European Communities (Animal Remedies) (No. 2) Regulations, 2007

• Jurisdiction: Ireland
• Citation: IR SI 786/2007

ARRANGEMENT OF REGULATIONS

PART I

PRELIMINARY AND GENERAL

1. Citation and commencement.

2. Interpretation.

PART II

AUTHORISATION OF AN ANIMAL REMEDY

3. Requirement for an animal remedies authorisation.

4. Application for a veterinary product authorisation.

5. Examination of an application for a veterinary product authorisation.

6. Authorisation of an animal remedy referred to in Articles 13,13a-d of the Directive (‘generics’, ‘bibliographics’ etc.).

7. Authorisation of a homeopathic animal remedy.

8. Mutual recognition.

9. Decision etc. on an application.

10. Validity of a veterinary product authorisation.

11. Certain obligations of a marketing authorisation holder.

12. Pharmacovigilance.

13. Suspension, revocation or variation of a veterinary product authorisation.

14. Recall of an animal remedy.

PART III

EXCEPTIONAL AUTHORISATION AND ADMINISTRATION OF AN ANIMAL REMEDY

15. Cross border practice.

16. Certain health situations.

17. Miscellaneous situations.

18. ‘The cascade’.

19. Research etc.

PART lV

MANUFACTURE, IMPORT AND EXPORT OF AN ANIMAL REMEDY AND STARTING MATERIALS

20. Manufacture of an animal remedy.

21. Application for manufacturer’s licence.

22. Decision on application for a manufacturer’s licence.

23. Certain obligations of a holder of a manufacturer’s licence.

24. Validity of a manufacturer’s licence.

25. Revocation, suspension or variation of a manufacturer’s licence.

26. Certification by the Board.

27. Consignment to a person or address in another member state.

PART V

SALE, SUPPLY AND POSSESSION OF AN ANIMAL REMEDY

28. Restriction on sale of an animal remedy.

29. Restriction on use of a premises.

30. Wholesale of an animal remedy.

31. Retail sale of an animal remedy.

32. Training.

33. Sale of an animal remedy designated ‘companion animal medicine’.

34. Record-keeping and other requirements for a veterinary practitioner and a pharmacist.

35. Prohibition on sale of an animal remedy after expiry date.

36. Fixed premises.

37. Advertising.

38. Possession of certain animal remedies.

PART VI

ADMINISTRATION OF AN ANIMAL REMEDY AND PROVISIONS RELATING TO ANIMALS AND ANIMAL PRODUCE

39. Administration of an animal remedy.

40. Administration of an animal remedy to a food producing animal.

41. Import of an animal.

42. Animal remedies record and disposal of animal remedies.

PART VII

VETERINARY PRACTICE AND VETERINARY MEDICINE

43. Prescribing and dispensing.

44. Emergency supply of certain animal remedies by a pharmacist.

45. Certain animal disease situations.

PART VIII

MISCELLANEOUS

46. Publication of certain decisions.

47. Information to the Agency.

48. Forgery.

49. Licences, registrations and approvals granted under a specified Regulation.

50. Fixed Penalty Notice.

51. Implied condition in certain contracts of sale.

52. Inspection by authorised officers, etc.

53. Search warrant.

54. Search of suspects, etc.

55. Power of arrest.

56. Saving for certain power.

57. Obstruction.

58. Impersonation of an authorised officer, etc. and possession of certainidentity documents.

59. Evidence of class of animal remedies to which a contravention relates.

60. Disposal of things seized.

61. Recoupment of costs of certain disposals.

62. Fees and levies etc.

63. Evidence on certificate, etc.

64. Evidential Burden.

65. Service.

66. Revocation and savers.

67. Offences by bodies corporate, etc.

68. Prosecution of summary proceedings.

69. Offences.

ARRANGEMENT OF SCHEDULES

SCHEDULE 1

ROUTES OF SALE

PART 1

Routes of sale

PART II

Criteria taken account of by the Board in designating route of sale

SCHEDULE 2

LABELLING REQUIREMENTS FOR AN ANIMAL REMEDY

PART I

General labelling etc. requirements

PART II

Small containers

PART III

Package leaflet

PART IV

Symbols denoting route of sale

SCHEDULE 3

A VETERINARY PRESCRIPTION

SCHEDULE 4

QUALIFIED PERSON FOR MANUFACTURING

PART I

Duties of a qualified person

PART II

Requirements applicable to a qualified person

SCHEDULE 5

REQUIREMENTS TO BE MET BY A HOLDER OF A MANUFACTURER’S LICENCE

SCHEDULE 6

GENERAL REQUIREMENTS FOR A LICENSED MERCHANT’S PREMISES

SCHEDULE 7

ANIMAL REMEDIES RECORD

SCHEDULE 8

REQUIREMENTS OF THE PROGRAMME REFERRED TO IN REGULATION 43(9)

S.I. No. 786 of 2007

EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (No. 2) REGULATIONS 2007

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 7th December, 2007.

