IE
S.I. No. 786/2007 - European Communities (Animal Remedies) (No. 2) Regulations 2007
Table of Provisions (69)
Statutory Text (69 Articles)
1. The Programme shall—
(
a
) be in writing,
(
b
) identify—
(i) the herd number or other relevant identifier and the owner or person in charge (referred to in this Schedule as “the farmer”) of the animals to which it relates,
(ii) the milk purchaser registered under the European Communities (Food and Feed Hygiene) Regulations 2005 (
S.I. No. 910 of 2005
), who purchases milk from the farmer referred to at (i) and who, along with this person, the veterinary practitioner referred to at (iii) and, where appropriate, the veterinary practitioner referred to at (iv), is responsible for implementing the Programme,
(iii) the veterinary practitioner under whose direction it operates,
(iv) any other person, including any other veterinary practitioner who has responsibility for the care of the animals in accordance with Regulation 43(8), who is assigned formal responsibilities under the Programme relating to its implementation in accordance with subparagraph (
f
),
(
c
) specify that the primary objective of the Programme is the prevention and treatment of clinical and sub-clinical bovine mastitis in a manner designed to minimise use of antibiotic treatments and, where necessary, set targets for a reduction in the number of mastitis cases for that herd,
(
d
) cover in scope the critical herd disease and husbandry factors essential for effective mastitis control,
(
e
) specify the ongoing measures under the Programme designed to meet the objectives at (
c
) and (
d
) as well as the specific measures to be implemented in cases where particular intervention is deemed to be appropriate and identifying which of the persons in (
b
)(i) to (iv) is responsible for the implementation of each specified measure. These measures shall include at least the measures specified in paragraphs (2) to (4),
(
f
) define the respective roles of and the reporting relationship between the persons referred to in (
b
)(iii) and (iv),
(
g
) be signed by each of the persons at (
b
)(i) to (iv), such signature to be deemed as representing confirmation that each person understands and confirms that he or she will carry out his or her responsibilities, and
(
h
) be updated at least on an annual basis and in any event where a change of any of the personnel referred to in (
b
)(i) to (iv) occurs.
Copies of the Programme shall be retained by any person who has signed it in accordance with (
g
) and shall be made available to an authorised officer on request.
2. The milk purchaser referred to in paragraph 1(
b
)(ii) shall—
(
a
) Implement a structured sampling programme, at a level consistent with the aims of the Programme or as may be directed by the Minister, in respect of the milk supplied by the farmer as follows—
(i) Milk samples shall be taken in accordance with a written protocol which ensures the integrity of the samples and traceability to the farm of origin,
(ii) Milk samples shall be tested using recognised analytical methods, or, where appropriate, in accordance with methods stipulated by the Minister,
(iii) Milk samples shall be tested for:—
(A) Antibiotic residues in accordance with Regulation 22 of the European Communities (Control of Animal Remedies and their Residues) Regulations 2007 (
S.I. No. 143 of 2007
),
(B) Somatic Cell Counts,
(C) Where appropriate, the presence of mastitis causing pathogens and their sensitivity to a range of antimicrobial agents, including any that may be specified by the Minister, and
(D) Total Bacterial Count,
(
b
) Compile results of testing referred to in (
a
) and make these available to the farmer and the registered veterinary practitioner named in the Programme,
(
c
) Report to the Minister, if requested and in the form specified, data arising from the testing referred to in (
a
)(iii), and
(
d
) Arrange for the compilation of an annual report on the implementation of the Programme and submit the report to the Minister.
3. The farmer named in the Programme shall—
(
a
) Implement a management regime in respect of the herd and milking operations in the context of the programme designed to reduce the incidence of mastitis and use of antibiotic treatments,
(
b
) Participate in testing conducted by the milk purchaser referred to in paragraph 1(
b
)(ii), or in any additional testing programmes, needed to implement the Programme,
(
c
) Arrange for appropriate monitoring and testing of milking equipment on the farm and for reports arising from such testing to be made available to the milk purchaser and to the registered veterinary practitioner named in the Programme, and
(
d
) Maintain (in addition to the record stipulated in Regulation 42) a record in a structured manner and supply the registered veterinary practitioner named in the Programme at the end of each lactation year details of—
(i) Total number of cows in herd during lactation,
(ii) Total number of cows infected with mastitis during lactation,
(iii) Total number of mastitis cases treated during lactation, and
(iv) Total number of intramammary animal remedies used, with a breakdown by type.
4. The registered veterinary practitioner under whose direction the Programme operates may prescribe intramammary animal remedies for animals in the herd referred to at paragraph 1(
b
)(i) provided that he or she complies with the following—
(
a
) He or she takes full consideration of the data and recommendations of the Programme and his or her knowledge of the animals,
(
b
) He or she maintains an up to date knowledge of current developments in relation to mastitis control, in particular, by participation in continuing professional development programmes on this subject,
(
c
) He or she maintains an up to date knowledge of the general herd health situation on the farm and of the milking operations thereon, by reference to relevant data and reports and visits as necessary,
(
d
) He or she provides, as necessary, advice and training, either directly or through the person referred to in paragraph 1(
b
)(iv), to the farmer designed to reduce the incidence of mastitis and use of antibiotic treatments,
(
e
) He or she reviews the results of the effectiveness of the Programme in herds under his or her care with particular reference to antibiotic usage and effectiveness,
(
f
) Where required by reference to the incidence of mastitis on an individual farm, he or she approves a programme of specific remedial measures, or where appropriate, additional testing required to determine the causal agents and their antibiotic sensitivity, and
(
g
) He or she provides advice on the annual report on the implementation of the Programme with particular reference to achievement of the targets referred to in paragraph 1, together with any recommendations to improve the Programme.
5. Notwithstanding paragraph 4, save in exceptional circumstances, where a registered veterinary practitioner who fulfils the conditions at paragraph 1(
b
)(iv) has signed the Programme as provided for at paragraph 1(
g
), the prescription may only be written by that person. Furthermore, he or she shall, without prejudice to any other requirement of these Regulations, carry out the functions listed at paragraph 4(
a
), (
b
), (
c
), (
d
) and (
f
). The other functions listed at paragraph 4 must be carried out either by the veterinary practitioner under whose direction the programme operates or by the veterinary practitioner mentioned at paragraph 1(
b
)(iii).
GIVEN under my Official Seal,
22 November 2007
MARY COUGHLAN,
Minister for Agriculture, Fisheries and Food.
EXPLANATORY NOTE.
(This note is not part of the Instrument and does not purport to be a legal interpretation)
These Regulations update the regime governing the approval and distribution of animal remedies, in particular, by transposing Commission Directive 2006/130/EC of 11 December 2006 implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food producing animals from the requirement of a veterinary prescription and providing for certain enforcement provisions for Regulation (EC) No. 726/2004.
1 O.J. L 311, 28.11.2001
2 O.J. L 136, 30.04.2004
3 O.J. L 224, 18.08.1990
4 O.J. L 136, 30.04.2004
5 O.J. L 1, 3.1.1994
6 O.J. L 311, 28.11.2001
7 O.J. L 367, 22.12.2006
8 O.J. L 125, 23.5.1996
9 O.J. L 349, 12.12.2006
10 O.J. L 228, 17.8.1991
6. Animal remedies shall be stored in a manner that will facilitate proper rotation of stock.
7. The premises shall have a designated area for the storage, prior to return or disposal, of out of date stock and damaged stock. This area shall also be used for the temporary storage of products subject to recall due to quality defect or for reasons relating to the pharmacovigilance system provided for under these regulations.
8. The premises shall have refrigerated storage and display facilities for animal remedies which require to be kept under controlled temperature conditions.
9. Storage and display facilities shall be adequate to ensure that animal remedies do not become contaminated by other animal remedies or stock on the premises or cause such contamination.
SCHEDULE 7
ANIMAL REMEDIES RECORD
Form of record to be kept in accordance with Regulation 42(1)
1.
Purchase/incoming details—
(
a
) Quantity
(
b
) Authorised name of the animal remedy
(
c
) Date of Receipt
(
d
) Name and address of supplier
2.
Administration/Outgoing details—
(
a
) Date of Administration,
(
b
) Authorised name and quantity of the animal remedy administered,
(
c
) Identity of animal to which the animal remedy was administered including Ear Tag No. if appropriate,
(
d
) Date of expiry of a withdrawal period,
(
e
) Name of person who administered the animal remedy,
(
f
) Name of prescribing veterinary practitioner (if applicable),
(
g
) Quantities of unused or expired animal remedies which were returned.
SCHEDULE 8
Requirements of the Programme referred to in Regulation 43(9).
10. The licence holder shall keep readily available for inspection by an authorised officer, durable records of the details of manufacture of each batch of an animal remedy manufactured under his or her licence and of the tests carried out thereon, in such form that the records will be easily identifiable from the number of the batch as shown on each container in which an animal remedy is sold, supplied or exported and he shall permit the officer to take copies or make extracts from the records.
The records shall be retained for at least one year after the expiry date of the batches to which they relate or at least 5 years from the date of certification by the qualified person as referred to in Schedule 4, whichever is the longer period.
11. The licence holder shall maintain a system for recording and reviewing complaints concerning reported defects associated with an animal remedy to which his licence relates and of the outcome to any investigation carried out in respect of each complaint.
12. The licence holder shall keep such documents as will facilitate the withdrawal or recall from sale, supply or exportation of an animal remedy to which the licence relates. The documents shall be readily available for inspection by an authorised officer.
13. The licence holder shall keep a sample of each batch and of each active substance used in the manufacture of an animal remedy to which the licence relates for the period which ends one year after the labelled expiry date of the product, and shall furnish on request by the Board a sample of each batch for the purpose of any test, examination or analysis which may be requested by the Board.
