S.I. No. 179/1996 - Animal Remedies Regulations, 1996 Arrangement of Regulations

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.

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/EEC^1 of 28 September, 1981, Council Directive 81/852/EEC of 28 September, 1981^2, Council Directive 87/20/EEC of 22 December, 1986^3, Council Directive 87/22/EEC of 22 December, 1986^4, Council Directive 90/676/EEC of 13 December, 1990^5, Council Directive 90/677/EEC of 13 December, 1990^6, Commission Directive 91/412/EEC of 23 July 1991^7, Commission Directive 92/18/EEC of 20 March 1992^8, Council Directive 92/74 of 22 September, 1992^9 Council Directive 93/40/EEC of 14 June, 1993^10 and Council Directive 93/41/EEC of 14 June, 1993^11 , and to give further effect to Council Regulation (EEC) 2377/90 of 26 June, 1990^12 and Council Regulation (EEC) 2309/93 of 22 July, 1993^13, 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.

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.

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) 2804/95^14 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 immunological homeopathic animal remedy;

"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" means an animal remedy, including a homeopathic animal remedy, which is administered to animals in order to produce active or passive immunity or to diagnose the state of immunity or which is intended for use for such purpose;

"imported" means brought by any means into the State from outside the State and "importation" shall be construed accordingly;

"intermediate product" means a combination of an authorised pre-mix for a medicated feedingstuff and one or more feedingstuffs which are intended for the subsequent manufacture of a ready to use medicated feedingstuff;

"Irish Medicines Board" means the Board established by the Irish Medicines Board Act, 1995 , (No. 29 of 1995);

"Manufacturer's Licence" means a licence granted under Regulation 21;

"meat" includes the flesh of fish;

"medical preparation" has the same meaning as in section 65 (1) of the Health Act, 1947 (No. 28 of 1947);

"medicated feedingstuff" means any mixture of an animal remedy or remedies and feed or feeds which is ready prepared for placing on the market or for use and which is intended to be fed to animals without further processing because of its curative or preventative or other properties as an animal remedy;

"person" includes a legal person;

"pharmacist" means a registered dispensing chemist and druggist, a registered druggist and a registered pharmaceutical chemist as defined in Section 4(10) of the Act or any other person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977;

"pharmacy" means a premises where the business of keeping open shop for the dispensing or compounding of medical prescriptions in carried on in accordance with the Pharmacy Acts, 1875 to 1977;

"pre-mix for a medicated feedingstuff" means an animal remedy prepared in advance with a view to use in the subsequent manufacture of a medicated feedingstuff;

"prescription" in these Regulations means a prescription issued by a registered veterinary surgeon in accordance with, and in the form prescribed by, Regulation 45.

"registered dentist" means a person currently entered in the register established under the Dentists Act, 1985 (No. 9 of 1985);

"registered medical practitioner" means a person currently entered in the register established under the Medical Practitioners Act, 1978 (No. 4 of 1978);

"registered veterinary surgeon" means a person currently entered in the register established under the Veterinary Surgeon Act, 1931 (No. 6 of 1931);

"veterinary product authorisation" means an authorisation granted pursuant to Regulation 6;

• (2) Subject to paragraph (1), a word or expression that is used in these Regulations and is also used in an act of the institutions of the European Communities cited in the aforesaid paragraph (1) has, unless the contrary intention appears, the meaning in these Regulations that it has in the act of the institutions of the European Communities in which it occurs.

• (3) In these Regulations any reference to a Regulation or Schedule shall be construed as a reference to a Regulation contained in these Regulations, or, as the case may be, to a Schedule thereto, unless it is indicated that a reference to some other provision is intended, and any reference in a Regulation to a paragraph or sub-paragraph shall be construed as a reference to a paragraph or a sub-paragraph of that Regulation, unless it is indicated that a reference to some other provision is intended.

3 GENERAL PROVISIONS RELATING TO THE MANUFACTURE, IMPORT, SALE AND SUPPLY OF BULK SUBSTANCES.

3.

3. (1) This Regulation applies to a substance which has anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties,

• (2) Subject to paragraph (7) a person shall not engage in —

• (a) the manufacture of a substance, or

• (b) the sale or supply of a substance, or

• (c) the manufacture or production of an animal remedy, medical preparation or any other pharmaceutical product based on a substance,

unless and until —

• (i) the person and the substance has been entered in the register maintained by the Minister in accordance with this Regulation, and

• (ii) such registration has been confirmed in writing by, or on behalf of, the Minister.

• (3) A person entered in the register under this Regulation —

• (a) shall keep a record available for inspection by an authorised officer for at least three years detailing, in chronological order, quantities of a substance acquired, manufactured, sold, supplied or used as, or for, the production of an animal remedy, a medical preparation or other pharmaceutical product, and

• (b) shall make such returns to the Minister as and when, and in such form as, the Minister may from time to time direct,

• (c) shall not sell or supply a substance unless and until the outer container bears a label indicating the appropriate commercial name or scientific name of the substance, the name and address of the manufacturer and, where the substance is sold or supplied in bulk, the name and address of the consignee; or where road tankers or similar containers are used for the transport of the substance it shall be sufficient for this information to be contained in the accompanying documents.

• (4) Notwithstanding paragraph (2), a person lawfully engaged in the manufacture, sale or supply of a substance, an animal remedy, a medical preparation, or other pharmaceutical product consisting of, or containing a substance, and who is lawfully carrying on such business on the date on which these Regulations come into force shall, within six calendar months of that date, apply to be registered and furnish to the Minister the particulars required to be furnished pursuant to paragraph (5).

