S.I. No. 734/2005 - Animal Remedies Regulations 2005

• (j) an approval under Regulation 37.

• (4) A person who was, immediately before the revocation of the Animal Remedies Regulations 1996, a responsible person within the meaning of those Regulations is considered to be a responsible person for the purpose of these Regulations.

• (5) Nothing in these Regulations affects the European Communities (Additives in Feedingstuffs) Regulations 1999 to 2003.

• (6) Section 35(1)(c) of the Diseases of Animals Act 1966 (No 6 of 1966) is repealed.

Offences

55. (1) A person who by act or omission -

• (a) contravenes Regulations 3(1), (2), 4(1), 12, 13(3), (4), (6), (7), (8), 14(4) 15(4), (5), (6), 18(1)(c), (e), (f), (3), (6), 19(3), (4), (5), (6), (7), 20(1) (2), 21(1), (3)(b), 24(1), (2), (3), (4), 26(3), (5), 28(1), (3), (4), (5), 29 30(1), (7), (8), 31(1),(7), (9), 33(1), (5), (6), 34, 35, 36, 37(1), (3), 38(1) (2), (4), 39, 40, 41(1), (2), (5), 43, 44(2), (3)(a), 45, 46(2), (3) or 50,

• (b) (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

• (c) (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,

commits an offence to which section 20(1)(a) of the Act relates.

• (2) A person who contravenes a term or condition of an animal remedies authorisation commits an offence.

• (3) For the avoidance of doubt, a contravention of a term or condition of a licence registration, approval or authorisation or a direction or notice is an offence to which Section 20(1)(c) of the Act relates.

• (4) In a prosecution for an offence under these Regulations in relation to an animal remedy which is also an additive, premix or feedingstuff within the meaning, of the European Communities (Additives in Feedingstuffs) Regulations 1999 to 2003, it is a good defence to show that those Regulations were complied with.

SCHEDULE 1 PART 1 - 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 administered only by a registered veterinary practitioner.

2. ‘Veterinary Practitioner Only (VPO)’ - which refers to an animal remedy which may be administered only by -

• (i) a registered veterinary practitioner, or

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

3. ‘Prescription Only (POM)’ - refers to an animal remedy which may be sold or supplied only by -

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

• (ii) a registered veterinary practitioner and the animal is under his or her care and he or she has issued a veterinary prescription in respect of the animal remedy, or

• (iii) from 1^st January 2007, 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 animal remedy presented as an intramammary preparation for the prevention or treatment of mastitis in an animal;

• (II) an antifungal animal remedy;

• (III) an endo/ecto parasiticide;

• (VI) an immunological animal remedy;

• (V) an injectable digestive stimulant;

• (VI) an injectable vitamin and mineral.

4. ‘Prescription Only Exempt (POM(E))’ - 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 (PS)’ - 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 (LM)’ - 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 (CAM)’ - refers to a companion animal medicine 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

1. In deciding the route of sale or supply for an animal remedy, the Board has due regard to the need to protect public health, animal health, animal welfare and the environment and accordingly has due regard to -

• (a) the need for prior professional diagnosis,

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

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

2. If, in the opinion of the Board, an animal remedy requires to be administered by, or under the direct supervision of a registered veterinary practitioner, because

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

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

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

the animal remedy is restricted to administration by, or, as the case may be, under the direct supervision of a registered veterinary practitioner (VPO).

3. Without prejudice to stricter provisions pursuant to the law of the State, an animal remedy to which the following conditions apply is restricted to supply in accordance with the prescription of a registered veterinary practitioner (POM) -

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

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

• (ii) the restrictions on the use of animal remedies from Community Law,

• (b) with effect from 1 January 2007, an animal remedy authorised for administration to a food producing animal, except for an animal remedy exempted in accordance with criteria established under Article 67(a)(aa) second indent, of the Directive,

• (c) an animal remedy in respect of which special precautions shall be taken by a registered veterinary practitioner when prescribing the animal remedy in order to avoid any unnecessary risk to -

• (i) the target species,

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

• (iii) the environment;

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

• (e) officinal formulae intended for animals,

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

4. In the case of an animal remedy to which some or all of the provisions of paragraph 3 apply, other than subparagraph (b) or (d), the Board having regard to -

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

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

• (c) the strength of the active substance,

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

• (e) the pharmaceutical form, and

• (f) the potential for misuse,

may designate the animal remedy as prescription only exempt (POM(E)).

5. If the Board considers that sale or supply of an animal remedy should be accompanied by professional point of sale advice regarding -

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

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

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

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

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

the animal remedy is designated pharmacy only sale (PS).

