1989 No. 1183
The Medicines (Data Sheet and Labelling) Amendment Regulations 1989
Made
Laid before Parliament
Coming into force
for all purposes except regulation 4
for the purposes of regulation 4
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Scotland and in Wales, 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 the powers conferred upon them by sections 85(1), 91(3), 96(6), 129(1) and (5) and 132(1)1 of the Medicines Act 1968,2 and now vested in them3, and of all other powers enabling them in that behalf and after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the following Regulations pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Medicines Commission pursuant to section 129(7) of that Act, hereby make the following Regulations:
Citation and commencement1
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.
Amendment of the Medicines (Data Sheet) Regulations 19722
The Medicines (Data Sheet) Regulations 19724 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)”.
Amendment of the Medicines (Labelling) Regulations 19763
The Medicines (Labelling) Regulations 19765 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.
Deferred commencement where directions currently in force4
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 19716 is in force on the 31st July 1989 the amendments made by regulations 2 or 3 shall come into force on 1st February 1990.
Signed by authority of the Secretary of State for Health.
In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 7th July 1989.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 7th day of July 1989.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 7th day of July 1989.
(This note is not part of the Regulations)