• (5) An application for registration shall be in writing and be accompanied by the following particulars in regard to such manufacture, sale or supply —

• (a) the name and address of the manufacturer, seller or supplier, and

• (b) in the case of a body corporate, the address of its registered office, the names of its directors and other officers, and the company registration number, and

• (c) the address and location of the premises at which the business of manufacture, sale, or supply and storage of such substances is, or is to be, carried on, and

• (d) the appropriate commercial common name or appropriate scientific name and active principles of the substance , animal remedy, medical preparation or pharmaceutical product being, or to be, manufactured, sold or supplied.

• (6)
• (a) No person shall be registered under this Regulation unless the person applying for registration is lawfully entitled (otherwise than by reference to this Regulation) to so manufacture, sell, or, as the case may be, supply the substance, animal remedy, medical preparation or pharmaceutical product to which the application relates.

• (b) Where a person registered by the Minister is not lawfully entitled to manufacture, sell or, as the case may be, supply, the substance, animal remedy, medical preparation or pharmaceutical product in relation to which the registration relates, or ceases to be so entitled, such registration shall be cancelled by the Minister.

• (7)
• (a) The provisions of paragraph (2) shall not apply to a person who engages in the sale or supply of any substance to which paragraph (1) refers where such person is

• (i) a pharmacist, or

• (ii) a registered veterinary surgeon, or

• (iii) a registered medical practitioner, or

• (iv) a registered dentist.

• (b) The provisions of paragraph (2) shall not apply to the manufacture, wholesale or retail sale or supply of an animal remedy or a medical preparation where the person is lawfully entitled (otherwise than by reference to this Regulation) to so manufacture, sell or supply the said preparation or remedy.

• (8) The Minister may grant registration or may refuse an application under this Regulation.

4 RESTRICTION ON POSSESSION, SALE OR SUPPLY OF CERTAIN ANIMAL REMEDIES

4.

4. (1) A person shall not have possession of, sell or supply a ready made animal remedy otherwise than in the form of a proprietary animal remedy unless —

• (a) the person is the holder of a Manufacturer's Licence, and

• (b) the container or outer wrapper and accompanying document bears a notice stating the information required by section 4 of the Act or Regulations made thereunder and, where appropriate, the name of the consignee.

• (2) In this Regulation —

"proprietary animal remedy" means a ready made animal remedy sold or supplied under a special name and in a special pack, as specified in the animal remedies authorisation relating to the said animal remedy;

"ready made animal remedy" means any animal remedy prepared in advance which is presented in a pharmaceutical form which may be used without further processing and which does not comply with the definition of proprietary animal remedy.

PART II AUTHORISATION OF ANIMAL REMEDIES

5 COMPETENT AUTHORITY

5.

5. (1) Subject to the subsequent provisions of this Regulation, the Competent Authority in the State for the purpose of the Council Directive shall be the Irish Medicines Board.

• (2)
• (a) The Competent Authority in the State for the purpose of an animal remedy to which Council Directive 90/677/EEC applies shall be the Minister.

• (b) The Minister may delegate or by contract appoint persons whether officers of the Minister or otherwise to carry out the examination of applications for product authorisations in respect of animal remedies, or any part of such examination, for the purpose of these Regulations.

6 PROHIBITION ON SALE OR SUPPLY OF ANIMAL REMEDIES THAT ARE NOT AUTHORISED

6.

6. (1) A person shall not sell or supply an animal remedy save under and in accordance with an animal remedies authorisation for the time being in force.

• (2) Subject to Regulation 7 or, as the case may, Regulation 16, a person shall not sell or supply an animal remedy which is a veterinary medicinal product within the meaning of the Council Directive unless there is for the time being in force a veterinary product authorisation relating to such animal remedy.

• (3) A marketing authorisation granted or renewed by the European Agency for the Evaluation of Medicinal Products in accordance with the provisions of Council Regulation (EEC) 2309/93 is hereby deemed to be a veterinary product authorisation for the purposes of these Regulations.

• (4) A licence granted under the Therapeutic Substances Act, 1932 (No. 25 of 1932) shall be deemed to be a veterinary product authorisation in respect of the animal remedy or remedies named therein until the date of expiry of such licence.

• (5) A homeopathic animal remedy, other than an immunological homeopathic animal remedy, which, on the date of making of these Regulations, is registered under the Animal Remedies (Registration of Manufacturers, Importers and Wholesalers) Regulations, 1980 shall be deemed to be an authorised animal remedy provided application is made for a licence under Regulation 7 within three calendar months of the coming into force of these Regulations until such application is determined.

7 LICENSING OF CERTAIN ANIMAL REMEDIES BY THE MINISTER

7.

7. (1) (a) Notwithstanding Regulation 6 (2), the Competent Authority may, following consultation with the Minister, where it is considered appropriate, exempt from that paragraph —

• (i) an animal remedy intended solely for aquarium fish, cage birds, homing pigeons, terrarium animals and small rodents provided that the animal remedy so exempted is presented, packaged and labelled in an appropriate manner to render it unsuitable for use in other species or classes of animal, or,

• (ii) an animal remedy which, in the opinion of the Competent Authority, does not come within the terms of the Council Directive

• (b) This paragraph shall not apply to an animal remedy which consists of, or contains, an active ingredient which requires an animal remedy containing it to be designated as veterinary surgeon only, prescription only, prescription only exempt or pharmacy only.

• (c) Where the Competent Authority

• (i) exempts an animal remedy from Regulation 6, or

• (ii) is of the opinion that an animal remedy does not come within the terms of Council Directive

the Competent Authority shall issue a notification setting out the exemption or, as the case may be, the opinion.