14. The licence holder shall ensure that any tests for determining conformity with the standards and specifications applying to an animal remedy to which the licence relates, are, except insofar as the conditions of the relevant marketing authorisation may otherwise permit or require, applied to samples taken from the animal remedy after all manufacturing processes have been completed, and/or at such earlier stage(s) in the manufacture as may be required or approved in writing by the Board.
15. The licence holder, who is not the holder of a marketing authorisation in respect of an animal remedy to which the licence relates, shall comply with any provisions of the licence which relate to the sale or supply of that animal remedy and shall, by means of a label or otherwise, communicate the particulars of those provisions as they relate to method of sale or supply or restriction as to sale or supply to any person to whom the authorisation holder sells or supplies that animal remedy.
16. The licence holder shall supply such information as may be requested by the Board for the purposes of these Regulations about an animal remedy being manufactured and about the operations being carried out in relation to the manufacture.
17. The licence holder shall, for the purpose of enabling the Board, to—
(
a
) verify a statement contained in an application for a manufacturer’s licence or marketing authorisation, or
(
b
) ascertain whether there are any grounds for suspending, revoking or amending any such licence or authorisation,
permit authorised officers to enter and inspect his or her premises at any time and to take samples or copies of any documents relating to an application or authorisation as may be required.
18. The licence holder shall from time to time permit an inspection and make available information as may be required to satisfy the Board that the conditions of the licence are being complied with.
19. If the licence holder has been informed by the Board that any part of a batch of an animal remedy to which his or her licence relates has been found not to conform as regards strength, quality or purity with the specifications of the relevant product, he or she shall, if so directed by the Board, immediately withhold the remainder of that batch from sale, supply or exportation and, insofar as may be practicable, immediately recall all supplies already sold, supplied or exported from that batch.
20. If the licence holder has been informed by the Board that an animal remedy to which his or her licence relates has been found to give rise to unacceptable adverse reactions, he or she shall, if so directed by the Board, immediately withhold that product from sale, supply or exportation and, insofar as may be practicable, immediately recall all supplies of the product already sold, supplied or exported.
21. If the licence holder has been informed by the Board that any batch of an animal remedy, or part thereof, to which his or her licence relates, has not been manufactured in accordance with the principles and guidelines of good manufacturing practice, he or she shall, if so requested by the Board, immediately withhold that product from sale, supply or exportation and, insofar as may be practicable, immediately recall all supplies of the product already sold, supplied or exported.
22. If the licence holder recalls a particular batch of an animal remedy manufactured by him or her, or part thereof, he shall forthwith inform the Board of the decision to recall and of the reason for such recall.
23. If the licence holder considers that there may be grounds for the recall, or for the imposition of an abnormal restriction on the supply of an animal remedy manufactured by him or her, or of a batch or part of a batch thereof, he or she shall consult with the Board in relation to the action which may be considered appropriate in the circumstances.
24. The licence holder shall ensure that all manufacturing operations are carried out in accordance with the principles and guidelines of good manufacturing practice specified by Commission Directive 91/412/EEC
10
and Article 51 of the Directive.
10 O.J. L 228, 17.8.1991
25. The licence holder shall use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.
26. For the purposes of paragraph 25, manufacture of active substances used as starting materials shall include both total and partial manufacture or import of an active substance used as a starting material and the various processes of dividing up, packaging or presentation prior to its incorporation into an animal remedy, including repackaging or re-labelling, such as are carried out by a distributor of starting materials.
SCHEDULE 6
GENERAL REQUIREMENTS FOR A LICENSED MERCHANT’S PREMISES
27. (1) If a person resident or having a place of business in the State sells or supplies an animal remedy to a person or address in another member state, the sale or supply of the animal remedy is, for the purposes of these Regulations, governed by the law of the State.
(2) A person shall not sell or supply an animal remedy to a person in another member state unless—
(
a
) the animal remedy may be lawfully sold, supplied or administered in that member state, and
(
b
) the manner in which the animal remedy is sold or supplied is in accordance with the law of that member state.
(3) In proceedings alleging a breach of paragraph (2), a certificate signed by an officer of a competent authority in another member state, stating that the authority is the competent authority and that on a particular date or during a particular period—
(
a
) it was not lawful to sell, supply or administer a particular animal remedy in that member state, or
(
b
) the manner in which a particular animal remedy was sold or supplied into that member state was not in accordance with the law of that member state, is, until the contrary is shown, sufficient evidence of the facts stated in the certificate and it is not necessary to prove the signature of the person signing the certificate, that he or she is an officer of the authority or that the authority is a competent authority.
PART V
SALE, SUPPLY AND POSSESSION OF AN ANIMAL REMEDY
Restriction on sale of an animal remedy.
28. (1) Without prejudice to the generality of these Regulations, a person shall not sell or supply an animal remedy other than in accordance with the routes of sale stipulated in Part I of Schedule 1.
(2) Subject to paragraph (3), a person shall not sell or supply an animal remedy except under and in accordance with a licence or registration granted under Regulation 30, 31 or 33.
(3) Paragraph (2) does not apply to—
(
a
) the sale or supply of an authorised animal remedy by, or under the supervision of, a pharmacist from a pharmacy, in accordance with these Regulations,
(
b
) the sale or supply of an authorised animal remedy by a registered veterinary practitioner in accordance with Regulation 43, or
(
c
) the sale or supply by wholesale of an authorised animal remedy by the holder of a manufacturer’s licence, if the animal remedy is manufactured by him or her under and in accordance with the manufacturer’s licence.
(4) Notwithstanding paragraphs (2) and (3), a person shall not sell or supply an animal remedy designated prescription only unless—
(
a
) he or she is a pharmacist and he or she has a veterinary prescription relating to the animal remedy in his or her possession,
(
b
) he or she is a registered veterinary practitioner, the animal is under his or her care and he or she issues a veterinary prescription in respect of the animal remedy, or
(
c
) in the case of an animal remedy which comes within the scope of paragraph 3 (iii) of Part I of Schedule 1, he or she is a responsible person selling or supplying from a premises to which an animal remedies merchant’s licence relates and he or she has a veterinary prescription relating to the animal remedy in his or her possession.
(5) Without prejudice to Regulation 20(3)(
b
), a person who sells or supplies an animal remedy designated prescription only shall affix to the animal remedy, at the time of sale or supply, (in a manner that does not obscure the information required by the animal remedies authorisation) a label indicating—
(
a
) his or her name and address,
(
b
) the serial number of the veterinary prescription,
(
c
) the name of the prescribing veterinary practitioner,
(
d
) the date of sale or supply, and
(
e
) the dosage and duration of treatment (unless indicated on the proprietary label).
(6) (
a
) Notwithstanding Paragraph (4)(
b
), a registered veterinary practitioner need not write a veterinary prescription in respect of an animal remedy prescribed for a companion animal, other than an equid, if he or she offers a veterinary prescription to the owner or person in charge of the animal and the offer is declined.
(
b
) For the purposes of subparagraph (
a
), a veterinary practitioner shall display, prominently, at his or her premises, signage which makes clear that a client is entitled to receive a written veterinary prescription.
(7) Notwithstanding Paragraphs (2) and (3), a person shall not sell or supply an animal remedy designated prescription only exempt unless—
(
a
) he or she is a pharmacist, or
(
b
) he or she is a registered veterinary practitioner and the animal is under his or her care.
(8) Notwithstanding Paragraphs (2) and (3), a person shall not sell or supply an animal remedy designated pharmacy only unless—
(
a
) he or she is a pharmacist or is under the supervision of a pharmacist in a pharmacy, or
(
b
) he or she is a registered veterinary practitioner and the animal is under his or her care.
(9) Paragraphs (1), (5), (7) and (8) do not apply to the holder of a manufacturer’s licence, or the holder of an animal remedies wholesaler’s licence supplying a person who may lawfully sell or supply the animal remedy.
(10) A person shall not possess, sell or supply an animal remedy if the label or package leaflet has been altered or if the label or package leaflet has been removed unless authorised by the Board.
Restriction on use of a premises.
29. A person shall not use a premises for storage for the purpose of sale or supply or for the sale or supply of an animal remedy unless the premises is—
(
a
) a premises in respect of which there is a manufacturer’s licence,
(
b
) a premises in respect of which there is an animal remedies wholesaler’s licence,
(
c
) a premises in respect of which there is an animal remedies merchant’s licence,
(
d
) a premises owned or operated by a person registered in accordance with Regulation 33,
(
e
) a pharmacy, or
(
f
) a part of a premises, which is not a retail outlet to which Regulation 31 applies, used by a registered veterinary practitioner in respect of which a certificate of suitability has been granted or deemed to have been granted under Part 9 of the
Veterinary Practice Act 2005
(No. 22 of 2005).
Wholesale of an animal remedy.
30. (1) A person shall not sell or supply an animal remedy by wholesale except under and in accordance with a licence (“animal remedies wholesaler’s licence”).
(2) An applicant for an animal remedies wholesaler’s licence shall satisfy the Minister that he or she has suitable premises, equipment and staff and suitable arrangements for record-keeping, handling, storage and distribution of an animal remedy.
(3) An animal remedies wholesaler’s licence may relate to animal remedies generally, to animal remedies of a particular class or description specified in the licence, or to one or more animal remedies specified in the licence.
(4) An animal remedies wholesaler’s licence may not relate to a premises used for purposes referred to in Regulation 31 or 33.
