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

"herd or flock health scheme" means a documented and recorded programme agreed between a registered veterinary surgeon and the owner or person in charge of an intensive system for the purpose of the identification, monitoring and reduction of animal disease and welfare problems, the elimination of zoonoses, and the ensuring of quality livestock production, effected in a manner that reduces unnecessary reliance on animal remedies.

47 SCHEMES FOR THE ERADICATION AND CONTROL OF ANIMAL DISEASES

47.

47. (1) This Regulation applies to the administration of an animal remedy to an animal, for the purpose, or in the course, of an official or voluntary scheme or programme operated by, or on behalf of, the Minister, for the treatment, control, eradication, monitoring, or surveillance of disease in animals or for the determination of the health or disease status of animals.

• (2) The provisions of these Regulations regarding animals under the care of a registered veterinary surgeon shall not apply to the administration of an animal remedy to an animal for the purposes set out in paragraph 1, where the administration is carried out by—

( a ) a registered veterinary surgeon, or

( b ) other person,

where such registered veterinary surgeon or other person is for such purpose authorised by, or acting on behalf of, the Minister.

• (3) In this Regulation "disease" has the same meaning as in the Diseases of Animals Act, 1966 (No. 6 of 1966).

PART VII MISCELLANEOUS

48 ADAPTATION OF CERTAIN ENACTMENTS

48.

48. (1) ( a ) This Regulation applies to the following provisions, namely

• (i) the Food Hygiene Regulations, 1950 ( S.I. No. 205 of 1950 ),

• (ii) the Agricultural Produce (Fresh Meat) Acts, 1930 to 1988, and Regulations thereunder,

• (iii) the Abattoirs Act, 1988 (No. 8 of 1988), and Regulations thereunder,

• (iv) the Slaughter of Cattle and Sheep Acts, 1934 to 1936,

• (v) orders under the Agricultural and Fishery Products (Regulation of Export) Act, 1947 (No. 18 of 1947),

• (vi) the Pigs and Bacon Acts, 1935 to 1988, and Regulations thereunder.

• (vii) the European Communities (Fresh Poultry Meat) Regulations, 1996 ( S.I. No. 3 of 1996 ), and

• (viii) the European Communities (Hygienic production and placing on the market of raw milk, heat treated milk and milk-based products) Regulations, 1996 ( S.I. No. 9 of 1996 ).

( b ) A food producing animal to which an animal remedy, which is not an authorised animal remedy, has been administered and any meat or meat product derived from such animal shall, for the purposes of the provisions to which this paragraph applies, be deemed to be unfit for human consumption.

• (2) Meat or a meat product, milk or a milk product, or as the case may be egg or an egg product or honey that contains an amount of an animal remedy or residue thereof or of a substance contained in an authorised animal remedy or residue thereof in excess of the maximum levels permitted by law or authorised by the law of the State or by Council Regulation (EEC) No. 2377/90 or otherwise authorised by a decision of the European Communities shall, be deemed to be unfit for human consumption.

49 AUTHORISED OFFICERS

49.

49. Without prejudice to the powers of an authorised officer appointed pursuant to the Act, the Minister may appoint such persons

• (1) nominated by the Competent Authority to be authorised officers for the purposes of enforcing the provisions of these Regulations in relation to any function conferred on, or, duly exercisable by, the Competent Authority under these Regulations, or

• (2) nominated by the Pharmaceutical Society of Ireland to be authorised officers for the purpose of enforcing the provisions of these Regulations in relation to a person and the premises of a person keeping shop for the dispensing and compounding of medical preparations or for the sale of poisons in accordance with the Pharmacy Acts, 1875 to 1977,

which persons may, at all reasonable times, exercise such and so many of the powers conferred on an authorised officer by section 11 of the Act as he or she may deem appropriate.

50 PUBLICATION OF CERTAIN DECISIONS

50.

50. (1) Where the Competent Authority grants or revokes a veterinary product authorisation, notice of such grant or revocation shall be published in Iris Oifigiúil.

