S.I. No. 39/1993:

MEDICAL PREPARATIONS (WHOLESALE LICENCES) REGULATIONS, 1993.

MEDICAL PREPARATIONS (WHOLESALE LICENCES) REGULATIONS, 1993.

The Minister for Health, in exercise of the powers conferred on him by section 5 of the Health Act, 1947 (No. 28 of 1947) and section 65 of that Act as amended by section 39 of the Health Act, 1953 (No. 26 of 1953) and section 36 of the Misuse of Drugs Act, 1977 (No. 12 of 1977), hereby makes the following Regulations:--

1. These Regulations may be cited as the Medical Preparations (Wholesale Licences) Regulations, 1993.

2. The Medical Preparations (Wholesale Licences) Regulations, 1974 ( S.I. No. 333 of 1974 ), are hereby revoked.

3. In these Regulations--

" the Minister" means the Minister for Health;

"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.

4. Subject to the exemptions provided for in article 5 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.

5. (1) The provisions of article 4 of these Regulations shall not apply to--

( a ) the sale or supply or the keeping or offering for sale or supply of a medical preparation by a person who has manufactured it in accordance with a manufacturer's licence held by him under the Medical Preparations (Licensing of Manufacture) Regulations, 1993 ( S.I. No. 40 of 1993 ), or

( b ) the sale by retail of a medical preparation to a registered medical practitioner or a registered dentist for administration to his patients, or

( c ) arrangements for the distribution of medical preparations amongst themselves by one member of a group of persons not exceeding three in number who co-operate in the purchase by wholesale of those medical preparations.

(2) "Person" for the purposes of paragraph (c) of sub-article (1) of this article means a registered pharmaceutical chemist, a registered dispensing chemist and druggist or a registered druggist.

6. A wholesaler's licence may relate to medical preparations generally, to medical preparations of a class or description specified in such licence or to one or more medical preparations specified in such licence.

7. (1) The Minister may grant a wholesaler's licence to any person who applies in the form and manner required by the Minister and who satisfies the Minister in regard to the medical preparation or preparations which he proposes to sell by wholesale, that he has suitable premises, equipment and staff and suitable arrangements for record-keeping, handling, storage and distribution.

(2) A wholesaler's licence granted under sub-article (1) of this article shall be subject to such conditions as the Minister may specify and may, in particular, require that the holder of the licence--

( a ) shall supply a medical preparation only to a person who is in possession of a licence as referred to in sub-article (1) of this article or to a person carrying on a business of shopkeeping provided he has reasonable grounds for believing that the person is a person entitled to sell the medical preparation under and in accordance with the provisions of the Medical Preparations (Licensing, Advrtisement & Sale) Regulations, 1984 and 1989 ( S.I. No. 210 of 1984 and S.I. No. 347 of 1989 ) or the Poisons Regulations, 1982 ( S.I. No. 188 of 1982 ) as amended.

( b ) shall not sell by wholesale or keep or offer for sale by wholesale

(i) any medical preparation other than those to which the licence relates,

(ii) any medical preparation which requires a product authorisation under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 and 1989 ( S.I. No. 210 of 1984 and S.I. No. 347 of 1989 ) and which is not the subject of such an authorisation for the time being in force,

(iii) any medical preparation otherwise than in conformity with the provisions of the aforementioned product authorisation,

( c ) shall provide and maintain such premises, equipment and staff, and have in operation such arrangements as are necessary to avoid deterioration of the medical preparation to which the licence relates and shall notify the Minister promptly of any material change in such premises, equipment, staff or arrangements,

( d ) shall undertake proceudres for storage, stock turnover and maintenance of records which are in compliance with the particulars furnished in connection with the application for the licence or with such other arrangements as may be approved by the Minister from time to time,

( e ) shall, on being informed by the Minister or the manufacturer that any batch or part of a batch of a medical preparation to which the licence relates has been found not to conform as regards the provisions of the relevant product authorisation in force under the Medical Preparations (Licensing, Advertisement and Sale) Regulations 1984 and 1989, or as regards strength, quality or purity with the appropriate specification of that medical preparation, if so directed by the Minister, immediately withdraw from sale any supplies of that batch held by him and immediately recall all supplies already sold or distributed from that batch,

