SCHEDULE 2AMENDMENTS
Amendment of 1988 RegulationsI11
The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 19885 shall be amended as follows—
a
in regulation 2(1)—
i
in the definition of “active ingredient”, the words “, veterinary written direction” shall be omitted;
ii
the following definitions shall be omitted—
“appropriate non-proprietary name”;
“approved name”;
“approved synonym”;
iii
in the definition of “container”, after the words “medicated feeding stuff” there shall be inserted the words “, intermediate product or zootechnical product”;
iv
in the definition of “dosage unit” the words “or excepted medicated feeding stuff shall” be omitted at both places where they occur;
v
the following definitions shall also be omitted—
“data sheet”;
“excepted medicated feeding stuff”;
“expiry date”;
“final medicated feeding stuff”;
“foreign or international compendium of standards”;
“intermediate medicated feeding stuff”;
“international non-proprietary name”;
vi
immediately before the definition of “marketing authorisation” there shall be inserted the following definition—
“intermediate product” has the same meaning as in Part I of Schedule 2 to the Medicated Feedingstuffs Regulations 1998
vii
for the definition of “medicated feeding stuff” there shall be substituted the following definition—
“medicated feeding stuff” has the same meaning as that given to “medicated feedingstuff” in Part I of Schedule 2 to the Medicated Feedingstuffs Regulations 1998
viii
in the definition of “package” there shall be inserted after the words “medicated feeding stuffs” the words “intermediate products or zootechnical products”;
ix
the following definitions shall also be omitted—
“person responsible for the composition of the medicinal product or excepted medicated feeding stuff”;
“prescription only medicine”;
“proprietary designation”;
x
in the definition of “quantity”, there shall be omitted the words “, excepted medicated feeding stuff”; and
xi
after the definition of “quantity”, there shall be substituted for all the remaining definitions the following definition—
“zootechnical product” has the same meaning as in regulation 2( 1) of the Feedingstuffs (Zootechnical Products) Regulations 1998.
b
in regulation 3, after the words “medicated feeding stuffs” there shall be inserted the words “, intermediate products and zootechnical products”;
c
regulations 4, 5 and 7 shall be omitted;
d
for regulation 6 there shall be substituted the following regulation—
Medicinal tests on animals6
1
Subject to paragraph (2) below, where a medicated feeding stuff, an intermediate product or a zootechnical product is for administration in a medicinal test on animals, every container and package of such feeding stuff or product shall be labelled with the words “For Animal Test Use Only” and to show the particulars set out in Schedule 4.
2
Where any container or any package enclosing the container of—
a
a medicated feeding stuff,
b
an intermediate product, or
c
a zootechnical product,
for administration in a medicinal test on animals is of such a size as to make it impracticable for such container or package to be labelled to show all particulars required by paragraph (1) above, such container or package shall be labelled with the words “For Animal Test Use Only”, and to show the particulars set out in paragraphs 1, 2, 7, and 8 of Schedule 4, and a leaflet containing all the particulars required by paragraph (1) above (other than those set out in paragraph 9 of that Schedule) shall be supplied with such container or package and be delivered to the purchaser or consignee thereof.
e
for regulation 8 there shall be substituted the following regulation—
Sale or supply of medicated feeding stuffs, intermediate products or zootechnical products not enclosed in a container8
A person who, in the course of a business carried on by him, sells or supplies a medicated feeding stuff, an intermediate product or a zootechnical product for administration in a medicinal test on animals without its being enclosed in a container shall not be taken to contravene regulation 6 if a leaflet which complies with the requirements of regulation 6 is supplied with such feeding stuff or product and such leaflet is delivered to the purchaser or consignee with such feeding stuff or product.
f
in regulation 9—
i
after the words “medicated feeding stuffs”, at each place where they occur, there shall be inserted the words “, intermediate products or zootechnical products”;
ii
after the words “medicated feeding stuff”, at each place where they occur, there shall be inserted the words “, intermediate product or zootechnical product”; and
iii
paragraphs (3), (7) and (8) shall be omitted;
g
in regulation 10—
i
after the words “medicated feeding stuff” in the first place where they occur there shall be inserted the words “, intermediate product or zootechnical product”; and
ii
the words “(not being an excepted medicated feeding stuff)” shall be omitted;
h
in regulation 11—
i
after the words “medicated feeding stuff”, in each place where they occur, there shall be inserted the words “, intermediate product or zootechnical product”; and
ii
in paragraph (b), after the words “medicated feeding stuffs” there shall be inserted the words “, intermediate products or zootechnical products”;
i
regulation 12 shall be omitted;
j
in regulation 13, the words from “or who contravenes” to “excepted medicated feeding stuffs” shall be omitted;
k
Schedules 1, 2 and 3 shall be omitted; and
l
in Schedule 4—
i
for the heading there shall be substituted the following heading:
SCHEDULE 4PARTICULARS REQUIRED IN THE LABELLING OF CONTAINERS AND PACKAGES OF MEDICATED FEEDING STUFFS, INTERMEDIATE PRODUCTS OR ZOOTECHNICAL PRODUCTS FOR MEDICINAL TESTS ON ANIMALS
ii
in paragraph 2, sub-paragraph (a) shall be omitted, and in sub-paragraph (b), the words “or excepted medicated feeding stuff” shall be omitted in both places where they occur and the words “, intermediate product or zootechnical product” shall be inserted immediately after the words “medicated feeding stuff” in both places where they survive;
iii
in paragraphs 3, 4, 6, 8 and 9, after the words “medicated feeding stuff”, in each place where they occur, there shall be inserted the words “, intermediate product or zootechnical product”;
iv
paragraph 5 shall be omitted;
v
in paragraph 7, sub-paragraph (a) shall be omitted and in sub-paragraph (b) the words “(not being an excepted medicated feeding stuff)” shall be omitted and the words “, intermediate product or zootechnical product” shall be inserted immediately after the words “feeding stuff” in each place where they survive; and
vi
in paragraph 9, for the words “regulation 6(3)” there shall be substituted the words “regulation 6(2)”.
Amendment of 1994 RegulationsI22
After paragraph (iii) of regulation 6(2)(b) of the Marketing Authorisations for Veterinary Medicinal Products Regulations 19946 shall be inserted the following paragraphs:
iiiA
in the case of an authorised medicated pre-mix, as defined in regulation 2(1) of the Medicated Feedingstuffs Regulations 1998, other than one which falls within the next paragraph of this sub-paragraph, the capital letters “MFS”;
iiiB
in the case of an authorised medicated pre-mix, as so defined, which falls within regulation 18(3), 21(3) or 28(4) of those Regulations, the capital letters “MFSX”;
Amendment of 1997 RegulationsI33
Paragraph 3 of Schedule 3 to the Medicines (Products for Animal Use—Fees) Regulations 19977 shall be omitted.