• (2) ( a ) Notwithstanding paragraph (1), the Competent Authority, may at the request of the holder of a veterinary product authorisation, defer publication of the notice required by that paragraph where it is not proposed to sell or supply the animal remedy.

( b ) Where the Competent Authority accedes to a request under this paragraph, the animal remedy to which the request relates shall not be sold or supplied until the publication of the notice required by paragraph (1).

51 INFORMATION TO BE FURNISHED TO THE COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

51.

51. (1) The Competent Authority shall, through the Agency, inform the Committee for Veterinary Medicinal Products immediately of each decision to grant a veterinary product authorisation and of each decision refusing, varying, suspending or revoking a veterinary product authorisation, or of prohibiting the sale or supply, or the recall of an animal remedy already sold or supplied together with the reasons on which such decisions are based.

• (2) The Competent Authority shall inform the Agency of any notification received pursuant to Regulation 18(7) if it concerns the efficacy or safety (including the protection of public health) of the animal remedy concerned.

• (3) The Competent Authority shall ensure that appropriate information about actions taken pursuant to paragraph (1), or, Regulation 18(5) which may affect the protection of health in third countries is forthwith brought to the attention of the relevant international organisations and a copy of any such notification shall be furnished to the Agency.

52 Fees

52.

52. An application for an animal remedies authorisation, licence or registration under these Regulations shall not be considered valid or processed unless the application is accompanied by the appropriate fee.

53 PROVISIONS RELATING TO FORGERY ETC.

53.

53. (1) A person shall not forge, or utter a document knowing it to be forged, purporting to be —

( a ) a prescription granted under these Regulations by a registered veterinary surgeon, or

( b ) an animal remedies authorisation, or

( c ) a licence, or

( 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 prescription issued under these Regulations by a registered veterinary surgeon, or

( b ) an animal remedies authorisation, or

( c ) a licence, or

( 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 falsely endorsed document or an altered document knowing it to be such.

• (5) A person shall not have in his or her possession a forged document, a falsely endorsed document or an altered document.

• (6) Paragraph (5) of this Regulation shall not apply in relation to any of the following persons —

( a ) a member of the Garda Síochána when acting in the course of his or her duty as such;

( b ) an authorised officer for the purposes of executing and enforcing these Regulations:

( c ) an officer of the Competent Authority for the purposes of executing and enforcing these Regulations;

( d ) a person who has taken into his or her possession such document for the purpose of —

• (i) preventing another from committing or continuing to commit an offence under the Act, or

• (ii) delivering it into the custody of a person specified in paragraph (a), (b) or (c) of this sub-paragraph.

54 LICENCES AND REGISTRATIONS

54.

54. (1) An application to the Minister for a licene or registration under a specified Regulation shall be made in such form and contain such information as the Minister may specify.

• (2) An application may be refused if, in relation to the application, information required has not been furnished or information that is, in the opinion of the Minister, false or misleading in a material particular has been furnished.

• (3) The Minister may refuse an application for a licence or registration under a specified Regulation or may revoke a licence or registration held by a person if the applicant or person has been convicted of, or committed, an offence, whether he or she has been convicted or not, under the Act or Regulations deemed to have been made thereunder, or for any other conviction, or failure to comply with the conditions attached to a previous licence or animal remedies authorisation, or, is not, in the opinion of the Minister, a fit and proper person to hold a licence;

• (4) The Minister shall refuse an application for a licence or registration under a specified Regulation and shall revoke a licence or registration held by a person if the applicant or person has been convicted, on indictment, of an offence under the Act or regulations made or deemed to have been made thereunder.

• (5) ( a ) Where the Minister proposes to refuse an application or to revoke a licence or registration under a specified Regulation or to attach a condition to, or amend or revoke a condition attached to, such a licence or registration, he or she shall notify in writing the person who made the application for or, holds the licence or registration of the proposal and the reasons for it.

