Animal Remedies Regulations, 1996 Arrangement of Regulations

• Jurisdiction: Ireland

S.I. No. 179 of 1996.
ANIMAL REMEDIES REGULATIONS, 1996 ARRANGEMENT OF REGULATIONS
PART I
PRELIMINARY AND GENERAL
1. CITATION AND COMMENCEMENT
2. DEFINITIONS
3. GENERAL PROVISIONS RELATING TO THE MANUFACTURE, IMPORT SALE AND SUPPLY OF BULK SUBSTANCES.
4. RESTRICTION ON POSSESSION, SALE OR SUPPLY OF CERTAIN ANIMAL REMEDIES.
PART II
AUTHORISATION OF ANIMAL REMEDIES
5. COMPETENT AUTHORITY.
6. PROHIBITION ON SALE OR SUPPLY OF ANIMAL REMEDIES THAT ARE NOT AUTHORISED.
7. LICENSING OF CERTAIN ANIMAL REMEDIES BY THE MINISTER.
8. PROVISIONS FOR APPLICATIONS FOR VETERINARY PRODUCT AUTHORISATIONS.
9. PROVISIONS FOR ASSESSMENT OF APPLICATIONS FOR VETERINARY PRODUCT AUTHORISATIONS.
10. CONDITIONS OF VETERINARY PRODUCT AUTHORISATION.
11. REFUSAL OF APPLICATION FOR VETERINARY PRODUCT AUTHORISATION.
12. REFUSAL OF APPLICATION FOR VETERINARY PRODUCT AUTHORISATION IN RESPECT OF AN ANIMAL REMEDY FOR FOOD PRODUCING ANIMALS.