SCHEDULE 2 LABELLING REQUIREMENTS FOR AN ANIMAL REMEDY

PART I - General labelling etc. requirements

The outer packaging, immediate packaging, label or package leaflet shall contain at least the following as appropriate -

• (1) in the case of an animal remedy, including a homeopathic animal remedy covered by Regulation 8(1) -

• (a) the following information, which shall conform with the particulars and documents provided pursuant to Articles 12 to 13d of the Directive and the summary of product characteristics, which has been approved by the Board, shall appear in legible characters -

• (i) name of the animal remedy as approved by the Board followed by its strength and pharmaceutical form,

• (ii) a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using the common names of the active substances,

• (iii) the manufacturer's batch number,

• (iv) the authorisation number,

• (v) the name or corporate name and permanent address or registered place of business of the authorisation holder and where appropriate of the representative designated by that holder,

• (vi) the species of animal for which the animal remedy is intended including the method and where appropriate, the route of administration (adequate space shall be provided for the prescribed dose to be indicated),

• (vii) the withdrawal period, even if nil, in the case of an animal remedy to be administered to a food-producing animal (details shall be given for each animal species and each foodstuff concerned),

• (viii) expiry date,

• (ix) special storage precautions,

• (x) special precautions relating to the disposal of an unused animal remedy or its waste, including details of any collection system in place,

• (xi) particulars required by Article 26(1) of the Directive,

• (xii) the words “For animal treatment only” and where appropriate in addition “to be supplied only on veterinary prescription” or in the case of a homeopathic animal remedy covered by Regulation 8(1) the words: “homeopathic animal remedy for veterinary use”.

• (b) The pharmaceutical form and the contents by weight, volume or number of dose-units is required to be shown on the outer package only.

• (c) The provisions of Part 1, A of Annex 1 to the Directive, in so far as they concern the qualitative and quantitative composition of an animal remedy in respect of active substances, shall apply to the particulars provided for in point (a)(ii).

• (d) Particulars provided for in Point (a)(vi) to (xii) shall be in the English or Irish language.

• (e) In the case of an animal remedy in respect of which a marketing authorisation has been granted under Regulation (EC) No 726/2004, the Board may, if it considers it appropriate to do so, permit or require additional information as specified in Article 58(5) of the Directive.

• (2) In the case of a homeopathic animal remedy covered by Regulation 8(2), only the following information shall appear -

• (a) the name and address of the registration holder and where appropriate the manufacturer,

• (b) the words: “homeopathic animal remedy without approved therapeutic indications”,

• (c) the scientific name of the stock or stocks followed by the degree of dilution using the symbols of the pharmacopoeia (if the homeopathic animal remedy is composed of more than one stock, the labelling may mention an invented name in addition to the scientific name of the stocks),

• (d) the method of administration and if necessary, the route,

• (e) the expiry date,

• (f) the pharmaceutical form,

• (g) the contents of the sales presentation,

• (h) special storage precautions,

• (i) the target species,

• (j) any special warning,

• (k) the manufacturer's batch number,

• (l) the reference number of the registration granted by the Board.

PART II - AMPOULES AND SINGLE DOSE CONTAINERS

• (i) name of the animal remedy,

• (ii) quantity of the active substances,

• (iii) route of administration,

• (iv) manufacturer's batch number,

• (v) date of expiry,

• (vi) the words “For animal treatment only”.

• (b) The particulars mentioned in (a)(iii) and (vi) shall appear on the immediate packaging or container in the English or Irish Language.

PART III -PACKAGE LEAFLET

The inclusion of a package leaflet in the packaging of an animal remedy shall be obligatory unless all the information required by this Part can be conveyed on the immediate and outer packaging. Information on the leaflet shall solely relate to the animal remedy with which it is included. The leaflet shall be comprehensible and in the English or Irish language and shall include at least the following information in the order indicated and conform with the particulars and documents provided in accordance with the application for the product authorisation (the package leaflet may contain other languages as long as the information provided is identical) -

• (a) name or corporate name and permanent address or registered place of business of the authorisation holder and of the person responsible for marketing and of the manufacturer, if different,

• (b) name of the animal remedy as approved by the Board followed by its strength and pharmaceutical form. (If the animal remedy has been authorised according to the procedure provided for in Articles 31 to 43 of the Directive, under different names in the concerned Member States, a list of the names authorised in each Member State),

• (c) the main therapeutic indications, contra-indications and side-effects,

• (d) the species of animal for which the animal remedy is intended, the dosage for each species, the method and route of administration and advice on correct administration, if necessary,

• (e) the withdrawal period, even if this is nil, in the case of an animal remedy to be administered to a food-producing animal,

• (f) special storage precautions,

• (g) particulars required to be indicated pursuant to the Article 26(1) of the Directive,

• (h) special precautions for the disposal of unused product or waste materials.

