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

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:—

1. These Regulations may be cited as the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984.

2. (1) Subject to sub-article (2) these Regulations shall come into operation on the 1st day of October, 1984.

(2) Article 4 of these Regulations shall come into operation, in the case of each category of medical preparation specified in the first column of the Second Schedule, with effect from the commencement date specified in the third column of that Schedule in respect of each sub-category of such preparation specified in the second column thereof.

(3) A person who on the 1st day of October, 1984, in circumstances to which article 4 applies, is responsible for the sale of any medical preparation or for procuring the manufacture for sale of any medical preparation specified in sub-category (2) of category 2 of the Second Schedule shall by the 1st day of December, 1984 notify the Minister in respect of such preparation, giving the name of the preparation its dosage form and its active constituents in qualitative and quantitative terms.

3. (1) In these Regulations—

"the Act" means the Health Act, 1947 ;

"import" includes procure the importation, and cognate words shall be construed accordingly;

"the Minister" means the Minister for Health:

"manufacture" includes processing, compounding, formulating, assembling, filling, packaging, labelling and importing from countries other than Member States of the European Economic Communities;

"pharmacist" means a registered pharmaceutical chemist or a registered dispensing chemist and druggist:

"registered dentist" means a person registered in the register established under the Dentists Act. 1928 (No. 25 of 1928):

"registered dispensing chemist and druggist" means a person registered in the register of dispensing chemists and druggists established under the Pharmacy Act, 1951 (No. 30 of 1951);

"registered medical practitioner" means a person registered in the register established under the Medical Practitioners Act, 1978 (No. 4 of 1978):

"registered pharmaceutical chemist" means a person registered in the register of pharmaceutical chemists for Ireland established under the Pharmacy Act (Ireland), 1875:

"sell" includes distribute or offer or keep for sale or distribution or procure the sale or distribution, and cognate words shall be construed accordingly.

(2) In these Regulations any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or as the case may be, to a Schedule thereto, any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article and any reference in a Schedule to a paragraph shall be construed as a reference to a paragraph of that Schedule.

4. (1) A person shall not. in the course of a business carried on by him and in the circumstances to which this article applies—

( a ) sell any medical preparation, or

( b ) procure the manufacture for sale of any medical preparation,

except in accordance with a licence granted or renewed by the Minister under these Regulations, hereinafter referred to as a "product authorisation".

(2) This article shall apply in each of the following circumstances:—

( a ) where the person selling the preparation or procuring the manufacture for sale of the preparation has imported the preparation;

( b ) where the person selling the preparation or procuring the manufacture for sale of the preparation is responsible for the composition of the preparation and has not imported the preparation.

(3) For the purposes of sub-article (2) (b) a person shall be taken to be responsible for the composition of a medical preparation where he either:—

( a ) manufactures the preparation to his own order or specification, or

( b ) procures, to his own order or specification, the manufacture of the preparation by another person.

(4) Subject to article 5 a person shall not import a medical preparation except in accordance with a product authorisation.

5. The provisions of article 4 shall not apply as respects:—

( a ) the sale of a medical preparation by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts, 1875 to 1977 where such sale is carried out and the preparation is extemporaneously compounded by or under the supervision of a pharmacist for such particular sale;

( b ) the importation or sale of a medical preparation by or to the order of a registered medical practitioner or registered dentist for the treatment of a patient under his care;

( c ) the importation of a medical preparation by any person for his own personal use, not being an importation resulting directly from a mail order advertisement directed to members of the public;

( d ) the importation or sale of a medical preparation solely for the purpose of its being exported.

6. (1) The Minister may grant or renew a product authorisation to any person who applies for such authorisation in accordance with article 7.

(2) A product authorisation shall be subject to the general conditions specified in the First Schedule to the Regulations and to such special conditions as may be specified in the authorisation.

(3) Unless sooner revoked by the Minister a product authorisation shall remain in force for a period of five years and may be renewed on application by the holder.

7. (1) An application for a product authorisation shall be made to the Minister and shall be in such form and be accompanied by the appropriate charge provided for under article 10 and by such information, documents, samples and other materials, as the Minister may require.

