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

I, BRIAN COWEN, Minister for Health and Children, in exercise of the powers conferred on me by section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), as adapted by the Health (Alteration of Name of Department and Title of Minister) Order, 1997 ( S.I. No. 308 of 1997 ), hereby make the following Regulations—

1. These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 1999.

2. These Regulations shall be construed as one with the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 ( S.I. No. 256 of 1996 ) and the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 1996 ( S.I. No. 309 of 1996 ) and may be cited together with those Regulations as the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 to 1999.

3. (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(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—

(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 )”;

(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;

(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;

(d) the deletion in the Second Schedule thereto of the reference to “Regaine Topical Solution 2%;

(e) the insertion in Part 1 of the Third Schedule thereto of the substance “minoxidil”;

(f) the insertion in Part 1 of the Fourth Schedule thereto of the substance “diflorasone diacetate”; and

(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:
Pseudoephedrine Hydrochloride			(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.