Regulation 44(2)
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.
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.
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)
| (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 |