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Schedule

Original text. Later amendments are not shown.

“PART III

FEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES

Product licences

1

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' licences

2

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' licences

3

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 Certificates

4

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.”