S.I. No. 271/1999 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 1999.

(1)Subject to paragraph

(2)of this Regulation, these Regulations shall come into force on the 1st day of September, 1999.

(2)The provisions of Regulation 5(

1. b)shall not come into operation until the 1st day of January, 2000. 4. In these Regulations— “international non-proprietary name” or “INN” means the international non-proprietary name recommended by the World Health Organisation for pharmaceutical substances; “the Principal Regulations” mean the Medicinal Products (Prescription and Control of Supply) Regulations, 1996. 5. The Principal Regulations are hereby amended by— (
2. a)the substitution in Regulation 4

(1)of the following definition for “product authorisation”— “‘product authorisation’ means an authorisation granted or in force in pursuance of the Medicinal Products (Licensing and Sale) Regulations, 1998 ( S.I. No. 142 of 1998 )”; (

1. b)the insertion in the First Schedule thereto of the various substances specified in Column 1 of the First Schedule to these Regulations and any entries that may appear in any of the Columns of the said First Schedule opposite the entry for each such substance; (
2. c)the substitution in the First Schedule thereto for the entries in respect of the various substances specified in Column 1 of the Second Schedule to these Regulations of the entries specified in the said Second Schedule and any entries that may appear in any of the Columns of the said Second Schedule opposite the entry for each such substance; (
3. d)the deletion in the Second Schedule thereto of the reference to “Regaine Topical Solution 2%; (
4. e)the insertion in Part 1 of the Third Schedule thereto of the substance “minoxidil”; (
5. f)the insertion in Part 1 of the Fourth Schedule thereto of the substance “diflorasone diacetate”; and (
6. g)the insertion in Part 2 of the Fourth Schedule thereto of the substance “cyproterone acetate”. 6. In the case of substances specified in Column 1 of the First Schedule of the Principal Regulations, where the name of the substance used is a name specified in Column 1 of the Third Schedule to these Regulations, such substance may also be known by the name (being the international non-proprietary name) as specified opposite the name of the said substance in Column 2 of the said Third Schedule. FIRST SCHEDULE Additional substances which when contained in medicinal products are subject to prescription control and circumstances excluding certain products from such control Column 1 Column 2 Circumstances excluding medicinal products from prescription control Column 3 Column 4 Column 5 Substance Part in Schedule Maximum strength, pack size or period of treatment Use, pharmaceutical form or manner of administration Maximum dose and maximum daily dose 19-nor-Androstenediol in its various isomeric forms A 19-nor-Androstenedione in its various isomeric forms A 19-nor-Testosterone A 4-Hydroxybutanoic acid lactone (GBL) A 4-Hydroxybutanoic acid, sodium salt (GBH) A Acamprosate B Alatrofloxacin A Amisulpride B Androstenediol in its various isomeric forms A Androstenediol in its various isomeric forms A Apraclonidine Hydrochloride A Arcitumomab A Aristolochia A Aristolochia Clematitis A Aristolochia Contorta A Aristolochia Debelis A Aristolochia Fang-chi A Aristolochia Manshuriensis A Aristolochia Serpentaria A Atorvastatin Calcium B Basiliximab C Becapiermin A Brimonidine Tartrate B Candesartan Cilexetil B Caulophyllum thalictroides Mich., the root thereof A Cefpirome Sulphate A Cefprozil A Cerivastatin Sodium B Cetrorelix Acetate A Chymopapain A Ciclopirox Olamine B Cidofovir A Clopidogrel Hydrogen Sulphate B Dactomycin A Deanol Aceglumate B Deanol Acetamidobenzoate B Desirudin A Deslorelin A Dexketoprofen B Dexketoprofen Trometamol B Didanosine A Diflorasone Diacetate A Diphtheria, Tetanus, Pertussis and Hepatitis B Vaccine A Dodecafluoropentane C Dolasetron Mesylate A Donepezil Hydrochloride A Doxorubicin Hydrochloride A Emedastine B Emedastine Difumarate B Entacapone B Eprosartan Mesylate Dihydrate B Estradiol Hemihydrate A Etonogestrel A Etoposide Phosphate A Fenoldopan Mesylate A Fenticonazole Nitrate B Ferristene C Fexofenadine Hydrochloride B Fluvastatin Sodium B Fosphenytoin B Fosphenytoin Sodium B Gadobenate Dimeglumine C Gadobenic Acid C Gemcitabine Hydrochloride A Grepafloxacin Hydrochloride Sesquihydrate A Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine A Hemin, Human A Hepatitis A Vaccine (Inactivated) A Hepatitis A Virus (Inactivated) and Hepatitis B Vaccine A Hypericum perforatum L (St. John's Wort) B External Ibandronic Acid B Igovomab A Imiglucerase A Imiquimod B Indinavir A Interferon alfacon-1 A Interferon Beta-1b A Interferon Beta-1a A Irbesartan B Irinotecan Hydrochloride Trihydrate A Lamivudine A Lanreotide Acetate A Latanoprost A Lepirudin A Letrozole A Levacetylmethadol A Levacetylmethadol Hydrochloride A Levocabastine Hydrochloride B Levofloxacin A Levoleucovorin Calcium A Lofepramine Hydrochloride A Magafodipir C Mannitol Hexanitrate A Mefenorex A Meloxicam B Mercaptamine Bitartrate B Metronidazole Benzoate B Mibefradil Dihydrochloride B Mibolerone A Miglitol B Mirtazapine A Mizolastine B Modafinil A Moexipril Hydrochloride B Montelukast Sodium B Nebivolol Hydrochloride B Nelfinavir Mesylate A Nevirapine A Nicofuranose B Nilvadipine B Nonacog alpha A Noxytiolin A Octafluoropropane C Olanzapine A Orlistat A Pancreatin B

