LegalizeS.I. No. 734/2005 - Animal Remedies Regulations 2005
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ANIMAL REMEDIES REGULATIONS 2005
S.I. No. of 734 of 2005.
ANIMAL REMEDIES REGULATIONS 2005
I, Mary Coughlan, Minister for Agriculture and Food, in exercise of the powers conferred on me by section 8 of the Animal Remedies Act 1993 (No 23 of 1993)(as adapted by the Agriculture, Food and Forestry (Alteration of name of Department and Title of Minister) Order 2002 ( S.I. No 306 of 2002 )) and in respect of Regulation 63(5) section 3 of the European Communities Act 1972 (No 27 of 1972) for the purpose, inter alia, of giving effect to Directive 2001/82/EC on the Community code relating to veterinary medicinal products1 as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 20042 and to give further effect to Council Regulation (EEC) No. 2377/90 of 26 June 19903 and to give full effect to Regulation (EC) No. 726/2004 of the European Parliament and the Council of 31 March 20044 and following consultation with the Animal Remedies Consultative Committee, hereby make the following regulations:
PART I PRELIMINARY AND GENERAL
Citation and commencement
1.
1. (1) These Regulations may be cited as the Animal Remedies Regulations 2005.
- (2) Regulations 44 and 45 come into operation on the 1 January 2006.
Interpretation
2.
2. (1) In these Regulations -
“animal remedies authorisation” means -
- (a) a veterinary product authorisation within the meaning of Article 5 of the Directive,
- (b) a licence granted under the Therapeutic Substances Act 1932 (No. 25 of 1932) in respect of an animal remedy named on the licence until the date of expiry of the licence,
- (c) a licence under Regulation 16, 17, 18(5), or 20,
- (d) a marketing authorisation granted under Regulation (EC) No. 726/2004,
- (e) a registration granted by the Board in accordance with Regulation 8(2), or
- (f) such other document, registration, licence or authorisation deemed by these Regulations to be an animal remedies authorisation;
“Act” means the Animal Remedies Act 1993 (No. 23 of 1993);
“Agency” means the European Medicines Agency established by Regulation (EC No. 726/2004;
“Board” means the Irish Medicines Board;
“companion animal” includes domestic dog, cat, rabbit (other than a rabbit kept for human consumption), a small rodent, cage bird, homing pigeon, terrarium animal and an aquarium fish or an equid declared as not intended for use as food for human consumption in accordance with the European Communities (Equine Stud-Book Competition) Regulations 2004 ( S.I. No. 399 of 2004 ));
“companion animal medicine” means an animal remedy authorised by the Board for administration to a companion animal only;
“companion animal medicine seller” means a person registered under Regulation 33;
“Council Regulation (EEC) No 2377/90” means Council Regulation (EEC 2377/90 of 26 June, 1990, as amended and any act of an institution of the European Union which amends, extends or replaces the said Council Regulation (EEC) No 2377/90;
“Directive” means Directive 2001/82/EC of the European Parliament and of the Council, of 6 November 2001, as amended by Directive 2004/28/EC, of the European Parliament and of the Council of 31 March 2004;
“EEA Agreement” means the Agreement on the European Economic Area signed in Oporto on 2 May 1992 as adjusted by the Protocol to that Agreement done at Brussels on 17 March 19935 ;
“EEA State” means a state which is a contracting state to the EEA Agreement within the meaning given to that phrase in the European Communities (Amendment) Act 1993 (No. 25 of 1993);
“European Economic Area” means the European Economic Area created by the EEA Agreement;
“food producing animal” means an animal of the bovine, caprine, ovine or porcine species, poultry, rabbits, deer, fish or honey bees if such rabbits, deer or fish are intended for use as food for human consumption, or equidae intended for use as food for human consumption in accordance with the European Communities (Equine Stud-Book and Competition) Regulations 2004, ( S.I. No. 399 of 2004 );
“group veterinary practice” means a formally associated group of registered veterinary practitioners who are available to provide services of veterinary medicine and surgery and to carry out clinical procedures on animals under their care;
“holder” in respect of a registration, licence, approval or animal remedies authorisation means the person to whom the registration, licence, approval, or animal remedies authorisation is granted and who is identified as the holder on the registration, licence, approval or animal remedies authorisation, and reference to a holder includes a reference to a representative, employee, servant or agent of the holder;