(5) Without prejudice to Regulation 49, the holder of an animal remedies wholesaler’s licence, shall—
(
a
) sell or supply an animal remedy only to a person who holds an animal remedies wholesaler’s licence, an animal remedies merchant’s licence, or, is a person registered in accordance with Regulation 33, a pharmacist or a registered veterinary practitioner,
(
b
) provide and maintain premises, equipment and staff, and have in operation arrangements to avoid deterioration of an animal remedy to which the licence relates and to notify the Minister within seven days of any material change in the premises, equipment, staff or arrangements,
(
c
) undertake procedures for storage, stock rotation and maintenance of records in compliance with the particulars furnished with the application or with other arrangements as may be approved in advance by the Minister,
(
d
) immediately withdraw, if directed by the Minister, the Agency, the Board or the marketing authorisation holder, from sale or supply any quantity and, in so far as is practicable, immediately recall any quantity sold or supplied of—
(i) a batch, or part of a batch, of an animal remedy that does not conform with an animal remedies authorisation, or the strength, quality or purity does not conform with the specification of that animal remedy, or
(ii) an animal remedy that has given rise to unacceptable adverse reactions,
(
e
) keep, at the premises to which the licence refers, records of purchase and sale invoices in respect of each incoming and outgoing transaction detailing at least the following information—
(i) the date of transaction,
(ii) the precise identity of the animal remedy including name and pharmaceutical form and pack sizes,
(iii) the manufacturer’s batch number,
(iv) the name and address, as appropriate, of the supplier or consignee,
(v) the quantity received or supplied (including the quantity received and returned in accordance with subparagraph (
j
), or otherwise disposed of),
(
f
) keep at his or her premises the records referred to in subparagraph (
e
) for a period of five years from the date of receipt, sale or supply of the animal remedy and make these records available to an authorised officer on request,
(
g
) permit inspections and make available information as may be required to satisfy the Minister that the conditions of the licence are being complied with,
(
h
) furnish to the purchaser with each supply of an animal remedy, information detailing—
(i) the date of supply,
(ii) the precise identity of the animal remedy including proprietary name and pharmaceutical form and pack size,
(iii) the quantity supplied, and
(iv) the manufacturer’s batch number,
(
i
) comply with Article 65(5) of the Directive, and
(
j
) have in place the necessary systems to receive from—
(i) a registered veterinary practitioner,
(ii) a pharmacist,
(iii) the holder of an animal remedies merchant’s licence, or
(iv) a person registered under Regulation 33,
an animal remedy which is unused or has reached its expiry date, for return to the marketing authorisation holder or other person acting on his or her behalf in accordance with the arrangements put in place by that person.
(6) The holder of an animal remedies wholesaler’s licence shall not sell or supply an animal remedy to a person unless—
(
a
) that person is lawfully entitled to sell or supply an animal remedy, and
(
b
) the sale or supply of the animal remedy by that person would not contravene these Regulations.
(7) The holder of an animal remedies wholesaler’s licence shall, at least once a year, carry out a detailed audit to reconcile incoming and outgoing supplies with supplies currently held in stock and any discrepancies shall be specifically recorded and such record shall be retained and made available at the premises for inspection by an authorised officer for a period of not less than five years.
(8) This Regulation does not apply to the—
(
a
) sale or supply of an animal remedy by a person who manufactured or imported it in accordance with a manufacturer’s licence, or
(
b
) sale or supply by a pharmacist to a registered veterinary practitioner for use in accordance with Regulation 18.
(9) An animal remedies wholesaler’s licence remains in force for a period of three years or for a shorter period as may be specified in the licence, unless it is suspended, varied or revoked at an earlier date.
Retail sale of an animal remedy.
31. (1) (
a
) A person shall not sell or supply an animal remedy by retail except under and in accordance with a licence (“animal remedies merchant’s licence”),
(
b
) Subparagraph (
a
) does not apply to a person registered in accordance with Regulation 33, but only in so far as sale or supply of an animal remedy designated ‘companion animal medicine’ is concerned.
(2) An applicant for an animal remedies merchant’s licence shall satisfy the Minister that he or she has suitable premises, equipment and staff and suitable arrangements for record-keeping, handling, storage and distribution of an animal remedy or class of animal remedy.
(3) An animal remedies merchant’s licence may relate to animal remedies generally, to animal remedies of a particular class or description specified in the licence, or to one or more animal remedies specified in the licence.
(4) An animal remedies merchant’s licence may not relate to a premises used for purposes referred to in Regulation 30.
(5) Without prejudice to Regulation 49, the holder of an animal remedies merchant’s licence, shall—
(
a
) provide and maintain premises, equipment and staff and have in operation arrangements necessary to avoid deterioration of an animal remedy and to notify the Minister within seven days of a material change in the premises, equipment, staff or arrangements,
(
b
) keep, at the premises to which the licence relates, records of purchase or sale invoices in respect of each incoming and outgoing transaction detailing at least the following information—
(i) the date of transaction and in the case of an animal remedy designated prescription only, the serial number of the veterinary prescription,
(ii) the precise identity of the animal remedy including name and pharmaceutical form and pack sizes,
(iii) the manufacturer’s batch number,
(iv) the name and address, as appropriate, of the supplier or consignee, and
(v) the quantity received or supplied (including the quantity received and or returned in accordance with subparagraph (
g
), or otherwise disposed of),
(
c
) keep at his or her premises, the records referred to in subparagraph (
b
) for a period of five years from the date of receipt, sale or supply of the animal remedy and make these records available to an authorised officer on request,
(
d
) permit inspections and make available information required to satisfy the Minister that the conditions of the licence are being complied with,
(
e
) undertake procedures for storage, stock rotation and maintenance of records specified with the particulars furnished with the application or with such other arrangements as may be approved in advance by the Minister,
(
f
) immediately withdraw, if directed by the Minister, the Agency, the Board, the marketing authorisation holder or the holder of an animal remedies wholesalers licence, from sale or supply any quantity, and, in so far as is practicable, immediately recall any quantity sold or supplied of—
(i) a batch or part of a batch of an animal remedy that does not conform with an animal remedies authorisation or the strength, quality or purity does not conform with the specification of that animal remedy, or
(ii) an animal remedy that has given rise to unacceptable adverse reactions,
(
g
) have in place arrangements to receive from customers for return to the person from whom he or she purchased it, an animal remedy that is unused or has reached its expiry date and in addition take steps to ensure that customers are aware of the arrangements, and
(
h
) ensure that an animal remedy is not sold from the premises other than by a responsible person.
Subparagraph (
b
) does not apply in the case of an animal remedy designated ‘companion animal medicine’.
(6) The Minister may not grant a licence in respect of a premises unless the premises conforms to the general conditions set out in Schedule 6.
(7) The holder of an animal remedies merchant’s licence shall not sell or supply an animal remedy for the purpose of sale or supply to a person to whom Regulation 30(5)(
a
) refers.
(8) An animal remedies merchant’s licence remains in force for a period of three years, or for a shorter period if specified in the licence unless it is suspended, varied or revoked at an earlier date.
(9) The holder of an animal remedies merchant’s licence shall, at least once a year, carry out a detailed audit to reconcile incoming and outgoing supplies with supplies currently held in stock and any discrepancies shall be specifically recorded and the record shall be retained and made available at the premises for inspection by an authorised officer for a period of not less than five years.
(10) This Regulation does not apply to—
(
a
) a pharmacy, or
(
b
) a part of a premises, which is not a retail outlet to which this Regulation applies, used by a registered veterinary practitioner, in respect of which a certificate of suitability has been granted or deemed to have been granted under Part 9 of the
Veterinary Practice Act 2005
(No. 22 of 2005).
Training.
32. (1) The Minister may approve appropriate training courses for the purpose of ensuring that a person, other than a registered veterinary practitioner or a pharmacist, has adequate training in the proper and safe handling and storage of animal remedies to be responsible for the retail sale or supply of such remedies.
(2) Without prejudice to Regulation 49, it shall be a condition of approval that the person providing the course shall furnish the Minister with the names and addresses of persons who have successfully completed the course.
(3) (
a
) A person who has successfully completed a training course approved under paragraph (1) is referred to as “a responsible person”.
(
b
) Notwithstanding subparagraph (
a
), the Minister may require a responsible person to undergo additional training, if the Minister considers it necessary.
(4) The Minister may refuse to accept the nomination of a person to be a responsible person if, notwithstanding that the person has successfully completed an approved training course, the person has been convicted of an offence under the Act or these Regulations.
Sale of an animal remedy designated ‘companion animal medicine’.
33. (1) A person shall not sell or supply by retail an animal remedy designated ‘companion animal medicine’ unless he or she is registered in the register maintained under this Regulation (“companion animal medicine sellers register”).
(2) The Minister shall maintain a register of persons selling an animal remedy designated ‘companion animal medicine’ by retail.
(3) Registration of a person under this Regulation ceases if—
(
a
) a notice in writing is served on the Minister by or on behalf of a person to whom an entry in the register relates, stating that the person has ceased to carry on the business of selling an animal remedy designated ‘companion animal medicine’, or
(
b
) a person is notified in writing by the Minister of the Minister’s belief that he or she has ceased to carry on the business of selling an animal remedy designated ‘companion animal medicine’.
(4) On the death of a person registered in the register, the Minister may, on application by the personal representative of that person, enter in the register the name of the personal representative.
(5) A person registered under this Regulation shall comply with the storage requirements for an animal remedy as specified by the outer packaging, immediate packaging or package leaflet.
(6) A person registered under this Regulation shall have in place arrangements to receive and return to the person from whom he or she purchased it, an animal remedy that is unused or has reached its expiry date and shall take steps to ensure that customers are aware of these arrangements.
(7) This Regulation does not apply to—
(
a
) a registered veterinary practitioner,
(
b
) a pharmacist,
(
c
) the holder of an animal remedies merchant’s licence, or
(
d
) the holder of an animal remedies wholesaler’s licence.
Record-keeping and other requirements for a veterinary practitioner and a pharmacist.