• (d) A notification issued pursuant to subparagraph (c) shall contain a declaration to the effect that the animal remedy to which the said notification relates is not an authorised animal remedy, that it should not be sold or supplied within the State, and the person to whom the notification issues may make application to the Minister for a licence to possess, sell or supply the said animal remedy within the State.

• (2)
• (a) The Minister may, by licence, authorise the possession, sale or supply and the administration to an animal of an animal remedy to which a notification issued under paragraph (1) or to which Regulation 6(5) applies.

• (b) The Minister may grant a licence under this Regulation or he or she may refuse an application.

• (3)
• (a) An animal remedy to which this Regulation applies shall be labelled in accordance with the provisions of the Act or Regulations made under section 4 of the Act.

• (b) The label or outer container and package insert of a homeopathic animal remedy licensed under this Regulation shall, in addition to the particulars prescribed by section 4 of the Act bear the words "homeopathic medicinal product for veterinary use"

• (4) An animal remedy licensed under this Regulation and to which paragraph 1(a)(i) applies shall be designated a companion animal medicine.

• (5)
• (a) The Minister shall if he or she considers it appropriate to do so for the purpose of compliance with these Regulations or the law of the State attach conditions to a licence granted under this Regulation at the time of the grant of the licence or subsequently and may amend or revoke any such condition.

• (b) A licence granted under this Regulation shall specify the route of sale or supply of the animal remedy to which it relates in accordance with Regulation 13.

• (6) The Minister shall not grant a licence under this Regulation for the administration of an animal remedy to a food producing animal unless he or she is satisfied that the administration, and the conditions attached thereto, of such animal remedy will not result in produce derived from treated animals containing residues harmful to consumers of such produce.

8 PROVISIONS FOR APPLICATIONS FOR VETERINARY PRODUCT AUTHORISATIONS

8.

8. (1) An application for a veterinary product authorisation shall be made to the Competent Authority and the application shall –

• (a) be in such form as the Competent Authority may require and be accompanied by the particulars and documents specified in Article 5 of the Council Directive, and

• (b) where the documents and particulars relate to matters referred to in points 8, 9 or 10 of the said Article 5, be drafted and signed by experts with the requisite technical or professional qualifications as specified by the Council Directive.

• (2) Prior to making an application for a veterinary product authorisation the requirements of Council Directive 81/852/EEC as amended by Council Directive 87/20/EEC and Commission Directive 92/18/EEC relating to analytical, pharmac-toxicological and clinical standards and protocols in respect of the testing of the animal remedy shall have been complied with.

• (3) Notwithstanding paragraph (1), where an application is made for a veterinary product authorisation in respect of an animal remedy which has been authorised in accordance with the provisions of the Council Directives in another Member State, the Competent Authority may, and with effect from 1 January, 1998, shall, consider the application on the basis of the summary of product characteristics as laid down by Articles 5 (a) of the Council Directive furnished by the applicant and the assessment report as laid down by Article 5 (b) of the Council Directive furnished by the appropriate authority of the Member State which has granted the authorisation.

• (4) Where application for a veterinary product authorisation is made in respect of an animal remedy which is already under active examination in another Member State, the Competent Authority may suspend the detailed examination of the application in order to await the assessment report prepared by the appropriate authority in the other Member State and then consider the application in accordance with paragraph (3).

• (5) Where the Competent Authority suspends the examination of an application in accordance with the provisions of paragraph(4), the Competent Authority shall inform the appropriate authority in the other Member State and the applicant accordingly.

9 PROCEDURE FOR ASSESSMENT OF APPLICATIONS FOR VETERINARY PRODUCT AUTHORISATIONS.

9.

9. (1) In the examination and determination of an application for a veterinary product authorisation, the Competent Authority shall take into consideration such criteria as appear to be relevant for the purposes of the Council Directives and, in particular, the information supplied by the applicant in relation to –

• (a) the quality, safety and efficacy of the animal remedy to which the application relates;

• (b) the proposed indications, sales presentation, labelling and, where appropriate, package inserts of the animal remedy;

• (c) the measures, in the case of an animal remedy to be imported from a country other than a Member State of the European Community, to ensure that the animal remedy is produced to an equivalent standard to those applicable in the European Community, and, if necessary, an inspection of the manufacturing facility by the Competent Authority shall be required.

• (2) For the purpose of examining an application, the Competent Authority may require the applicant to furnish, without charge, a sample of the animal remedy, its active ingredients or intermediate products for testing, by a laboratory designated by the Competent Authority for that purpose, to ensure that the testing methods employed by the applicant and described in the application documents are satisfactory.

• (3) For the purpose of verifying the analytical detection methods proposed by the applicant for the carrying out of routine checks for residues of an animal remedy in food producing animals or, in the flesh or produce of such animals, the Competent Authority may require the applicant to supply sufficient quantities of any substance or other materials as may be necessary for this purpose.

• (4) Subject to paragraph (5) and paragraph (7), the Competent Authority shall, within 210 days of the receipt of a valid application, notify an applicant for a product authorisation of its decision to grant a veterinary product authorisation or to refuse an application.

• (5) Where an application for a veterinary product authorisation is being examined in accordance with paragraph (3) or paragraph (4) of Regulation 8 the Competent Authority shall, within 90 days of receipt of the assessment report, either recognise the decision of the other Member State and the summary of product characteristics approved by it or, if it considers that there are grounds for supposing that the authorisation of the animal remedy concerned may pose a risk to human or animal health or the environment, apply the procedures set out in articles 18 to 22 of the Council Directive.

• (6) If the Competent Authority proposes to refuse an application, the applicant shall be notified in writing of the reasons for such proposal and be invited to make representations to the Competent Authority, within 30 days of the giving of such notice, and the Competent Authority shall consider any such representations before reaching a final decision.