13. ROUTES OF SALE OR SUPPLY OF ANIMAL REMEDIES
14. RESTRICTION ON SALE OF CERTAIN ANIMAL REMEDIES.
15. LABELLING OF ANIMAL REMEDIES.
16. LICENSING OF CERTAIN ANIMAL REMEDIES IN SPECIFIED CIRCUMSTANCES.
17. VALIDITY OF VETERINARY PRODUCT AUTHORISATION.
18. PHARMACOVIGILANCE.
19. SUSPENSION AND REVOCATION OF VETERINARY PRODUCT AUTHORISATION.
20. RECALL OF ANIMAL REMEDIES.
PART III
MANUFACTURE, IMPORT AND EXPORT OF ANIMAL REMEDIES
21. MANUFACTURE OF ANIMAL REMEDIES.
22. PROVISIONS RELATING TO IMPORT OF ANIMAL REMEDIES FOR EXPORT.
23. APPLICATION FOR MANUFACTURER'S LICENCE.
24. DECISION ON APPLICATION FOR MANUFACTURER'S LICENCE.
25. SUSPENSION OF MANUFACTURER'S LICENCE.
26. POSSESSION ETC OF A PROHIBITED ANIMAL REMEDY.
27. CERTIFICATES.
PART IV
SALE AND SUPPLY OF ANIMAL REMEDIES
28. RESTRICTION ON SALE OF CERTAIN ANIMAL REMEDIES.
29. RESTRICTION ON USE OF PREMISES.
30. WHOLESALE OF ANIMAL REMEDIES.
31. RETAIL SALE OF ANIMAL REMEDIES.
32. SALE OF COMPANION ANIMAL REMEDIES.
33. RECORDS.
34. EMERGENCY SUPPLY OF CERTAIN ANIMAL REMEDIES BY PHARMACISTS.
35. PROHIBITION ON SALE OF ANIMAL REMEDIES AFTER EXPIRY DATE
36. SALE OF ANIMAL REMEDIES RESTRICTED TO FIXED PREMISES.
37. TRAINING OF CERTAIN PERSONS.
PART V
ADMINISTRATION OF ANIMAL REMEDIES AND PROVISIONS RELATING TO ANIMALS AND ANIMAL PRODUCE
38. ADMINISTRATION OF ANIMAL REMEDIES.
39. PROVISIONS RELATING TO CERTAIN ANIMALS TO WHICH AN ANIMAL REMEDY HAS BEEN ADMINISTERED.
40. ADMINISTRATION OF ANIMAL REMEDIES.
41. CLINICAL TRIALS.
42. WITHDRAWAL PERIODS.
PART VI
VETERINARY MEDICINE AND SURGERY
43. CROSS BORDER PRACTICE BY VETERINARY SURGEONS.
44. ANIMALS UNDER THE CARE OF A VETERINARY SURGEON.
45. PRESCRIPTIONS FOR ANIMAL REMEDIES.
46. PRESCRIPTIONS FOR ANIMALS IN INTENSIVE PRODUCTION SYSTEMS.
47. SCHEMES FOR THE ERADICATION OR CONTROL OF ANIMAL DISEASE.
PART VII
MISCELLANEOUS
48. ADAPTATION OF CERTAIN ENACTMENTS.
49. AUTHORISED OFFICERS.
50. PUBLICATION OF CERTAIN DECISIONS.
51. INFORMATION TO BE FURNISHED TO THE COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS.
52. FEES.
53. PROVISIONS RELATING TO FORGERY.
54. LICENCES AND REGISTRATIONS.
55. REGISTER.
56. LICENCES NON-TRANSFERABLE.
57. PROSECUTIONS.
58. IMPORT OF ANIMALS.
59. RECORD KEEPING.
60. SERVICE OF NOTICE.
61. REPEALS AND CONTINUANCE OF CERTAIN DOCUMENTS.
S.I. No. 179 of 1996.
ANIMAL REMEDIES REGULATIONS, 1996
I, Ivan Yates, Minister for Agriculture, Food and Forestry in exercise of the powers conferred as me by section 8 of the Animal Remedies Act, 1993 (No. 23 of 1993), for the purpose of giving effect to Council Directive 81/851/EEC1 of 28 September, 1981, Council Directive 81/852/EEC of 28 September, 19812, Council Directive 87/20/EEC of 22 December, 19863, Council Directive 87/22/EEC of 22 December, 19864, Council Directive 90/676/EEC of 13 December, 19905, Council Directive 90/677/EEC of 13 December, 19906, Commission Directive 91/412/EEC of 23 July 19917, Commission Directive 92/18/EEC of 20 March 19928, Council Directive 92/74 of 22 September, 19929 Council Directive 93/40/EEC of 14 June, 199310 and Council Directive 93/41/EEC of 14 June, 199311 , and to give further effect to Council Regulation (EEC) 2377/90 of 26 June, 199012 and Council Regulation (EEC) 2309/93 of 22 July, 199313, and after consultation with the Animal Remedies Consultative Committee, hereby make the following Regulations:
1 O.J. No.L. 317 of 6.11.81 p.1
2 O.J. No.L.317 of 6.11.81, p.18.
3 O.J. No.L. 15 of 17.1.87, p. 38.
4 O.J. No.L. 15 of 17.1.87, p. 38.
5 O.J. No.L.373 of 31.12.90, p. 15.
6 O.J. No.L.373 of 31.12.90, p.26.
7 O.J. No.L.228 of 17.8.91, p.70.
8 O.J. No.L. 97 of 10.4.92, p. 1.
9 O.J. No L 297 of 13.10.92 p.12.
10 O.J. No L. 214 of 24.8.93, p.31.
11 O.J. No.L.214 of 24.8.93, p.40.
12 O.J. No L 224 of 18.8.90 p. 1.
13 O.J. No.L. 214 of 24.8.93 p.1.
PART I PRELIMINARY AND GENERAL
	1 CITATION AND COMMENCEMENT	1. (a) These Regulations may be cited as the Animal Remedies Regulations, 1996.
(b) These Regulations shall come into operation on the 1st day of August, 1996.
