S.I. No. 439/1994 - Medical Preparations (Licensing, Advertisement and Sale) (Amendment) Regulations, 1994.

1. The holder of the certificate of registration (hereinafter referred to as the registration holder) shall report to the Minister any change in his name and address an in any address at which there is carried on a business to which the registration relates.

2. The registration holder shall ensure that any preparation to which the registration relates is manufactured only in accordance with the methods set out in, or furnished in connection with, his application for registration 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 in so far as may otherwise be approved by the Minister.

3. The registration 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 registration 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 storge of the preparation,

(

f

) in the route(s) of administration or in the dosage schedules, or

(

g

) in the method of retail sale or supply.

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

5. The registration 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 registration 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.

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

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

(

a

) to be harmful under normal conditions of use, or

(

b

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

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 registration holder shall comply with the conditions set out in sub-paragraph (1) where the controls on the preparation to which registration 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 registration or in compliance with the conditions set out in this Schedule, have not been carried out.

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

9. The registration holder shall ensure—

(

a

) that the preparation to which the registration 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.

10. The registration holder shall in the event of the registration being revoked surrender it to the Minister.".

GIVEN under the Official Seal of the Minister for Health this 20th

day of December, 1994.

MICHAEL NOONAN,

Minister for Health

EXPLANATORY NOTE.

These regulations amend the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 (

S.I. no. 210 of 1984

) so as to give effect to—

(1) EC Council Directive 92/73/EEC of 22 September 1992 (O.J. No. L297 of 13.10.91) widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products.

(2) EC Council Regulation No. (EEC) 2309/93 of 22 July 1993 (O.J. No. L214 of 24.8.93) with particular regard to licences for medicinal products for human use granted in accordance therewith.

S.I. No. 439 of 1994.

MEDICAL PREPARATIONS (LICENSING, ADVERTISEMENT AND SALE) (AMENDMENT) REGULATIONS, 1994.

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),

section 36

of the

Misuse of Drugs Act, 1977

(No. 12 of 1977) and by

section 7

of the

Health (Family Planning) (Amendment) Act, 1992

(No. 20 of 1992) hereby makes the following Regulations:—