PART IV - SYMBOLS DENOTING ROUTE OF SALE

VPO-1

• (b) an animal remedy designated ‘veterinary practitioner only’ may be designated by the following symbol:

VPO

POM

POM(E)

4 An animal remedy designated ‘pharmacy only’ may be designated by the following symbol:

PS

LM

CAM.

SCHEDULE 3 A VETERINARY PRESCRIPTION

A veterinary prescription shall bear a serial number, contain a declaration that the prescription is granted in respect of an animal under the care of the prescribing veterinary practitioner and contain at least the following —

• (a) details of the animal remedy (and if Regulation 45(5) applies, alternatives) to be administered specifying the authorised name and the number of the veterinary product authorisation,

• (b) date of issue,

• (c) the manner and site of administration,

• (d) the dose rate and withdrawal period to be observed,

• (e) a description of the animal or animals to which the prescription relates,

• (f) the name and address of the person to whom the prescription is granted,

• (g) the period during which the prescription is valid,

• (h) special instructions, precautions or risks, and

• (i) the name, address and signature of the registered veterinary practitioner.

SCHEDULE 4 QUALIFIED PERSON FOR MANUFACTURING

PART 1 - DUTIES OF A QUALIFIED PERSON

• (1) If the holder of a manufacturer's licence personally fulfils the requirements set down in Part 2, the holder may himself act as a qualified person.

• (2) The functions of a qualified person shall be -

• (a) in the case of an animal remedy other than those to which sub-paragraph (b) refers, to ensure that every batch to which the authorisation relates has been manufactured and checked in compliance with:-

• (i) the laws in force in the State in respect of the product,

• (ii) the provisions of the manufacturer's licence, and

• (iii) the provisions of an animal remedies authorisation,

• (b) in the case of an animal remedy imported by the holder of a manufacturer's licence, to ensure that every batch of the product undergoes a full qualitative analysis, a quantitative analysis of at least all of the active substances and all other tests or checks necessary to ensure that the quality of the animal remedy is in accordance with the requirements of the animal remedies authorisation, and

• (c) in all cases, to certify in a register, or other equivalent document appropriate for the purpose, whether each production batch of the animal remedy to which the authorisation relates, satisfies the requirements set out in sub-paragraphs (a) or (b) and to ensure that the register or other document is regularly maintained and in particular that the appropriate entries in the register or other document are made as soon as practicable after each batch has been manufactured or imported.

• (3) A batch of an animal remedy which has undergone the controls referred to in paragraph (2) in another EEA State shall be exempt from these controls if they are marketed in the State, accompanied by the control reports signed by the qualified person.

• (4) In the case of an animal remedy imported from a third country, where appropriate arrangements in the form of a Mutual Recognition Agreement have been made by the Community with that country, ensuring that the manufacturer of the animal remedy applies standards of good manufacturing practice at least equivalent to those laid down by the Community, and ensuring that the controls referred to in paragraph (2)(b) are carried out in the exporting country, the qualified person shall be relieved of responsibility for carrying out those controls.

• (5) Where, after giving the holder of a manufacturer's licence and the person acting as the qualified person the opportunity of making representations (either orally or in writing), the Board is of the opinion that the person so acting is failing to carry out the functions specified in paragraph (2) and has notified the holder accordingly in writing the holder shall not permit that person to continue to act as the qualified person so long as the said notification has not been withdrawn by the Board.

• (6) The Board may require the holder of a manufacturer's licence to temporarily suspend the person acting as the qualified person upon the commencement of administrative or disciplinary proceedings against him or her for failure to fulfil his or her functions as required under paragraph (2) and the holder shall not permit that person to act as the qualified person pending the determination of such proceedings.

PART II - REQUIREMENTS APPLICABLE TO A QUALIFIED PERSON.

A person shall only have the capacity to act as a qualified person if he or she fulfils the conditions of qualification at one of (a), (b) or (c) below:

• (a) He or she is in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognised as equivalent by the Board, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. However, a university course of shorter duration may suffice if either of the conditions set out in clause (i) or (ii) are satisfied:

• (i) The minimum duration of the university course may be three and a half years if the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level;

• (ii) If two university courses or two courses recognised by the State in question as equivalent co-exist in an EEA State and if one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognised equivalent shall be considered to fulfil the condition of duration referred to at clause (i) above insofar as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognised as equivalent by the State in question.

If qualification is dependent on clause (i) or (ii), it shall be shown that the course included theoretical and practical study bearing upon at least the following basic subjects:

Experimental physics,

General and inorganic chemistry,

Organic chemistry,

Analytical chemistry,

Pharmaceutical chemistry including analysis of medicinal products,

General and applied biochemistry (medical),

Physiology,

Microbiology,

Pharmacology,

Pharmaceutical technology,

Toxicology,

Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin).

