Statutory Instrument 1996 No. 2420

The Medicines (Data Sheet) Amendment Regulations 1996

---

© Crown Copyright 1996

Statutory Instruments printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Queen's Printer of Acts of Parliament.

The legislation contained on this web site is subject to Crown Copyright protection. It may be reproduced free of charge provided that it is reproduced accurately and that the source and copyright status of the material is made evident to users.

It should be noted that the right to reproduce the text of Statutory Instruments does not extend to the Queen's Printer imprints which should be removed from any copies of the Statutory Instrument which are issued or made available to the public. This includes reproduction of the Statutory Instrument on the Internet and on intranet sites. The Royal Arms may be reproduced only where they are an integral part of the original document.

The text of this Internet version of the Statutory Instrument which is published by the Queen's Printer of Acts of Parliament has been prepared to reflect the text as it was Made. A print version is also available and is published by The Stationery Office Limited as the The Medicines (Data Sheet) Amendment Regulations 1996, ISBN 0110630467. The print version may be purchased by clicking here. Braille copies of this Statutory Instrument can also be purchased at the same price as the print edition by contacting TSO Customer Services on 0870 600 5522 or e-mail:customer.services@tso.co.uk.

Further information about the publication of legislation on this website can be found by referring to the Frequently Asked Questions.

To ensure fast access over slow connections, large documents have been segmented into "chunks". Where you see a "continue" button at the bottom of the page of text, this indicates that there is another chunk of text available.

1996 No. 2420

MEDICINES

The Medicines (Data Sheet) Amendment Regulations 1996

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 96(6) and 129(1) and (5) of the Medicines Act 1968^[1] and now vested in them^[2] and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations^[3] hereby make the following Regulations:—

Citation, commencement and interpretation
    1.—(1)  These Regulations may be cited as the Medicines (Data Sheet) Amendment Regulations 1996 and subject to paragraph (2) of this regulation shall come into force on 10th October 1996.

    (2)  Regulation 4 shall come into force immediately after regulation 3(b).

    (3)  In these Regulations, "the principal Regulations" means the Medicines (Data Sheet) Regulations 1972^[4].

Amendment of regulation 1 of the principal Regulations
    2.    Regulation 1 of the principal Regulations shall be amended so that—
 (a) in paragraph (2) after the definition of "monograph" the following definitions are inserted—
""product information compendium" has the meaning it bears in regulation 2A(1)(b);
"summary of product characteristics" has the meaning it bears in regulation 2(1) of the Medicines (Advertising) Regulations 1994^[5];" , and

 (b) after paragraph (2) the following paragraph is inserted—
"  (2A)  In these Regulations unless the context otherwise requires "product licence" includes a marketing authorisation in respect of medicinal products intended for use by being administered to human beings and granted under Council Regulation (EEC) No. 2309/93^[6] or under the Medicines for Human Use (Marketing Authorisations, Etc.) Regulations 1994^[7];" .

Amendment of regulation 2 of the principal Regulations
    3.    Regulation 2 of the principal Regulations (form of data sheets) shall be amended so that—
 (a) in paragraph (1) after the words "for the purposes of the Act, every data sheet" the words "in respect of medicinal products for use by being administered to animals" are inserted, and
 (b) in paragraphs (2) and (3) for the words "regulations 3 and 4" there are substituted the words "regulation 4".

Insertion of regulation 2A in the principal Regulations
    4.    After regulation 2 of the principal Regulations there shall be inserted the following regulation—

"Data Sheets for medicinal products for human use
    2A.—(1)  Subject to the following provisions of these Regulations, for the purposes of the Act every data sheet in respect of medicinal products for use by being administered to human beings shall be either in the form of—
(a) a loose sheet containing the particulars specified in these Regulations, or

(b) a page or part of a page, containing such particulars and forming part of a publication (in these Regulations referred to as a "product information compendium") consisting of a list of entries in respect of such medicinal products (whether or not it also consists of summaries of product characteristics, or other explanatory material which may be of use to the practitioner).


    (2)  The provisions of paragraphs (2) and (5) of regulation 2 shall apply in respect of data sheets to which paragraph (1) of this regulation applies as they apply in respect of data sheets to which regulation 2 applies but as if in paragraph (2) for the words "regulation 4" there were substituted "regulation 3"."

Amendment of regulation 3 of the principal Regulations
    5.    In regulation 3(8) and (9) of the principal Regulations (particulars in data sheets relating to medicinal products for human use) for the words "data sheet compendium" wherever they appear there shall be substituted the words "product information compendium".

Amendment of Schedule 1 to the principal Regulations
    6.    Schedule 1 to the principal Regulations shall be amended so that—
 (a) at the beginning for the reference to "Regulation 2(2) and 3" a reference to "Regulations 2(2) and (3) and 2A(2)" is substituted, and
 (b) at the end of the heading of Part II after the word "REQUIREMENTS" the words "IN RESPECT OF MEDICINAL PRODUCTS FOR USE BY BEING ADMINISTERED TO ANIMALS" are added.

Amendment of Schedule 2 to the principal Regulations
    7.    In paragraph 10 of column 2 (particulars) of Schedule 2 (particulars required in data sheets relating to medicinal products for human use) for the words "data sheet compendium" there shall be substituted the words "product information compendium".

Revocation
    8.    Regulation 6 (temporary provisions) of the principal Regulations shall be revoked.

Stephen Dorrell

Secretary of State for Health

12th September 1996

Gwilym Jones

Parliamentary Under-Secretary of State, Welsh Office

17th September 1996

James Douglas Hamilton

Minister of State, The Scottish Office

17th September 1996

Tim Boswell

Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food

12th September 1996
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
17th September 1996


F. A. Elliott

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on
18th September 1996


J. Murray

Permanent Secretary

Regulation 2 of the Medicines (Data Sheet) Regulations 1972 ("the principal Regulations") prescribes the form of data sheets falling within section 96 of the Medicines Act 1968.
These Regulations remove certain requirements relating to the compilation of data sheets for medicinal products for human use by inserting a new regulation 2A into the principal Regulations (regulation 4). They also revoke transitional provisions in the principal Regulations (regulation 8).

[1] 1968 c. 67 ("the Act"). The expression" the Ministers" used in section 129 of the Act is defined in section 1(1) of the Act as amended by S.I. 1969/388, Schedule 1. The word" prescribed" in section 96(6) is defined in section 132(1). back

[2] In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28). back

[3] See section 129(6) of the Act. back

[4] S.I. 1972/2076 as amended by S.I. 1979/1760, S.I. 1981/1633, S.I. 1989/1183 and S.I. 1994/3142. back

[5] S.I. 1994/1932. back

[6] OJ no. L214, 24.8.93, p. 1. back

[7] S.I. 1994/3144. back