1 Citation and commencement

2 Interpretation

3 Interpretation of Part 2

4 Fee for scientific advice: application for or variation to EC marketing authorization

5 Fee for scientific advice: classification of a medicinal product

6 Fee for advertising advice

7 Fee for pharmacovigilance advice

8 Fee for advice on labelling or leaflets

9 Fee for regulatory advice

10 Fee for advice for other purposes

11 Time for payment of fees under regulations 4 to 10

12 Fees for applications for authorizations, licences or certificates, etc

13 Fee for applications for copy certificates of good manufacturing practice

14 Fees for applications for certificates and copy certificates by exporters of medicinal products

15 Meaning of set of applications

16 Fees for applications for regulatory assistance under the mutual recognition procedure

17 Time for payment of fees under regulation 16

18 Fees for variations of authorizations, registrations, licences and authorisations

19 Fees for amendments to clinical trial authorisations

20 Applications for multiple variations

21 Meaning of set of proposed changes

22 Fees for assessment of a set of proposed changes to labels and leaflets

23 Time for payment of fees under regulation 22

24 Fees for renewals of certain manufacturer's licences

25 Fees for renewals in terms which are not identical to the existing authorization, licence or certificate

26 Fees for regulatory assistance for certain marketing authorizations

27 Fees for inspections

28 Payer of inspection fee (contract laboratories and API manufacturing sites)

29 Inspections in connection with multiple applications.

30 Fees for inspections relating to good clinical practice in clinical trials

31 Periodic fees

32 Periodic fees for clinical trial authorisations

33 Meaning of good clinical practice accreditation scheme

34 Fees for applications for membership and certificate

35 Fees for persons appointed hearing

36 Time for payment under regulation 35

37 Payment of fees to Ministers

38 Time for payment of capital fees in connection with applications or inspections

39 Time for payment of capital feesapplications made by small companies

40 Time for payment of periodic fees

41 Penalty fees for late payment of periodic fees

42 Daily penalty fees for late payment of periodic fees

43 Refund or waiver of fees under regulation 41 or 42

44 Adjustment, waiver, reduction or refund of fees

45 Suspension of licences and certificates

46 Civil proceedings to recover unpaid fees

47 Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

48 Revocation and savings

Signature

SCHEDULE 2 Fees for Inspections

SCHEDULE 4 Time for Payment of Capital Fees

SCHEDULE 5 Waiver, Reduction or Refund of Capital Fees

SCHEDULE 6 Adjustment, Reduction or Refund of Periodic Fees

SCHEDULE 7 Revocation Schedule

EXPLANATORY NOTE