34. A registered veterinary practitioner or a pharmacist shall—
(
a
) keep, at his or her premises, a record of purchases and sales (including quantities administered) in respect of each incoming and outgoing transaction, detailing at least—
(i) the date of transaction, and in the case of an animal remedy designated ‘veterinary practitioner only (VPO-1)’, ‘veterinary practitioner only (VPO)’, or prescription only (POM), the serial number of the veterinary prescription,
(ii) the precise identity of the animal remedy or where Regulation 18 applies, the medicinal product, including name, pharmaceutical form and pack size,
(iii) the manufacturer’s batch number,
(iv) the name and address of the supplier or consignee, and
(v) the quantity received or supplied (including the quantity received or returned in accordance with subparagraph (
c
) or otherwise disposed of),
(
b
) keep the records referred to in subparagraph (
a
) for a period of five years from the date of receipt, sale or supply or administration of the animal remedy and these records shall be made available to an authorised officer on request, and
(
c
) have in place arrangements to receive from consignees and return to the person from whom he or she purchased it, an animal remedy that is unused or reached its expiry date and shall take steps to ensure that clients are aware of these arrangements.
Subparagraphs (
a
) and (
b
) do not apply in the case of an animal remedy designated ‘companion animal medicine’.
Prohibition on sale of an animal remedy after expiry date.
35. A person shall not sell or supply an animal remedy after the date specified by the manufacturer as the expiry date.
Fixed premises.
36. (1) A person shall not sell or supply an animal remedy other than from a fixed premises.
(2) Paragraph (1) does not apply to the sale or supply of an animal remedy in the course of the provision of a veterinary service by a registered veterinary practitioner for the treatment of an animal under his or her care.
(3) Subject to paragraph (4)(
a
), a person shall not—
(
a
) except under and in accordance with a licence granted by the Minister, sell or supply an animal remedy by retail, via the internet or by mail order,
(
b
) except under and in accordance with a licence granted by the Minister, make a visit from house to house to collect, solicit or obtain an order for an animal remedy,
(
c
) sell or supply an animal remedy from a travelling shop, vehicle or automatic vending machine, or
(
d
) sell or supply an animal remedy at a trade fair or at a public or private place where animals are placed for exhibition or competition.
Subparagraph (
b
) does not apply in the case of a visit made by the representative of the holder of an animal remedies wholesaler’s licence to any of the following persons at his or her place of business—
(i) a registered veterinary practitioner,
(ii) a pharmacist,
(iii) the holder of an animal remedies merchant’s licence, or
(iv) a person entered in the ‘companion animal medicine sellers register’.
(4) (
a
) The Minister shall not grant a licence under paragraph (3)(
a
) or (
b
) unless the applicant is—
(i) the holder of an animal remedies merchant’s licence, or
(ii) a pharmacist.
(
b
) A licence granted under paragraph (3)(
a
) or (
b
) may only relate to an animal remedy referred to in paragraphs 6 and 7 of Part I of Schedule 1.
(5) In this Regulation:—
“house” includes land or other premises;
“fixed premises” does not include a vehicle, trailer, caravan, or other thing which may be transported on, in, or attached to a vehicle, or, a tent, awning, or hut, shed, or an unroofed or temporary structure or stall or a yard, field, roadway, or casual trading area.
Advertising.
37. (1) A person shall not publish or cause to be published an advertisement or other promotion for an animal remedy unless the animal remedy is an authorised animal remedy.
(2) Notwithstanding paragraph (1), a person shall not advertise an animal remedy—
(
a
) which contains a substance subject to restrictions resulting from implementation of United Nations Conventions on narcotic and psychotropic substances,
(
b
) which is designated Veterinary Practitioner Only (VPO-1), veterinary practitioner only (VPO) or Prescription Only, or
(
c
) in contravention of an animal remedies authorisation.
(3) Paragraph (2) does not apply to the advertisement of an animal remedy, which is solely directed at the holder of an animal remedies wholesaler’s licence, a registered veterinary practitioner, a pharmacist or the holder of an animal remedies merchant’s licence.
(4) A registered veterinary practitioner, the holder of an animal remedies merchant’s licence, a pharmacist or the holder of a registration under Regulation 33 shall display a list of prices of animal remedies held in stock.
Possession of certain animal remedies.
38. (1) A person shall not have an animal remedy, which is designated prescription only, in his or her possession or under his or her control, unless he or she has a veterinary prescription relating to the animal remedy in his or her possession.
(2) Paragraph (1) does not apply to—
(
a
) the holder of a manufacturer’s licence,
(
b
) the holder of an animal remedies wholesaler’s licence,
(
c
) a registered veterinary practitioner,
(
d
) a pharmacist,
(
e
) the holder of an animal remedies merchant’s licence, but only in the case of an animal remedy referred to in paragraph 3(iii) of Part I of Schedule 1, or
(
f
) a person in charge of a companion animal (other than an equid) in the circumstances referred to in Regulation 28(6).
(3) Paragraph (2) does not make it lawful for a person to whom that paragraph applies, other than a person referred to in subparagraph (
c
) or (
f
), to have an animal remedy designated prescription only in his or her possession or under his or her control on a farm or other premises where a food producing animal is kept.
(4) A person, other than a registered veterinary practitioner, shall not have an animal remedy designated ‘veterinary practitioner only (VPO-1)’ or ‘veterinary practitioner only (VPO)’ in his or her possession or under his or her control on a premises where an animal is kept, sold, supplied or slaughtered.
(5) A registered veterinary practitioner shall not cause or permit a person (other than a registered veterinary practitioner) to have an animal remedy designated ‘veterinary practitioner only (VPO-1)’ or ‘veterinary practitioner only (VPO)’ in his or her possession or under his or her control.
PART VI
ADMINISTRATION OF AN ANIMAL REMEDY AND PROVISIONS RELATING TO ANIMALS AND ANIMAL PRODUCE
Administration of an animal remedy.
39. (1) Without prejudice to Regulations 15(1) and 18 and subject to paragraph (2), a person shall not administer, cause or permit administration of an animal remedy to an animal unless—
(
a
) there is in force an animal remedies authorisation in respect of the animal remedy,
(
b
) the administration is carried out in accordance with the animal remedies authorisation,
(
c
) the animal remedies authorisation authorises administration of the animal remedy to the animal, class of animal or species,
(
d
) the animal remedies authorisation permits administration of the animal remedy by the person, and
(
e
) the Act and these Regulations have been complied with in respect of the animal remedy.
(2) Notwithstanding paragraph (1) a person shall not administer—
(
a
) an animal remedy designated ‘veterinary practitioner only (VPO-1)’ to an animal unless he or she is a registered veterinary practitioner and the animal is under his or her care,
(
b
) an animal remedy designated ‘veterinary practitioner only (VPO)’ to an animal unless—
(i) he or she is a registered veterinary practitioner and the animal is under his or her care,
(ii) he or she carries out the administration in the presence and under the direct supervision of the prescribing veterinary practitioner, or
(iii) in the case of administration of an animal remedy to an animal in a user establishment registered under the Cruelty to Animals Act 1876 (39 & 40 Vict.), he or she has been duly authorised in writing to do so by the appropriate authority of the institution concerned and by the supervising veterinary practitioner, or
(
c
) an animal remedy designated ‘prescription only’, unless it has been prescribed by a registered veterinary practitioner and, without prejudice to Regulation 28(6), the person administering the animal remedy has a veterinary prescription in his or her possession relating to that animal remedy and to the animal concerned.
Administration of an animal remedy to a food producing animal.
40. (1) A person shall not—
(
a
) notwithstanding Regulations 15 and 18, administer to a food producing animal, an animal remedy which consists of or contains a substance, the administration of which to the animal, species or class of animal, is unlawful,
(
b
) import, export, sell, supply, or slaughter for human consumption, a food producing animal to which an animal remedy has been administered in contravention of subparagraph (
a
),
(
c
) without prejudice to Regulation 41, import, export, sell or supply for human or animal consumption meat, milk, eggs or honey derived from, or produced by, an animal to which an animal remedy has been administered in contravention of subparagraph (
a
),
(
d
) process meat, milk, eggs or honey referred to in subparagraph (
c
) or import, export or sell produce of any meat, milk, eggs or honey prepared from, or with, such meat, milk, eggs or honey, or
(
e
) have in his or her possession or under his or her control a food producing animal to which an animal remedy has been administered in contravention of subparagraph (
a
) or meat, milk, eggs or honey derived from, or produced by, the animal.
(2) (
a
) The owner or person in charge of an animal to which an animal remedy has been administered shall—
(i) comply with the conditions of use of the animal remedy to be complied with after administration,
(ii) ensure that the animal is not slaughtered in order to be offered for human consumption (or sold, supplied or exported in order to be so offered) before the end of the withdrawal period and that produce obtained from the animal before the end of a withdrawal period is not disposed of with a view to being offered for human consumption.
(
b
) If a person, other than the owner or person in charge of the animal, administers an animal remedy to that animal, he or she shall inform the owner or person in charge of the animal of the obligations specified in subparagraph (
a
).
(3) In paragraph (2), “conditions of use” means information and directions that, pursuant to the animal remedies authorisation, are required to appear on the container, outer package and package leaflet of the animal remedy.
Import of an animal.
41. An animal lawfully imported is considered to have been treated with an authorised animal remedy, if—
(
a
) the animal remedy was administered prior to import,
(
b
) the animal remedy was administered in accordance with the law of the state where administration occurred, and
(
c
) the animal remedy does not consist of or contain a substance the administration of which to the class or classes of animal is unlawful.
Animal remedies record and disposal of animal remedies.
42. (1) The owner or person in charge of a food producing animal shall keep at his or her premises a record (“Animal Remedies Record”) of all animal remedies purchased and administered, which shall conform to Schedule 7.