I, MARY COUGHLAN, Minister for Agriculture, Fisheries and Food, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) for the purpose of giving effect to Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products 1 as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 2 and to give further effect to Council Regulation (EEC) No. 2377/90 of 26 June 1990 3 and to give full effect to Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 4 , so far as that Regulation relates to a veterinary medicinal product, hereby make the following regulations:

PART I

PRELIMINARY AND GENERAL

Citation and commencement.

1. (1) These Regulations may be cited as the European Communities (Animal Remedies) (No. 2) Regulations 2007.

(2) Regulation 43(9) comes into operation on 1 January 2008.

Interpretation.

2. (1) In these Regulations—

“Act” means Animal Remedies Act 1993 (No. 23 of 1993);

“Agency” means European Medicines Agency established by Regulation (EC) No. 726/2004;

“animal remedies authorisation” means—

(a) a veterinary product authorisation within the meaning of Article 5 of the Directive, issued by the Board,

(b) a licence granted under the Therapeutic Substances Act 1932 (No. 25 of 1932) in respect of an animal remedy named on the licence, until the date of expiry of the licence,

(c) a licence under Regulation 16, 17, or 19,

(d) a marketing authorisation granted under Regulation (EC) No. 726/2004,

(e) a registration granted by the Board in accordance with Regulation 7(2), or

(f) such other document, registration, licence or authorisation deemed by these Regulations to be an animal remedies authorisation;

“animal” has the same meaning as it has in Section 2 of the Act and in the Animal Remedies Act 1993 (Section 2) Order 2005 ( S.I. No. 733 of 2005 );

“authorised officer” means a person who is an authorised officer within the meaning of the Act;

“Board” means Irish Medicines Board;

“companion animal” includes a domestic dog, cat, rabbit (other than a rabbit kept for human consumption), a small rodent, cage bird, homing pigeon, terrarium animal and an aquarium fish or an equid declared as not intended for use as food for human consumption in accordance with the European Communities (Equine Stud-Book Competition) Regulations 2004 ( S.I. No. 399 of 2004 ));

“companion animal medicine” means an animal remedy authorised by the Board for administration to a companion animal only;

“companion animal medicine seller” means a person registered under Regulation 33;

“Council Regulation (EEC) No. 2377/90” means Council Regulation (EEC) 2377/90 of 26 June, 1990, as amended and any act of an institution of the European Union which amends, extends or replaces the said Council Regulation (EEC) No. 2377/90;

“Directive” means Directive 2001/82/EC of the European Parliament and of the Council, of 6 November 2001, as amended by Directive 2004/28/EC, of the European Parliament and of the Council of 31 March 2004;

“EEA Agreement” means the Agreement on the European Economic Area signed in Oporto on 2 May 1992 as adjusted by the Protocol to that Agreement done at Brussels on 17 March 1993 5 ;

“EEA State” means a state which is a contracting state to the EEA Agreement within the meaning given to that phrase in the European Communities (Amendment) Act 1993 (No. 25 of 1993);

“European Economic Area” means the European Economic Area created by the EEA Agreement;

“food producing animal” means an animal of the bovine, caprine, ovine or porcine species, poultry, rabbits, deer, fish or honey bees, if such rabbits, deer or fish are intended for use as food for human consumption, or equidae intended for use as food for human consumption in accordance with the European Communities (Equine Stud-Book and Competition) Regulations 2004, ( S.I. No. 399 of 2004 );

“group veterinary practice” means a formally associated group of registered veterinary practitioners who are available to provide services of veterinary medicine and surgery and to carry out clinical procedures on animals under their care;

“holder” in respect of a registration, licence, approval or animal remedies authorisation means the person to whom the registration, licence, approval, or animal remedies authorisation is granted and who is identified as the holder on the registration, licence, approval or animal remedies authorisation, and reference to a holder includes a reference to a representative, employee, servant or agent of the holder;

“homeopathic animal remedy” has the same meaning as a homeopathic veterinary medicinal product;

“human consumption” includes a thing intended for incorporation in, or manufacture into, a food intended for human consumption and kindred words shall be construed accordingly;

“immunological animal remedy” has the same meaning as immunological veterinary medicinal product;

“imported” means brought into the State from outside the State and “importation” shall be construed accordingly;

“intramammary animal remedy” means an animal remedy which is licensed for sale (whether being packaged or otherwise) as an intramammary preparation for the prevention or treatment of...