(1)21,000 European Pharmacopoeia units of lipase per capsule (MS)

(1)Capsules

(2)25,000 European Pharmacopoeia units of lipase per gram (MS)

(2)Powder Penciclovir A Piperazine Adipate B Piperazine Citrate B Piperazine Hydrate B Piperazine Phosphate B Pramipexole B Pregnenolone A Pregnenolone Succinate A Proparacaine Hydrochloride B Rabeprazole B Raloxifene Hydrochloride B Reboxetine Methanesulphonate A Remifentanil Hydrochloride A Repaglinide B Reteplase A Ribavirin A Riluzole A Ritonavir A Rituximab A Rivastigmine A Ropinirole Hydrochloride B Rotavirus Vaccine A Samarium(153Sm) Lexidronam Pentasodium C Saquinavir Mesylate A Sertindole A Sidenafil Citrate A Sulesomab C Tacalcitol Monohydrate B Tacrolimus A Tamsulosin Hydrochloride B Tasonermin A Tazarotene B Telmisartan B Temozolomide A Tiagabine B Tiludronate Disodium B Tiludronic Acid B Tirofiban Hydrochloride A Tolcapone B Tolterodine L-Tartrate B Topiramate B Topotecan Hydrochloride A Torasemide Sodium B Tribulus terrestris L B Trifluridine A Trovafloxacin Mesylate A Urea-C13 A Valsartan B Votumumab C Yellow Fever Vaccine (Live) A Yohimbine Bark B Zaleplon A Zanamivir A Zofenopril Calcium B Zolmitriptan B SECOND SCHEDULE Substances which when contained in medicinal products are subject to prescription control and circumstances excluding certain products from such control Column 1 Column 2 Circumstances excluding medicinal products from prescription control Column 3 Column 4 Column 5 Substance Part in Schedule Maximum strength, pack size or period of treatment Use, pharmaceutical form or manner of administration Maximum dose and maximum daily does Astemizole B Azelastine Hydrochloride B Container or package containing not more than 5,040 meg of Azelastine Hydrochloride For nasal administration, in a non-aerosol, aqueous form For the treatment of seasonal allergic rhinitis For use in adults and children not less than 12 years 140 meg per nostril (MD) 280 meg per nostril (MDD) Beclomethasone Dipropionate B Container or package containing not more than 9,000 mcg of Beclomethasone Dipropionate 3 months (MPT) For the prevention and treatment of seasonal allergic rhinitis In the form of a non-pressurised nasal spray For use in persons aged 18 years and over 100 mcg per nostril (MD) 200 mcg per nostril (MDD) Budesonide B Diclofenac Diethylammonium B Equivalent of 1.0% of Diclofenac (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 less than 12 years Famotidine B 14 days (MPT) Internal For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion, and hyperacidity, and the prevention of these symptoms when associated with food and drink, including nocturnal symptoms 10 mg (MD) 20 mg (MDD) Felbinac B 3.17% (MS) External 30.0 g (MPS) 7 days (MPT) 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 Flunisolide B 0.025% (MS) Container or package containing not more than 6,000 mcg of Flunisolide (MPS) For the prevention and treatment of seasonal allergic rhinitis, including hay fever In the form of a non-pressurised nasal spray 50 mcg per nostril (MD) 100 mcg per nostril (MDD) 3 months (MPT) For use in persons aged 18 years and over Fluticasone Propionate B Hydrocortisone acetate A

