Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1989.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: (1) These Regulations may be cited as the Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1989.
(2) These Regulations shall be construed as one with the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ) (hereinafter referred to as "the Principal Regulations") and may be cited together with those Regulations as the Medical Preparations (Licensing, Advertisement and Sale) Regulations 1984 and 1989.
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paragraphs: In these Regulations:
"sale by wholesale" means sale or supply for the purposes of sale in the course of a business or for administration to patients in the course of a professional practice and cognate words shall be construed accordingly.
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paragraphs: The Principal Regulations are hereby amended by:—
(1) the substitution of the following sub-article for sub-article (1) of article 14:—
"(1) The enforcement and execution of the provisions of these Regulations may be carried out by officers of the Minister and by health boards and their officers.".
(2) the substitution of the following sub-article for sub-article (2) of article 14:—
"(2) Subject to sub-article (3) any such officer as aforesaid (with in the case of an officer of the Minister, a written authorisation of the Minister and in the case of an officer of a health board, a written authorisation of the board), may, at all reasonable times, for the purpose of ascertaining whether or not there is or has been a contravention of these Regulations:—
( a ) enter premises of any class or description,
( b ) inspect any substance, preparation or article which is stored, kept or offered for sale at such premises,
( c ) require the production of any book, record or other document, and inspect and, if he thinks fit, take copies of any entry in any such book, record or other document at such premises, and
( d ) take (without payment) samples of any substance, preparation or article stored or offered or kept for sale at such premises for test, examination or analysis".
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paragraphs: For the Second Schedule to the Principal Regulations there shall be substituted the Schedule to these Regulations.
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paragraphs: (1) An application for a product authorisation in respect of a medical preparation which by virtue of these Regulations is required to be the subject of a product authorisation from the 20th day of May, 1990 shall be made to the Minister before the 1st day of April, 1990.
(2) With effect from the 1st day of April, 1990 a person shall not keep or offer for sale by wholesale or sell by wholesale any medical preparation which is not the subject of a product authorisation granted under article 6 of the Principal Regulations unless he holds or has been supplied with a copy of a receipt issued by the Minister showing that the said medical preparation is the subject of an application for a product authorisation made in accordance with article 7 of the said Regulations.
(3) This article shall not apply to the manufacturer or importer of a medical preparation which:—
( a ) is kept on the written orders of a registered medical practitioner or registered dentist for the treatment of a patient under his care;
( b ) is intended for use in the conducting of a clinical trial, in accordance with a permission granted under section 4 of the Control of Clinical Trials Act, 1987 (No. 28 of 1987); or
( c ) is intended solely for export.
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paragraphs: Article 7 (2) of the Principal Regulations is hereby revoked.
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paragraphs: The Schedule to the Medical Preparations (Advertisement and Sale) Regulations, 1958 ( S.I. No. 135 of 1958 ) is hereby amended by the insertion of:—
( a ) the words "Alopecia (including male pattern baldness)" after the word "Albuminuria" and
( b ) the word "Impotency" after the words "Heart and vascular diseases".