( b ) A person who has been notified of a proposal under subparagraph (a) may, within 21 days of the receipt of the notification, make representations in writing to the Minister and the Minister shall —

• (i) before deciding the matter, take into consideration any representation duly made in relation to the proposal, and

• (ii) notify the person in writing of his or her decision and the reasons therefor.

( c ) A notification under subparagraph (a) shall include a statement that the person concerned may make representations to the Minister within 21 days of the receipt by him of the notification.

• (6) In this Regulation "a specified Regulation" means either Regulation 3 or Regulation 30 or Regulation 31 or Regulation 32.

55 REGISTER

55.

55. (1) The Minister shall establish and maintain a register of licences and registrations granted by him for the purposes of these Regulations, ('the Register').

• (2) There shall be entered in the Register —

( a ) the full name, address and description of the holder of the licence or registration,

( b ) an exact description of the location and, if relevant, the limits and extent of the premises and activity to which the licence or registration relates,

( c ) the date on which the licence or registration was granted and the expiry date thereof,

( d ) such particulars as the Minister may, from time to time, direct of an animal remedy or substance to which the licence or registration relates, and

( e ) such other particulars as the Minister may, from time to time, direct.

• (3) Whenever a licence or registration to which this Regulation applies is altered or revoked, there shall be entered in the Register such particulars of the alteration or revocation, as the case may be, as the Minister may, from time to time, direct.

• (4) A certificate purporting to be under the hand of an officer, authorised by the Minister in that behalf, that the name of the person, premises or animal remedy specified in the certificate is not entered in the register shall, until the contrary is proved, be evidence of the matters so certified and it shall not be necessary to prove the signature of such officer, or that he or she was such an officer, or that he or she was in fact so authorised.

• (5) Where in proceedings for an offence under these Regulations there is produced a certificate which —

• (1)
• (a) purports to be signed by the Secretary of the competent authority for that purpose, and

( b ) states that the certificate is given for the purposes of these Regulations, and

( c ) certifies that in the case of a particular substance or person, a manufacturer's licence or veterinary product authorisation, as the case may be has not been granted by the competent authority.

or

• (2) ( a ) purports to be signed by a person authorised by the Minister for that purpose, and

( b ) states that the certificate is given for the purposes of these Regulations, and

( c ) certifies that in the case of a particular substance or person

• (i) a manufacturer's licence, or

• (ii) an animal remedies wholesaler's licence, or

• (iii) an animal remedies merchants licence, or

• (iv) companion animal remedies licence, or

• (v) an animal remedies authorisation, or

• (vi) any other licence required by these Regulations, or

• (vii) registration required by these Regulations.

has not been granted by the Minister, then such certificate shall, without proof of the signature of the person purporting to sign it, or, in case the certificate purports to be signed by a person appointed by the competent authority or authorised by the Minister, proof that at time at which the certificate purports to have been given, such person stood so appointed or authorised, be evidence for all purposes that such license, authorisation or registration was not granted unless the defendant requires the person who issued the certificate to be called as a witness.

56 LICENSES NON-TRANSFERRABLE

56.

56. (1) The holder of a licence granted under these Regulations shall not transfer the licence to any other person and any such purported transfer shall be void and of no effect.

• (2) A licence granted under these Regulations shall have no effect if the holder of the licence —

• (a) ceases trading or operation, or

• (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, on dissolution, or

• (c) sells or otherwise ceases to occupy the premises to which the licence relates.

57 PROSECUTIONS

57.

57. In a prosecution for an offence under these Regulations in relation to an animal remedy which is also an additive, premixture or feedingstuff within the meaning, in each case, of the European Communities (Additives in Feedingstuffs) Regulations, 1989 and 1991, it shall be a good defence to show —

• (a) that either —

• (i) where the animal remedy is such an additive, it is an additive specified in the First or Second Schedule to the European Communities (Additives in Feedingstuffs) Regulations, 1979 ( S.I. No. 49 of 1989 ), as amended by the European Communities (Additives in Feedingstuffs) (Amendment) Regulations, 1991 ( S.I. No. 124 of 1991 ), or it is a medicinal additive manufactured or imported in pursuance of an additive licence under those Regulations,

or,

• (ii) where the animal remedy is such a premixture or feedingstuff, it contains an additive that complies with subparagraph (i) of this paragraph,

and

• (b) that the European Communities (Additives in Feedingstuffs) Regulations, 1989 to 1993, were complied with in relation to the additive.