(2) The owner or person in charge of a food producing animal to which an animal remedy has been administered shall—
(
a
) enter in the Animal Remedies Record, on each occasion when the animal remedy is administered, the required details in chronological order, and
(
b
) retain the Animal Remedies Record at his or her premises for five years after administration of the animal remedy and make this Record available on request to an authorised officer.
(3) The owner or person in charge of a food producing animal to which an animal remedy designated veterinary practitioner only (VPO-1), veterinary practitioner only (VPO) or prescription only has been administered shall keep, in date order, for five years, a copy of each veterinary prescription issued by a registered veterinary practitioner for the supply and use of the animal remedy administered to an animal under his or her control and make the copies and the record available for inspection on request by an authorised officer.
(4) The owner or person in charge of an animal shall return an unused animal remedy or an animal remedy which has reached its expiry date to the person from whom he or she purchased that animal remedy and shall record this in the Animal Remedies Record.
PART VII
VETERINARY PRACTICE AND VETERINARY MEDICINE
Prescribing and dispensing.
43. (1) A person shall not prescribe an animal remedy unless he or she is a registered veterinary practitioner, the animal to which the veterinary prescription relates is under his or her care and he or she is satisfied that—
(
a
) the veterinary prescription will be used to treat the animal to which the prescription relates,
(
b
) use of the animal remedy is justified for the animal,
(
c
) administration of the animal remedy is, to the best of his or her knowledge and belief, not incompatible with a current or previous treatment, (where appropriate, by consulting with any other veterinary practitioner who has responsibility for the care of the animals), and
(
d
) there is no contra-indication and there will not be an adverse reaction if other animal remedies have been, or are to be, administered or prescribed.
(2) A registered veterinary practitioner shall only prescribe an animal remedy in a quantity necessary for the treatment of the condition in respect of which the animal remedy is prescribed subject, in the case of a food producing animal, to a maximum quantity of 12 months supply from the date the veterinary prescription is issued.
(3) Without prejudice to Regulation 28(6), a registered veterinary practitioner who prescribes or administers an animal remedy designated veterinary practitioner only (VPO-1), veterinary practitioner only (VPO), or prescription only for or to an animal shall, at that time, issue a veterinary prescription to the owner or person in charge of the animal.
(4) Without prejudice to Regulation 28(6), a veterinary prescription shall—
(
a
) be issued by a registered veterinary practitioner,
(
b
) be written in ink or printed, legible and indelible and be signed in ink by, and bear, in block capital letters, the name and address of, the registered veterinary practitioner,
(
c
) be issued in triplicate of which the original and one copy shall be given to the owner or person in charge of the animal to be treated and a copy retained by the registered veterinary practitioner, and
(
d
) contain at least the particulars listed in Schedule 3.
(5) A registered veterinary practitioner shall retain, at his or her premises, a copy of a veterinary prescription for 5 years and make the copy available for inspection on request by an authorised officer.
(6) If a registered veterinary practitioner issues a veterinary prescription, he or she shall (if there is more than one authorised animal remedy suitable for treatment of the condition to which it applies) specify at least two animal remedies on the veterinary prescription.
(7) A person—
(
a
) who dispenses a veterinary prescription in part, shall immediately record on the prescription and on the copy, in a conspicuous, legible and indelible manner, the quantity of an animal remedy sold or supplied by him or her on foot of the veterinary prescription and the date of each such sale or supply and shall attest to this by means of his or her signature and shall retain a copy (which could be a photocopy) of the prescription,
(
b
) who has completed dispensing a veterinary prescription shall—
(i) at that time write on the prescription and on the copy thereof in a conspicuous, legible and indelible manner, the word “dispensed” and shall attest to this by means of his or her signature and the date,
(ii) return a copy of the veterinary prescription to the person who presented it, and
(iii) he or she shall retain, at his or her premises, the original veterinary prescription for five years and shall make this available on request to an authorised officer, and
(
c
) not complete dispensing an animal remedy on foot of a veterinary prescription later than 12 months after the date the veterinary prescription is issued.
(8) For the purposes of this Regulation, an animal is considered to be under the care of a registered veterinary practitioner if—
(
a
) the registered veterinary practitioner (or another member of the group veterinary practice of which he or she is a member) has been consulted and has been given responsibility for the professional veterinary care of the animal, herd or flock by the owner or person in charge,
(
b
) the registered veterinary practitioner (or other member of the group veterinary practice of which he or she is a member) has sufficient knowledge of the animal, herd or flock to form an opinion of the condition of the animal and for this purpose he or she (or another member of the group veterinary practice), shall have visited the farm or other premises on which the animal, herd or flock is kept (or otherwise examined the animal), sufficiently often and recently enough and, in any event, at least once in a 12 month period, to have acquired an accurate picture of the current health, welfare and disease status of the animals on that farm or premises,
(
c
) the registered veterinary practitioner (or other member of the group veterinary practice) is available to respond to requests to provide services of veterinary medicine and surgery and clinical procedures on the animal (or in the herd or flock) in accordance with ethical veterinary practice,
(
d
) the registered veterinary practitioner is readily available for follow up consultation or monitoring of the condition and evaluation of the therapy, and
(
e
) the records kept by the registered veterinary practitioner make it evident that the professional veterinary responsibility for the animal, herd or flock in question is real and not merely nominal.
(9) The 12 month period, referred to in paragraph (8)(
b
), does not apply to the prescribing of an intramammary animal remedy, if the animal to be treated belongs to a herd covered by a programme meeting the requirements of Schedule 8.
(10) In order to comply with paragraph (8)(
e
), a registered veterinary practitioner shall maintain, at his or her premises, records as follows
(
a
) in relation to each client, a record, containing at least the following—
(i) the date of each visit to the premises on which the animal, herd or flock is kept or on which the animal was seen,
(ii) the identity or other reference to animals clinically examined,
(iii) the condition identified,
(iv) details of treatment of each condition, and
(v) a cross-reference to any relevant results of laboratory tests
undertaken for the purpose of diagnosis, or any other test results,
and
(
b
) copies of invoices and statements regarding professional services and supply of medicines in respect of each client.
(11) (
a
) Invoices referred to in paragraph (10)(
b
) shall detail the cost of an animal remedy, administered, sold or supplied separately from a professional veterinary service.
(
b
) These records may be maintained in the form of a herd health programme.
Emergency supply of certain animal remedies by a pharmacist.
44. (1) It is not a contravention of these Regulations for a pharmacist to sell or supply an authorised animal remedy which is designated prescription only, if—
(
a
) the pharmacist is requested to sell or supply the animal remedy for the treatment of an animal by a registered veterinary practitioner who, by reason of an emergency, is unable to furnish a veterinary prescription immediately,
(
b
) the registered veterinary practitioner undertakes to furnish a veterinary prescription within 72 hours,
(
c
) the animal remedy is sold or supplied in accordance with the directions of the registered veterinary practitioner requesting it,
(
d
) the animal remedy is not a controlled drug specified in Schedule 1 or 2 to the Misuse of Drugs Regulations1988, (
S.I. No. 328 of 1988
),
(
e
) the animal remedy is labelled in accordance with Regulation 28(5), and
(
f
) the pharmacist maintains the records prescribed by Regulation 34.
(2) A registered veterinary practitioner who makes a request in accordance with paragraph (1) shall immediately issue a veterinary prescription for the animal remedy and shall ensure that the prescription reaches the pharmacist and the owner or person in charge of the animal within the period specified in paragraph 1(
b
).
(3) If a registered veterinary practitioner fails to comply with an undertaking under paragraph (1)(
b
), the pharmacist shall not, at any future date, sell or supply an animal remedy under this Regulation at the request of that registered veterinary practitioner.
Certain animal disease situations.
45. (1) These Regulations, in so far as they relate to an animal under the care of a registered veterinary practitioner, do not apply to the administration of an animal remedy, if the animal remedy is administered for the purpose, or in the course of an official or voluntary scheme or programme authorised and operated by, or on behalf of, the Minister for the treatment, control, eradication, monitoring, or surveillance of disease (within the meaning of the
Diseases of Animals Act, 1966
(No. 6 of 1966)) in an animal or for the determination of the health or disease status of an animal.
(2) An animal to which an animal remedy has been administered under and in accordance with a scheme or programme under paragraph (1) is considered, subject to the terms and conditions of the scheme or programme, to have had an authorised animal remedy administered to it.
PART VIII
MISCELLANEOUS
Publication of certain decisions.
46. The Board shall publish notice of the grant or revocation of a veterinary product authorisation in
Iris Oifigiúil
.
Information to the Agency.
47. (1) The Board shall inform the Agency of a decision to grant, refuse, suspend or revoke a veterinary product authorisation or a manufacturer’s licence, or to prohibit the sale or supply, or to recall an animal remedy and the reasons for the decision.
(2) The Board shall make available to the Agency information relating to reports received by it under Regulation 12.
(3) The Board shall ensure that appropriate information about actions taken pursuant to paragraph (1) or Regulation 12, which may affect the protection of health in a third country, is brought to the attention of the relevant international organisations and the Agency.
Forgery.
48. (1) A person shall not forge a document purporting to be—
(
a
) a veterinary prescription,
(
b
) an animal remedies authorisation,
(
c
) a licence, registration or approval,
(
d
) a record required to be kept pursuant to these Regulations, or
(
e
) any other document issued or maintained pursuant to these Regulations,
(which document is, in this Regulation, referred to as a “forged document”).
(2) A person shall not forge an endorsement or other entry purporting to be for any purpose of these Regulations on any document whatsoever required to be kept for the purposes of these Regulations (which document with such entry in this Regulation is referred to as a “falsely endorsed document”).
