1991 No. 2063
The Medicines (Fees Relating to Medicinal Products for Animal Use) (Amendment) Regulations 1991
Made
Laid before Parliament
Coming into force
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, 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, with the consent of the Treasury, in exercise of the powers conferred by section 1(1) and (2) of the Medicines Act 19711 and now vested in them2 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 Regulations3, hereby make the following Regulations:—
Citation and commencement1
These Regulations may be cited as the Medicines (Fees Relating to Medicinal Products for Animal Use) (Amendment) Regulations 1991 and shall come into force on 4th October 1991.
Amendments2
1
The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 19914 shall be amended in accordance with the following provisions of this regulation.
2
In regulation 2(1) (interpretation) the definition of “inactive biological medicinal product” shall be deleted.
3
For paragraph (b) in regulations 3, 5 and 8 respectively there shall be substituted the following paragraph—
b
in respect of any inspection specified in Schedule 2 made in connection with that application, the fee payable in accordance with paragraphs 2 to 6 of that Schedule.
4
In regulation 10 (inspections of a site) for the words “paragraphs 2, 3, 4 and 6 of Schedule 2” there shall be substituted the words “paragraphs 2 to 6 of Schedule 2”.
5
In regulation 16(1) (late payment of annual fees) for the words “one month” there shall be substituted the words “three months”.
6
For Part III of Schedule 1 (fees for applications for variations of licences or certificates) there shall be substituted Part III as set out in the Schedule to these Regulations.
7
In Schedule 2 (fees for inspections)—
a
in paragraph 1(1) (interpretation) before the definition of “major inspection” there shall be inserted the following definition—
“dormant biological medicinal product” means a product which is not currently being manufactured or sold and in respect of which there is no current intention to recommence the manufacture or sale;
b
in paragraph (5) for the words “an inactive biological medicinal product” there shall be substituted the words “a dormant biological medicinal product”.
8
In Schedule 4—
a
in Part I, paragraph 5 for the words “paragraph 5 of Part II of this Schedule” there shall be substituted the words “paragraph 4 of Part II of this Schedule”;
b
in Part III for the words “paragraph 2 of Part I” there shall be substituted the words “the provisions of Part I of this Schedule”.
9
In paragraph 1 of Schedule 5 the words “in accordance with paragraph 5(a) of Part I of Schedule 4”5 shall be deleted.
In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 2nd September 1991.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland 29th September 1991.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland 30th September 1991.
We consent,
SCHEDULE
PART IIIFEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES
Product licences1
The fee payable under regulation 5(a) in connection with an application for variation of a product licence—
a
in the case of a complex application, shall be £1,050;
b
in any other case—
i
requiring veterinary, scientific or pharmaceutical assessment–
aa
for a variation, shall be £315;
bb
for any other consequential variation to other licences, in identical terms, shall be £105;
ii
not requiring veterinary, scientific or pharmaceutical assessment, shall be £105 in respect of each variation;
iii
where the variation applied for involves the reissue of the product licence in the new name of the company, shall be £105;
iv
where the product licence relates solely to an emergency vaccine, shall be £30.
Manufacturers' licences2
The fee payable under regulation 5(a) in connection with an application for variation of a manufacturer’s licence—
a
in the case of a manufacturer’s licence referred to in paragraph 5(2) of Part II of this Schedule, shall be £85;
b
in any other case—
i
requiring veterinary, scientific or pharmaceutical assessment, shall be £325;
ii
not requiring veterinary, scientific or pharmaceutical assessment, shall be £90.
Wholesale dealers' licences3
The fee payable under regulation 5(a) in connection with an application for variation of a wholesale dealer’s licence—
a
requiring veterinary, scientific or pharmaceutical assessment, shall be £325;
b
not requiring veterinary, scientific or pharmaceutical assessment, shall be £90.
Animal Test Certificates4
The fee payable under regulation 5(a) in connection with an application for variation of—
a
an animal test certificate—
i
requiring veterinary, scientific or pharmaceutical assessment, shall be £315;
ii
not requiring veterinary, scientific or pharmaceutical assessment, shall be £105;
iii
where the variation applied for involves the reissue of the animal test certificate in the new name of the company, shall be £105; or
b
an animal test (confirmation of exemption) certificate—
i
requiring veterinary, scientific or pharmaceutical assessment, shall be £300;
ii
not requiring veterinary, scientific or pharmaceutical assessment, shall be £85;
iii
where the variation applied for involves the reissue of the animal test (confirmation of exemption) certificate in the new name of the company, shall be £85.
(This note is not part of the Regulations)