(2) An application for a product authorisation for a medical preparation in sub-category (2) of category 2 of the Second Schedule shall be made to the Minister at least twelve months before the commencement date applicable to medical preparations listed in the said sub-category.

(3) In the examination and determination of an application for a product authorisation the Minister shall take into consideration such criteria as appear to him to be relevant in the case of the application and, in particular, the information supplied by the applicant in relation to:—

( a ) the safety and efficacy of the medical preparation to which the application relates and the purpose for which the medical preparation is intended by the applicant to be administered, and

( b ) the quality of the medical preparation.

8. Where the applicant for a product authorisation is not the manufacturer of the medical preparation or where the medical preparation is to be imported into the State, the Minister may require the applicant to furnish a written undertaking in a form approved by the Minister and signed by or on behalf of the manufacturer of the preparation that in the event of the product authorisation being granted or renewed the manufacturer will comply with such conditions as may be specified in such undertaking and, in particular, that he will:—

( a ) permit the inspection by or on behalf of the Minister of the premises where the preparation is to be manufactured and of the operations to be carried out in the course of manufacture;

( b ) comply with any conditions relating to the manufacture of the preparation subject to which the authorisation is granted or renewed;

( c ) comply with any requirements imposed by or under the law of the country in which the preparation is to be manufactured.

9. (1) The Minister may refuse an application for a product authorisation where:—

( a ) the applicant fails to submit information, documents, samples or other materials in accordance with article 7 (1), or

( b ) the Minister is satisfied, following examination of such information, documents, samples or other materials that:—

(i) the information contained in or furnished in connection with the application is found to be incorrect in any material respect, or

(ii) the preparation is harmful under normal conditions of use, or

(iii) the therapeutic efficacy of the preparation is lacking or is insufficiently substantiated by the applicant, or

(iv) the qualitative or quantitative composition of the preparation to which the application relates is not as declared by the applicant.

(2) The Minister may revoke a product authorisation with the written consent of the holder thereof, or where he is satisfied that:—

( a ) the preparation to which the authorisation relates is harmful under normal conditions of use, or

( b ) the therapeutic efficacy of such preparation is lacking, or

( c ) the qualitative or quantitative composition of such preparation is not in accordance with the information declared by the holder, or

( d ) the controls on the preparation, or on any of its constituents, in the course of its manufacture as indicated in or in connection with the application or in compliance with any conditions subject to which the authorisation was granted or renewed have not been carried out, or

( e ) the requirements of the Medical Preparations (Licensing of Manufacture) Regulations, 1974 and 1975 have not been complied with, or

( f ) the information contained in or furnished in connection with the application for the authorisation is incorrect in any material respect, or

( g ) any condition subject to which the authorisation was granted or renewed has not been complied with.

10. A charge shall be paid to the Minister in respect of an application made to him pursuant to article 7, in accordance with such scale as the Minister, with the consent of the Minister for Finance, may from time to time determine.

11. (1) An authorisation granted or renewed pursuant to the European Communities (Proprietary Medicinal Products) Regulations, 1975 ( S.I. No. 301 of 1975 ) and in force immediately before the commencement of these Regulations shall continue in force until it expires or is sooner revoked and shall have effect as if it were a product authorisation granted or renewed under these Regulations.

(2) An application made pursuant to the said Regulations which had not been determined prior to the making of these Regulations shall be treated as if it were an application for a product authorisation under these Regulations.

12. These Regulations shall not apply as respects:—

( a ) any medical preparation which is a homoeopathic preparation, or

( b ) any substance or preparation which is intended solely for use as an ingredient in the manufacture of a medical preparation, or

( c ) any medical preparation, consisting of a dried, crushed or cominuted herb or combination of herbs which is to be sold:—

(i) under a designation which specifies the herb or herbs and the process of production only and does not apply any other name to the preparation, and

(ii) without any recommendation as to the use of the preparation as a medical preparation.