58 IMPORT OF ANIMALS

58.

58. (1) This Regulation applies to an animal which is lawfully imported into the State and to which

• (a) an animal remedy was administered prior to such import, and

• (b) the animal remedy was administered in accordance with the law of the State where such 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 to which the animal belongs is prohibited pursuant to Community law or the Law of the State.

• (2) An animal to which paragraph (1) relates shall, in respect of such administration, be deemed to have been treated with an authorised animal remedy.

59 RECORD KEEPING

59.

59. Where a record required by these Regulations or a registration or a licence or animal remedies authorisation is maintained in machine readable form, the person responsible for maintaining such record shall, in respect of each day's transactions, make a hard copy of the record and attest to the accuracy of such copy by his or her signature and retain such copy for the period specified in these Regulations or such registration or licence or animal remedies authorisation aforesaid and make it available on request to an authorised officer.

60 SERVICE OF NOTICE

60.

60. (1) Subject to paragraph (2), a notification or notice under these Regulations shall be served on the person to be affected thereby, either by delivering it to him or her personally or by leaving it addressed to the person to be affected at his or her last known place of business or abode or by sending it through the post in a prepaid envelope addressed to the person there.

• (2) Service of a notification or notice, in the manner prescribed in paragraph (1), on a person's legal representative shall be deemed to be service on that person.

• (3) This Regulation shall apply to service of a notification or notice by, or on behalf of, the competent authority and service of a notification or notice by, or on behalf of, the Minister.

61 REPEALS AND CONTINUANCE OF CERTAIN DOCUMENTS

61.

61. (1) Subject to the subsequent provisions of this Regulation, these Regulations are in addition to and not in substitution for

• (a) the Poisons Regulations, 1982 to 1986,

• (b) the European Communities (Control of Veterinary Medicinal Products and Their Residues) Regulations, 1988 and 1990, and

• (c) the European Communities (Animal Remedies and Medicated Feedingstuffs) Regulations, 1994 ( S.I. No. 176 of 1994 )

• (2)
• (a) The following Regulations are hereby revoked

• (i) the Animal Remedies (Registration of Manufacturers, Importers and Wholesalers) Regulations, 1980 ( S.I. No. 115 of 1980 );

• (ii) the Poisons (Control of Residues in Food of Animal Origin) Regulations, 1985 and 1986;

• (iii) the Animal Remedies (Control of Sale) Regulations, 1985 and 1986;

• (iv) the European Communities (Veterinary Medicinal Products) Regulations, 1986 ( S.I. No. 22 of 1986 );

• (v) Regulations 5 and 7 of the European Communities (Control of Veterinary Medicinal Products and Their Residues) Regulations, 1990 ( S.I. No. 171 of 1990 ); and,

• (vi) the Animal Remedies (Prohibition of Certain Sales) Regulations, 1991 ( S.I. No. 244 of 1991 ).

• (b) A veterinary product authorisation or a licence granted by the Competent Authority and in force immediately before the revocation of the aforementioned European Communities (Veterinary Medicinal Products) Regulations, 1986, shall continue in force upon such revocation as if granted under these Regulations.

• (c) All licences granted by the Minister and in force immediately before the revocation of the aforementioned Regulations 5 and 7 of the European Communities (Control of Veterinary Medicinal Products and Their Residues) Regulations, 1990 shall continue in force upon such revocation as if granted under these Regulations.

• (d) All licences granted by the Minister and in force immediately before the revocation of the aforementioned Animal Remedies (Prohibition of Certain Sales) Regulations, 1991 shall continue in force upon such revocation as if granted under these Regulations.

• (4) Nothing in these Regulations shall be construed as affecting any provision of the European Communities (Additives in Feedingstuffs) Regulations, 1989 to 1993.