	2 DEFINITIONS	2. (1) In these Regulations:
"animal remedies authorisation" means
(a) a veterinary product authorisation granted by the Competent Authority, or
(b) a licence granted by the Minister under Regulation 7, or
(c) a licence granted by the Minister under Regulation 16, or
(d) a marketing authorisation granted under Council Directive (EEC) 2309/93, or
(e) such other document, registration, licence or authorisation deemed by these Regulations to be an animal remedies authorisation;
"Animal Remedies Merchant's licence" means a licence granted under Regulation 31.
"Animal Remedies Wholesaler's licence" means a licence granted under Regulation 30.
"animal remedy" except where the contrary intention appears, includes an immunological animal remedy, a homeopathic animal remedy and an immunological homeopathic animal remedy;
"authorised animal remedy" means an animal remedy in respect of which there is for the time being in force an animal remedies authorisation;
"authorised pre-mix for a medicated feedingstuff" means an animal remedy which is a pre-mix for a medicated feedingstuff in respect of which there is for the time being in force a veterinary product authorisation;
"the Act" means the Animal Remedies Act, 1993 (No. 23 of 1993);
"the Agency" means the European Agency for the Evaluation of Medicinal Products established by Council Regulation (EEC) No 2309/93 of 22 July, 1993.
"bona fide client" means a person who owns or is in charge of an animal which has been placed under the care of a registered veterinary surgeon in accordance with Regulation 44 or, who has an agreement with a registered veterinary surgeon in respect of a herd or flock health scheme in accordance with Regulation 46;
"Companion Animal Medicine Seller's Licence" means a licence granted under Regulation 32;
"Competent Authority" has the meaning assigned to it by Regulation 5;
"Council Regulation (EEC) 2377/90" means Council Regulation (EEC) 2377/90 of 26 June, 1990, as last amended by Commission Regulation (EEC) 2804/9514 of 5 December, 1995 and any future Regulation of the Council, or, as the case may be, the Commission, made after the making of these Regulations which amends, extends or replaces the said Council Regulation (EEC) 2377/90;
14 O.J. L.No. L291 of 6.12.95, p.8
"the Council Directive" means Council Directive 81/851/EEC, 28 September, 1981 as amended by Council Directives 90/676/EEC, of 13 December 1990 and 93/40/EEC of 14 June, 1993 and as extended by Council Directive 90/677/EEC of 13 December, 1990 and Council Directive 92/74/EEC of 22 September, 1992 and any future directive of the Council, or, as the case may be, the Commission, made after the making of these regulations which amends, extends or replaces the said Council Directive 81/851/EEC;
"the Council Directives" means Council Directive 81/851/EEC of 28 September, 1987, Council Directive 81/852/EEC of 28 September, 1987, Council Directive 90/676/EEC of 13 December 1990, Council Directive 90/677/EEC of 13 December, 1990, Commission Directive 91/412/EEC of 23 July, 199I, Commission Directive 92/18/EEC of 20 March, 1992, Council Directive 93/40/EEC of 14 June, 1993 and Council Directive 93/41/EEC of 14 June, 1993 and any future Directive of the Council, or, as the case may be, the Commission, made after the making of these regulations which amends, extends or replaces all or any of the aforesaid Council, or , as the case may be, Commission Directives;
"food producing animal" means an animal of the bovine, caprine, equine, ovine or porcine species or poultry or rabbits or deer or fish or honey bees where such rabbits, deer or fish are intended for use as food for human consumption;
"group veterinary practice" means a formally associated group of registered veterinary surgeons who are all available to provide services of veterinary medicine and surgery and to carry out clinical procedures on animals under their professional care;
"holder" in respect of a registration, licence or animal remedies authorisation means the person to whom such registration, licence, or, as the case may, animal remedies authorisation has been granted and who is identified as such in the relevant registration, licence, or, as the case may be, animal remedies authorisation, and reference to a holder shall include a reference to an employee, servant or agent of the holder.
"homeopathic animal remedy" means an animal remedy prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in a Member State of the European Union but does not include an...