Paragraph 4

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

Sch 7, para 2 am by Medicines (Products for Animal Use—Fees) 2001 reg 2(1), (8)(a)
Sch 7, para 4 am by Medicines (Products for Animal Use—Fees) 2001 reg 2(1), (8)(b)
regs 12,13.14. Sch 1. Pt.II, paras.1 -3,6-9, Pt.III. paras 4,5, Pt.IV, paras.1- 3,5-7, Pt.V, paras.1 -3. Sch.2. paras.2.3 amended by Medicines (Products for Animal Use—Fees) 2000 reg.2. Sch.
Sch 7, para 4 am by Medicines (Products for Animal Use—Fees) 2003 regs 3(1), (6), 4

(1)

Subject to sub-paragraph (2) below, where an application for a marketing authorisation or product licence or manufacturer’s or wholesale dealer’s licence is withdrawn before determination by the relevant authority, the relevant authority shall refund, or where no payment has been made, waive the following percentage of the fee otherwise payable (under regulation 3) in connection with that application–

(a)

if the application has been received but no veterinary, scientific or pharmaceutical assessment of it has begun, 90%;

(b)

if, except in a case to which paragraph (c) below applies, veterinary, scientific or pharmaceutical assessment has begun but not been completed, 50%;

(c)

if, in a case to which paragraph (b) above applies, a request for further information in connection with the application has been made by the relevant authority under section 44(1) of the Act, or under Article 9 of Directive 81/851/EEC as applied by regulation 5 of the 1994 Regulations, 25%,

and, in the case of paragraph (b) above, where an application has been withdrawn because it is deficient and a 50% refund of the fee has been made by the relevant authority any subsequent reapplication in respect of the same authorisation or licence by the same applicant shall be charged at 50% of the fee otherwise payable under regulation 3.

(2)

If an application for a marketing authorisation or product licence is withdrawn either after scientific or veterinary pharmaceutical assessment has been completed or following consideration of that application by the Veterinary Products Committee or by the Medicines Commission, no refund or waiver of the fee payable (under regulation 3 of these Regulations) in connection with that application shall be made under this paragraph.