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:
(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.