Studies in these subjects should be balanced so as to enable the person concerned to fulfil the obligations specified in Part I.

If a qualification under paragraph (a) is not dependent on clause (i) or (ii), the Board shall ensure that the person in question provides evidence of adequate knowledge of the aforementioned basic subjects.

All persons qualifying under this paragraph shall have acquired practical experience over at least two years, in one or more undertakings which are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of an animal remedy. The duration of practical experience may be reduced by one year if a university course lasts for at least five years and by a year and a half if the course lasts for at least six years.

• (b) He or she has engaged in the activities of a qualified person from the date referred to in Article 54 of the Directive without complying with the requirements of paragraph (a).

• (c) He or she is the holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course (or a course recognised as equivalent by the Board) in a scientific discipline allowing him or her to engage in the activities of a qualified person, and may, if he or she began his or her course before 9^th October 1981, be considered as qualified to carry out within the State the duties of a qualified person provided that he or she has previously engaged in the following activities for at least two years before 9^th October 1991 at one or more undertakings authorised to manufacture an animal remedy: production supervision and/or qualitative and quantitative analysis of active substances and the necessary testing and checking under the direct authority of a qualified person to ensure the quality of an animal remedy.

If the person concerned has acquired this practical experience before 9^th October 1971, a further one year's practical experience of this kind will be required to be completed immediately before the person may act as a qualified person for the purposes of these Regulations.

SCHEDULE 5 REQUIREMENTS TO BE MET BY A HOLDER OF A MANUFACTURER'S LICENCE

1. The holder of the manufacturer's licence shall -

• (a) provide and maintain staff, premises, installations and equipment as are necessary for the carrying out, in accordance with the terms of his or her licence and relevant marketing authorisation, of the stages of manufacture as are undertaken by him or her; and

• (b) not use for such purposes premises other than those specified in his or her licence or which may be approved in writing from time to time by the Board.

2. The holder of the manufacturer's licence shall -

• (a) provide and maintain such staff, premises, installations and equipment for the handling, storage and distribution of an animal remedy that he or she handles, stores or distributes under his or her licence as are necessary to maintain the quality of an animal remedy to which the licence relates; and

• (b) not use for such purposes premises other than those specified in his or her licence or which may be approved in writing from time to time by the Board.

3. The licence holder shall conduct all manufacturing operations in such a way as to ensure that an animal remedy conforms with the standards of strength, quality and purity applicable to them whether under the relevant marketing authorisation, or under a pharmacopoeial standard or other specification to which they may be manufactured.

4. The licence holder shall at all times provide and maintain such staff, premises equipment and facilities as will enable the qualified person at his or her disposal to carry out the duties referred to in Part I of Schedule 4.

5. The licence holder shall give prior notice to the Board of any changes he or she may wish to make to any of the particulars supplied in his or her application made pursuant to Regulation 22.

6. The licence holder shall immediately inform the Board if the qualified person is replaced unexpectedly.

8. The licence holder may use a contract laboratory if the laboratory and the person operating it has been approved by the Board.

9. The licence holder shall inform the Board -

• (a) before making a material change in the premises, installations or equipment used under his or her licence, or in the operations for which they are used; and

• (b) of a change that he or she proposes to make in the personnel named in his or her licence as respectively -

• (i) responsible for supervising production operations; or

• (ii) responsible for quality control of an animal remedy being manufactured, divided up, packaged, labeled, presented or imported including the person named as the qualified person for the purposes of Schedule 4.

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/EEC⁸ and Article 51 of the Directive.

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

1. The premises shall be a permanent structure of sound construction.

2. The premises shall be capable of being adequately secured.

3. Premises contained within the curtilage of a domestic dwelling shall not be considered suitable. If a premises is attached to the dwelling, the limits of the premises to be used as a retail premises shall be clearly defined and it shall be possible to access the premises directly without trespass into the dwelling and animal remedies shall not be stored or kept for sale or supply outside the confines of the licensed premises.

4. The premises shall preferably be a separate unit but if part of another retail facility all activities concerning the sale, supply, display and storage of animal remedies shall take place in a separate designated area.

5. The premises shall have adequate storage space to store animal remedies in accordance with good pharmaceutical practice and in accordance with manufacturers directions.

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 43(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.

	Given under my Official Seal 17 November 2005
	[image omitted]
	SIGNED Mary Coughlan, Minister for Agriculture 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 Directive (EC) No. 2004/28 and providing for certain enforcement provisions for Regulation (EC) No. 726/2004.

Footnotes