• (7) Where the Competent Authority requires further information from an applicant for the purpose of considering an application for a veterinary product authorisation, the time limit referred to in paragraph (4) shall be suspended until the information required has been supplied.

10 CONDITIONS OF VETERINARY PRODUCT AUTHORISATION

10.

10. (1) The Competent Authority may, if it considers it appropriate to do so, for the purpose of safety or health protection, or, for compliance with these Regulations or the law of the State attach conditions to a veterinary product authorisation at the time of the grant of the authorisation or subsequently and may amend or revoke a condition attached to an authorisation.

• (2) The Competent Authority in granting a veterinary product authorisation shall specify the manner in which an animal remedy shall be packaged, presented and labelled and the particulars which shall appear on such label or other container and package insert if appropriate.

• (3) The form of label and package insert shall comply with the requirements of the Council Directive and the Second Schedule, and shall include any other particulars, which are prescribed by the Competent Authority for the purpose of safety or health protection, including any special precautions for use or other warnings resulting from clinical and pharmacological trials, or, from experience gained during the use of the animal remedy and, in particular, matters arising as a result of pharmacovigilance reports.

• (4) A veterinary product authorisation shall, in accordance with Regulation 13, specify the authorised routes of sale and supply and any restrictions or conditions on promotion necessary to comply with the law of the State.

• (5) A veterinary product authorisation may, if deemed necessary, also require the inclusion of a tracer or marker substance.

• (6) A veterinary product authorisation may require that the holder of the authorisation makes available, to the appropriate authorities within the State, such quantities of a specified substance as may be necessary to carry out routine checks for the presence of residues of the animal remedy to which the authorisation relates in food producing animals or in the flesh or produce of such animals, if such specified substance is not readily available through normal commercial channels.

• (7) The holder of a veterinary product authorisation shall up-date the documents and particulars relating to an animal remedy, as necessary, in order to –

• (a) comply with the requirements of Article 14 of the Council Directive;

• (b) take account of technical and scientific progress;

• (c) take account of any prohibitions or restrictions placed on the marketing of the animal remedy in any other State or jurisdiction;

• (d) take account of any serious unexpected adverse reactions arising out of the use of the animal remedy.

• (8) Any changes notified under paragraph (7) shall be subject to the approval of the Competent Authority.

• (9) The holder of a veterinary product authorisation shall maintain records of all undesirable effects observed in animals or human beings arising out of the use of the animal remedy, which records shall be kept for at least five years and made available to the Competent Authority upon request.

11 REFUSAL OF APPLICATION FOR VETERINARY PRODUCT AUTHORISATION

11.

11. (1) The Competent Authority shall not grant a veterinary product authorisation where –

• (a) the animal remedy is harmful under the conditions of use stated at the time of application for authorisation;

• (b) the animal remedy has no therapeutic effect or the applicant has not provided sufficient proof of such effect as regards the species or class of animal which is to be treated;

• (c) the qualitative or quantitative composition of the animal remedy is not as stated;

• (d) the withdrawal period recommended by the applicant is not long enough to ensure that foodstuffs obtained from the treated animal do not contain residues which exceed those prescribed by Council Regulation 2377/90/EEC, any other instrument of Community Law, or any limit prescribed by Regulations made under the Act, or which might constitute a health hazard to the consumer of produce derived from the treated animal, or is insufficiently substantiated;

• (e) the animal remedy is, or is to be, offered for sale or supply for a use prohibited under Community Law or the Act or Regulations made or deemed to have been made pursuant to the Act;

• (f) the animal remedy is intended for administration to food producing animals whose flesh or products are intended for human consumption and the animal remedy consists of, or contains a substance, which is mentioned in Annex IV of Council Regulation (EEC) No. 2377/90;

• (g) the animal remedy consists of, or contains, a substance the administration of which, to the particular class or classes of animal for which the animal remedy is intended, is prohibited pursuant to Community Law or the Law of the State ;

• (h) such action is necessary for the protection of public or animal health or the environment;

• (j) the application documents do not comply with the requirements of the Council Directive;

• (k) the animal remedy is not manufactured in accordance with the principles and guidelines of good manufacturing practice for veterinary medicinal products as prescribed by Commission # Directive 91/412/EEC;

(l ) a request by the Competent Authority for further particulars, to enable compliance with the requirements of the Council Directive to be determined satisfactorily, has not been complied with within the time specified by the Competent Authority.

• (2) For the purpose of these Regulations an animal remedy shall be deemed to have no therapeutic effect unless it can be shown that it produces the appropriate therapeutic effect for the condition to be treated in the species or class of animal for which the treatment is intended.

12 REFUSAL OF APPLICATION FOR VETERINARY PRODUCT AUTHORISATION IN RESPECT OF AN ANIMAL REMEDY FOR FOOD PRODUCING ANIMALS

12.

12. Without prejudice to Regulation 11, the Competent Authority shall not grant a veterinary product authorisation in respect of an animal remedy intended for administration to a food producing animal unless

• (1)
• (a) the active substance or substances capable of pharmacological action contained in the animal remedy were authorised for use in other animal remedies on the date of entry into force of Council Regulation (EEC) No 2377/90 laying down a Community procedure for the fixing of maximum levels of residues of veterinary medicinal products in foodstuffs of animal origin, and

• (b) the time for obtaining a listing in the Annex of the said Council Regulation in respect of such substances has not expired, or

• (2) the active substance or substances capable of pharmacological action is, or, are mentioned in Annex I, II or III of the aforementioned Council Regulation.

13 ROUTES OF SALE OR SUPPLY OF ANIMAL REMEDIES

13.