(3) A person shall not, with intent to deceive, alter—
(
a
) a veterinary prescription issued under these Regulations,
(
b
) an animal remedies authorisation,
(
c
) a licence, registration or approval,
(
d
) a record required to be kept pursuant to these Regulations, or
(
e
) any other document issued or maintained pursuant to these Regulations,
(which document if so altered is, in this Regulation, referred to as an “altered document”).
(4) A person shall not utter a forged document, a falsely endorsed document or an altered document.
(5) A person shall not have in his or her possession or under his or her control, a forged document, a falsely endorsed document or an altered document.
(6) Paragraph (5) does not apply to—
(
a
) an authorised officer or a member of the Garda Síochána or an officer of Customs and Excise, when acting in the course of his or her duty, or
(
b
) a person who has taken into his or her possession a document for the purpose of—
(i) preventing another from committing or continuing to commit an offence, or
(ii) delivering it into the custody of a person specified in subparagraph (
a
).
Licences, registrations and approvals granted under a specified Regulation.
49. (1) The Minister may grant a licence, registration or approval under a specified Regulation or refuse an application and may attach conditions to a licence, registration or approval, revoke or vary a condition or suspend or revoke the licence, registration or approval.
(2) An application to the Minister for a licence, registration or approval under a specified Regulation shall be made in a form, be accompanied by any material, and fee and contain any particulars that the Minister specifies.
(3) In the case of an application for an animal remedies wholesaler’s licence, the decision to grant a licence or refuse an application is notified to the applicant within 90 days of receipt of a valid application.
(4) Without prejudice to the generality of paragraph (1), the Minister may refuse an application or revoke a licence, registration or approval if—
(
a
) the applicant or holder has been convicted of, or committed, an offence, whether he or she has been convicted or not, under the Act or these Regulations,
(
b
) the applicant or holder has failed to comply with a condition attached to a licence, registration or approval,
(
c
) the applicant or holder is not, in the opinion of the Minister, a fit and proper person to hold the licence, registration or approval, or
(
d
) in relation to the application, information required has not been furnished or information that is, in the opinion of the Minister, false or misleading, has been furnished.
(5) Without prejudice to the generality of paragraph (1) and the specified Regulation concerned, the Minister shall refuse an application or revoke a licence, registration or approval under a specified Regulation, if the applicant or person to whom it is granted is convicted, on indictment, of an offence under the Act or these Regulations.
(6) If the Minister proposes to refuse an application, or to revoke a licence, registration or approval under a specified Regulation, or to attach a condition or vary or revoke a condition attached to a licence, registration or approval, he or she shall—
(
a
) notify the applicant or holder in writing of the proposal and of the reasons for the proposal, and that he or she may make representations to the Minister in relation to the proposal within twenty one days of the notification,
(
b
) consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and
(
c
) notify the applicant or holder of the decision and the reasons for the decision.
(7) The holder shall not transfer a licence, registration or approval to any other person and any purported transfer is void and of no effect.
(8) A licence, registration or approval granted under these Regulations has no effect if the holder—
(
a
) ceases trading or operation,
(
b
) is adjudged bankrupt or, in the case of a body corporate, goes into liquidation, or, in the case of an unincorporated body or partnership is dissolved, or
(
c
) sells or otherwise ceases to occupy the premises to which the licence relates.
(9) In this Regulation “a specified Regulation” means Regulation 16, 17, 18(11), 19, 30, 31, 32, 33 or 36(3)(
a
) or (
b
).
Fixed Penalty Notice.
50. (1) If an officer authorised in that behalf has reasonable grounds for believing that a person has committed an offence under Regulation 18(3)(
d
) or (10), 20(3)(
b
), 28(5) or (6)(
b
), 30(5) or (7), 31(5) or (9), 33, 34, 36(3), 37, 43(4), (5) or (7), or 44(2), he or she may serve a notice in writing on that person stating that—
(
a
) the person is alleged to have committed the offence or contravention,
(
b
) the person may during the period of 28 days from the date of the notice, make to the Minister a payment of €250 accompanied by the notice, and
(
c
) a prosecution in respect of the alleged offence will not be instituted during the period specified in the notice and, if the payment specified in the notice is made during that period, no prosecution in respect of the alleged offence will be instituted.
(2) If notice is given under paragraph (1)—
(
a
) the person to whom the notice applies may, during the period specified in the notice, make the payment specified in the notice to the Minister,
(
b
) the Minister shall receive the payment, issue a receipt for it and retain the money so paid, and any payment so received shall not be recoverable in any circumstances by the person who made it, and
(
c
) a prosecution in respect of the alleged offence shall not be instituted in the period specified in the notice, and if the payment so specified is made during that period, no prosecution in respect of the alleged offence shall be instituted.
(3) In a prosecution for an offence under the Act or these Regulations, the onus of proving that a payment, pursuant to a notice under this Regulation, has been made, lies on the defendant.
Implied condition in certain contracts of sale.
51. (1) In every contract of sale there shall be an implied condition on the part of the seller that all reasonable precautions have been taken and all due diligence has been exercised to ensure—
(
a
) in the case of the sale of an animal, that the animal was not treated with any animal remedy and, in the case of an agreement to sell an animal, the animal was not so treated and will not be so treated prior to the time when the property is to pass, and
(
b
) in the case of the sale of, or an agreement to sell, the carcase of any animal or food derived from any animal, that the animal had not been treated with any animal remedy,
otherwise than in accordance with these Regulations.
(2) (
a
) Subject to subparagraph (
b
), any term of a contract, implied by virtue of paragraph (1), may be negatived or varied by an express term in the contract, in so far as the first-mentioned term relates to an animal remedy—
(i) which has been administered to an animal before being imported into the State, and
(ii) in respect of which the Minister has granted an exemption from destruction,
but only if the express term is fair and reasonable and has been specifically brought to the attention of the buyer.
(
b
) Subparagraph (
a
) shall not apply to an animal imported into the State where the sale of the animal would not be in accordance with a condition imposed by the Minister on the exemption.
(3) Any term of a contract implied by virtue of paragraph (1) may not be negatived or varied in so far as it relates to an animal remedy other than in respect of an animal remedy to which paragraph (2) relates.
Inspection by authorised officers, etc.
52. (1) If an authorised officer or member of the Garda Síochána or an officer of Customs and Excise has reasonable cause to suspect that—
(
a
) the manufacture, importation, preparation, handling, storage, transport, exportation, distribution, sale, supply or use of an animal remedy or any ingredient for an animal remedy is taking place or has taken place in, on, under or from any land, premises or in, on or from any vehicle,
(
b
) an offence is being or has been committed under these Regulations in, on, under or from any land, premises or in, on or from any vehicle,
(
c
) any land or premises is used for or in connection with the breeding, rearing, fattening, keeping, exhibiting, selling or transporting of animals,
(
d
) any land or premises is a slaughterhouse or is used for or in connection with the slaughter of animals,
(
e
) in, on, under or from any land or premises or in, on or from any vehicle, there is or was any animal of any species to which an animal remedy is being or has been administered or there is or was any food derived from such an animal or any carcase of such an animal, or
(
f
) in, on, under or from any land or premises or in, on or from any vehicle, there is or was any animal remedy, or any ingredients for animal remedies, or any machinery, instruments or other thing used in the manufacture, preparation, handling, storage, transport, exportation, distribution, sale, supply or use of animal remedies or ingredients for animal remedies,
the authorised officer or member of the Garda Síochána or officer of Customs and Excise (in this section referred to as “the relevant person”) may, subject to paragraph (2), stop any such vehicle or enter (if necessary by force) any such land or premises, or land or premises used in connection with such land or premises, or any such vehicle, and there, or at any other place, and with such authorised officers, members of the Garda Síochána and officers of Customs and Excise (if any) as the relevant person considers appropriate—
(i) search for and examine, inspect or test any animals, food derived from animals or carcases of animals or anything believed to be an animal remedy or an ingredient for an animal remedy or anything to which subparagraph (
f
) relates,
(ii) take such specimens (including blood, urine, faeces, tissue or remains of implants) from any animals, food derived from animals or carcases of animals, and may for that purpose perform or cause to be performed any procedure (including surgery) as is considered necessary on such animals, food or carcases,
(iii) take such reasonable samples of, or from, any substances, or of or from a thing which may be considered appropriate for the purposes of these Regulations,
(iv) seize and detain anything to which subparagraph (
f
) relates or anything which is believed to be or to contain an animal remedy or an ingredient for an animal remedy kept, used or intended to be used in contravention of the provisions of these Regulations,
(v) search for and examine any document and take extracts from and copies of any such document,
(vi) seize and detain an animal—
(I) in respect of which it is, with reasonable grounds, believed by the relevant person that a prohibited animal remedy or ingredient for an animal remedy has been administered to it in contravention of these Regulations, and
(II) in relation to which either or both—
(A) the relevant person is aware that an application has been made or will be made for the destruction of the animal, and
(B) the relevant person has reasonable grounds for believing that the animal has been or may be moved in contravention of any notice duly served, in accordance with these Regulations,
(vii) require any person who is suspected to be, or to have been engaged in the importation, manufacture, preparation, handling, storage, transport, exportation, distribution, sale, supply or use of, or any person who is suspected to have possession or control of or to have kept or to keep, any animal remedy, ingredient for an animal remedy, animal, food derived from animals, carcases of animals or anything to which subparagraph (
f
) relates, or any person who is suspected to be, or to have been, engaged in the breeding, rearing, fattening, keeping, exhibiting, selling or transporting or in the possession or control of any animal—
(I) in the case of any documents in the possession or control of that person or any such remedy, ingredient, animal, food, carcase or thing, to produce them to the relevant person or any authorised officer, member of the Garda Síochána or officer of Customs and Excise,
(II) in the case of any information in relation to such document, animal remedy, animal, food, carcase or thing which may be required (including the source of that document, remedy, animal, food, carcase or thing), to furnish them to the relevant person or any authorised officer, member of the Garda Síochána or officer of Customs and Excise,
(viii) require any person, being the owner or the person in charge of animals, or the owner or occupier of, or employed in or on, lands or premises so entered to give assistance, to carry out such instructions and to give such information as may be reasonably necessary for the purposes of subparagraphs (i) to (vii), and
(ix) require any person who is for the time being in charge or control of any vehicle so stopped or entered—
(I) to refrain from moving it, and
(II) to give assistance, to carry out such instructions and to give such information as may be reasonably necessary for the purposes of subparagraphs (i) to (vii).
