European Communities (Animal Remedies) Regulations, 2007

• Jurisdiction: Ireland
• Citation: IR SI 144/2007
• Year: 2007

S.I. No. 144 of 2007.
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007
Arrangement of Regulations
PART I
PRELIMINARY AND GENERAL
1. Citation and commencement 2. Interpretation. 3. Bulk substances.
PART II
AUTHORISATION OF AN ANIMAL REMEDY
4. Requirement for an animal remedies authorisation 5. Application for a veterinary product authorisation. 6. Examination of an application for a veterinary product authorisation. 7. Authorisation of an animal remedy referred to in Articles 13, 13a-d of the Directive (‘generics’ ‘bibliographics’ etc.). 8. Authorisation of a homeopathic animal remedy. 9. Mutual recognition. 10. Decision etc. on an application. 11. Validity of a veterinary product authorisation. 12. Certain obligations of a marketing authorisation holder. 13. Pharmacovigilance. 14. Suspension, revocation or variation of a veterinary product authorisation. 15. Recall of an animal remedy.
PART 111
EXCEPTIONAL AUTHORISATION AND ADMINISTRATION OF AN ANIMAL REMEDY
16. Certain health situations. 17. Miscellaneous situations. 18. ‘The cascade’. 19. Cross border practice. 20. Research etc.
PART IV
MANUFACTURE, IMPORT AND EXPORT OF AN ANIMAL REMEDY AND STARTING MATERIALS
21. Manufacture of an animal remedy. 22. Application for manufacturer's licence. 23. Decision on application for a manufacturer's licence. 24. Certain obligations of a holder of a manufacturer's licence. 25. Validity of a manufacturer's licence. 26. Revocation, suspension or variation of a manufacturer's licence. 27. Certification by the Board.
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 a companion animal medicine. 34. Record-keeping and other requirements for a veterinary practitioner and a pharmacist. 35. Labelling of certain animal remedies. 36. Prohibition on sale of an animal remedy after expiry date. 37. Fixed premises. 38. Advertising 39. Possession of certain animal remedies.
PART VI
ADMINISTRATION OF AN ANIMAL REMEDY AND PROVISIONS RELATING TO ANIMALS AND ANIMAL PRODUCE
40. Administration of an animal remedy. 41. Administration of an animal remedy to a food producing animal. 42. Import of an animal. 43. Animal remedies record and disposal of animal remedies.
PART VII
VETERINARY PRACTICE AND VETERINARY MEDICINE
44. Under the care of a veterinary practitioner 45. Prescribing and dispensing. 46. Emergency supply of certain animal remedies by a pharmacist 47. Certain animal disease situations.
PART VIII
MISCELLANEOUS
48. Publication of certain decisions. 49. Information to the agency. 50. Forgery. 51. Licences, registrations and approvals granted under a specified Regulation. 52. Implied condition in certain contracts of sale 53. Inspection by authorised officers, etc. 54. Search warrant 55. Search of suspects, etc. 56. Power of arrest 57. Saving for certain power 58. Obstruction 59. Impersonation of authorised officer, etc. and possession of identity document 60. Evidence of class of animal remedies to which a contravention relates 61. Offences by bodies corporate, etc. 62. Prosecution of summary proceedings 63. Disposal of things seized 64. Recoupment of costs of certain disposals 65. Fees and levies 66. Evidence of certificate etc. 67. Service. 68. Revocations and savers. 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 - Ampoules and single dose 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
S.I. No. 144 of 2007.
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007
I, Mary Coughlan, Minister for Agriculture 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 on the Community code relating to veterinary medicinal products1 as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 20042 and to give full effect to Council Regulation (EEC) No. 2377/90 of 26 June 19903 and to give full effect to Regulation (EC) No. 726/2004 of the European Parliament and the Council of 31 March 20044 , 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 Regulations) 2007.
(2) These Regulations come into operation on the 2nd day of April 2007.
	Interpretation	2. (1) In these Regulations -
“Act” means the Animal Remedies Act 1993 (No. 23 of 1993);
“Agency” means the 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,
(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, 18(5), or 20,
(d) a marketing authorisation granted under Regulation (EC) No. 726/2004,
(e) a registration granted by the Board in accordance with Regulation 8(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 (SI no 733 of 2005):
“authorised officer” means a person who is an authorised officer within the meaning of the Animal Remedies Act 1993.
“Board” means the Irish Medicines Board;
“companion animal” includes 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 that 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 19935 ;
“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 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...