The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

1. Introductory Text

2. 1. Title, commencement and interpretation

3. 2. Circumstances in which these Regulations do not apply

4. 3. Placing veterinary medicinal products on the market

5. 4. Form and manner of application

6. 5. Grant of an authorisation

7. 6. Duties on persons responsible for placing products on the market

8. 7. Products manufactured outside the European Economic Area

9. 8. Duties on an importer who holds a marketing authorisation

10. 9. Variations of authorisations

11. 10. Renewals of authorisations

12. 11. Suspension and revocation

13. 12. Refusal, etc., of a marketing authorisation on grounds relating to safety, quality or efficacy

14. 13. Refusal, etc., of a marketing authorisation on other grounds

15. 14. Confidentiality

16. 15. Fees

17. 16. Offences and penalties

18. 17. Defence

19. 18. Application of the Medicines Act 1968, the Trade Descriptions Act 1968 and the Consumer Protection Act 1987 to marketing authorisations

20. 19. Transitional Provisions

21. 20. Revocations

22. 21. Amendments

23. Signature

24. 1. SCHEDULE 1

       REQUIREMENTS IN RESPECT OF PRODUCTS OTHER THAN IMMUNOLOGICAL PRODUCTS

       1. 1. The applicant shall comply with all the requirements set out...

       2. 2. (1) Subject to sub-paragraphs (2) and (3) below, the applicant...

       3. 3. The applicant shall comply with the requirements set out in...

    2. SCHEDULE 2

       REQUIREMENTS IN RESPECT OF IMMUNOLOGICAL PRODUCTS

       1. 1. The applicant shall comply with the requirements set out in...

       2. 2. (1) Subject to sub-paragraphs (2) and (3) below, the applicant...

    3. SCHEDULE 3

       PROCEDURE ON REFERENCE TO APPROPRIATE COMMITTEE OR COMMISSION

       1. 1. Where the appropriate committee or the commission consulted under regulation...

       2. 2. Whether the applicant or authorisation holder has been heard or...

       3. 3. If, within the time allowed in the notification of a...

    4. SCHEDULE 4

       REVOCATIONS

    5. SCHEDULE 5

       AMENDMENTS

       1. 1. Article 3 of the Sheep Scab Order (Northern Ireland) 1970,...

       2. 2. In the Medicines (Importation of Medicinal Products for Re-exportation) Order...

       3. 3. The Medicines (Data Sheet) Regulations 1972, shall be amended as...

       4. 4. In the Medicines (Labelling) Regulations 1976 after regulation 3 there...

       5. 5. In the Medicines (Prohibition of Importation and Possession of Veterinary...

       6. 6. The Medicines (Fluted Bottles) Regulations 1978 shall be amended as...

       7. 7. In the Importation of Animal Products and Poultry Products Order...

       8. 8. In the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980,...

       9. 9. The Medicines (Pharmacy and General Sale — Exemption) Order 1980...

       10. 10. In the Health and Safety (Dangerous Pathogens) Regulations 1981, in...

       11. 11. The Warble Fly (Scotland) Order 1982 shall be amended as...

       12. 12. The Warble Fly (England and Wales) Order 1982, shall be...

       13. 13. In the Natural Mineral Waters Regulations 1985 in paragraph (c)...

       14. 14. In the Warble Fly (England and Wales) (Infected Areas) Order...

       15. 15. The Medicines (Veterinary Drugs) (Exemption from Licences) (Importation) Order 1986...

       16. 16. In the Control of Pesticides Regulations 1986 in Regulation 3(2)(b)...

       17. 17. The Medicines (Labelling of Medicinal Products for Incorporation in Animal...

       18. 18. In the Trade Descriptions (Places of Production) (Marking) Order 1988...

       19. 19. In the Medicines (Exemptions from Licences) (Intermediate Medicated Feeding Stuffs)...

       20. 20. The Medicines (Exemption from Licences) (Wholesale Dealing) Order 1990 shall...

       21. 21. The Medicines (Veterinary Drugs) (Prescription Only) Order 1991 shall be...

       22. 22. In the Children’s Homes Regulations 1991 in regulation 2(1) in...

       23. 23. In the Animals, Meat and Meat Products (Examination for Residues...

       24. 24. The Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) Order 1992...

       25. 25. In the Animals, Meat and Meat Products (Examination for Residues...

       26. 26. The Medicines (Medicated Feeding Stuffs) (No. 2) Regulations 1992 shall...

       27. 27. In the Specified Animal Pathogens Order 1993 in article 5(2)...

       28. 28. In the Aujeszky’s Disease Scheme Order (Northern Ireland) 1994 the...

       29. 29. In the General Product Safety Regulations 1994 in regulation 11(c)(ii)(aa)...

       30. 30. The Medicines (Standard Provisions for Manufacturer’s Licences for Veterinary Medicinal...

       31. 31. In the Medicines (Veterinary Medicinal Products) (Veterinary Surgeons from Other...

       32. 32. The Medicines (Restrictions on the Administration of Veterinary Medicinal Products)...

25. Explanatory Note