(1)Equivalent to 1.0% of Hydro- cortisone (MS) 15.0 g (MPS)

(1)External For use in irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema For use in adults and children not under 10 years

(2)10 mg (MS) 12 (MPS)

(2)External In suppositories when in combination with one of more of the following: Benzyl Benzoate, Bismuth Oxide, Bismuth Subgalate, Peru Balsam, Pramoxine Hydrochloride, Zinc Oxide, for use in haemorrhoids. For use in adults and children not under 10 years Ibuprofen B

(1)50 (MPS) 200 mg (MS)

(1)Internal: Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza

(1)400 mg (MD) 1,200 mg (MDD)

(2)5.0% 30 g (MPS)

(2)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 Ketoprofen B 2.5% (MS) External 30.0 g (MPS) 7 days (MPT) 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 Mefloquin Hydrochloride B Minoxidil B

(1)2%

(1)External: For application to the scalp

(2)5%

(2)External: For application to the scalp in the treatment of alopecia androgenetica in persons aged 18 to 65 years Naproxen Sodium B 5% (MS) External 30.0 g (MPS) 7 days (MPT) 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 Nizatidine B 8 (MPS) 14 days (MPT) For the prevention of heartburn, indigestion and excess acid 75 mg (MD) 150 mg (MDD) For use in adults and children not under 16 years Piroxicam B 0.5% (MS) External 30.0 g (MPS) 7 days (MPT) 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 Pseudoephedrine Hydrochloride B Internal:

(1)Ali prolonged release products

(1)120 mg (MD) 240 mg (MDD)

