The Medicines (Data Sheet and Labelling) Amendment Regulations 1989

• Citation: S.I. 1989/1183
• Sections: 4

Section 1 Citation and commencement

(1) These Regulations may be cited as the Medicines (Data Sheet and Labelling) Amendment Regulations 1989.

(2) Except as provided in regulation 4, these Regulations shall come into force on 1st of August 1989.

Section 2 Amendment of the Medicines (Data Sheet) Regulations 1972

The Medicines (Data Sheet) Regulations 1972 shall be amended by –

(a) in paragraph (10) in column 2 of Schedule 2 to those Regulations (product licence numbers, names and addresses);

(i) omitting all the words from “or (d) the name” to the words “Order 1971 are applicable”; and

(ii) substituting for the words “either (a), (b), (c) or (d)”, the words “either (a), (b) or (c)”;

(b) in paragraph (10) in column 2 of Schedule 3 to those Regulations (product licence numbers, names and addresses);

(i) omitting all the words from “or (d) the name” to the words “Order 1971 are applicable”; and

(ii) substituting for the words “either (a), (b), (c) or (d)”, the words “either (a), (b) or (c)”.

Section 3 Amendment of the Medicines (Labelling) Regulations 1976

The Medicines (Labelling) Regulations 1976 shall be amended by, in Schedule 1 to those Regulations (standard particulars required in the labelling of containers and packages), omitting:—

(a) in paragraph 8(b) the final “, or”;

(b) paragraph 8(c) (name and address of specified person);

(c) in paragraph 9 (product licence number) all the words from “or, where the licensing authority” to the words “or the number of the relevant direction”; and

(d) in paragraph 12 (particulars specified by Licensing Authority) all the words from “or by a direction given” to the end of that paragraph.

Section 4 Deferred commencement where directions currently in force

For the purposes of any case where a direction issued pursuant to article 3 of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 is in force on the 31st July 1989 the amendments made by regulations 2 or 3 shall come into force on 1st February 1990.