S.I. No. 348/1989:

MEDICAL PREPARATIONS (WHOLESALE LICENCES) (AMENDMENT) REGULATIONS, 1989.

MEDICAL PREPARATIONS (WHOLESALE LICENCES) (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 (Wholesale Licences) (Amendment) Regulations, 1989.

(2) These Regulations shall be construed as one with the Medical Preparations (Wholesale Licences) Regulations, 1974 ( S.I. No. 333 of 1974 ) (hereinafter referred to as "the Principal Regulations") and may be cited together as the Medical Preparations (Wholesale Licences) Regulations, 1974 and 1989.

2. The Principal Regulations are hereby amended by--

(1) the substitution in article 2 of the following definition for "sale by wholesale"--

" '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.".

(2) the substitution of the following article for article 3

"3. Subject to the exemptions provided for in article 4 of these Regulations, no person shall keep or offer for sale by wholesale or sell by wholesale, any medical preparation except in accordance with a licence (hereinafter called a wholesaler's licence) granted by the Minister.".

(3) the insertion in paragraph (a) of article 4 (1) after "supply" of "or the keeping or offering for sale or supply".

(4) the insertion in paragraph (a) of article 6 (2) after "wholesale" of "or keep or offer for sale by wholesale".

(5) the substitution of the following article for article 10--

"10 (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) 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 or preparation which is stored, kept or offered for sale at such premises,

( c ) require the production of and, if he thinks fit, take copies of any order, invoice or other document or of any entry in any register at such premises, and

( d ) take (without payment) samples of any substance or preparation stored, or offered or kept for sale at such premises for test, examination or analysis.

(3) Sub-article (2) shall not apply as respects any of the following premises--

( a ) such part of any premises (not being a shop) as is used by a registered medical practitioner or registered dentist for carrying on his practice, or

( b ) a premises used only as a private dwelling.".

(6) the insertion of the following new article after article 10--

"10A In any proceedings for an offence under section 65 of the Health Act, 1947 , as amended by section 39 of the Health Act, 1953 , and section 36 of the Misuse of Drugs Act, 1977 , in relation to these Regulations a certificate signed by--

( a ) the State Chemist, or

( b ) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875,

stating the result of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of such result.".

3. The certificate referred to in article 10A of the Principal Regulations as amended by these Regulations shall be in the form set out in the Schedule to these Regulations.

SCHEDULE

Medical Preparations (Wholesale Licences) Regulations, 1974 and 1989

Certificate stating results of Test, Examination or Analysis

This Certificate is issued by me, the undersigned, for the purpose of article 10A of the Medical Preparations (Wholesale Licences) Regulations, 1974 being (1) ............................................................ ..............

I hereby certificate that I received on the ........... day of ............................ 19........... from (2) ....................... of ............................................................ . a sample of (3) ........................... for test, examination or analysis; which was undamaged, duly sealed and marked (4) ............................................................ ............................................

I further certify that the said sample has been tested, examined or analysed by me or under my direction and that the results are as follows:--(5)

Results

(1) Here insert official title of analyst.

(2) Here insert the name of the sampling officer who submitted the sample for analysis.

(3) Here insert the name or description of the substance or preparation.

(4) Here insert the distinguishing mark on the sample and the date of sampling shown thereon.

(5) Here insert the relevant results as appropriate.

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 principally to facilitate enforcement of the statutory wholesale licensing scheme for medicines provided for in the Medical Preparations (wholesale Licences) Regulations, 1974 by:

(1) providing that the offering or keeping for sale by wholesale in addition to sale by wholesale be subject to the licensing scheme, and

(2) extending the authority to enforce the Regulations to health boards and their officers.