S.I. No. 347/1989 - Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1989.

S.I. No. 347 of 1989.

MEDICAL PREPARATIONS (LICENSING, ADVERTISEMENT AND SALE) (AMENDMENT) REGULATIONS, 1989.

In exercise of the powers conferred on the Minister for Health by sections 5 and 65 of the Health Act, 1947 (No. 28 of 1947) as amended by section 39 of the Health Act, 1953 (No. 26 of 1953) and by section 36 of the Misuse of Drugs Act, 1977 (No. 12 of 1977), which said powers are delegated to me by the Health (Delegation of Ministerial Functions) Order, 1989 ( S.I. No. 235 of 1989 ), I, NOEL TREACY, Minister of State at the Department of Health, hereby make the following Regulations:

1. (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.

2. 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.

3. 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".

4. For the Second Schedule to the Principal Regulations there shall be substituted the Schedule to these Regulations.

5. (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.

6. Article 7 (2) of the Principal Regulations is hereby revoked.

7. 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".

SCHEDULE

Second Schedule

Category of medical preparation.	Sub-category of medical preparation.	Commencement Date
Preparations other than any of those hereinafter specified in this Schedule.		1st April, 1989
Preparations intended for sale or supply to the public otherwise than in dispensing or compounding of medical prescriptions within the meaning of the Pharmacy Acts, 1875 to 1977 and (a) which are not the subject of product authorisations under article 6 of the Principal Regulations, and	(1) preparations containing— — amino acids, — enzymes, — fish oils (including omega-3- fatty acids), — minerals, — vitamins, — mixtures of one or more of the above-mentioned substances whether or not containing other ingredients.	20 May, 1990
(b) which were effectively on the market prior 1st April, 1989.	(2) preparations containing herbal or other vegetable ingredients or extracts or other preparations or constituents obtained from such ingredients.	20 May, 1990
	(3) preparations intended for appetite control or weight loss.	20 May, 1990
	(4) preparations intended for use in the eye.	20 May, 1990
	(5) medicated soaps, shampoos and dressings.	20 May, 1990
	(6) medicated pastilles, lozenges, toothpastes and other medicated preparations for use in the oral cavity.	20 May, 1990

Dated this 19th day of December, 1989.

NOEL TREACY,

Minister of State at the

Department of Health.

EXPLANATORY NOTE.

The purpose of these Regulations is to amend the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 in order principally to overcome the problem of the availability of a wide range of unlicensed medical preparations by:—

(i) requiring that application for licences for the products in question — i.e. those listed by category in the Schedule to the Regulations — be made to the Minister by 1st April, 1990, and

(ii) facilitating enforcement by extending the authority to enforce the statutory requirements to health boards and their officers.

In addition, the Regulations also amend the Medical Preparations (Advertisement and Sale) Regulations, 1958 for the purpose of prohibiting the advertisement of medical preparations in respect of certain conditions i.e. alopecia and impotency.