(2)Any other product

(2)60 mg (MD) 240 mg (MDD) Pyridoxine Hydrochloride B 50 mg (MDD) Ranitidine Hydrochloride B 14 days (MPT) Internal For the short term symptomatic relief of acid indigestion and heartburn For use in adults and children not under 16 years Equivalent to 75 mg of Ranitidine (MD) Equivalent to 150 mg of Ranitidine (MDD) Terfenadine B THIRD SCHEDULE Substances specified in the First Schedule of the Principal Regulations for which there are International Non-proprietary Names recommended by the World Health Organisation Name in First Schedule of Principal Regulations International Non-proprietary Name (INN) Column 1 Column 2 Acrosoxacin Rosoxacin Adrenaline Epinephrine Adrenaline Acid Tartrate Epinephrine Acid Tartrate Adrenaline Hydrochloride Epinephrine Hydrochloride Allyloestrenol Allylestrenol Alphadolone Acetate Alfadolone Acetate Alphaxalone Alfaxalone Amethocaine Tetracaine Amethocaine Gentisate Tetracaine Gentisate Amethocaine Hydrochloride Tetracaine Hydrochloride Amoxycillin Amoxicillin Amoxycillin Trihydrate Amoxicillin Trihydrate Amphetamine Sulphate Amfetamine Sulphate Amphomycin Calcium Amfomycin Calcium Amylobarbitone Amobarbital Amylobarbitone sodium Amobarbital sodium Barbitone Barbital Barbitone Sodium Barbital Sodium Beclomethasone Beclometasone Beclomethasone Dipropionate Beclometasone Dipropionate Bendrofluazide Bendroflumethizide Benoryiate Benorilate Benzathine penicillin Benzathine benzylpenicillin Benzhexol Hydochloride Trihexyphenidyl Hydrochloride Bethanidine Sulphate Betanidine Sulphate Busulphan Busulfan Butobarbitone Butobarbital Butobarbitone Sodium Butobarbital Sodium Cephalexin Cefalexin Cephalexin Sodium Cefalexin Sodium Cephaloridine Cefaloridine Cephalothin Sodium Cefalotin Sodium Cephamandole nafate Cefamandole nafate Cephazolin Sodium Cefazolin Sodium Cephradine Cefradine Chlorhexadol Chloralodol Chlormethiazole Clomethiazole Chlormethiazole Edisylate Clomethiazole Edisilate Chlorthalidone Chlortalidone Cholecalciferol Colecalciferol Clomiphene Citrate Clomifene Citrate Colistin Sulphomethate Colistimethate Colistin Sulphomethate Sodium Colistimethate Sodium Corticotrophin Corticotropin Cromoglycate, Sodium Cromoglicate, Sodium Cyclobarbitone Cyclobarbital Cyclobarbitone calcium Cyclobarbital calcium Cyclosporin Ciclosporin Danthron Dantron Deoxycortone Acetate Desoxycortone Acetate Deoxycortone Pivalate Desoxycortone Pivalate Dexamphetamine Sulphate Dexamfetamine Sulphate Diatrizoate Meglumine Amidotrizoate Meglumine Diatrizoate Sodium Amidotrizoate Sodium Diatrizoic acid Amidotrizoic acid Dichlorphenamide Diclofenamide Dicyclomine Hydrochloride Dicycloverine Hydrochloride Dienoestrol Dienestrol Dimethisoquin Hydrochloride Quinisocaine Hydrochloride Dothiepin Dosulepin Dothiepin Hydrochloride Dosulepin Hydrochloride Epithiazide Epitizide Ethacrynic acid Etacrynic acid Ethamivan Etamivan Ethinyloestradiol Ethinylestradiol Ethopropazine Hydrochloride Profenamine Hydrochloride Ethyloestrenol Ethylestrenol Ethynodiol Diacetate Etynodiol Diacetate Flurandrenolone Fludroxycortide Frusemide Furosemide Hexachlorophane Hexachlorophene Hexamine Hippurate Methanamine Hippurate Hexobarbitone Hexobarbital Hexobarbitone Sodium Hexobarbital Sodium Hydroxyprogesterone Hexanoate Hydroxyprogesterone Caproate Hydroxyurea Hydroxycarbamide Indomethacin Indometacin Iodipamide Adipiodone Iodipamide Meglumine Adipiodone Meglumine Iophendylate Iofendylate Iothalamic acid Iotalamic acid Lignocaine Lidocaine Lignocaine Hydrochloride Lidocaine Hydrochloride Lynoestrenol Lynestrenol Mefloquin Hydrochloride Mefloquine Hydrochloride Methallenoestrol Methallenestrol Methohexitone Sodium Methohexital Sodium Methoin Mephenytoin Methotrimeprazine Levomepromazine Methotrimeprazine Hydrochloride