• (5) An animal remedy which would but for the making of these Regulations be a therapeutic substance to which the Therapeutic Substances Act, 1932 applies, shall no longer be a therapeutic substance to which the said Therapeutic Substances Act, 1932 applies.

FIRST SCHEDULE

A label insert for an animal remedy shall contain at least the following

PART I

The following information, which shall conform with the particulars and documents provided pursuant to Article 5 of the Council Directive and be approved by the Competent Authorities, shall appear in legible characters on containers and outer packages of animal remedies.

Where the special name of an animal remedy containing only one active ingredient is a brand name, this name must be accompanied in legible characters by the international non-propriety name recommended by the World Health Organisation, where such name exists, or where no such name exists, by the usual non-proprietary name.

The pharmaceutical form and the contents by weight, volume or number of dose-units need only be shown on the outer package.

The provisions of Part 2 A of the Annex to Commission Directive 92/18/EEC, in so far as they concern the qualitative and quantitative composition of veterinary medicinal products in respect of active ingredients, shall apply to the particulars provided for in point 2.

PART II

— name of the animal remedy,

— quantity of the active ingredients,

— route of administration,

— reference number for production identification

(manufacturer's batch number),

— date of expiry,

— the words 'For animal treatment only'.

PART III

The inclusion of a package insert in the packaging of an animal remedy shall be obligatory unless all the information required by this part can be conveyed on the container and the external packaging. Information on the insert shall solely relate to the animal remedy with which it is included. The insert shall be in the English or Irish language and shall include at least the following information and conform with the particulars and documents provided in accordance with the application for the product authorisation.

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

• (b) name of the animal remedy and a statement of its active ingredients expressed qualitatively and quantitatively.

The international non-proprietary names recommended by the World Health Organisation shall be used wherever they exist;

• (c) the main therapeutic indications, contra-indications and side-effects in so far as these particulars are necessary for the use of the animal remedy;

• (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 animal remedies administered to food-producing animals;

• (f) special storage precautions, if any;

• (g) particulars required to be indicated pursuant to the first paragraph of Article 12 of the Council Directive, if any.

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

Part IV

VSO

POM

POM (E)

PS

LM

CAM

SECOND SCHEDULE

PART I

Substances with oestrogenic, androgenic or gestagenic action within the meaning of Council Directive 81/602/EEC of the 31st July 1981^16 (which relates to the prohibition of certain substances having a hormonal action and of any substance having a thyrostatic action) or any enactment amending or replacing the said Council Directive and in particular the following substances their esters and derivatives—

Oestradiol 17B

Progesterone

Testosterone

Trenbolone and its acetate

Zeranol

PART II

^16 O.J. L.222 of 7.8.81

Actinomycins

Amikacin

Aminoglycocides (other than those specifically set out in this Part)

Amoxycillin

Amphomycin

Amphotericins

Ampicillin

Apramycin

Avoparcin

Azidamfenciol

Bacitracin

Bambermycin

Benzylpencillin

Bleomycin

Candicidin

Capreomycin

Carbenicillin

Cefaclor

Cefamandole

Cefoxitin

Cefuroxime

Cephacetrile

Cephalexin

Cephalonium

Cephalosporins (other than those specifically set out in this Part)

Cephaloridine

Cepalothin

Cephamycins (other than those specifically set out in this Part)

Cephapirin

Cephazolin

Cephoxazole

Cephradine

Chloramphenicol

Chlortetracyllines

Ciclacillin

Clavulanic Acid

Clindamycin

Clomocycline

Cloxacillin

Colistin

Cycloserine

Daunorubicin

Demeclocycline

Dicloxacillin

Dihydrostreptomycin

Dimethylchlortetracycline

Doxorubicin

Doxycycline

Epicilline

Erythromycin esters

Erythromycin

Flucloxacillin

Framycetin

Fumagillin

Fusafungine

Fusidic Acid

Gentamicins

Gramacidin

Griseofulvin

Hachimycin

Kanamycin

Lincomycins

Macrolide antibiotics (other than those specifically set out in this Part)

