LegalizeS.I. No. 69/1993 - Medical Preparations (Prescription and Control of Supply) Regulations, 1993
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.
2 amending acts · 2017-05-05, S.I. No. 173/2017 - Misuse of Drugs Regulations 2017
Note: In relation to a medical preparation 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 l mg 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
(Article 5 (6))
PART I Substances which when contained in certain non-prescription medical preparations may only be supplied in the manufacturers original container showing the legal classification for supply.
Acyclovir
Diclofenac Diethylammonium
Hydrocortisone
Hydrocortisone Acetate
Ibuprofen
Ketoprofen
Naproxen
Nicotine
Nicotine Resinate
Piroxicam
PART 2
(Article 6)
Substances which when contained in certain non-prescription medical preparations may be supplied in non-pharmacy outlets.
Aspirin
Cholecalciferol
Cyanocobalamin
Ergocaliferol
Folic Acid
Paracetamol
Pyridoxine Hydrochloride
Socium Fluoride
Sodium Monofluorophosphate
Stannous Fluoride
Vitamin A
Vitamin A Acetate
Vitamin A Palmitate
THIRD SCHEDULE
(Article 7 (3))
Substances which, when contained in certain Medical Preparations may be dispensed in the manner prescribed for a preparation which is or which contains a substance specified in Part B of the First Schedule
PART 1
| Alclomethasone Dipropionate | Fluocortolone Hexanoate |
| Beclomethasone Dipropionate | Fluocortolone Pivalate |
| Betamethasone | Fluorometholone |
| Betamethasone Benzoate | Fluprednidene Acetate |
| Betamethasone Dipropionate | Fluandrenolone |
| Betamethasone Sodium Phosphate | Formocortal |
| Betamethasone Valerate | Halcinonide |
| Clobetasol Propionate | Hydrocortisone |
| Clobetasone Butyrate | Hydrocortisone Acetate |
| Desonide | Hydrocortisone Butyrate |
| Desoxymethasone | Medrysone |
| Dexamethasone | Methylprednisolone Acetate |
| Dexamethasone Sodium Phosphate | Prednisolone |
| Diflucortolone Valerate | Prednisolone Acetate |
| Fluclorolone Acetonide | Prednisolone Hexanoate |
| Flumethasone Pivalate | Prednisolone Sodium Phosphate |
| Fluocinolone Acetonide | Prednisolone Steaglate |
| Fluocinonide | Triamcinolone Acetonide |
| Fluocortolone |
PART 2
| Desogestrel | Ethinyloestradiol |
| Ethynodiol Diacetate. | Gestodene |
| Levonorgestral | Lynoestrenol |
| Mestranol | Norgestimate |
| Norethisterone | Norethisterone Acetate |
FOURTH SCHEDULE
(Article 8)
Substances not to be contained in a medical preparation supplied under the exemption conferred by Article 8 (2).
| Ammonium Bromide | Meclofenoxate Hydrochloride |
| Calcium Bromidolactobionate | Mifepristone |
| Calcium Bromide | Piracetam |
| Chlormethiazole Edisylate | Potassium Bromide |
| Chlormethiazole | Sodium Bromide |
| Embutramide | Strychnine Hydrochloride |
| Fluanisone | Tacrine Hydrochloride |
| Hydrobromic Acid | Thiopentone Sodium |
FIFTH SCHEDULE
(Article 9 (2) (i))
Cautionary and Warning Notices for Dispensed Medical Preparations.
| Notice | Examples of medical preparations 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. | Anti-histamines (except where intended for external use only), barbiturates, hypnotics and tricyclic anti-depressants. |
| 2. | Warning. May cause drowsiness. | Alternative for Children's preparations of the examples specified in 1 above. |
| 3. | Warning. Avoid alcoholic drink. | |
| 4. | Do not take indigestion remedies at the same time of day as this medicine. | Capsules, tablets or granules incorporating an enteric coat. |
| 5. | Do not take iron preparations or indigestion remedies at the same time of day as this medicine. | Preparations containing doxycycline, minocycline or penicillamine. |
| 6. | Do not take milk, iron preparations or indigestion remedies at the same time of day as this medicine. | Preparations containing tetracyclines other than doxycycline and minocycline. |
| 7. | Do not stop taking this medicine except on your doctor's advice. | Preparations (such as betaadrenoceptor blocking drugs, antihypertensives, those for the treatment or prophylaxis of asthma, or allopurinol) required to be taken over a prolonged period for a benefit to be noticed. |
| 8. | Take at regular intervals. Complete the prescribed course unless otherwise directed. | Antimicrobial drugs given by mouth. |
| 9. | Warning. Follow the printed instructions you have been given with this medicine. | Preparations in respect of which a treatment card or other written instructions are given to the patient. |
| 10. | Avoid exposure of skin to direct sunlight or sun-lamps. | Preparations which may cause phototoxic or photoallergic reactions. |
| 11. | Do not take remedies containing aspirin while taking this medicine, | Preparations containing salicylate derivatives. |
| 12. | Dissolve or mix with water before taking. | |
| 13. | This medicine may colour the urine or stools. | |
| 14. | Caution flammable: keep away from naked flames. | |
| 15. | Allow to dissolve under the tongue. Do not transfer from this container. Keep tightly closed. Discard eight weeks after opening. | Glyceryl Trinitrate Tablets. |
| 16. | Discard eight weeks after opening. | Glyceryl Trinitrate Tablets supplied in manufacturer's original pack. |
| 17. | Not more than . . in 24 hours or . . .in any one week. | Preparations containing Ergotamine and intended for the treatment of acute migraine. |
| 18. | Not more than...in 24 hours. | Alternative for preparations specified in 17 above. |
| 19. | 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. |
| 20. | Take half to one hour before food. | Preparations the action of which is thereby improved. |
| 21. | To be swallowed whole, not chewed. | Sustained release preparations. |
| 22. | Take with plenty of water. | |
| 23. | To be applied sparingly. | Preparations for external use containing a corticosteroid or dithranol. |
| 24. | To be dissolved under the tongue. | Preparations intended for sublingual use. |
| 25. | To be sucked or chewed. | |
| 26. | Take with or after food. | Preparations liable to cause gastric irritation with nausea and vomiting or those that are better absorbed with food. |
| 27. | Caution. It is dangerous to exceed the stated dose. | |
| 28. | Not to be taken. | |
| 29. | Shake the bottle. | |
| 30. | Store in a cool place. | |
| 31. | Dot not use after... | |
| 32. | Discard...days after opening. | |
| 33. | Not to be used for babies. | |
| 34. | Warning. Do not exceed the stated dose. | |
| 35. | Not to be used for prolonged periods or at higher levels than those recommended without medical advice. | Sympathomimetics for internal use. |
