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Irish Statutory Instruments


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

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

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STATUTORY INSTRUMENTS.

S.I. No. 271 of 1999.


MEDICINAL PRODUCTS (PRESCRIPTION AND CONTROL OF SUPPLY) (AMENDMENT) REGULATIONS, 1999.

S.I. No. 271 of 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

../images/seal.jpg

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.


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URL: http://www.bailii.org/ie/legis/num_reg/1999/0271.html