(2) The functions of a relevant person under this Regulation may only be exercised in respect of a dwelling or so much of a vehicle or premises as constitutes a dwelling where the relevant person has reasonable cause to suspect that, before a search warrant could be sought in relation to the dwelling under Regulation 53, anything to which the said paragraph (1) relates—
(
a
) is being destroyed or disposed of, or
(
b
) is likely to be destroyed or disposed of.
(3) An authorised officer, member of the Garda Síochána or officer of Customs and Excise accompanying the relevant person may exercise all the functions conferred on the relevant person by virtue of paragraph (1) or (2).
Search warrant.
53. (1) If a judge of the District Court is satisfied by information on oath of an authorised officer, member of the Garda Síochána or an officer of Customs and Excise that there is reasonable cause for suspecting that—
(
a
) evidence of or relating to the commission or intended commission of an offence under these Regulations is to be found in, on or under any land or premises or in or on any vehicle and that such land, premises or vehicle or any part thereof consists of a dwelling,
(
b
) there is or was or is intended to be in, on or under any land or premises, in or on any vehicle and that such land, premises or vehicle or any part thereof consists of a dwelling, any animal remedy or ingredient for an animal remedy in relation to which a contravention of these Regulations, is being or has been or is intended to be committed, or
(
c
) a document directly or indirectly relating to, or connected with, a transaction or dealing which was, or an intended transaction or dealing which would if carried out be, an offence under these Regulations, is in the possession or under the control of a person in, on or under any land or premises or in or on any vehicle and that such land, premises or vehicle or any part thereof consists of a dwelling,
the judge may issue a search warrant under this Regulation.
(2) A search warrant issued under this Regulation shall be expressed and operate to authorise a named authorised officer, named member of the Garda Síochána or named officer of Customs and Excise, accompanied by such authorised officers, members of the Garda Síochána and officers of Customs and Excise as the named officer or member thinks necessary, at any time or times within one month from the date of issue of the warrant, on production if so requested of the warrant to enter (if necessary by force) the land, premises or vehicle named in the warrant.
(3) Where any premises, land or vehicle is entered pursuant to a warrant issued under this Regulation, an authorised officer, a member of the Garda Síochána or an officer of Customs and Excise so entering may—
(
a
) stop and detain any person found in, on or under such land or premises, or in or on such vehicle, for the purpose of searching that person and to search or cause to be searched that person, and
(
b
) exercise all or any of the powers referred to in Regulation 52.
Search of suspects, etc.
54. (1) If with reasonable cause a member of the Garda Siochána or an officer of Customs and Excise suspects that a person is in possession, in contravention of these Regulations, of an animal remedy or an ingredient for an animal remedy, the member or officer may without warrant—
(
a
) search or cause to be searched by such a member or officer the person and, if the member or officer considers it necessary for that purpose, detain the person for such time as is reasonably necessary to carry out the search,
(
b
) search or cause to be searched by such a member or officer any vehicle in which the member or officer suspects that such substance may be found and for the purpose of carrying out the search, if any such member or officer thinks fit, require the person who is, for the time being, in charge or control of the vehicle to bring it to a stop and when stopped to refrain from moving it or, in case the vehicle is already stationary, to refrain from moving it, or
(
c
) seize and detain, or cause to be seized and detained by such a member or officer, anything found in the course of a search under this section which any such member or officer reasonably suspects to be something which might be required as evidence in proceedings for an offence under these Regulations.
(2) Where a member of the Garda Síochána or an officer of Customs and Excise decides to search or cause to be searched a person under this section the member or officer may require the person to accompany that member or officer to either a Garda Síochána station or a customs office for the purpose of being so searched at that station or office.
Power of arrest.
55. (1) Where with reasonable cause a member of the Garda Síochána suspects that—
(
a
) an offence under these Regulations has been committed and so suspects a person of having committed the offence, or
(
b
) a person is committing or has committed an offence under these Regulations in relation to the manufacture, importation, preparation, handling, storage, transport, exportation, distribution, sale, supply or use of any animal remedy or any ingredient for an animal remedy, the possession of which by such a person would be prohibited by these Regulations,
the member may arrest the person without warrant.
(2) Where with reasonable cause a member of the Garda Síochána—
(
a
) suspects that an offence under these Regulations has been committed or attempted, and
(
b
) suspects a person of having committed the offence or having made the attempt,
the member may arrest the person without warrant if—
(i) with reasonable cause the member suspects that the person, unless arrested, either will abscond for the purposes of evading justice or will obstruct the course of justice, or
(ii) having enquired of the person, the member has reasonable doubts as to the person’s identity or place of abode, or
(iii) having enquired of the person, the member knows that the person does not ordinarily reside in the State, or has reasonable doubts as to whether the person so resides.
(3) Nothing in subparagraphs (i), (ii) and (iii) of paragraph (2) shall apply where a person is required to accompany a member of the Garda Síochána or an officer of Customs and Excise to a Garda Síochána station or a customs office for the purpose of Regulation 54(2) and who fails to comply with the requirement.
Saving for certain power.
56. Nothing in these Regulations shall operate to prejudice any power to search, or to seize or detain property, which may, apart from these Regulations, be exercised by a member of the Garda Síochána or an officer of Customs and Excise.
Obstruction.
57. A person shall not obstruct or impede an authorised officer, member of the Garda Síochána or officer of Customs and Excise in the due exercise of any of the functions conferred or exercisable by the authorised officer, member of the Garda Síochána or officer of Customs and Excise under these Regulations.
Impersonation of an authorised officer, etc. and possession of certain identity documents.
58. (1) A person shall not, with the intention to deceive—
(
a
) purport to be, or
(
b
) act in a manner that would lead another person to believe that he or she is,
a person duly appointed as an authorised person, officer, inspector, examiner or other officer of the Minister or a person otherwise duly appointed by or with the authority of the Minister or of any other purported member of the Government exercising any functions of the Minister either—
(i) generally, or
(ii) for the purposes of these Regulations.
(2) A person shall not, without lawful excuse, have in his or her possession any document which—
(
a
) has been,
(
b
) purports to be, or
(
c
) could lead another person to believe that it has been,
duly issued for the purpose of identifying the person in possession of the document as a person duly authorised by, or a duly authorised officer, inspector, examiner or other officer of, the Minister or otherwise duly appointed by or with the authority of the Minister or, in the case of subparagraph (
b
) or (
c
), of any other purported member of the Government exercising any functions of the Minister either—
(i) generally, or
(ii) for the purposes of these Regulations.
Evidence of class of animal remedies to which a contravention relates.
59. In any proceedings for an offence under these Regulations in which it is alleged that a contravention of these Regulations has occurred in relation to a class of animal remedy or a class of ingredient for an animal remedy, it shall not be necessary to show that the contravention relates to a particular animal remedy or ingredient for an animal remedy where it can be shown that it relates to a thing which is a member of such a class of animal remedy or class of ingredient for an animal remedy.
Disposal of things seized.
60. If, in the course of exercising a power under these Regulations, a person, being an authorised officer, a member of the Garda Síochána or an officer of Customs and Excise, finds or comes into possession of any thing which such a person believes to be evidence of any offence or suspected offence under these Regulations, it may be seized and retained for use in evidence in any criminal proceedings, for such period from the date of seizure as is reasonable or, if proceedings are commenced in which the thing so seized is required for use in evidence, until the conclusion of the proceedings, and thereafter the Police (Property) Act, 1897 (59 & 60 Vict.), and where appropriate,
section 25
of the
Criminal Justice Act, 1951
(No. 2 of 1951), shall apply to the thing so seized in the same manner as that Act and the said section 25 shall apply to property which has come into the possession of the Garda Síochána in the circumstances mentioned in that Act.
Recoupment of costs of certain disposals.
61. If any thing which is seized from a person under these Regulations is duly disposed of by or on behalf of the State, the costs of such disposal, less any moneys arising from such disposal, shall (except where such costs have been waived in writing) be recoverable from such person as a simple contract debt in any court of competent jurisdiction.
Fees and levies, etc.
62. (1) There shall be paid—
(
a
) on an application for the grant of any licence, the issue of an authorisation or a certificate or the provision of a service under these Regulations or a renewal or amendment of any of them, such fee (if any), and
(
b
) in respect of a licence, authorisation or certificate under these Regulations which is in force for a definite or indefinite period of more than 12 months, such fee (if any),
as may be fixed by the Minister with the consent of the Minister for Finance.
(2) Different fees may be fixed in respect of different classes of licences, authorisations, certificates or services.
Evidence on certificate etc.
63. (1) In proceedings for an offence consisting of a contravention of these Regulations, a certificate purporting to be signed by a person employed at a laboratory named in the certificate stating the capacity in which that person is so employed and stating one or more of the following, namely—
(
a
) that the person received a sample submitted to the laboratory,
(
b
) that, for a period as is specified in the certificate, the person had in his or her custody a sample so submitted,
(
c
) that the person gave to such other person as is specified in the certificate a sample so submitted,
(
d
) that the person carried out a laboratory examination for the purpose of detecting the presence, in a sample so submitted, of a substance, ingredient for an animal remedy or animal remedy, or
(
e
) that a particular substance, ingredient for an animal remedy or animal remedy was present in the sample,
is, unless the contrary is proved, evidence of the matters stated in the certificate.