13. (1) For the purposes of these Regulations the following routes of sale or supply shall apply–

• (a) veterinary surgeon only in respect of an animal remedy which may be administered only by

• (i) a registered veterinary surgeon, or

• (ii) under the direct supervision of a registered veterinary surgeon where such registered veterinary surgeon is present at the time of administration and in a position to render assistance if required;

• (b) prescription only in respect of an animal remedy which may be sold or supplied only by –

• (i) a pharmacist from a pharmacy in accordance with the prescription of a registered veterinary surgeon, or

• (ii) a registered veterinary surgeon in the course of his or her professional practice for the treatment of animals under his or her care and concerning which he or she has been consulted in a professional capacity;

• (c) prescription only exempt in respect of an animal remedy which may be sold or supplied only by –

• (i) a pharmacist, from a pharmacy, or

• (ii) a registered veterinary surgeon in accordance with subparagraph (b)(ii);

• (d) pharmacy only in respect of an animal remedy which may be sold or supplied only–

• (i) from a pharmacy under the personal supervision of a pharmacist, or

• (ii) by a registered veterinary surgeon in accordance with subparagraph (b) (ii);

• (e) licensed merchant in respect of an animal remedy, to which subparagraphs (a), (b), (c) or (d) do not apply, and which may be sold or supplied from a pharmacy, a premises to which an Animal Remedies Merchant's Licence relates and which may be sold or supplied by a registered veterinary surgeon in accordance with subparagraph (b) (ii);

• (f) companion animal medicine in respect of an animal remedy to which subparagraphs (a), (b), (c), (d) or (e) do not apply, which may be sold or supplied from a pharmacy, a premises to which an Animal Remedies Merchant's Licence or a Companion Animal Medicine Seller's Licence relates and which may be sold or supplied by a registered veterinary surgeon in accordance with subparagraph (b) (ii);

• (2) The authorised routes of sale or supply for an animal remedy shall be stated on the container, label or package insert for which purpose the symbols set out in Part IV of the First Schedule may be used.

• (3) In deciding the route of sale or supply for an animal remedy the Competent Authority shall have due regard to the need to protect public health, animal health, animal welfare and the environment and shall accordingly have due regard to –

• (a) the need for prior professional diagnosis,

• (b) the need for particular skill or training in the administration of the animal remedy in order to avoid unnecessary risk to the target animal or the person administering the product to the animal, and

• (c) the need for professional or specialist training in relation to the storage, handling or disposal of the animal remedy.

• (4) Where an animal remedy requires to be administered by, or, under the direct supervision of a registered veterinary surgeon, because,

• (a) the method of administration is novel, or

• (b) the professional skill of a registered veterinary surgeon is necessary in order to avoid unnecessary risk to the animal to be treated or to the person administering the animal remedy, or

• (c) to comply with the Law of the State, or restrictions arising from Community Law or the relevant United Nations Conventions on narcotic or psychotropic substances.

the animal remedy shall be restricted to administration by, or, as the case may be, under the direct supervision of, a registered veterinary surgeon.

• (5) Without prejudice to stricter provisions pursuant to the law of the State, an animal remedy to which the following conditions apply shall be restricted to supply by, or in accordance with the prescription of, a registered veterinary surgeon –

• (a) an animal remedy subject to official restriction on sale, supply or use, such as:

• (i) the restrictions resulting from the implementation of the relevant United Nations conventions on narcotic and psychotropic substances,

• (ii) the restrictions on the use of veterinary medicinal products resulting from Community Law;

• (b) an animal remedy in respect of which special precautions must be taken by a registered veterinary surgeon when supplying or prescribing the animal remedy in order to avoid any unnecessary risk to:

• (i) the target species,

• (ii) the person administering the animal remedy to the animal,

• (iii) the consumer of foodstuffs derived from the treated animal, or

• (iv) the environment;

• (c) an animal remedy intended for treatments or pathological processes which require a precise prior diagnosis or the use of which may cause effects which impede or interfere with subsequent diagnostic or therapeutic measures;

• (d) magisterial formulae intended for animals;

• (e) an animal remedy containing an active ingredient which has been authorised for use in animal remedies for less than five years unless. having regard to the information and particulars supplied by the applicant, or experience acquired in the practical use of the product. the Competent Authority is satisfied that None of the other criteria referred to in this paragraph apply.

• (6) Notwithstanding paragraph (5) the Competent Authority, may, in the case of an animal remedy to which some or all of the provisions of paragraph (5), other than subparagraph (5) (c) or subparagraph (5) (d), apply, having regard to

• (a) the purposes for which the animal remedy is intended, and

• (b) the extent to which the container, label and package insert are specific to such purpose, and

• (c) the strength of the active ingredient contained therein, and

• (d) the maximum dose specified in the product authorisation, and

• (e) the pharmaceutical form, and

• (f) the potential for misuse, designate such animal remedy as prescription only exempt.

• (7) Where the Competent Authority considers that the sale or supply of an animal remedy should be accompanied by professional point of sale advice regarding

• (a) potential risks to the person administering the animal remedy, or

• (b) possible contra-indications with other commonly used animal remedies, or

• (c) the method of administration or use or the handling or preparation prior to use, or

• (d) storage conditions, in particular unusual conditions, both prior to and during use, or

( e ) unusual conditions for safe disposal of used, or, unused, material including containers

the animal remedy shall be designated pharmacy only sale.

14 RESTRICTION ON SALE OF CERTAIN ANIMAL REMEDIES

14.

14. (1) This Regulation applies to an animal remedy which consists of, or, contains any substance, or any substance belonging to a class of substances, set out in the Second Schedule.