Levomepromazine Hydrochloride Methotrimeprazine Maleate Levomepromazine Maleate Methsuximide Mesuximide Methyleysteine Hydrochloride Mecysteine Hydrochloride Methylphenobarbitone Methylphenobarbital Mitozantrone Hydrochloride Mitoxantrone Hydrochloride Mustine Hydrochloride Chlormethine Hydrochloride Nicoumalone Acenocoumarol Noradrenaline Norepinephrine Noradrenaline Acid Tartrate Norepinephrine Acid Tartrate Octacosactrin Tosactide Oestradiol Estradiol Oestradiol Benzoate Estradiol Benzoate Oestradiol Cypionate Estradiol Cipionate Oestradiol Dipropionate Estradiol Dipropionate Oestradiol Diundecanoate Estradiol Diundecanoate Oestradiol Enanthate Estradiol Enantate Oestradiol Phenylpropionate Estradiol Phenylpropionate Oestradiol Undecanoate Estradiol Undecanoate Oestriol Estriol Oestriol Dihemisuccinate Estriol Dihemisuccinate Oestrone Estrone Oxethazaine Oxetacaine Oxpentifylline Pentoxifylline Pentobarbitone Pentobarbital Pentobarbitone Sodium Pentobarbital Sodium Phenbutrazate Hydrochloride Fenbutrazate Hydrochloride Phenethicillin Potassium Pheneticillin Potassium Phenobarbitone Phenobarbital Phenobarbitone Sodium Phenobarbital Sodium Phthalysulphathiazole Phthalysulfathiazole Procaine penicillin Procaine benzylpenicillin Quinalbarbitone Secobarbital Quinalbarbitone Sodium Secobarbital Sodium Salcatonin Calcitonin (salmon) Salcatonin Hydrated Polyacetate Calcitonin (salmon) Hydrated Polyacetate Secbutobarbitone Secbutobarbital Secbutobarbitone Sodium Secbutobarbital Sodium Sissomicin Sisomicin Sissomicin Sulphate Sisomicin Sulphate Stanolone Androstanlone Stilboestrol Diethylstilbestrol Stilboestrol Dipropionate Diethylstilbestrol Propionate Succinylsulphathiazole Succinylsulfathiazole Sulphacetamide Sulfacetamide Sulphacetamide Sodium Sulfacetamide Sodium Sulphadiazine Sulfadiazine Sulphadiazine Silver Sulfadiazine Silver Sulphadiazine Sodium Sulfadiazine Sodium Sulphadimidine Sulfadimidine Sulphadimidine Sodium Sulfadimidine Sodium Sulphafurazole Sulfafurazole Sulphafurazole Diethanolamine Sulfafurazole Diethanolamine Sulphaguanidine Sulfaguanidine Sulphaloxic acid Sulfaloxic acid Sulphamethizole Sulfamethizole Sulphamethoxazole Sulfamethoxazole Sulphamethoxydiazine Sulfametoxydiazine Sulphamethoxypyridazine Sulfametoxypyridazine Sulphamethoxypyridazine Sodium Sulfametoxypyridazine Sodium Sulphamoxole Sulfamoxole Sulphaphenazole Sulfaphenazole Sulphasalazine Sulfasalazine Sulphathiazole Sulfathiazole Sulphathiazole Sodium Sulfathiazole Sodium Sulphaurea Sulfacarbamide Sulphinpyrazone Sulfinpyrazone Tetracosactrin Tetracosactide Tetracosactrin Acetate Tetracosactide Acetate Thioguanine Tioguanine Thiopentone Sodium Thiopental Sodium Thymoxamine Hydrochloride Moxisylyte Hydrochloride Thyroxine Sodium Levothyroxine Sodium Trimeprazine Alimemazine Trimeprazine Tartrate Alimemazine Tartrate Troxidone Trimethadione Urofollitrophin Urofollitropin Vitamin A Retinol Vitamin A Acetate Retinol Acetate Vitamin A Palmitate Retinol Palmitate GIVEN under my Official Seal, this 27th day of August, 1999. BRIAN COWEN, 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 purpose of these regulations is to update the list of medicinal products which are subject to prescription-only controls, to de-regulate certain medicinal products currently only available on prescription, to adjust existing controls applicable to certain medicinal products and to identify certain substances by their International Non-Proprietary Names as recommended by the World Health Organisation. Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government of Ireland. Oireachtas Copyright Material is reproduced with the permission of the Houses of the Oireachtas © Rialtas na hÉireann. Atáirgtear ábhar faoi Chóipcheart le cead ó Thithe an Oireachtais