13. The Medical Preparations (Advertisement and Sale) Regulations, 1958 ( S.I. No. 135 of 1958 ) are hereby amended by:—

(1) The substitution of the following article for article 6 thereof:—

"6. (1) Subject to sub-articles (2), (3), (4) and (5) of this article, a person shall not, in the course of a business carried on by him, sell a medical preparation unless there is legibly written in a conspicuous position on the container in which the preparation is sold and on every box or other covering of whatever nature enclosing the container:—

( a ) the name of the preparation being either the appropriate non-proprietary name or a proprietary designation,

( b ) a description of the pharmaceutical form of the preparation,

( c ) the quantity of the preparation in the container expressed in terms of mass, volume or capacity or number of dosage units,

( d ) a statement of the appropriate quantitative particulars of the preparation,

( e ) the manufacturer's batch reference number.

( f ) (i) the reference number of any product authorisation granted or renewed pursuant to the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ) which relates to the preparation, and

(ii) the name and address of the holder of any such authorisation,

( g ) the method of administration,

( h ) the expiry date of the preparation where the duration of its shelf-life is less than three years,

( i ) any special requirements for the handling and storage of the preparation,

( j ) any other statements or particulars required to be stated by the provisions of any product authorisation granted or renewed pursuant to the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ) which relates to the preparation.

(2) With effect from the 1st day of May, 1990 the expiry date referred to in paragraph (h) of sub-article (1) shall be stated regardless of the duration of the shelf life of the preparation.

(3) It shall be sufficient compliance with paragraphs (b) and (c) of sub-article (1) if the particulars specified in those paragraphs are written only on the box or other covering of whatever nature enclosing the container.

(4) ( a ) In the case of a preparation sold in a container which is an ampoule enclosed in a package it shall be sufficient compliance with sub-article (1) insofar as that sub-article relates to a container if only the particulars specified in paragraphs (a), (d) and (h) of that sub-article together with the route of administration are written on the container.

( b ) In the case of a preparation sold in a small single dose container (other than an ampoule) on which it is impossible to give the particulars mentioned in paragraph (a) of this sub-article it shall be sufficient compliance with sub-article (1) if the particulars required by the said sub-article (1) are written only on the package enclosing the container.

(5) The particulars specified in paragraphs (g), (h) and (i) of sub-article (1) shall appear in the Irish or the English language.

(6) In this article:—

'appropriate non-proprietary name' in relation to a medical preparation or active ingredient means—

( a ) where such preparation or ingredient is described in a monograph in any pharmacopoeia for the time being in force in the State, any name or abbreviation of such name at the head of that monograph or, in the case of the European Pharmacopoeia, an approved synonym, or, where such name consists of two or more words, any name derived from a suitable inversion of such words which is provided for by such pharmacopoeia, or

( b ) where such preparation or ingredient is not so described but has an international non-proprietary name, such international non-proprietary name, or

( c ) where such preparation or ingredient is not so described and does not have an international non-proprietary name, the accepted scientific name or any other name descriptive of the true nature of the preparation or ingredient;

'appropriate quantitative particulars' in relation to a medical preparation means the quantity of each active ingredient identified by its appropriate non-proprietary name in each dosage unit or, where there is no such unit, in the container of the preparation, expressed in terms of mass, volume, capacity, or units of activity, or percentage by mass, or volume of the total quantity.

'international non-proprietary name' means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name.

(7) Sub-article (1) shall not apply to a medical preparation which is:—

( a ) prepared or dispensed by or in accordance with a prescription issued by a registered medical practitioner or registered dentist, or

( b ) sold or supplied by a registered medical practitioner or registered dentist for or to a patient under his care, or

( c ) sold or supplied by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons in accordance with the Pharmacy Acts, 1875 to 1977 where such sale or supply is carried out by or under the supervision of a pharmacist:—

(i) in accordance with a specification furnished by the person to whom the preparation is to be sold, or

(ii) in circumstances where the person under whose supervision the preparation is sold or supplied exercises his own judgement as to the treatment required.".

(2) The addition of the following article 7:—

"7. These Regulations shall be enforced and executed by officers of the Minister.".

14. (1) These Regulations shall be enforced and executed by officers of the Minister.

(2) Subject to sub-article (3) any such officer, with a written authorisation of the Minister, 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 article which is stored or offered or kept for sale or distribution at such premises,

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

( d ) take (without payment) samples of any substances or articles stored or offered or kept for sale or distribution 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.

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

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.

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)

(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.