• (2) Subject to paragraph (3) the sale or supply of an animal remedy to which this Regulation applies is prohibited save under licence granted by the Minister.

• (3) This Regulation shall not apply to an animal remedy which is—

( a ) sold or supplied by a registered veterinary surgeon for the treatment of animals under his or her care and concerning which he or she has been consulted in a professional capacity, or

( b ) sold or supplied by a pharmacist in accordance with the prescription of a registered veterinary surgeon, or

( c ) an animal remedy which is designated prescription only exempt in accordance with the provisions of Regulation 13 (7) and is sold or supplied by a pharmacist.

• (4) Paragraph (2) shall not apply to an animal remedy which—

( a ) is sold or supplied (whether by being packaged in a particular manner or otherwise) as an intramammary preparation for the prevention or treatment of mastitis in bovine animals, and

( b ) is intended for use exclusively as such a preparation, and

( c ) whose container and any outer wrapper bears a notice clearly indicating that the animal remedy is so sold or supplied and is intended for such use only.

15 LABELLING OF ANIMAL REMEDIES

15.

15. (1) The holder of an animal remedies authorisation shall not sell or supply an animal remedy unless and until the package and label comply with the provisions and conditions attached to the animal remedies authorisation.

• (2) No person shall remove, deface or otherwise alter a label or, package insert, prescribed by these Regulations prior to the sale or supply of an animal remedy.

• (3) No person shall sell or supply an animal remedy where the label or package insert has been defaced or otherwise altered or where the label or package insert has been removed.

16 LICENSING OF CERTAIN ANIMAL REMEDIES IN SPECIFIED CIRCUMSTANCE

16.

16. (1) ( a ) Notwithstanding Regulation 6(2), the Minister may, by licence, where the animal health situation so requires—

• (i) in particular to deal with a serious disease epidemic, or

• (ii) for the treatment of minor or exotic species, or

• (iii) in exceptional circumstances where issues of public or environmental health arise relating to the use of authorised animal remedies,

authorise the possession, sale or supply and the administration to an animal of an animal remedy, in respect of which there is not otherwise in force an animal remedies authorisation, which is authorised in another Member State in accordance with the provisions of the Council Directive.

( b ) The Minister shall not grant a licence under this paragraph unless and until he or she is satisfied that the animal remedy subject of the application is authorised in another Member State and, for such purpose, may require confirmation of such authorisation to be furnished by the applicant.

• (2) ( a ) For the purposes set out in paragraph (1)(a), in exceptional circumstances, where there is no appropriate animal remedy authorised within the State or in another Member State, the Minister may, by licence, authorise the manufacture, import, sale, supply or use of an animal remedy, in respect of which there is not otherwise in force an animal remedies authorisation, pending the consideration of an application for such authorisation by the Competent Authority.

( b ) The Minister shall not grant a licence under this paragraph for the administration of an animal remedy to a food producing animal unless he or she is satisfied that the administration, and the conditions attached thereto, of such animal remedy will not result in produce derived from treated animals containing residues harmful to the consumers of such produce.

• (3) ( a ) The Minister may, if he or she thinks it appropriate to do so for the purposes of ensuring compliance with these Regulations or the law of the State and having regard to the provisions of this Regulation, attach conditions to a licence at the time of the grant of a licence or subsequently and may amend or revoke a condition attached to a licence

( b ) A licence granted under this Regulation shall specify the route of sale or supply of the animal remedy to which it relates in accordance with Regulation 13.

• (4) The Minister may make the granting of a licence under this Regulation conditional on application for a veterinary product authorisation being made to the Competent Authority.

• (5) The Minister shall not grant a licence under this Regulation when, following consultation with the Competent Authority, he or she is satisfied that in the circumstances it is more appropriate that an application for a veterinary product authorisation should be made to, and determined by, the Competent Authority.

17 VALIDITY OF VETERINARY PRODUCT AUTHORISATION

17.

17. (1) A veterinary product authorisation shall, unless previously revoked be valid for a period, specified therein, not exceeding five years, commencing on the date of the grant of the authorisation.

• (2) A veterinary product authorisation shall be renewable where application for renewal is made by the holder in accordance with the provisions of these Regulations and the Council Directives.

• (3) Where application for renewal of a veterinary product authorisation is made by the holder, in accordance with the provisions of these Regulations and the Council Directives, at least 90 days before the expiry date, the veterinary product authorisation shall remain in force pending the decision of the Competent Authority.

• (4) Where a veterinary product authorisation is renewed the period of validity of the authorisation shall commence immediately following the expiry of the authorisation which it replaces.

• (5) In exceptional circumstances and following consultation with the applicant, a veterinary product authorisation may be granted subject to annual review or subject to certain specific obligations, including—

( a ) the carrying out of further studies following the granting of authorisation, or

( b ) the notification to the Competent Authority of all, or specified, adverse reactions to the animal remedy.

• (6) The applicant for the grant or renewal of a veterinary product authorisation must be established in the European Community.

18 PHARMACOVIGILANCE

18.

18. (1) The Competent Authority shall establish a pharmacovigilance system for the purpose of surveillance of animal remedies with particular reference to

( a ) adverse reactions and to evaluate such information scientifically,

( b ) to collate information on frequently observed misuse and serious abuse of animal remedies, and

( c ) to collate information on the consumption and use of animal remedies.

• (2) ( a ) The holder of an animal remedies authorisation shall have permanently and continuously at his or her disposal an appropriately trained person responsible for pharmacovigilance.

