SCHEDULE 4

PERIODIC FEES FOR LICENCES
Regulation 33(2) and (3), 34(2)
PART 1

Interpretation
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 2

Value of the Product Sold or Supplied

Determining the total value of the product
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer's prices
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Information requirements
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3

Periodic Fees for Marketing Authorizations and Licences

Marketing authorizations
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Marketing authorization: where Part 2 of the Act applies
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Marketing authorization: derivatives
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Number of fee periods
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Authorisation for two or more kinds of medicinal product
9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reduced fees
10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturer's licences or manufacturing authorisations
11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licences
12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licences: evidence
13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wholesale dealer's licences: exempt imported products
14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Additional amount for manufacturer's licences and wholesale dealer's licences which relate to exempt imported products
15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinical trial authorisations
16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Traditional herbal registrations
17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 4

Types of Marketing Authorization for which only One Periodic Fee is Payable

Parallel import licences
18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulations revoked (1.4.2013) by The Medicines (Products for Human Use) (Fees) Regulations 2013 (S.I. 2013/532), reg. 59(1) (with reg. 59(2)-(4))