( f ) shall, on being informed by the Minister that a medical preparation to which the licence relates has been found to give rise to unacceptable adverse reactions, if so directed by the Minister, immediately withdraw any supplies held by him of that medical preparation from sale and, so far as may be practicable, immediately recall all supplies of it already sold or distributed by him,

( g ) in order to facilitate the withdrawal or recall as mentioned in paragraphs (e) and(f) of this sub-article, shall keep records either in the form of purchase/sales invoices, or on computer or in any other form giving for any transaction in the medical preparations received or dispatched at least the following information:

-- date of supply

-- name of the medical preparation

-- quantity received or supplied

-- name and address of the supplier or consignee, as appropriate,

( h ) shall keep available the records referred to in paragraph (2) (g) for inspection by an officer responsible for the enforcement or execution of these Regulations for a period of five years from the date of issue of a licence under these Regulations,

( i ) shall comply with such principles and guidelines of good distribution practice for medical preparations as may be laid down by the Minister,

( j ) shall from time to time, permit such inspections and make available such information as may be required to satisfy the Minister that the conditions of the licence are being complied with,

( k ) shall give without payment, an adequate sample of the medical preparation to any person authorised to take such a sample and

( l ) shall furnish with the supply of a medical preparation information confirming:

-- the date of supply

-- the name and pharmaceutical form of medical preparation

-- the quantity supplied

-- the name and address of the supplier and consignor.

8. A wholesaler's licence shall remain in force for a period of three years, or such shorter period as may be specified in the licence, unless it is sooner revoked by the Minister.

9. (1) There shall be paid to the Minister an annual fee in respect of each wholesaler's licence.

(2) The amount of the annual fee shall be £625 where the selling by wholesale is from a single premises with an additional £205 in respect of each additional such premises.

10. (1) The Minister may refuse to grant an application for a licence under these Regulations or he may revoke a licence already granted.

(2) If the Minister proposes to refuse or to revoke a wholesaler's licence, he shall notify the applicant or the holder as the case may be, of the reasons for such proposal and invite him to make representations in the matter to him within thirty days of the giving of such notice, and the Minister shall consider any such representations.

(3) The Minister shall inform the applicant or licence holder in writing of his decision regarding such proposed refusal or revocation as mentioned in sub-article (2) of this article within sixty days of the notice referred to in that sub-article.

11. (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 and by the Pharmaceutical Society of Ireland and its 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 and in the case of an officer of the Pharmaceutical Society of Ireland, a written authorisation of that Society), 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) of this article 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.

(4) So much of sub-article (2) of this article as enables officers of the Pharmaceutical Society of Ireland to enter premises of any class or description shall not apply as respects any of the following premises--

( a ) a hospital, nursing home, clinic or similar institution;

( b ) the premises of a manufacturer of a medical preparation.

12. 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.

13. The certificate referred to in article 12 of these Regulations shall be in the form set out in the Schedule to these Regulations.

SCHEDULE

Medical Preparations (Wholesale Licences) Regulations, 1993

CERTIFICATE STATING RESULTS OF TEST, EXAMINATION OR ANALYSIS

This Certificate is issued by me, the undersigned, for the purpose of article 12 of the Medical Preparations (Wholesale Licences) Regulations, 1993, being (1) __________________________

(1) Here insert the official title of analyst.

I hereby certify 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) _________________________________________

(2) Here insert the name of the samping 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.

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

Signature _______________________________ Date________________________________

Address ________________________________

________________________________

GIVEN under the Official Seal of the Minister for Health, this 11th day of February, 1993.

BRENDAN HOWLIN,

Minister for Health.

The Minister for Finance hereby consents to article 9 of these Regulations.

Dated this 11th day of February, 1993.

BERTIE AHERN,

Minister for Finance.

EXPLANATORY NOTE.

These Regulations consolidate the statutory controls of the sale of medical preparations by wholesale and incorporate provisions to give effect to Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medical preparations for human use (O.J. of the European Communities No. L113 of 30/4/92, pages 1-4). The regulations also provide for an increase in the fees charged for licences granted in respect of the sale by wholesale of medical preparations.