(2) A certificate purporting to be signed by an officer of the Minister and to certify that on a specific day or days or during the whole of a specified period—
(
a
) a particular person did not stand registered in the companion animal medicines sellers register,
(
b
) the registration of a particular person in the companion animal medicines sellers register had been revoked,
(
c
) a person was or was not the holder of a licence or approval under Regulations 16, 17, 18(11), 19, 30, 31, 32 or 36,
(
d
) that a particular registration, licence or approval referred to in this paragraph, was subject to a particular condition or conditions,
is, without proof of the signature of the person purporting to sign the certificate or that he or she is an officer of the Minister, evidence, unless the contrary is shown, of the matters stated in the certificate.
(3) A certificate purporting to be signed by the secretary of the Board or other officer of the Board authorised by the Board in that regard, certifying that on a specific day or days or during the whole of a specified period—
(
a
) a person was or was not the holder of a veterinary product authorisation or registration granted under Regulation 9 or the holder of a manufacturer’s licence granted under Regulation 22,
(
b
) that a particular authorisation, licence or registration, referred to in this paragraph, was subject to a particular condition or conditions,
is, without proof of the signature of the person purporting to sign the certificate or that he or she is the Secretary or an officer of the Board, evidence, unless the contrary is shown, of the matters stated in the certificate.
(4) In proceedings for an offence under these Regulations the court may, if it considers that the interests of justice so require, direct that oral evidence of the matters stated in a certificate under paragraph (1), (2) or (3) be given, and the court may for the purpose of receiving oral evidence adjourn the matter.
(5) In proceedings for an offence, evidence of the Directive, Council Regulation (EEC) 2377/90, or Regulation (EC) No. 726/2004 may be given by production of a copy of the said Directive or Regulation certified by an officer of the Minister to be a copy of the said Directive or Regulation, and it is not necessary to prove the signature of the officer or that he or she is an officer of the Minister.
(6) Paragraph (5) is in addition to and not in substitution for the European Communities (Judicial Notice and Documentary Evidence) Regulations 1972 (
S.I. No. 341 of 1972
).
Evidential Burden.
64. In proceedings for an offence consisting of a contravention of these Regulations, it is not necessary to negative by evidence the existence of a marketing authorisation granted under Regulation (EC) No 726/2004 and accordingly the onus of proving the grant or issue of such authorisation lies on the defendant.
Service.
65. (1) A notification under these Regulations (hereinafter in this Regulation referred to as a “notification”) shall be addressed to the person concerned by name, and may be served on or given to the person in one of the following ways—
(
a
) by delivering it to the person,
(
b
) by leaving it at the address at which the person ordinarily resides or if an address for service has been furnished, at that address,
(
c
) by sending it by post in a prepaid registered letter to the address at which the person ordinarily resides or, if an address for service has been furnished, at that address, or
(
d
) if the address at which the person ordinarily resides cannot be ascertained by reasonable enquiry and the notice relates to a premises, by delivering it to some person over sixteen years of age resident or employed on the premises or by affixing it in a conspicuous position on or near the premises.
(2) A person shall not at any time within six months after a notification or notice is affixed under paragraph (1)(
d
), remove, damage or deface it without lawful authority.
(3) For the purposes of this Regulation, a company, within the meaning of the Companies Acts 1963 to 2003, is deemed to be ordinarily resident at its registered office and every other body corporate and every unincorporated body is deemed to be ordinarily resident at its principal office or place of business.
Revocation and savers.
66. (1) The European Communities (Animal Remedies) Regulations 2007 (
S.I. No 144 of 2007
) are revoked.
(2) Each of the following within the meaning of, or deemed to have been re-issued under, the Regulations revoked by paragraph (1), that is in force immediately before the revocation of the first cited Regulations, remains in force and may be dealt with as if granted under the corresponding provision of these Regulations—
(
a
) an animal remedies authorisation,
(
b
) a manufacturer’s licence,
(
c
) an animal remedies wholesaler’s licence,
(
d
) an animal remedies merchant’s licence,
(
e
) a licence issued under Regulation 18,
(
f
) an approval under Regulation 32,
(
g
) a registration under Regulation 33, or
(
h
) a licence under Regulation 37.
(3) A person who was, immediately before the revocation of the European Communities (Animal Remedies) Regulations 2007 (
S.I. No. 144 of 2007
), a responsible person within the meaning of those Regulations is considered to be a responsible person for the purpose of these Regulations.
(4) Nothing in these Regulations affects the European Communities (Additives in Feedingstuffs) Regulations 1999 to 2005.
Offences by bodies corporate, etc.
67. (1) Where an offence under these Regulations has been committed by a body corporate and it is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of any person who, when the offence was committed, was a director, manager, secretary or other officer of the body corporate, or a person purporting to act in any such capacity, that person, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if guilty of the first-mentioned offence.
(2) Where the affairs of a body corporate are managed by its members, paragraph (1) shall apply in relation to the acts and defaults of a member in connection with the functions of management as if such a member were a director or manager of the body corporate.
Prosecution of summary proceedings.
68. (1) Proceedings in relation to a summary offence under these Regulations may be brought and prosecuted by the Minister.
(2) Notwithstanding section 10(4) of the Petty Sessions (Ireland) Act, 1851(14 & 15 Vict.), summary proceedings for an offence under these Regulations may be instituted within 2 years from the date of the offence.
Offences.
69. (1) A person who by act or omission—
(
a
) contravenes Regulation 3(1), 7(2)(
d
), 11, 12(3), (4), (7) or (8), 13(4) or (5), 14(4) or (6), 15(4), (5) or (6), 18(1), (8) or (10), 19(1) or (2), 20(1) or (3), 23(1) or (3), 25(3) or (5), 27(2), 28(1), (2), (4), (5), (6), (7), (8) or (10), 29, 30(1), (5), (6) or (7), 31(1),(5), (7) or (9), 33(1), (5) or (6), 34, 35, 36(1) or (3), 37(1), (2) or (4), 38(1), (4) or (5), 39, 40(1) or (2), 42, 43(1), (2), (3), (4), (5), (6), (7), (10) or (11), 44(2), 48(1), (2), (3), (4) or (5), 57, 58, or 65(2),
(
b
) fails to give assistance to an authorised officer,
(
c
) fails to comply with a requirement of an authorised officer under Regulation 52,
(
d
) (i) contravenes Article 5 or 14, or
(ii) contravenes an act of the institutions of the European Communities adopted pursuant to Article 8, 9 or 10,
of Council Regulation (EEC) No. 2377/90 of 26 June 1990, or
(
e
) (i) contravenes Article 38(4), 41(1), (2), (3), (4), the third paragraph of Article 47, Article 49(1), (2), (3) or (5) of, or
(ii) places a veterinary medicinal product to which it applies on the market in contravention of, Regulation (EC) No. 726/2004,
(
f
) contravenes a term or condition of an animal remedies authorisation, a licence, registration or approval within the meaning of these Regulations, or
(
g
) aids or abets a contravention to which this paragraph relates,
commits an offence.
(2) A person who commits an offence to which paragraph (1) refers is liable—
(
a
) on summary conviction to a fine not exceeding €5,000 or to a term of imprisonment not exceeding 6 months, or to both, or
(
b
) on conviction on indictment to a fine not exceeding €500,000 or to a term of imprisonment not exceeding 3 years, or to both.
SCHEDULE 1
PART I
ROUTES OF SALE (FOR WHICH THE SYMBOLS SET OUT IN PART IV OF SCHEDULE 2 MAY BE USED).
1.
‘Veterinary Practitioner Only (VPO-1)’
— refers to an animal remedy which may be sold or supplied only by a registered veterinary practitioner and administered in accordance with Regulation 39(2)(
a
).
2.
‘Veterinary Practitioner Only (VPO)’
— refers to an animal remedy which may be sold or supplied only by a registered veterinary practitioner and administered in accordance with Regulation 39(2)(
b
).
3.
‘Prescription Only’
— refers to an animal remedy which may be sold or supplied only by—
(i) a pharmacist from a pharmacy in accordance with a veterinary prescription,
(ii) a registered veterinary practitioner and the animal is under his or her care and, without prejudice to Regulation 28(6), he or she has issued a veterinary prescription in respect of the animal remedy, or
(iii) a responsible person from a premises to which an animal remedies merchant’s licence relates in accordance with a veterinary prescription, in the case of the following animal remedies (if designated Prescription Only),—
(I) an intramammary animal remedy;
(II) an antifungal animal remedy;
(III) an endo or ecto parasiticide;
(IV) an immunological animal remedy;
(V) an injectable digestive stimulant;
(VI) an injectable vitamin and mineral.
4.
‘Prescription Only Exempt’
— refers to an animal remedy which may be sold or supplied only by—
(i) a pharmacist from a pharmacy,
(ii) a registered veterinary practitioner and the animal is under his or her care.
5.
‘Pharmacy Only’
— refers to 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 practitioner and the animal is under his or her care.
6.
‘Licensed Merchant’
— refers to an animal remedy which may be sold or supplied only—
(i) from a pharmacy,
(ii) by a registered veterinary practitioner and the animal is under his or her care, or
(iii) from a premises to which an animal remedies merchant’s licence relates.
7.
‘Companion Animal Medicine’
— refers to an animal remedy which may be sold or supplied only—
(i) from a pharmacy,
(ii) by a registered veterinary practitioner,
(iii) from a premises to which an animal remedies merchant’s licence relates, or
(iv) from a premises to which a companion animal medicine seller’s registration relates.
PART II
CRITERIA TAKEN ACCOUNT OF BY THE BOARD IN DESIGNATING ROUTE OF SALE