Mecillinam

Methacycline

Minocycline

Mithramycin

Mitomycins

Nafcillin

Natamycin

Neomycin

Novobiocin

Nystatin

Oleandomycin

Oxacillin

Oxytetracycline

Paromomycin

Penethamate

Penicillins (other than those specifically set out in this Part)

Pivampicillin

Pivmicillinam

Polymyxins

Polymyixin B

Procaine Benzyl penicillin

Rifamycins

Ristocetins

Spectinomycin

Talampicillin

Tetracyclines (other than those specifically set out in this Part)

Thiamphenicol

Tetracycline hydrochloride

Tiamulin

Tobramycin

Tylosin

Vancomycin

Viomycin

Virginiamycin

p - Aminobenzenesulphonamide and its derivatives (where such derivatives have any of the hydrogen atoms of the p - amino group or of the sulphonamide group substituted by another radical) other than those specifically set out in this Part.

Carbadox

Dimetridazole

Dapsone

Furaltadone

Furazolidone

Metronidazole

Nitrofurantoin

Nitrofurazone

Nitroxoline

Olaquindox

Phtalylsulphacetamide

Phthalylsulphathiazole

Ronidazole

Succinylsulphathiazole

Sulfadoxine

Sulfametopyrazine

Sulfanitran

Sulfapyrazole

Sulfatroxazole

Sulphacetamide

Sulphachlorpyridazine

Sulphadiazine

Sulphadimethoxine

Sulphadimidine

Sulphaethidole

Sulphafurazole

Sulphaguanidine

Sulphaloxic acid

Sulphamerazine

Sulphamethizole

Sulphamethoxazole

Sulphamethoxydiazine

Sulphamethoxypyridazine

Sulphamopine

Sulphamoxole

Sulphanilamide

Sulphaphenazole

Sulphaproxyline

Sulphapyridine

Sulphaquinoxaline

Sulphasalazine

Sulphasamidine

Sulphasomizole

Sulphathiazole

Sulphormethoxine

Tinidazole

Alcometasone

Aldosterone

Beclometasone

Betamethasone

Clobetasol

Cortisone

Cortivasol

Deoxycorticosterone

Desonisde

Desoxymethasone

Dexamethasone

Diflucortolone

Fluclorolone acetonide

Fludrocortisone

Flumethasone

Flunisolide

Fluocinolone acetonide

Fluocinonide

Fluocortolone

Flurometholone

Fluperolone

Fluprednidine

Flurandrenolone

Formocortal

Halcinonide

Hydrocortisone

Isoflupredone acetate

Medrysone

Medprednisone

Methylprednisolone

Paramethasone

Prednisolone

Prednylidene

Triamcinolone

Triamcinolone acetonide

Triamcinolone hexacetonide

Alfaprostol

Arbaprostil

Carboprost

Clopostenol

Delprostenate

Dinoprost

Fluprostenol

Gemeprost

Luprostiol

Prostalene

Cimaterol

Clenbuterol

Dobutamine

Fenoterol

Isoprenaline

Isoxuprine

Mabuterol

Prenalterol

Ractopamine

Ritodrine

Salbutamol

Terbutaline

THIRD SCHEDULE

QUALIFIED PERSON

A qualified person is a person who fulfils the following minimum conditions of qualification: —

• (a) 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 Minister, 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:

— the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and includes a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level;

—- where two university course or two courses recognised by the State in question as equivalent co-exist in a Member State of the European Union and where 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 in this sub-paragraph in so far 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.

The course shall include theoretical and practical study bearing upon at least the following basic subjects and shall be so balanced as to enable the person concerned to fulfil the obligations specified in paragraph 7(3) of the First Schedule

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 act ive principles of natural substances of plant and animal origin).

In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in the first paragraph do not fulfil the criteria laid down above the person concerned shall provide evidence to the Competent Authority of adequate knowledge of the subjects involved;

• (b) practical experience for at least two years, in one or more undertakings which are authorised to manufacture medical preparations or animal remedies, in the act ivities of qualitative analysis of medical preparations or animal remedies of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medical preparations or animal remedies provided that the duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.

