The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

1. Introductory Text

2. PART I General

   1. 1. Title and commencement.

   2. 2. Interpretation.

   3. 3. Homoeopathic veterinary medicinal products to which these Regulations apply.

3. PART II Registration of products

   1. 4. Applications for registration.

   2. 5. Examination of registration applications.

   3. 6. Registration of products.

   4. 7. Renewal of registrations.

   5. 8. Alteration of Article 8 dossiers relating to registered products.

   6. 9. Suspension and revocation of registrations.

   7. 10. Prohibition and withdrawal notices.

   8. 11. Procedure where the Ministers propose to take certain action on grounds relating to safety or quality.

   9. 12. Procedure where the Ministers propose to take certain action on grounds other than grounds relating to safety or quality.

4. PART III Article 24 authorisations

   1. 13. Applications for Article 24 authorisations.

   2. 14. Issue of Article 24 authorisations.

   3. 15. Change of Article 25 particulars.

   4. 16. Suspension and revocation of Article 24 authorisations.

   5. 17. Procedure where the Ministers propose to refuse Article 24 authorisations or to suspend or revoke such authorisations.

5. PART IV Controls

   1. 18. Restrictions on the marketing of products.

   2. 19. Duties on persons responsible for marketing registered products.

   3. 20. Prohibition on supply and withdrawal from the market.

   4. 21. Labelling and package inserts.

   5. 22. Restrictions on the manufacture of products.

   6. 23. Restrictions on imports of products from third countries.

   7. 24. Restrictions on exports of certain products to EEA States.

   8. 25. Duties on holders of Article 24 authorisations.

   9. 26. Duties on qualified persons.

   10. 27. Suspension of persons acting as qualified persons.

6. PART V Miscellaneous and supplemental provisions

   1. 28. Confidentiality.

   2. 29. Issue of certificates.

   3. 30. Article 34 duties.

   4. 31. Enforcement.

   5. 32. Offences and penalties.

   6. 33. Defence.

   7. 34. Application of various sections of the Act.

   8. 35. Partial disapplication of various enactments.

   9. 36. Disapplication of various statutory instruments.

   10. 37. Amendment.

7. Signature

8. THE SCHEDULES

   1. Schedule 1

      Interpretation:

      1. Part I Expressions having the same meaning as in the Homoeopathics Directive.

      2. Part II Expressions having the same meaning as in Directive 81/851.

   2. Schedule 2

      Procedure where the Ministers propose to take certain action on grounds relating to safety or quality.

   3. Schedule 3

      Procedure where the Ministers propose to take certain action on grounds other than grounds relating to safety or quality.

   4. Schedule 4

      Procedure where the Ministers propose to refuse Article 24 authorisations or to suspend or revoke such authorisations.

   5. Schedule 5

      Application of various sections of the Act.

   6. Schedule 6

      Amendment.

9. Explanatory Note