LegalizeS.I. No. 18/1987 - Medical Preparations (Control of Sale) Regulations, 1987
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.
1 amending act · 1993-03-11, S.I. No. 69/1993 - Medical Preparations (Prescription and Control of Supply) Regulations, 1993
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 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).
Article 6 (3)
SECOND SCHEDULE
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 I
| Alclomethasone Dipropionate | Fluocortolone Hexanoate |
| Beclomethasone Dipropionate | Fluocortolone Pivalate |
| Betamethasone | Fluorometholone |
| Betamethasone Benzoate | Fluprednidene Acetate |
| Betamethasone Dipropionate | Flurandrenolone |
| 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 II
Desogestrel
Ethinyloestradiol
Ethynodiol Diacetate
Levonorgestrel
Lynoestrenol
Mestranol
Norethisterone
Norethisterone Acetate
Article 7
THIRD SCHEDULE
Substances not to be contained in a medical preparation sold or supplied under the exemption conferred by Article 7 (2).
| Ammonium Bromide | Methylphenobarbitone |
| Amylobarbitone | Pemoline |
| Amylobarbitone Sodium | Pentobarbitone |
| Barbitone | Pentobarbitone Sodium |
| Barbitone Sodium | Phenobarbitone |
| Butobarbitone | Phenobarbitone Sodium |
| Butobarbitone Sodium | Phentermine Hydrochloride |
| Calcium Bromide | Phentermine Resinate |
| Calcium Bromidolactobionate | Phenylmethylbarbituric Acid |
| Chlormethiazole | Piracetam |
| Chlormethiazole Edisylate | Potassium Bromide |
| Cyclobarbitone | Prolintane Hydrochloride |
| Cyclobarbitone Calcium | Quinidine Phenylethylbarbiturate |
| Embutramide | Secbutobarbitone |
| Fencamfamin Hydrochloride | Secbutobarbitone Sodium |
| Fluanisone | Sodium Bromide |
| Heptabarbitone | Strychnine Hydrochloride |
| Hexobarbitone | Tacrine Hydrochloride |
| Hexobarbitone Sodium | Thiopentone Sodium |
| Hydrobromic Acid | |
| Meclofenoxate Hydrochloride | |
| Methohexitone Sodium |
Article 8 (2) (i)
FOURTH SCHEDULE
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 tetracycline other than doxycycline and minocycline. |
| 7. | Do not stop taking this medicine except on your doctor's advice. | Preparations (such as beta-adrenoceptor 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. | |
| 12. | 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. | Do 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:— | Monoamine-oxidase inhibitors. |
| 1. Do not eat cheese, pickled herrings or broad bean pods. | ||
| 2. Do not eat or drink bovril, oxo, marmite or any similar meal 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. |
Note: Certain of these notices may be incorporated in the directions for use on the label.
Article 14
FIFTH SCHEDULE
| Medical Preparations (Control of Sale) Regulations, 1987 | Medical Preparations (Control of Sale) Regulations, 1987 | Medical Preparations (Control of Sale) Regulations, 1987 | Medical Preparations (Control of Sale) Regulations, 1987 |
| ( S.I. No. 18 of 1987 ) | ( S.I. No. 18 of 1987 ) | ( S.I. No. 18 of 1987 ) | ( S.I. No. 18 of 1987 ) |
| CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS | CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS | 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 article 14 of the Medical Preparations (Control of Sale) Regulations, 1987, being ^1............................................................ ...................................... | This Certificate is issued by me, the undersigned, for the purpose of article 14 of the Medical Preparations (Control of Sale) Regulations, 1987, being ^1............................................................ ...................................... | This Certificate is issued by me, the undersigned, for the purpose of article 14 of the Medical Preparations (Control of Sale) Regulations, 1987, being ^1............................................................ ...................................... | This Certificate is issued by me, the undersigned, for the purpose of article 14 of the Medical Preparations (Control of Sale) Regulations, 1987, being ^1............................................................ ...................................... |
| I hereby certify that I received on the................................ | I hereby certify that I received on the................................ | I hereby certify that I received on the................................ | day of............................................................ .............. |
| 19 | from^2............................................of............................................................ ............................... | from^2............................................of............................................................ ............................... | from^2............................................of............................................................ ............................... |
| a sample of ^3............................... | a sample of ^3............................... | for test, examination or analysis; which was undamaged, duly sealed and | for test, examination or analysis; which was undamaged, duly sealed and |
| marked^4............................................................ ............................................................ ................................................. | marked^4............................................................ ............................................................ ................................................. | marked^4............................................................ ............................................................ ................................................. | 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 | 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 | 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 | Results | Results | Results |
| Signature............................................................ .............. | Signature............................................................ .............. | Signature............................................................ .............. | Date............................................................ ................ |
| Address............................................................ ...................... | Address............................................................ ...................... | Address............................................................ ...................... | Address............................................................ ...................... |
| ^1Here insert official title of analyst. | ^1Here insert official title of analyst. | ^1Here insert official title of analyst. | ^1Here insert official title of analyst. |
| ^2Here insert the name of the sampling officer or agent who submitted the sample for analysis. | ^2Here insert the name of the sampling officer or agent who submitted the sample for analysis. | ^2Here insert the name of the sampling officer or agent who submitted the sample for analysis. | ^2Here insert the name of the sampling officer or agent who submitted the sample for analysis. |
| ^3Here insert the name or description of the substance or preparation. | ^3Here insert the name or description of the substance or preparation. | ^3Here insert the name or description of the substance or preparation. | ^3Here insert the name or description of the substance or preparation. |
| ^4Here insert the distinguishing mark on the sample and the date of sampling shown thereon. | ^4Here insert the distinguishing mark on the sample and the date of sampling shown thereon. | ^4Here insert the distinguishing mark on the sample and the date of sampling shown thereon. | ^4Here insert the distinguishing mark on the sample and the date of sampling shown thereon. |
| ^5Here insert the relevant results as appropriate. | ^5Here insert the relevant results as appropriate. | ^5Here insert the relevant results as appropriate. | ^5Here insert the relevant results as appropriate. |
GIVEN under the Official Seal of the Minister for Health this 19th day of January, 1987.
BARRY DESMOND,
Minister for Health.
EXPLANATORY NOTE.
The purpose of these Regulations is to apply an up-to-date and comprehensive system of control to those medical preparations which should only be sold or supplied against a prescription issued by a registered medical practitioner or registered dentist. The Regulations specify the classes of medical preparations and the substances, which, when contained in medical preparations, are subjected to prescription control. The circumstances excluding certain preparations from such control are also specified.
In addition, the Regulations include restrictions in relation to the dispensing of prescriptions, conditions under which the emergency sale or supply of "prescription-only" medical preparations may be made by pharmacists, requirements as to the labelling of dispensed medical preparations, pharmacy record-keeping requirements and prohibitions on the advertising to the public of "prescription-only" medical preparations and on the sale of medical preparations after their expiry dates.
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