LegalizeS.I. No. 256/1996 - Medicinal Products (Prescription and Control of Supply) Regulations, 1996
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.
8 amending acts · 2017-05-05, S.I. No. 173/2017 - Misuse of Drugs Regulations 2017
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
Article 5 (3)
| OTHER MEDICINAL PRODUCTS EXCLUDED FROM PRESCRIPTION CONTROL | OTHER MEDICINAL PRODUCTS EXCLUDED FROM PRESCRIPTION CONTROL |
| NAME, FORM AND STRENGTH OF PRODUCT | PRODUCT AUTHORISATION NUMBER |
| Regaine Topical Solution 2% | PA16/41/1. |
(Article 5(6))
THIRD SCHEDULE
PART I
| 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 |
| Hydrocortisone |
| Hydrocortisone Acetate |
| Ibuprofen |
| Ketoprofen |
| Naproxen |
| Nicotine |
| Nicotine Resinate |
| Oxethazine |
| Piroxicam |
(Article 6)
THIRD SCHEDULE
PART 2
| SUBSTANCES WHICH WHEN CONTAINED IN CERTAIN NON-PRESCRIPTION MEDICINAL PRODUCTS MAY BE SUPPLIED IN NON-PHARMACY OUTLETS |
| Aspirin |
| Cholecalciferol |
| Cyanocobalamin |
| Ergocalciferol |
| Folic Acid |
| Nicotinic acid |
| Paracetamol |
| Pyridoxine Hydrochloride |
| Sodium Fluoride |
| Sodium Monofluorophosphate |
| Stannous Fluoride |
| Vitamin A |
| Vitamin A Acetate |
| Vitamin A Palmitate |
(Article 7(3))
FOURTH SCHEDULE
| 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 | 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 | PART 1 |
| 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 Fluocortolone | Triamcinolone Acetonide |
| PART 2 | PART 2 |
| Desogestrel | Lynoestrenol |
| Estradiol valerate | Mestranol |
| Ethinyloestradiol | Norethisterone Acetate |
| Ethynodiol Diacetate | Norethisterone |
| Gestodene | Norgestimate |
| Levonorgestrel |
FIFTH SCHEDULE
(Article 8)
| SUBSTANCES NOT TO BE CONTAINED IN A MEDICINAL PRODUCTS SUPPLIED UNDER THE EXEMPTION CONFERRED BY ARTICLE 8(2). | SUBSTANCES NOT TO BE CONTAINED IN A MEDICINAL PRODUCTS 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 |
SIXTH SCHEDULE
(Article 9(2)(i))
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. | Anti-histamines (except where intended for external use only), barbiturates, hypnotics and tricyclic anti-depressants. |
| 2 | Warning. May cause drowsiness. If affected do not drive or operate machinery. | Monoamine-oxidase inhibitors when "Treatment Card" is supplied. |
| 3. | Warning. May cause drowsiness. | Alternative for Children's products of the examples specified in 1 above. |
| 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. | Capsules, tablets or granules incorporating an enteric coat. |
| 7. | Do not take iron products or indigestion remedies at the same time of day as this medicine. | Products containing doxycycline, minocycline or penicillamine. |
| 8. | Do not take milk, iron products or indigestion remedies at the same time of day as this medicine. | Products containing 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. |
| 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 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 remedies 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 phenolthalein (pink), triamterene (blue), levodopa (dark reddish) 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 | Discard eight weeks after opening. | Glyceryl Trinitrate Tablets supplied in manufacturers original pack. |
| 19 | Not more than......in 24 hours or......in any one week. | Products containing Ergotamine and intended for the treatment of acute migraine. |
| 20 | Not more than......in 24 hours. | Alternative for products specified in 17 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. |
| 22 | Take half to one hour before food. | Products the act ion of which is thereby improved. |
| 23 | To be swallowed whole, not chewed. | Sustained release products. |
| 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 with nausea and vomiting or those that are better absorbed with food. |
| 29 | Caution. It is dangerous to exceed the stated dose. | |
| 30 | Warning. Do not exceed the stated dose. | |
| 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 prolonged periods or at higher levels than those recommended without medical advice. | Sympathomimetics for internal use. |
| 43 | 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. |
| 44 | Not to be applied to broken skin and not to be used for children under three years of age. | Products containing boric acid or borax. |
| 45 | 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). |
| 46 | If the condition is not improved, consult your doctor. | |
| 47 | 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.
(Article 16)
SEVENTH SCHEDULE
| Medicinal Products (Prescription and Control of Supply) Regulations, 1996 |
| CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS |
| This Certificate is issued by me, the undersigned, for the purpose of article 16 of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996, being |
| ^(1)__________ |
| I hereby certify that I received on the _day of ___ 19_ from^(2) __ 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_______ |
| _________ |
| (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 PRODUCT. |
| (4) HERE INSERT THE DISTINGUISHING MARK ON THE SAMPLE AND THE DATE OF SAMPLING SHOWN THEREON. |
| (5) HERE INSERT THE RELEVANT RESULTS AS APPROPRIATE |
Dated this 28th day of August, 1996.
Brian O'Shea
Minister of State at the Department of Health.
Explanatory Note
The main purpose of these Regulations is to update the controls applicable to the prescription and supply of medicinal products to the public. The Regulations are also intended to establish the classification for supply of medicinal products 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 medicinal products and identify those products which may only be supplied on medical prescription. The circumstances excluding medicinal products from prescription control are also specified and incorporates a pharmacy-only category into which most such non-prescription products now 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" has been 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.
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.
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