• (c) A person qualified by virtue of Article 32 of Council Directive 81/851/EEC

FOURTH SCHEDULE

GENERAL CONDITIONS SUBJECT TO WHICH MANUFACTURER'S LICENCES ARE GRANTED

• (a) provide and maintain such premises, equipment, facilities and staff as are necessary for carrying out any tests of strength, quality or purity of the medical preparations that he or she manufactures as requires by the relevant product authorisation and in accordance with the requirements as laid down by Commission Directive 91/412/-EEC as may be specified by the Competent Authority, or

• (b) make arrangements with a person approved in writing by the Competent Authority for such tests to be carried out on his or her behalf by that person.

• (a) responsible for the quality control of the animal remedies being manufactured including the person named as the qualified person for the purposes of paragraph 7 of this Part of this Schedule, or

• (b) responsible for supervising the production operations, or

• (c) responsible for biological or microbiological controls used in the manufacture or testing of the animal remedies being manufactured.

• (2) The licence holder shall at all times provide and maintain such staff, premises and facilities as will enable the qualified person to carry out the said functions.

• (3) The functions to be carried out by the qualified person shall be as follows:

• (a) to ensure that every batch of animal remedy to which the licence relates has been manufactured and checked in compliance with:—

• (i) the laws in force in the State in respect of such animal remedy

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

• (iii) the provisions of the product authorisation or other standard which relates to the said animal remedy.

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

• (c) in the case of an animal remedy coming from a country which is not a Member State of the European Union to ensure that each particular batch imported has undergone within the State or another Member State a full quantitative analysis of at least all the active ingredients and all the other tests or checks necessary to ensure the quality of the animal remedy in accordance with the requirements of the product authorisation.

• (4) Where, after giving the licence holder and the person acting as the qualified person the opportunity of making representations to it (either orally or in writing), the Competent Authority is of the opinion that the person so acting is failing to carry out the functions specified in paragraph (3) above and has notified the licence holder accordingly in writing, the licence 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 Competent Authority.

• (5) The Competent Authority may require the licence holder temporarily to suspend the person acting as such qualified person upon the commencement of administrative or disciplinary proceedings against him or her for failure to fulfil his or her functions in accordance with paragraph (3) above and the licence holder shall not permit that person to act as the qualified person pending the determination of such proceedings.

Such records shall be retained for not less than five years from the date of manufacture or for the period which ends one year after the labelled expiry date of the animal remedy whichever is the longer period.

FIFTH SCHEDULE

General conditions for licensed retail premises

SIXTH SCHEDULE

Form of record to be kept in accordance with paragraph (2) of Regulation 42

Date of Administration	Name and quantity of animal remedy administered	Identity of animal to which animal remedy administered including Ear Tag No. where appropriate	Date of expiry of withdrawal period (if any)	Name of person who administered the Animal Remedy	Name of prescribing Veterinary Surgeon (if applicable)	Name of supplier of animal remedy

GIVEN under my Official Seal, this 13 day of June, 1996

Ivan Yates TD

Minister for Agriculture, Food and Forestry

EXPLANATORY NOTE

The effect of these is to transpose into national law Council Directive 81/851/EEC, Council Directive 81/852/EEC, Council Directive 87/20/EEC, Council Directive 87/22/EEC, Council Directive 90/676/EEC, Council Directive 90/677/EEC, Commission Directive 91/412/EEC, Commission Directive 92/18/EEC, Commission Directive 92/74/EEC, Council Directive 93/40/EEC and Council Directive 93/41/EEC and give further effect to Council Regulation (EEC) 2377/90 and Council Regulation (EEC) 2309/93.

The Regulations lay down detailed rules regarding the authorisation of animal remedies and the manufacture, wholesale and retail sale of animal remedies. The Regulations also lay down rules for the administration of animal remedies and certain matters relating to veterinary practice in relation to animal remedies.