that a registered 

nurse. 

• Rx must include registration number (PIN) of nurse. 

[The validity of this can be checked at the Bórd Altranais website: 

www.nursingboard.ie -> Check the Register. (Need to enter PIN which is a 4- 

digit number.] 

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Schedule 3 

Substances which, when contained in certain medicinal products, may be dispensed in the 

manner prescribed for a product which is or which contains a substance specified in Part B of 

the First Schedule 

Part 1 

Alclomethasone dipropionate 

Diflucortolone valerate 

Halcinonide 

Beclomethasone dipropionate 

Betamethasone 

Betamethasone benzoate 

Betamethasone dipropionate 

Betamethasone sodium phosphate 

Betamethasone valerate 

Clobetasol propionate 

Clobetasone butyrate 

Desonide 

Diflorasone diacetate 

Fluclorolone acetonide 

Flumethasone pivalate 

Fluocinolone acetonide 

Fluocinonide 

Fluocortolone 

Fluocortolone hexanoate 

Fluocortolone pivalate 

Fluorometholone 

Hydrocortisone 

Hydrocortisone acetate 

Hydrocortisone butyrate 

Medrysone 

Methylprednisolone acetate 

Prednisolone 

Prednisolone acetate 

Prednisolone hexanoate 

Prednisolone sodium phosphate 

Desoxymethasone 

Dexamethasone 

Dexamethasone sodium phosphate 

Cyproterone acetate 

Desogestrel 

Estradiol valerate 

Ethinyloestradiol 

SF 2012-13 

Fluprednidene acetate 

t 

Flurandrenolone 

Formocortal 

Part 2 

Ethynodiol diacetate 

Gestodene 

Levonorgestrel 

Lynoestrenol 


Prednisolone steaglate 

t 

Triamcinolone acetonide 

Mestranol 

Norethisterone acetate 

Norethisterone 

Norgestimate 

16 

6

Repetition of prescriptions 

• No prescription-only preparation may be dispensed later than 6 months from the date 

on the prescription. 

• Except for sodium fluoride tablets, prescriptions written by dentists may not be 

repeated. 

• If a doctor’s prescription has no mention of repetition on it: 

– S1A items may be dispensed once only; 

– S1B items may be dispensed at appropriate intervals for up to six months from 

the date on the prescription. 

(If a doctor wishes a S1B item to be dispensed once only, he may write ‘Nonrepeatable’, 

‘Dispense once’ or a similar phrase on the prescription.) 

• If a doctor’s prescription is marked ‘Repeat’ but specifies neither the number of 

occasions nor the intervals for dispensing: 

– S1A items may be dispensed twice only (i.e. one repeat) [and see * overleaf]; 

– S1B items may be dispensed at appropriate intervals for up to six months from 

the date on the prescription. 

• Isotretinoin products (except external) for women of childbearing potential must be 

dispensed within 7 days of date on Rx and treatment on the Rx must be no more 

than 30 days. [2005 amendment] 

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Repetition of prescriptions (contd.) 

• If a doctor’s prescription specifies the number of occasions it is to be dispensed, 

but not the intervals, both S1A* and S1B items may be dispensed that number of 

occasions at appropriate intervals (but not later than 6 months from the 

prescription date). 

• If a doctor’s prescription specifies the intervals for dispensing (e.g. ‘Repeat 

monthly’) but not the number of occasions: 

– S1A items may be dispensed at those intervals a maximum of three times (i.e. 

max. two repeats) [and see * below]; 

– S1B items may be dispensed at those intervals for up to 6 months from the 

prescription date. 

* S1A items may only be repeated if this is indicated (e.g. by the intervals of supply 

or number of occasions) in the doctor’s own handwriting or typescript. For 

example, the pre-printed words ‘Repeat prescription set’ on GMS forms are not 

sufficient. 

• Repetition of CD1 / CD2 / CD3 drugs is banned (Misuse of Drugs Regulations, 

1988). 

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7

Schedule 4 

Substances not to be contained in a medicinal product supplied under the 

exemption conferred by Article 8(2) 

(i.e. emergency supply ppy at patient’s request) 

Ammonium bromide 

Calcium bromidolactobionate 

Calcium bromide 

Chlormethiazole edisylate 

Chlormethiazole 

Embutramide 

Fluanisone 

Hydrobromic acid 

Isotretinoin [added by 2005 amendment] 

Meclofenoxate hydrochloride 

Mifepristone 

Piracetam 

Potassium bromide 

Sodium bromide 

Strychnine hydrochloride 

Tacrine hydrochloride 

Thiopentone sodium 

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Definition: ‘Dispensed medicinal product’ 

A ‘dispensed medicinal product’ means a medicinal product: 

• supplied by a practitioner for or to a patient under his care; 

• supplied by, or under the supervision of, an authorised person (i.e. pharmacist 

or qualified assistant) 

– on prescription, or 

– in circumstances where the pharmacist (or qualified assistant) exercises his 

own judgement as to the treatment required. 

