S.I. No. 210/1984 - Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984.

1. The authorisation holder shall report to the Minister any change in his name and address and in any address at which there is carried on a business to which the authorisation relates.

2. The authorisation holder shall ensure that any preparation to which the authorisation relates is manufactured only in accordance with the methods set out in, or furnished in connection with, his application for the product authorisation and that the specifications of the constituents and of the finished preparation are in accordance with the information contained in, or furnished in connection with the said application except insofar as may otherwise be approved by the Minister.

3. The authorisation holder shall not issue, or cause another person to issue, or consent to the issue of any advertisement or recommendation, relating to any preparation to which the authorisation relates, which contains particulars as to the uses, nature or effects of such preparation or warnings or precautions in use concerning such preparation, unless the terms of the advertisement or recommendation, insofar as they relate to such particulars, warnings, or precautions in use correspond to or differ only to an extent that is not material from those specified in the authorisation.

4. The authorisation holder shall inform the Minister of any material change that has been made, or is proposed to be made in the particulars contained in or furnished in connection with his application, in relation to any preparation to which the authorisation relates, that is to say:—

(

a

) in the composition of the preparation, or of any of its constituents,

(

b

) in the specification of the preparation or of any of its constituents,

(

c

) in the methods of manufacture of the preparation or of any of its constituents,

(

d

) in the methods and procedures described in the application for ensuring compliance with such specifications,

(

e

) in the arrangements described in the application for storage of the preparation,

(

f

) in the recommended uses. routes of administration or dosage schedules, or

(

g

) in the method of retail sale, supply or sales promotion.

5. The authorisation holder shall inform the Minister of any additional information received by him which may alter the validity of data provided in support of the application, or may further the understanding of the substance and its effects or may alter the directions for use of the medical preparation which is the subject of the authorisation.

6. The authorisation holder shall keep a record of reports of adverse effects associated with the use of the preparation to which the authorisation relates. The record shall be available for inspection by a person authorised by the Minister who may take copies thereof. The authorisation holder shall furnish to the Minister a copy of any such report of which he has a record or of which he is aware.

7. The authorisation holder shall keep available for inspection by a person authorised by the Minister durable records of his arrangements

(

a

) for obtaining materials for the purpose of the manufacture by him or on his behalf of any preparation to which the authorisation relates, and

(

b

) for procuring the manufacture, importation, storage, sale or supply of any such preparation, and

(

c

) for the tests to be carried out on any such preparation or on the materials used for its manufacture

and shall permit the person so authorised to take copies of, or to make extracts from, such records. The records shall be retained for a period of five years from the date on which the relevant batch of the preparation was released for sale or was imported by or on behalf of the authorisation holder.

8. The authorisation holder shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any preparation to which the authorisation relates.

9. (1) The authorisation holder, on being informed by the Minister that any preparation to which the authorisation relates has been found:—

(

a

) to be harmful under normal conditions of use, or

(

b

) to be lacking in therapeutic efficacy, or

(

c

) not to be in accordance with the information contained in or furnished in connection with the application for such authorisation, or furnished in compliance with any of the conditions set out in this Schedule, as regards the qualitative or quantitative composition of the preparation, or

(

d

) not to he in accordance with any conditions, other than those set out in this Schedule, which are specified in the product authorisation.

shall, if so directed by the Minister, withhold from sale all batches of the preparation or such batch as may he specified by the Minister, and so far as may reasonably be practicable immediately recall all supplies of the preparation or of such batch of the preparation as has already been issued.

(2) The authorisation holder shall comply with the conditions set out in sub-paragraph (1) where the controls on the preparation to which the authorisation relates, or on any of its constituents, in the course of its manufacture as indicated in or in connection with his application for the product authorisation or in compliance with the conditions set out in this Schedule, have not been carried out.

10. The authorisation holder shall notify the Minister of any decision to withdraw from sale or supply any preparation to which the authorisation relates and shall state the reason for that decision.

11. The authorisation holder shall on request by the Minister:—

(i) furnish to him from such batch or batches as he may specify a sample of any preparation to which the authorisation relates for the purpose of test, examination or analysis, or

(ii) furnish to him full particulars of the tests which have been applied to such batch or batches of such preparation as he may specify and the result of such tests.