| 36. | Not to be used for children under three years of age or for application to large areas of skin unless on medical advice. | Preparations containing hexachlorophane. |
| 37. | Not to be applied to broken skin and not to be used for children under three years of age. | Preparations containing boric acid or borax. |
| 38. | 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. |
| 39. | If the condition is not improved, consult your doctor | |
| 40. | 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
(Article 15)
| Medical Preparations (Prescription and Control of Supply) Regulations, 1993 | Medical Preparations (Prescription and Control of Supply) Regulations, 1993 |
| CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS | CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS |
| This Certificate is issued by me, the undersigned, for the purpose of | This Certificate is issued by me, the undersigned, for the purpose of |
| article 15 of the Medical Preparations (Prescription and Control of Supply) Regulations, 1993, being1.................................................. | article 15 of the Medical Preparations (Prescription and Control of Supply) Regulations, 1993, being1.................................................. |
| I hereby certify that I received on the.................................day of............................................................ ................ | I hereby certify that I received on the.................................day of............................................................ ................ |
| 19 from 2 ............................................................ .....................................of............................................................ ......... | 19 from 2 ............................................................ .....................................of............................................................ ......... |
| a sample of 3............................................................ ..............................................for test, examination or analysis; | a sample of 3............................................................ ..............................................for test, examination or analysis; |
| which was undamaged, duly sealed and marked4............................................................ ........................................... | which was undamaged, duly sealed and marked4............................................................ ........................................... |
| 1 Here insert official title of analyst. 2 Here insert the name of the sampling officer or agent who submitted the sample for analysis. 3 Here insert the name or description of the substance or preparation. 4 Here insert the distinguishing mark on the sample and the date of sampling shown thereon. | 1 Here insert official title of analyst. 2 Here insert the name of the sampling officer or agent who submitted the sample for analysis. 3 Here insert the name or description of the substance or preparation. 4 Here insert the distinguishing mark on the sample and the date of sampling shown thereon. |
| 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 | 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 |
| 5 Here insert the relevant results as appropriate. | 5 Here insert the relevant results as appropriate. |
| Results | Results |
| Signature.......................................... Date............................................................ ........................... | Signature.......................................... Date............................................................ ........................... |
| Address............................................................ ............................................................ .......................... | Address............................................................ ............................................................ .......................... |
GIVEN under the Official Seal of the Minister for Health, this 11th day of March, 1993.
BRENDAN HOWLIN,
Minister for Health.
EXPLANATORY NOTE.
The main purpose of these Regulations is to establish the classification for supply of medical preparations with a view to giving effect, on an on-going basis, to E.C Council Directive 92/26/EEC of 31st March, 1992 concerning the classification for the supply of medicinal products for human use (O.J. No. L 113,30.4.92, p.5).
The Regulations apply an up-to-date and comprehensive system of control to medical preparations and identify those preparations which may only be supplied on medical prescription. The circumstances excluding medical preparations from prescription control are also specified and incorporates a new pharmacy-only category into which most such non-prescription preparations fall.
The Regulations up-date the list of medical preparations subject to prescription control and de-regulate certain preparations (e.g. oral nicotine preparations for those wishing to stop smoking) which were previously subject subject to prescription control. The Regulations also make certain adjustments arising out of Ireland's position as part of the E.C. Internal Market which came into being on 1st January, 1993 (e.g. supply has been re-defined in the broader context of the European Community).
In addition the Regulations set out the restrictions relating to the dispensing of prescriptions, the conditions for emergency supply of prescription-only medical preparations by pharmacists, the requirements for the labelling of dispensed medical preparations and for pharmacy records and a prohibition on the supply of medical preparations after their expiry dates.
Special record keeping requirements are established in the case of medical preparations containing mefipristone (RU 486) for which prescriptions may only be dispensed in a hospital.
This document does not substitute the official text published in the Irish Statute Book. We accept no responsibility for any inaccuracies arising from the transcription of the original into this format.
This text is published under Irish Statute Book's own terms of reuse, not a Legalize or public-domain licence.
Irish Statute Book
CC-BY 4.0 (Oireachtas Open Data PSI Licence)
Contains Irish Public Sector Information licensed under the Oireachtas (Houses of the Oireachtas) Open Data PSI Licence / Creative Commons Attribution 4.0 International, sourced from https://www.irishstatutebook.ie.