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8

Labelling of dispensed medicinal products 

(a) Unless the prescriber directs otherwise, the proprietary name of the product, 

or the generic name with the name of the manufacturer. 

(b) In the case of a prescription, any directions for use and precautions specified 

by the prescriber; otherwise, suitable directions for use. 

NB: Where pharmacist is of opinion that prescriber’s directions/precautions are 

inappropriate and has taken all practicable steps to consult prescriber but in vain, label 

with appropriate details of same kind as requested by prescriber. 

(c) Any cautionary notices specified in Sch. 5 that the pharmacist considers 

appropriate (i.e. warnings about drowsiness, cautions to take the preparation 

with food etc.). 

(d) The words ‘Keep out of reach of children’. 

(e) 

The words ‘For external use only’ on preparations for external use. 

(f) The name of the patient. 

(g) The name and address of the pharmacy (or supplying doctor, if this is the case). 

(h) The date of dispensing. 

In the case of medicines supplied in the manufacturer’s original pack, the manufacturer’s 

label will suffice for the purpose of (a), (c), (d) and (e), provided none of the information on it 

been obscured/removed, and it is accompanied by the relevant PIL. 

SF 2012-13 


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Schedule 5: selected entries 

Cautionary and warning notices for dispensed medicinal products 

Notice 

Examples of medicinal products for which the 

notice appearing opposite may be appropriate 

1. Warning. May cause drowsiness. If 

affected do not drive or operate 

machinery. Avoid alcoholic drink. 

10. Take at regular intervals. Complete 

the prescribed course unless 

otherwise directed. 

Antihistamines (except where intended for 

external use only), barbiturates, hypnotics and 

tricyclic antidepressants. 

Antimicrobial drugs given by mouth. 

13. Do not take remedies containing 

Products containing salicylate derivatives. 

aspirin while taking this medicine. 

23. To be swallowed whole, not chewed. Sustained release products. 

25. To be applied sparingly. Products for external use containing a 

corticosteroid or dithranol. 

SF 2012-13 


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9

Pharmacy records 

(a) The first time that pharmacy dispenses a particular Rx 

(i) Date of supply; 

(ii) Name, quantity of product (and form and strength unless apparent from 

name); 

(iii) Prescriber's name (and address if he is unknown to pharmacist); 

(iv) Patient's name and address; 

(v) Date on prescription; 

Also must give each entry a reference number so can refer back if necessary. 

(b) Where pharmacy is dispensing a repeatable Rx for the 2nd or 

subsequent time 

(i) All details as (a) above, or date of supply and reference to register entry for 

1st dispensing; 

(ii) Where immediately previous dispensing was at another pharmacy, that 

pharmacy's name and address, and their Rx register ref. no. for it. 

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Pharmacy records (contd.) 

(c) Emergency supply at request of Dr 

(i) All details as in (a) above; 

(ii) Date on which Rx received. 

(d) Emergency supply at request of patient 

(i) Details (i)-(iv) as in (a) above; 

(ii) Where previous supply was at another pharmacy, that pharmacy's name and 

address, and their Rx register ref. no. for it. 

(iii) The nature of the emergency. 

(e) Wholesale supply (unless keep copy/original of order or invoice) 

[NB This is where pharmacist is supplying by wholesale, not receiving.] 

(i) Date of supply; 

(ii) Name, quantity of product (and form and strength unless apparent from name); 

(iii) Name, address and occupation of recipient; 

(iv) Purpose for which supplied. 

SF 2012-13 


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10

Definition: Wholesale supply 

Supply by way of wholesale dealing means the supply of a medicinal product to a 

person who obtains the product for one or more of the following purposes: 

• supply in the course of a pharmaceutical business, 

or 

• administration in the course of a professional practice, 

or 

• for or in connection with a service provided by a hospital. 

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Mifepristone register 

• Record in register each time supply/administer: 

(a) Date of supply/admin. 

(b) Name and address of recipient. 

(c) Dosage form, strength and quantity supplied/administered. 

(d) Purpose or circumstances of supply/admin. 

(e) Signature of person who made supply or administration. 

• Keep register for 2 yrs from date of last entry. 

• Also S1C ⇒ hospital only. 

