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Regulation 44(2)

SCHEDULE 6 ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES

Refund on surrender or revocation of authorization, registration or licence

1.  Where, after payment of a periodic fee payable in accordance with the provisions of these Regulations, the marketing authorization, traditional herbal registration or licence in respect of which such a fee has been paid is either surrendered at the specific written invitation of the licensing authority, or is revoked by the licensing authority on a date earlier than the date of expiry stated in the marketing authorization, traditional herbal registration or licence, the licensing authority shall refund to the applicant the whole or any part of the difference between such periodic fee as has been paid and the amount of the periodic fee payable on the basis of the actual duration of the marketing authorization, traditional herbal registration or licence up to the date of such surrender or revocation.

Adjustment and refund: licences relating to exempt imported products

2.—(1) This paragraph applies to periodic fees payable in connection with a manufacturer’s licence or a wholesale dealer’s licence which relates to exempt imported products.

(2) If during a fee period the number of special import notices given by a licence holder is greater than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 3, the periodic fee payable in relation to that period shall be increased by the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.

(3) If during a fee period the number of special import notices given by a licence holder is less than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 3, the licensing authority shall refund the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.

Refunds: treated as having been paid on account

3.  Any sums payable to the applicant by way of refund of any fees under the provisions of this Schedule may be treated as having been paid on account of any other fee which the applicant is liable to pay (whether by instalments or otherwise) under the provisions of these Regulations.

Regulation 48(1)

SCHEDULE 7 REVOCATION SCHEDULE

(1) Regulations revoked (2) References (3) Extent of revocation
The Medicines (Products for Human Use – Fees) Regulations 1995 S.I. 1995/1116 The whole Regulations
The Medicines (Products for Human Use – Fees) Amendment Regulations 1996 S.I. 1996/683 The whole Regulations
The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998 S.I. 1998/574 Regulations 4 and 5 and the Schedule
The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000 S.I. 2000/592 Regulation 4 and the Schedule
The Medicines (Products for Human Use – Fees) Amendment Regulations 2000 S.I. 2000/3031 The whole Regulations
The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001 S.I. 2001/795 Regulations 5 and the Schedule
The Medicines (Codification Amendments etc.) Regulations 2002 S.I. 2002/236 Regulation 16
The Medicines for Human Use Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002 S.I. 2002/542 Regulation 5 and the Schedule
The Medicines for Human Use and Medical Devices (Fees Amendment)Regulations 2003 S.I. 2003/625 Regulation 4 and the Schedule
The Medicines for Human Use and Medical Devices (Fees Amendments)Regulations 2004 S.I. 2004/666 Regulations 4 to 15 and the Schedule
The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004 S.I. 2004/1157 The whole Regulations
Medicines for Human Use (Fees Amendments) Regulations 2005 S.I. 2005/1124 The whole Regulations
The Medicines for Human Use (Fees Amendments) (No. 2) Regulations 2005 S.I. 2005/2979 The whole Regulations
The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006 S.I. 2006/494 Regulation 2 and the Schedule
The Medicines for Human Use (Fees Amendments) Regulations 2006 S.I. 2006/2125 Regulations 2 to 4
The Medicines for Human Use and Medical Devices (Fees Amendments) (No. 2) Regulations 2007 S.I. 2007/803 Regulations 3 to 11 and the Schedule