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The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1994
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PART IIIFEES FOR APPLICATIONS FOR VARIATIONS OF LICENCES OR CERTIFICATES
Product licences
1.—(1) The fee for a complex application for variation of a product licence shall be £1,100.
(2) The fee for an application for the variation of a product licence other than a complex application shall be in accordance with the following Table:
| Kind of application | Fee payable |
|---|---|
| Variation requiring veterinary, scientific or pharmaceutical assessment | £340 for the first variation plus £140 for each additional consequential variation to other licences in identical terms |
| Variation not requiring veterinary, scientific or pharmaceutical assessment | £140 |
| Variation involving the re-issue of the licence in the new name of the company | £140 |
| Variation where the product licence relates solely to an emergency vaccine | £40 |
Manufacturers' licences
2. The fee for 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 £90;
(b)in any other case—
(i)requiring veterinary, scientific or pharmaceutical assessment, shall be £330;
(ii)not requiring veterinary, scientific or pharmaceutical assessment, shall be £110.
Wholesale dealers' licences
3. The fee for an application for variation of a wholesale dealer’s licence—
(a)requiring veterinary, scientific or pharmaceutical assessment, shall be £330;
(b)not requiring veterinary, scientific or pharmaceutical assessment, shall be £110.
Animal test certificates
4. The fee for an application for variation of an animal test certificate shall be in accordance with the following Table:
| Kind of application | Fee payable |
|---|---|
| Complex application | £1,150 |
| Non-complex application requiring veterinary, scientific or pharmaceutical assessment | £330 |
| Non-complex application not requiring veterinary, scientific or pharmaceutical assessment | £110 |
| Application for the re-issue of a certificate in the new name of the company | £110 |
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