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11

Circumstances for OTC paracetamol supply from pharmacy 

[updated 2008] 

1. Sold by or under the personal supervision of a pharmacist, and 

(a) 120 mg < dosage unit < 500 mg Max. pack size = 24; 

(b) 500 mg < dosage unit < 600 mg Max. pack size = 20; 

(c) 600 mg < dosage unit < 1000 mg Max. pack size = 12; 

(d) product for use in children < 6yrs of age, Max. pack size = 24; 

dosage unit < 120 mg 

(e) liquid product for use in children < 6yrs 

Max. pack size = 140 ml; 

of age, < 120 mg/5 ml 

(f) liquid product for use in children > 6yrs Max. pack size = 140 ml; 

and < 12 yrs of age, < 250 mg/5 ml, excluding 

products in (e) above 

(g) other liquid product < 250 mg / 5 ml, excluding Max. pack size = 240 ml. 

products in (e) and (f) above 

2. The pharmacist has personally interviewed the person requesting the product and is 

satisfied that supply is safe, and 

(a) total quantity < 50 dosage units; 

(b) if not a tablet, capsule or similar form, total quantity < 2 packs. 

SF 2012-13 


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Non-pharmacy paracetamol supply [updated 2008] 

• Product contains paracetamol as its only active analgesic ingredient. 

• Max. 1 pack per retail transaction. ['Retail transaction' not defined in regs.] 

• Maximum pack sizes – 

(a) 120 mg < dosage unit < 500 mg Max. pack size = 12 

(b) 500 mg < dosage unit < 600 mg Max. pack size = 10 

(c) 600 mg < dosage unit < 1000 mg Max. pack size = 6 

(d) Product for use in children < 6yrs of age, Max. pack size = 12 

dosage unit < 120 mg 

(e) Liquid product for use in children < 6yrs Max. pack size = 60 ml 

of age, < 120 mg/5 ml 

(f) Other liquid product < 250 mg/5 ml, excluding Max. pack size = 60 ml 

products in (e) above 

SF 2012-13 


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12

Outer packaging (or immediate packaging if no outer) for 

paracetamol 

• Contains Paracetamol. 

• Do not take any other paracetamol-containing products. 

• Do not exceed the stated t dose. 

• Immediate medical advice should be sought in the event of overdosage, even 

if you feel well. Please read the enclosed leaflet carefully. 

(Where product intended mainly for adults and package leaflet supplied.) 

• Immediate medical advice should be sought in the event of overdosage, even 

if the child seems well. Please read the enclosed leaflet carefully. 

(Where product intended mainly for children < 12 years of age and package 

leaflet supplied.) 

• Immediate medical advice should be sought in the event of overdosage, 

because of the risk of irreversible liver damage. 

(Where no package leaflet supplied.) 

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Package leaflet for paracetamol 

• Contains Paracetamol. 

• Do not take any other paracetamol-containing products. 

• Do not exceed the stated dose. 

• Immediate medical advice should be sought in the event of overdosage, 

because of the risk of irreversible liver damage. 

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13

Exemptions from normal requirements for medicinal products 

Need not be pharmacist to supply, no prescription required, can supply by mail 

order, paracetamol regs don’t apply: 

• to a university / higher education institution / scientific research institution, for 

the purposes of such education or research; 

• to a sampling officer, officer of the Irish Medicines Board (IMB) or a public 

analyst in connection with the performance of his duties; 

• to a person who needs the product to fulfil legal obligations with regard to the 

care of his workforce; 

• to a person employed in relation to testing the quality or amount of drugs, 

medicines or appliances supplied under any of the government health 

schemes (GMS, LTI, DPS etc.); 

• in wholesale supply [but see extra restrictions for opticians, optometrists]. 

Limited provisions for supply to their patients by doctors, dentists and nurses 

(i.e. non-pharmacists) without Rx also exist. However, supply by mail order in 

such cases is still banned. 

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Restrictions on wholesale exemption 

• Registered optometrist: wholesale exemption only applies where - 

• non-parenteral, 

& Rx only purely because it contains cyclopentolate hydrochloride 

fluorescein sodium 

oxybuprocaine hydrochloride 

tropicamide 

& signed order has been given by optometrist to supplier for each supply. 

• Exempt from need for Rx for administration only of the med prod (as above) to 

patient by registered optometrist in course of professional practice. 

• Registered dispensing optician who has certificate of entitlement to fit contact 

lenses issued by the Opticians i Board: wholesale l exemption only applies where - 

• non-parenteral, 

& contains fluorescein sodium 

& signed order has been given by dispensing optician to supplier for each supply. 

• Exempt from need for Rx for administration only of the med prod (as above) to 

patient by registered dispensing optician in course of professional practice. 

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14

Exemptions contd. 

Need not be pharmacist to supply, no prescription required [but mail order and 

paracetamol restrictions DO still apply] 

• Supply of medicinal product by authorised person or registered nurse in course 

of a hospital service (except hospital providing community mental health 

services) 

– where supply is according to written directions of Dr/dentist [even if don’t 

meet Rx writing requirements]. 

• Supply of medicinal product by registered nurse in course of a hospital service 

where hospital provides community mental health services, 

– where supply is according to written directions of registered Dr of that 

service [even if don’t meet Rx writing requirements]. 

– quantity sufficient for max. 3 days 

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Schedule 7 

• Added by 2005 amendment. Updated in 2008 amendment. 

• Medicinal products that may be supplied to pre-hospital emergency care 

providers 

– Part 1: for use by Advanced Paramedics 

– Part 2: for use by Paramedics 

– Part 3: for use by Emergency Medical Technicians 

• Each part of schedule has 4 columns: 

Medicinal 

product 

Route of 


Conditions of 


Authority to 

administer 

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15

Enforcement 

• Now controlled under terms of IMB (Miscellaneous Provisions) Act 2006 

• Schedule 6 (cert of analysis) deleted from these regulations. 

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2011 amendment - community pharmacy influenza vaccination 

• Medicinal Products (Prescription and Control of Supply) (Amendment) 


• Signed 14 October 2011 

• Facilitates vaccination by pharmacists in community pharmacies 

• New definitions: 

– pharmacy owner 

– retail pharmacy business 

copied from Pharmacy Act 2007. 

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16

Pharmacist vaccination permitted (in retail pharmacy business) 

• New Regulation 4B 

Authorised person (pharmacist ) can supply and administer medicines 

specified in Sch. 8 Col.1 [new schedule] 

– in the course of his/her professional practice as pharmacist 

– at the premises of the retail pharmacy business where he/she practices (or 

any place for adrenaline) 

– if and only if: 

a) certified to have undergone PSI-approved training on admin and ADR 

management; 

b) product is administered in accordance with Sch. 8 Cols. 2-5. 

• Regulation 5 amended so no need for prescription when administered by 

authorised person (pharmacist) under new Reg. 4B. 

• Regulation 19 amended so mail order supply of products in Sch. 8 Col. 1 is 

banned, even though prescription is not needed. 

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New Sch. 8: Products that can be administered under Reg. 4B 

Medicinal product 

Form and 

presentation of 

product 

administered 

Route of 


Indication for 

which the 

medicinal product 

may be 

administered 

Dosage and 

conditions of 


Column 1 Column 2 Column 3 Column 4 Column 5 

Influenza vaccine of 

a composition that 

has been approved 

for use in the 

European Union for 

the season in 

question 

Epinephrine 

(adrenaline) 

injection 

SF 2012-13 

Influenza vaccine 

suspension for 

injection presented 

as a prefilled 

syringe 

Epinephrine 

(adrenaline) 1 

mg/ml injection 

presented as a 

prefilled syringe or 

epinephrine 

(adrenaline) 1.7 

mg/ml injection 

presented as a 

prefilled syringe 

By intramuscular 

injection only 

Intramuscular or 

subcutaneous 

injection 

Prevention of 

seasonal influenza 

For the emergency 

treatment t tof 

anaphylactic shock 

arising as a result 

of the 

administration of 

seasonal influenza 

vaccine 


0.5 ml or less for 

single 

administration. In 

accordance with the 

SmPC of the 

product 

administered. 

0.5 mg repeated 

every 5-10 mins to 

a max. of 3 doses 

and otherwise in 

accordance with the 

SmPC of the 

product 

administered 

44 

17

Record-keeping 

• New Regulation 10A 

If medicine administered under new Reg. 4B, must make entry in a register 

kept for that purpose by the pharmacy owner at the premises of the retail 

pharmacy business: 

a) date of administration; 

b) name, address, date of birth and sex of the patient; 

c) personal public service (PPS) number of the patient unless the patient 

fails to provide this info; 

d) name, dosage, marketing authorisation number, batch number and expiry 

date of the product; 

e) name of the authorised person (pharmacist) and his/her PSI registration 

number; 

f) address of the premises of the retail pharmacy business in which the 

authorised person carries on his or her professional practice; and 

g) the name, address and contact particulars of the GP (if any) of the patient 

unless the patient fails to provide this info to the pharmacist. 

SF 2012-13 


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Record-keeping (contd.) 

• Within 7 days of administration, the record (see previous slide) must be 

forwarded to: 

– HSE 

– patient’s GP (if any) unless patient did not provide details. 

• Pharmacy owner (including new owner if pharmacy changes ownership) must : 

– keep records until 8 th anniversary of administration; 

– keep them available for inspection on the pharmacy premises for minimum 

of 2 years (unless cease business at those premises). 

• Can keep computerised record if: 

– daily printout; 

– the pharmacist (each pharmacist if >1) certifies, within 24 hours of printout, 

that the printout details relating to the info he/she recorded in the register 

are true and correct to the best of his/her knowledge and belief. 

SF 2012-13 


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Medicinal Products (Prescription and Control of Supply) Regulations ...

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