S.I. No. 116/2000 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 2000

I, Micheal Martin, 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, 2000.

2. These Regulations shall be construed as one with the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 to 1999 and may be cited together with those Regulations as the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 to 2000.

3. The Medicinal Products (Prescription and Control of Supply) Regulations, 1996 ( S.I. No. 256 of 1996 ), as amended by the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 1996 ( S.I. No. 309 of 1996 ) and by the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations, 1999 ( S.I. No. 271 of 1999 ), are hereby amended by the substitution in the First Schedule thereto, for the entries in Columns 2, 3, 4 and 5 in respect of the substance specified in Column 1 of the Schedule to these Regulations, of the entries in Columns 2, 3, 4 and 5 of the Schedule to these Regulations.

Schedule

Substances which when contained in medicinal products are subject to prescription control and circumstances excluding certain products from such control

		Circumstances excluding medicinal products from prescription control
Column	Column	Column	Column	Column
1	2	3	4	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
Hydrocortisone acetate	A	(1) Equivalent to 1.0% of Hydrocortisone (MS)	(1) External: For use in irritant dermatitis, contact allergic dermatitis, insect bite reactions and mild to moderate eczema.
		15.0g (MPS)
			For use in adults and children not under 10 years.
		(2) Equivalent to 1.0% of Hydrocortisone (MS) 15.0g (MPS)	(2) External:
			In ointments when in combination with one or 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.
		(3) 10mg (MS) 12 (MPS)	(3) External:
		(3) 10mg (MS) 12 (MPS)	In suppositories when in combination with one or 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.

	GIVEN under my Official Seal this 3rd day of May, 2000
	Micheal Martin, T.D.,
	_______________________
	Minister for Health and Children

Explanatory Note

(This is not part of the instrument and does not purport to be a legal interpretation)

The purpose of these Regulations is to de-regulate from prescription-only control certain ointments containing hydrocortisone acetate when intended for use in haemorrhoids.