12. The authorisation holder shall, if requested by the Minister withhold from sale any batch or batches in respect of which a sample is, or particulars are requested to be furnished under sub-paragraphs (i) and (ii) of paragraph 11 until a certificate authorising the sale of the batch or batches has been issued to him by the Minister.

13. The authorisation holder shall ensure:—

(

a

) that the preparation to which the authorisation relates is not sold unless it has been manufactured in the premises in respect of which any undertaking has been given pursuant to article 8.

(

b

) that such preparation has been manufactured in such premises and in such circumstances as to comply with any conditions specified in such undertaking.

14. The authorisation holder shall in the event of the authorisation being revoked surrender it to the Minister.

SECOND SCHEDULE.

Category of Medical Preparation

Sub-category of Medical

Preparation

Commencement

Date

1

Preparations which are to be sold under a proprietary designation

(1) Preparations which were not on the market prior to 1 October, 1974

1 October, 1984

(2) Preparations which were on the market prior to 1 October, 1974.

1 October, 1984

2

Preparations which are not to be sold under a proprietary designation

(1) Preparations which were not on the market prior to 1 October, 1984.

(2) Preparations of the following classes which were on the market prior to 1 October, 1984

1 October, 1984

( a ) Anti-Infectives.

1 December, 1985.

( b ) Hypno2tics, sedatives, tranquillisers and anti-depressants.

1 April, 1986.

( c ) Corticosteroids, hormones, diuretics and drugs affecting the cardiovascular system.

1 April, 1987.

( d ) Analgesics, miscellaneous central and autonomic nervous system drugs (including anaesthetics).

1 April, 1988.

( e ) Metabolic and haematinic drugs, products locally acting on skin or mucosa.

1 September, 1988.

( f ) Miscellaneous including products locally acting, on gastrointestinal or respiratory tract.

1 April, 1989.

THIRD SCHEDULE.

MEDICAL PREPARATIONS (LICENSING, ADVERTISEMENT AND SALE) REGULATIONS, 1984.

(

S.I. No. 210 of 1984

)

Certificate stating results of test, examination or analysis

This Certificate is issued by me, the undersigned, for the purpose of article 15 of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 being (1) ............................. I hereby certify that I received on the .................................. day of ......................... 19 ............... from (2) ............................ of........................................a sample of (3) ........................................... for test, examination and analysis: which was undamaged, duly sealed and marked (4) ............................................. I further certify that the said sample has been tested, examined and analysed by me or under my direction and that the results are as follows:— (5)

Signature ......................................................

Date ...........................................................

Address .........................................................

............................................................

(1) Here insert official title of analyst.

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

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

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

(5) Here insert the relevant results as appropriate.

GIVEN under the Official Seal of the Minister for Health this 3rd day of August,

1984.

BARRY DESMOND,

Minister for Health.

The Minister for Finance consents to article 10 of these Regulations.

Dated this 3rd day of August, 1984.

GARRET FITZGERALD,

Minister for Finance

EXPLANATORY NOTE.

The purpose of these Regulations is to control the marketing of medicines for human use. The control is effected by means of a common licensing scheme which applies to all human medicines, both proprietary and non-proprietary. In addition the Regulations provide for certain labelling requirements for medicines this provision is given effect by way of amendment to the Medical Preparations (Advertisement and Sale) Regulations, 1958 which apply to medicines generally.

The Regulations come into force on 1st October, 1984. The application of the licensing scheme to non-proprietary medicines will commence on 1st October, 1984 in the case of all new preparations and on a phased basis for those non-proprietaries already on the market.

15. (1) In any proceedings for an offence under section 65 of the Act 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.

(2) The certificate referred to in sub-article (1) shall be in the form set out in the Third Schedule.

FIRST SCHEDULE

General conditions applicable to product authorisations

S.I. No. 210 of 1984.

MEDICAL PREPARATIONS (LICENSING, ADVERTISEMENT AND SALE) REGULATIONS, 1984.

The Minister for Health, in exercise of the powers conferred on him 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) hereby makes the following Regulations:—