S.I. No. 70/1993:

MEDICAL PREPARATIONS (LICENSING, ADVERTISEMENT & SALE) (AMENDMENT) REGULATIONS, 1993.

MEDICAL PREPARATIONS (LICENSING, ADVERTISEMENT & SALE) (AMENDMENT) 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), section 6 of the Health Act, 1970 (No. 1 of 1970 ) 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 (Licensing, Advertisement and Sale) (Amendment) Regulations, 1993.

2. The Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ) are hereby amended--

( a ) by the substitution of the following sub-article for sub-article (2) of article 6:

(2) A product authorisation granted under this article shall:--

( a ) incorporate a summary of product characteristics containing the information set out in Part I of the First Schedule to these Regulations, and

( b ) be subject

(i) to the general conditions specified in Part II of the said First Schedule, and

(ii) to the special conditions, if any, specified in the product authorisation.",

( b ) by the addition of the following sub-paragraph to article 9 (1) (b):

"(v) the labelling or the package leaflet do not comply with the provisions of The Medical Preparations (Labelling & Package Leaflets) Regulations, 1993 ( S.I. No. 71 of 1993 ) or if they are not in accordance with the summary of product characteristics in respect of the medical preparation in question" and

( c ) by the substitution of the following schedule for the First Schedule:

"FIRST SCHEDULE

Part I

1. Name of the medical preparation.

2. Qualitative and quantitative composition in terms of the active ingredients and constituents of the excipient, knowledge of which is essential for proper administration of the medical preparation; the international non-proprietary names recommended by the World Health Organisation shall be used, where such names exist, or failing this, the usual common name or chemical description.

3. Pharmaceutical form.

4. Pharmacological properties and, in so far as this information is useful for therapeutic purposes, pharmacokinetic particulars.

5. Clinical particulars:

5.1 therapeutic indications,

5.2 contra-indications,

5.3 undesirable effects (frequency and seriousness),

5.4 special precautions for use,

5.5 use during pregnancy and lactation,

5.6 interaction with other medicaments and other forms of interaction,

5.7 posology and method of administration for adults and, where necessary, for children,

5.8 overdose (symptoms, emergency procedures, antidotes),

5.9 special warnings,

5.10 effects on ability to drive and to use machines.

6. Pharmaceutical particulars:

6.1 incompatibilities (major)

6.2 shelf life, when necessary after reconstitution of the product or when the container is opened for the first time,

6.3 special precautions for storage,

6.4 nature and contents of container,

6.5 name or style and permanent address or registered place of business of the holder of the product authorisation,

6.6 special precautions for disposal of unused products or waste materials derived from such products, if appropriate.

PART II

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 notify the Minister of any change proposed to be made in the labelling or package leaflet relating to any medical preparation to which the authorisation relates. Any such change not connected with the summary of product characteristics, which have not been opposed by the Minister within 90 days following the said notification shall be deemed to be approved by the Minister and may be put into effect by the authorisation holder.

6. 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.

7. 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.

8. 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.

9. 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.

10. (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 be 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 be 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.

11. 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.

12. 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.

13. 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 12 until a certificate authorising the sale of the batch or batches has been issued to him by the Minister.

14. 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.

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

GIVEN under the Official Seal of the Minister for Health, this 12th day of March, 1993.

BRENDAN HOWLIN,

Minister for Health.

EXPLANATORY NOTE.

These Regulations refine the term "summary of products characteristics" for the purposes of the medical preparations licensing scheme.