( b ) The trained person referred to in subparagraph (a) shall be responsible for —

• (i) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the authorisation holder, his or her servants or agents is collected and collated at a single point;

• (ii) the preparation for the Competent Authority of the reports referred to in paragraph (3) in such form as may be prescribed by the Competent Authority in accordance with the relevant national or Community guidelines;

• (iii) responding to requests from the Competent Authority for the provision of additional information necessary for the evaluation of the benefits and risks affected by an animal remedy including provision of information concerning volume of sales for the particular animal remedy concerned.

• (3) The holder of an animal remedies authorisation shall ensure that —

( a ) all suspected serious adverse reactions (including unexpected serious adverse reactions) are recorded and reported to the Competent Authority at the earliest opportunity and not later than 15 days following receipt of a report;

( b ) detailed records of all adverse reactions, (including unexpected adverse reaction), other than those to which subparagraph (a) refers, which are reported are recorded and reported to the Competent Authority at least every six months during the first two years following first authorisation and once a year for the following three years and thereafter at five yearly intervals together with the application for renewal of the veterinary product authorisation, unless other requirements have been laid down as a condition of the animal remedies authorisation;

( c ) the reports referred to in subparagraph (a) and subparagraph (b) shall be accompanied by a scientific evaluation, and where it is not possible to furnish such evaluation in respect of a report to which subparagraph (a) applies with the initial report it shall be sufficient compliance to forward such evaluation at the earliest opportunity.

• (4) ( a ) A person licenced to sell or supply animal remedies pursuant to Regulations 30, 31 or 32, a registered veterinary surgeon or a pharmacist shall report all adverse reactions which are reported to him or her, or, which otherwise come to his or her attention, to the Competent Authority.

( b ) In the case of a serious adverse reaction the report shall be made at the earliest opportunity and not later than 15 days following receipt of such information and other adverse reactions or any undesirable effects of animal remedies shall be reported within six months of the receipt of the report.

( c ) The Competent Authority shall prescribe the form in which such reports shall be made.

• (5) ( a ) Where as a result of evaluation of an adverse reaction report the Competent Authority considers that a veterinary product authorisation should be revoked, varied or suspended it shall inform the Agency and the holder of the veterinary product authorisation (who shall be afforded an opportunity to make representations within such period as may be fixed by the Competent Authority) forthwith.

( b ) A veterinary product authorisation shall not be revoked, varied or suspended until the representations, if any, of the holder of the veterinary product authorisation have been considered.

( c ) Notwithstanding sub paragraph (b), in case of urgency where public or animal health is threatened, the Competent Authority may temporarily suspend the distribution, sale and supply of an animal remedy.

• (6) The Competent Authority shall immediately inform the Agency and the holder of an animal remedies authorisation of all reports of serious adverse reactions and unexpected serious adverse reactions received by the Authority and in any event not later than 15 days following receipt of the report.

• (7) The person responsible for the sale or supply of an animal remedy shall notify the Competent Authority of any action taken by him to suspend the sale or supply of, or the recall of, an animal remedy together with the reasons for such action if it concerns the efficacy or safety (including the protection of public health) of the animal remedy.

• (8) In this Regulation:—

"adverse reaction" means a reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or modification of physiological function;

"serious adverse reaction" means an adverse reaction which is fatal, life threatening, lesion producing, disabling, incapacitating or which results in permanent or prolonged symptoms in the animals treated;

"unexpected adverse reaction" means an adverse reaction which is not mentioned in the summary of the product characteristics;

"serious unexpected adverse reaction" means an adverse reaction which is both serious and unexpected;

"appropriately trained person" means a person who, although not necessarily possessing the qualifications prescribed by the Third Schedule, as a result of professional qualification, and, or, education and training is competent to discharge the responsibilities prescribed by this Regulation.

19 SUSPENSION AND REVOCATION OF VETERINARY PRODUCT AUTHORISATION

19.

19. The Competent Authority shall suspend or revoke a veterinary product authorisation where in the opinion of the Competent Authority —

• (1) the animal remedy proves to be harmful under the conditions of use stated at the time of application for authorisation or subsequently, or where the animal remedy does not have any therapeutic effect or its qualitative and quantitative composition is not as stated;

• (2) the recommended withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer; or which exceed the maximum residue limits prescribed by Council Regulation (EEC) No. 2377/90 or under any other instrument of Community Law or the Law of the State;

• (3) the animal remedy is sold or supplied for a use which is prohibited by other provisions of Community Law; however, pending Community rules, the Competent Authority may suspend or revoke a veterinary product authorisation for an animal remedy where such action is necessary for the protection of public, consumer or animal health;

• (4) the animal remedy consists of, or contains, a substance the administration of which, to the particular class or classes of animal for which the animal remedy is intended, is prohibited pursuant to Community Law or the Law of the State;

• (5) the information given in the application documents pursuant to Articles 5 and 14 of the Council Directive is incorrect;

• (6) the control tests referred to in Article 35 of the Council Directive have not been carried out;

• (7) a requirement to include a tracer or marker substance pursuant to Regulation 10 (2) or the second paragraph of Article 12 of the Council Directive has not been complied with;

• (8) the particulars supporting the application, as provided for in Article 5 of the Council Directive, have not been amended in accordance with the first and third paragraphs of Article 14 of the Council Directive;

• (9) any new information as referred to in the second paragraph of Article 14 of the Council Directive has not been communicated to the Competent Authority;

• (10) the animal remedy is not manufactured in accordance with the principles and guidelines of good manufacturing practice for veterinary medicinal products as prescribed by Commission Directive 91/412/EEC; or

• (11) the animal remedy is not labelled in accordance with the provisions of the veterinary product authorisation.

20 RECALL OF ANIMAL REMEDIES

20.

