Office of Public Sector Information

CONTENTS

1. PART 1

   Introduction

   1. 1. Interpretation of Schedule 7

   2. 2. Payment of fees

   3. 3. Time of payment

   4. 4. Multiple inspections

   5. 5. Expenses for inspections

   6. 6. Translation

2. PART 2

   Fees relating to marketing authorisations

   1. 7. Fees for specified pharmaceutical applications

   2. 8. Decentralised pharmaceutical application where the United Kingdom is the reference member State

   3. 9. Application for a marketing authorisation for an immunological product

   4. 10. Decentralised immunological application where the United Kingdom is the reference member State

   5. 11. Application for a marketing authorisation using identical data

   6. 12. Application for a provisional marketing authorisation (pharmaceutical)

   7. 13. Fees for an application for a provisional marketing authorisation (immunological)

   8. 14. Fee for the conversion from a provisional to a full marketing authorisation

   9. 15. Application for a marketing authorisation relating to a parallel import

   10. 16. Application for a variation

   11. 17. Application for a variation to a marketing authorisation that has been issued in other member States

   12. 18. Application for an extension to a marketing authorisation

   13. 19. Decentralised application for an extension where the United Kingdom is the reference member State

   14. 20. Provision of information relating to the recognition of a United Kingdom marketing authorisation

   15. 21. Application for the renewal of a national marketing authorisation

   16. 22. Application for the renewal of a marketing authorisation granted in more than one member State

   17. 23. Registration of a homeopathic remedy

   18. 24. Annual fees for marketing authorisations

   19. 25. Auditor’s certificate

   20. 26. Late payment of annual fees

3. PART 3

   Fees payable by manufacturers

   1. 27. Application for a manufacturing authorisation

   2. 28. Application for a variation of a manufacturing authorisation

   3. 29. Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade

   4. 30. Annual fees

   5. 31. Site inspections—type of site

   6. 32. Inspection of a site where immunological veterinary medicinal products are manufactured

   7. 33. Inspection of a site where sterile veterinary medicinal products are manufactured

   8. 34. Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured

   9. 35. Inspection of a site where veterinary medicinal products are assembled

   10. 36. Test sites

   11. 37. Animal blood bank authorisations

4. PART 4

   Fees relating to a wholesale dealer’s authorisation

   1. 38. Application for a wholesale dealer’s authorisation

   2. 39. Variation of a wholesale dealer’s authorisation

   3. 40. Annual fee for a wholesale dealer’s authorisation

   4. 41. Inspection of a wholesale dealer’s premises

5. PART 5

   Fees relating to feedingstuffs

   1. 42. Fees relating to feedingstuffs

   2. 43. Fees relating to premises for supply by suitably qualified persons

   3. 44. Reduced fees

6. PART 6

   General

   1. 45. Testing samples

   2. 46. Animal test certificates

   3. 47. Treatment under the cascade

   4. 48. Treatment under the Animals (Scientific Procedures) Act 1986

   5. 49. Treatment in exceptional circumstances

   6. 50. Specific batch control

   7. 51. Submission of control tests of an immunological product

   8. 52. Export certificates

   9. 53. Appeals to the Veterinary Products Committee: marketing authorisations and ATCs

   10. 54. Appeals to the Veterinary Products Committee: variations

   11. 55. Appeal to the Veterinary Products Committee: suspensions

   12. 56. Appeal to the Veterinary Products Committee: active substance under Schedule 6

   13. 57. Fees relating to an appointed person

   14. 58. Refund of fees relating to the Veterinary Products Committee or appointed persons

   15. 59. Fees relating to an improvement notice

   16. 60. Non-payment of fees

   17. 61. Waiver or reduction of fees

   18. 62. Reduction of fees when an application is withdrawn