Office of Public Sector Information

Contents

1. PART 1

   Application for a marketing authorisation

   1. 1. Application for a marketing authorisation

   2. 2. Information with the application

   3. 3. Summary of product characteristics

   4. 4. Supply of a copy of the summary of product characteristics

   5. 5. Time limits for applications for products for use in food-producing animals

2. PART 2

   Derogations from some of the requirements in Part 1

   1. 6. Scope

   2. 7. Bibliographic application

   3. 8. Application for a product using a new combination of active substances

   4. 9. Application using existing data

   5. 10. Application for a pharmacologically equivalent medicinal product

   6. 11. Time limits for marketing authorisations granted under the procedure for a pharmacologically equivalent product

   7. 12. Extension of time limits

   8. 13. Parallel imports

   9. 14. Specific batch control scheme

   10. 15. Similar immunological products

   11. 16. Marketing in exceptional circumstances

3. PART 3

   Grant of a marketing authorisation

   1. 17. Time limits

   2. 18. Place of establishment of applicant

   3. 19. Procedure

   4. 20. Products authorised in another member State

   5. 21. Assessment reports

   6. 22. Grant of a marketing authorisation

   7. 23. Marketing authorisations for food-producing species

   8. 24. Refusal of a marketing authorisation

   9. 25. Publication following the grant of a marketing authorisation

   10. 26. Provisional marketing authorisation

   11. 27. Provisions of samples and expertise

   12. 28. Supply of information

   13. 29. Duties on the holder of a marketing authorisation relating to an immunological product

   14. 30. Control tests

   15. 31. Placing on the market

   16. 32. Duration and validity of a marketing authorisation

4. PART 4

   Variations of marketing authorisations on the application of the holder

   1. 33. Variation of a marketing authorisation for a mutually recognised veterinary medicinal product

   2. 34. Variation of a marketing authorisation not authorised in another member State

   3. 35. Administrative variations

   4. 36. Changes after a marketing authorisation has been issued

   5. 37. Compulsory variation

5. PART 5

   Suspension, etc. of a marketing authorisation

   1. 38. Suspension of a marketing authorisation: grounds

   2. 39. Suspension of a marketing authorisation: procedure

   3. 40. Revocation

   4. 41. Prohibiting the supply of veterinary medicinal products

6. PART 6

   Mutual recognition and multiple applications

   1. 42. Application for a marketing authorisation where one already exists in another member State

   2. 43. Application in another member State

   3. 44. Application for a marketing authorisation in multiple member States where a marketing authorisation does not exist in any member State

7. PART 7

   Labelling and package leaflets

   1. 45. Approval by the Secretary of State

   2. 46. Reference to being authorised

   3. 47. Language

   4. 48. Labelling with all the information on the immediate packaging

   5. 49. Products with immediate and outer packaging

   6. 50. Package leaflets

   7. 51. Ampoules

   8. 52. Small containers other than ampoules

   9. 53. Homeopathic remedies

   10. 54. Variations

8. PART 8

   Pharmacovigilance

   1. 55. Qualified persons responsible for pharmacovigilance

   2. 56. Duties relating to the qualified person

   3. 57. Adverse reactions to a veterinary medicinal product administered in the United Kingdom

   4. 58. Adverse reactions to a veterinary medicinal product administered in a third country

   5. 59. Periodic safety update reports

   6. 60. Release of information by the marketing authorisation holder

   7. 61. Action taken on account of pharmacovigilance

9. PART 9

   Homeopathic remedies

   1. 62. Meaning of “homeopathic remedy”

   2. 63. Placing a homeopathic remedy on the market in accordance with a registration

   3. 64. Application for registration

   4. 65. Procedure for registration

   5. 66. Products on the market before 1994

   6. 67. Classification