Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 1999

• Jurisdiction: Ireland
• Citation: IR SI 271/1999
• Year: 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 ...