20. (1) The Competent Authority shall ensure that the distribution, sale or supply of an animal remedy is prohibited and that the animal remedy concerned is withdrawn and an animal remedy already sold or supplied is recalled where in the opinion of the Competent Authority —

( a ) the animal remedy is harmful under the conditions of use stated at the time of the application for authorisation or subsequently, as a result of the report of undesirable effects observed in animals or humans pursuant to the third paragraph of Article 14 of the Council Directive; or

( b ) the animal remedy has no therapeutic effect on the species of animal for which it is intended; or

( c ) the qualitative and quantitative composition of the animal remedy is not as stated on the label or as specified in the veterinary product authorisation; or

( d ) the recommended withdrawal period is inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer; or

( e ) the control tests on the finished animal remedy referred to in Article 35 of the Council Directive have not been carried out, or any other requirement or obligation relating to the grant of the veterinary product authorisation referred to in Article 24 of the Council Directive has not been complied with; or

( f ) the animal remedy is not manufactured in accordance with the principles and guidelines of good manufacturing practice for veterinary medicinal products as prescribed by Commission Directive 91/412/EEC; or

( g ) the use of the animal remedy for the purpose for which it is authorised, or the use of a substance contained therein, is prohibited, whether in animals generally, or, to the particular class or classes of animals for which the animal remedy is authorised, pursuant to Community Law or the law of the State.

• (2) The Competent Authority may confine the prohibition on distribution, sale or supply and the requirement to withdraw and recall an animal remedy already sold or supplied solely to specific production batches.

PART III MANUFACTURE, IMPORT AND EXPORT OF ANIMAL REMEDIES

21 MANUFACTURE OF ANIMAL REMEDIES

21.

21. (1) A person shall not manufacture an animal remedy in the State or import an animal remedy from a country other than a Member State of the European Union save under and in accordance with a licence ('Manufacturer's licence') granted by the Competent Authority.

• (2) A Manufacturer's Licence may relate to animal remedies generally, to animal remedies of a particular class or description specified in such licence or to one or more animal remedies specified in such licence.

• (3) ( a ) A Manufacturer's Licence shall be required for both total and partial manufacture and for the various processes of dividing up, packaging or presentation.

( b ) A Manufacturer's licence, shall not be required for dividing up, packaging or presenting an animal remedy where those processes are not carried out in advance and are carried out by —

• (i) a pharmacist in respect of an animal remedy to be sold from a pharmacy, or

• (ii) a registered veterinary surgeon in respect of an animal remedy supplied by him or her for the treatment of an animal under his or her care concerning which he or she has been consulted in a professional capacity,

and the quantity to be supplied is less than that available in the smallest proprietary pack size lawfully available within the State.

( c ) Where an animal remedy is sold or supplied in accordance with paragraph (3) (b) it shall be labelled with, or bear a notice staling

• (i) the proprietary name of the animal remedy,

• (ii) for animal treatment only,

• (iii) the species to be treated,

• (iv) the route of administration,

• (v) the dose rate,

• (vi) the name of the person to whom supplied,

• (vii) the name and adress of the supplier, and

• (viii) where necessary, precautions regarding use and withdrawal period, if applicable, so as to ensure the safe use of the animal remedy so supplied.

( d ) The provisions of this paragraph shall not apply to an animal remedy which is authorised in the form of a sterile preparation which animal remedy may only be sold or supplied in the authorised container or package.

• (4) A Manufacturer's Licence shall not be required for the extemporaneous preparation of an animal remedy or magistral formula not prepared in advance in accordance with Regulation 40 by —

( a ) a registered veterinary surgeon for the treatment of an animal under his or her care concerning which he or she has been consulted in a professional capacity, or

( b ) a pharmacist, in accordance with the prescription of a registered veterinary surgeon issued for the treatment of an animal under his or her care concerning which he or she has been consulted in a professional capacity.

• (5) The provisions of this Regulation shall not apply to the manufacture of an animal remedy in a laboratory which is engaged in recognised veterinary or pharmaceutical education, research or analysis and used for such purposes in such a laboratory.

• (6) A licence granted under section 7 of the Therapeutic Substances Act, 1932 shall be deemed to be a Manufacturer's Licence in respect of the animal remedy or remedies named therein until the date of expiry of such licence.

• (7) Save under and in accordance with a licence granted under Regulation 26, a person shall not manufacture or import a prohibited animal remedy.

• (8) This Regulation shall not apply to the manufacture of a medicated feedingstuff or an intermediate product under and in accordance with a licence granted pursuant to Regulation 4 of the European Communities (Animal Remedies and Medicated Feedingstuffs) Regulations, 1994 ( S.I. No. 176 of 1994 ).

22 PROVISIONS RELATING TO IMPORT OF ANIMAL REMEDIES FOR EXPORT

22.

22. (1) A Manufacturer's licence shall not be required for the import of an animal remedy from a country other than a Member State of the European Union where the animal remedy is imported for the purpose of trans-shipment to another Member State of the European Union and is not intended to be sold or supplied within the State.

• (2) An animal remedy to which paragraph (1) applies must be accompanied by a copy of the authorisation granted for its importation duly certified by the appropriate authority of the Member State of destination.

23 APPLICATION FOR MANUFACTURE'S LICENCE

23.

23. (1) The Competent Authority may grant a Manufacturer's Licence to any person who applies in the form and manner required by the Competent Authority provided, in regard to the animal remedy which it is proposed to manufacture, the Competent Authority is satisfied that the applicant has suitable premises, equipment, staff and manufacturing operations and suitable arrangements for quality control, record keeping, handling, storage and distribution.

• (2) An application for a Manufacturer's Licence shall meet at least the following requirements —

( a ) the application shall specify the animal remedies and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled;