LegalizeS.I. No. 540/2003 - Medicinal Products (Prescription and Control of Supply) Regulations 2003
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
60 amending acts · 2026-09-08, S.I. No. 457/2026 - Medicinal Products (Prescription and Control of Supply) (Amendment) R…
NOTE: In relation to a medicinal product which contains more than one of the substances Atropine, Atropine Methobromide, Atropine Methonitrate, Atropine Oxide Hydrochloride Atropine Sulphate, Hyoscine, Hyoscine Butylbromide, Hyoscine Hydrobromide, Hyoscine Methobromide, Hyoscine Methonitrate, Hyoscyamine, Hyoscyamine Hydrobromide or Hyoscyamine Sulphate, for the purposes of column 4, the maximum daily dose (MDD) is 1mg of the total alkaloids contained in the product which are derived from belladonna, hyoscyamus stramonium or other solanaceous plant, and there is no maximum dose (MD).
Second Schedule
Part 1
( Regulation 5 (5))
| Substances which when contained in certain non-prescription medicinal products may only be supplied in the manufacturers original container showing the legal classification for supply |
| Acyclovir Diclofenac Diethylammonium Famotidine Flurbiprofen Hydrocortisone Hydrocortisone Acetate Ibuprofen Ketoprofen Minoxidil Naproxen Nicotine Nicotine Resinate Oxetacaine Piroxicam |
Second Schedule
Part 2
( Regulation 6 )
| Substances which when contained in certain non-prescription medicinal products may be supplied in non-pharmacy outlets |
| Aspirin Colecalciferol Cyanocobalamin Ergocalciferol Folic Acid Hypericum perforatum L. Nicotinic acid Pyridoxine Hydrochloride Retinol Retinol Acetate Retinol Palmitate Sodium Fluoride Sodium Monofluorophosphate Stannous Fluoride |
Second Schedule
Part 3
( Regulation 20 (4))
| Substances which when contained in certain homeopathic medicinal products may be supplied without a prescription and in non-pharmacy outlets |
| Aconitum napellus L Anamirta cocculus (L.) Wight & Arn. Arsenic Atropa belladonna L. Caulophyllum thalictroides (L.) Mich. Conium maculatum L. Cytisus scoparium L. Digitalis purpurea L. Ephedra vulgaris Rich. Gelsemium nitidum L. Ginkgo biloba L. Hypericum perforatum L. Mandragora autumnalis Bertol. Phytolacca species Podophyllum species Pilocarpus jaborandi Holmes Rauwolfia serpentina (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. |
Second Schedule
Part 4
( Regulation 20 (5))
| Herbal substances which when contained in extemporaneously prepared medicinal products may be supplied without a prescription in certain limited circumstances |
| Ginkgo biloba L. Hypericum perforatum L. |
Third Schedule
Part 1
( Regulation 7 (3))
| Substances which, when contained in Medicinal Products intended for external use that 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 | Substances which, when contained in Medicinal Products intended for external use that 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 |
| Alclomethasone Dipropionate | Fluocortolone |
| Beclometasone Dipropionate | Fluocortolone Hexanoate |
| Betametasone | Fluocortolone Pivalate |
| Betametasone Benzoate | Fluorometholone |
| Betametasone Dipropionate | Fluprednidene Acetate |
| Betametasone Sodium Phosphate | Formocortal |
| Betametasone Valerate | Halcinonide |
| Clobetasol Propionate | Hydrocortisone |
| Clobetasone Butyrate | Hydrocortisone Acetate |
| Desonide | Hydrocortisone Butyrate |
| Desoxymethasone | Medrysone |
| Dexamethasone | Methylprednisolone Acetate |
| Dexamethasone Sodium Phosphate | Mometasone Furoate |
| Diflorasone Diacetate | Prednisolone |
| Diflucortolone Valerate | Prednisolone Acetate |
| Fluclorolone Acetonide | Prednisolone Hexanoate |
| Fludroxycortide | Prednisolone Sodium Phosphate |
| Flumethasone Pivalate | Prednisolone Steaglate |
| Fluocinolone Acetonide | Triamcinolone Acetonide |
| Fluocinonide |
Third Schedule
Part 2
( Regulation 7 (3))
| Substances which, when contained in Medicinal Products that are intended for use as an oral contraceptive 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 | Substances which, when contained in Medicinal Products that are intended for use as an oral contraceptive 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 |
| Cyproterone acetate | Levonorgestrel |
| Drospirenone | Lynestrenol |
| Desogestrel | Mestranol |
| Estradiol valerate | Norelgestromin |
| Ethinylestradiol | Norethisterone |
| Etynodiol diacetate | Norethisterone acetate |
| Gestodene | Norgestimate |
Fourth Schedule
( Regulation 8 )
| Substances not to be contained in a Medicinal Product supplied under the exemption conferred by Regulation 8 | Substances not to be contained in a Medicinal Product supplied under the exemption conferred by Regulation 8 |
| Ammonium Bromide | Meclofenoxate Hydrochloride |
| Calcium Bromidolactobionate | Mifepristone |
| Calcium Bromide | Piracetam |
| Chlomethiazole Edisilate | Potassium Bromide |
| Chlomethiazole | Sodium Bromide |
| Embutramide | Strychnine Hydrochloride |
| Fluanisone | Tacrine Hydrochloride |
| Hydrobromic Acid | Thiopental Sodium |
Fifth Schedule
Cautionary and Warning Notices for Dispensed Medicinal Products
( Regulation 9 (2)(i))
| Notice | Examples of medicinal products for which the notice appearing opposite may be appropriate | |
| 1 | Warning. May cause drowsiness | Products for children containing antihistamines or other products given to children that can cause drowsiness. |
| 2 | Warning. May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink. | Products for adults that can cause drowsiness thereby affecting the ability to drive and operate hazardous machinery. |
| 3 | Warning. May cause drowsiness. If affected do not drive or operate machinery | Monoamine-oxidase inhibitors when “Treatment Card” is supplied. |
| 4 | Warning. Causes drowsiness which may continue the next day. If affected do not drive or operate machinery. Avoid alcoholic drink | Hypnotics and certain other products with sedative effects, prescribed to be taken at night |
| 5 | Warning. Avoid alcoholic drink | |
| 6 | Do not take indigestion remedies at the same time of day as this medicine. | Products coated to resist gastric acid (e.g. enteric coated tablets). This is to avoid the possibility of premature dissolution due to the presence of an alkaline pH. |
| 7 | Do not take indigestion remedies or medicines containing iron or zinc at the same time of day as this medicine | Products containing ciprofloxacin and some other quinolones, doxycycline, lymecycline, minocycline or penicillamine |
| 8 | Do not take milk, indigestion remedies or medicines containing iron or zinc at the same time of day as this medicine | Products containing norfloxacin, tetracyclines other than doxycycline and minocycline |
| 9 | Do not stop taking this medicine except on your doctor's advice | Products (such as beta-adrenoceptor blocking drugs, anti-hypertensives, those for the treatment or prophylaxis of asthma or allopurinol) required to be taken over a prolonged period for a benefit to be noticed or where withdrawal is likely to be a particular hazard (e.g. clonidine). |
| 10 | Take at regular intervals. Complete the prescribed course unless otherwise directed | Antimicrobial drugs given by mouth. |
| 11 | Warning. Follow the printed instructions you have been given with this medicine. | Products (such as anticoagulants, lithium and oral corticosteroids) in respect of which a treatment card or other written instructions are given to the patient. |
| 12 | Avoid exposure of skin to direct sunlight or sun-lamps. | Products which may cause photo toxic or photo allergic reactions. |
| 13 | Do not take products containing aspirin while taking this medicine. | Products containing salicylate derivatives |
| 14 | Dissolve or mix with water before taking. | |
| 15 | This medicine may colour the urine. | Products such as levodopa (dark reddish), phenolphthalein (pink), triamterene (blue), and rifampicin (red). |
| 16 | Caution flammable: keep away from fire or flames. | |
| 17 | Allow to dissolve under the tongue. Do not transfer from this container. Keep tightly closed. Discard eight weeks after opening | Glyceryl trinitrate Tablets. |
| 18 | Not to be used for prolonged periods or at higher levels than those recommended without medical advice. | Sympathomimetics for internal use. |
| 19 | Do not take more than.....in 24 hours or......in any one week | Products containing ergotamine. |
| 20 | Do not take more than.......in 24 hours. | Products for the treatment of acute migraine except for ergotamine (see above). |
| 21 | Take an hour before food or on an empty stomach. | Certain oral antibiotics the absorption of which may be reduced by the presence of food and acid in the stomach. |
| 22 | Take half to one hour before food. | Products the action of which is thereby improved. |
| 23 | To be swallowed whole, not chewed. | Enteric coated or modified release products or in the case of products that taste very unpleasant or may damage the mouth. |
| 24 | Take with plenty of water | |
| 25 | To be applied sparingly. | Products for external use containing a corticosteroid or dithranol. |
| 26 | To be dissolved under the tongue. | Products intended for sublingual use. |
| 27 | To be sucked or chewed | |
| 28 | Take with or after food. | Products liable to cause gastric irritation or which are better absorbed with food. |
| 29 | Warning. Do not exceed the stated dose. | |
| 30 | Caution. It is dangerous to exceed the stated dose. | Products that are recommended to be taken on an “as required” basis. |
| 31 | Do not take more than 2 at any one time. Do not take more than 8 in 24 hours. | Dispensed tablets or capsules containing paracetamol labelled to be taken “as required”. |
| 32 | Contains paracetamol. | Dispensed products containing paracetamol when the name on the label does not include the word “paracetamol”. |
| 33 | Contains aspirin and paracetamol. | Dispensed products containing aspirin and paracetamol when the name on the label does not include the words “aspirin” and “paracetamol”. |
| 34 | Contains aspirin. | Dispensed products containing aspirin when the name on the label does not include the word “aspirin”. |
| 35 | Contains an aspirin-like medicine. | Dispensed products containing a salicylate derivative. |
| 36 | Not to be taken. | |
| 37 | Shake the bottle. | |
| 38 | Store in a cool place. | |
| 39 | Do not use after.... | |
| 40 | Discard.....days after opening. | |
| 41 | Not to be used for babies. | |
| 42 | Not to be used for children under three years of age or for application to large areas of skin unless on medical advice. | Products containing hexachlorophane. |
| 43 | Not to be applied to broken skin and not to be used for | Products containing boric acid or borax. |
| children under three years of age. | ||
| 44 | When taking this medicine and for 14 days after your treatment finishes you must observe the following instructions:- 1. Do not eat cheese, pickled herrings or broad bean pods. 2. Do not eat or drink bovril, oxo, marmite or any similar meat or yeast extract. 3. Eat only fresh foods and avoid food that you suspect could be stale or going off. This is especially important with meat, fish, poultry or offal. Avoid game. 4. Do not take any other medicines whether purchased by you or previously prescribed for you by your doctor, without first consulting your doctor or your pharmacist. 5. Avoid alcoholic drinks. | Monoamine-oxidase inhibitors - (Treatment Card Text). |
| 45 | If the condition is not improved, consult your doctor. | |
| 46 | Do not use in pregnancy without medical advice |
Note: Certain of these notices may be incorporated in the directions for use given on the label.
Sixth Schedule
( Regulation 22 )
| Medicinal Products (Prescription and Control of Supply) Regulations 2003 CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS |
| This Certificate is issued by me, the undersigned, for the purpose of regulation 22 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, being - 1 _____ I hereby certify that I received on the _day of___ 20 from2 ___of______ a sample of 3 ___ for test, examination or analysis; which was undamaged, duly sealed and marked 4 ____. I further certify that the said sample has been tested, examined or analysed by me or under my direction and that the results are as follows:- 5 Results Signature____ Date_______ Address______ __________ |
| GIVEN under my Official Seal this 11th day of November, 2003. | |
| MICHEÁL MARTIN ______ Minister for Health and Children |
Explanatory Note
(This note is not part of the Instrument and does not purport to be a legal interpretation).
The main purpose of these Regulations is to consolidate and to update the controls applicable to the prescription and supply of medicinal products to the public in accordance with the requirements of E.U. Directive 2001/83/EC of 6^th November 2001 insofar as that Directive relates to the classification for the supply of medicinal products for human use (OJ No L311, 28.11.2001. p67). The Regulations also set out the classification for supply of medicinal products to the public as required by that Directive.
The Regulations apply an up-to-date and comprehensive system of control to medicinal products and identify those products which may only be supplied on medical prescription. The circumstances excluding medicinal products from prescription-only control are also specified and incorporates a pharmacy-only category into which most such non-prescription products fall.
The Regulations up-date the list of medicinal products subject to prescription control and de-regulate certain other products, which were previously subject to prescription control. In recognition of Ireland's position as part of the E.U. Internal Market, the term “supply” is defined in the broader context, so that the controls apply equally to supplies made to persons in the State and to persons who may at the time be in another Member State of the European Union. In this connection also, the supply of medicinal products by mail order is prohibited, as is the supply by means of automatic vending machines.
The Regulations also impose particular restrictions on the sale of medicinal products containing paracetamol. In this context they prescribe maximum pack size for products when sold in pharmacies and in non-pharmacies. They set out the precautionary and warning statements that must appear on the packs and they prohibit the sale of multiple packs in the course of a single transaction. They also require that all solid unit dosage forms be included in blister packs or other equivalent form on packaging with appropriate exemptions for supplies made on prescription.
Certain exemptions are also provided in respect of certain low strength homeopathic medicinal products, which will be available to the public without a prescription and also in the case of certain extemporaneously prepared herbal medicinal products that are used by medical herbalists who are not medical practitioners.
In addition, the Regulations set out the restrictions relating to the dispensing of prescriptions, the conditions for emergency supply of prescription-only medicinal products by pharmacists, the requirements for the labelling of dispensed medicinal products and for pharmacy records and a prohibition on the supply of medicinal products after their expiry dates.
Copies may be obtained from the Government Publications Sale Office, Sun Alliance House, Molesworth Street Dublin 2 or by mail order from Government Publications, Postal Trade Section, 51 St Stephen's Green, Dublin 2 Fax no: 01 6476843, Price €12.19.
Department of Health and Children
November, 2003
Footnotes
Here insert official title of analyst.
Here insert the name of the sampling officer or agent who submitted the sample for analysis.
Here insert the name or description of the substance or product.
Here insert the distinguishing mark on the sample and the date of sampling shown thereon.
Here insert the relevant results as appropriate.
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