“homeopathic animal remedy” has the same meaning as a homeopathic veterinary medicinal product;
“human consumption” includes intended for incorporation in, or manufacture into, a food intended for human consumption and kindred words shall be construed accordingly;
“immunological animal remedy” has the same meaning as immunological veterinary medicinal product;
“imported” means brought into the State from outside the State and “importation” shall be construed accordingly;
“meat” includes the flesh of fish;
“medicinal product” has the meaning assigned to it by Directive 2001/83/EC of 6 November 20016 ;
“medicated feedingstuff” means a mixture of an animal remedy or remedies and feed or feeds which is ready prepared for placing on the market or for use and which is intended to be fed to animals without further processing because of its curative or preventative or other properties as an animal remedy;
“Member State” means a Member State of the European Communities or of the European Union;
“pharmacist” means a person lawfully keeping open shop for dispensing or compounding medical prescriptions or for the sale of poisons under the Pharmacy Acts 1875 to 1977;
“pharmacy” means a shop being lawfully kept open for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts 1875 to 1977;
“pre-mix for a medicated feedingstuff” means an animal remedy prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs;
“record” means a record in writing and -
- (a) a disc, tape, sound-track or other device, including an electronic device in which information, sounds or signals are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in legible or audible form,
- (b) a film, tape or other device, including an electronic device, in which visual images are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in visual form, and
- (c) a photograph,
and a reference to a copy of a record includes -
- (i) in the case of a record to which paragraph (a) refers, a transcript of the sounds or signals embodied in it,
- (ii) in the case of a record to which paragraph (b) refers, a still reproduction of the images embodied in it, and
- (iii) in the case of a record to which paragraphs (a) and (b) refer, such a transcript together with such a still reproduction;
“registered dentist” means a person entered in the register established under the Dentists Act 1985 (No. 9 of 1985);
“registered medical practitioner” means a person entered in the register established under the Medical Practitioners Act 1978 (No. 4 of 1978);
“registered veterinary practitioner” means a veterinary surgeon registered under the Veterinary Surgeons Act 1931 (No. 36 of 1931);
“Regulation (EC) No. 726/2004” means Regulation (EC) No. 726/2004 of the European Parliament and of the Council of the 31 March 2004 and any act of an institution of the European Union which amends, extends or replaces this Regulation;
“Regulations of 1998” means the Control of Animal Remedies and their Residues Regulations, 1998 ( S.I. No. 507 of 1998 );
“risk-benefit balance” means an evaluation of the positive therapeutic effects of an animal remedy in relation to the risks relating to use of the animal remedy;
“risks relating to use of an animal remedy” means -
- (a) any risk relating to the quality, safety and efficacy of the animal remedy as regards animal or human health, or
- (b) any risk of undesirable effects on the environment;
“third country” means a state other than a member state;
“veterinary prescription” means a written prescription (containing the information specified in Schedule 3) issued by a registered veterinary practitioner in respect of an animal under his or her care that provides for the administration of an animal remedy to the animal.
- (2) A word or expression used in these Regulations and also used in an act of the institutions of the European Communities cited in the preamble to these Regulations or paragraph (1) has, unless the contrary intention appears, the meaning in these Regulations that it has in the act of the institutions of the European Communities in which it occurs.
- (3) In these Regulations, unless the contrary intention appears, a reference to a Part Regulation or Schedule is to a Part or Regulation of, or Schedule to, these Regulations and a reference to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs.
Bulk substances
3.
3. (1) A person shall not import, manufacture, sell or supply a substance that consists of or contains a thing that has anabolic, anti-infectious, anti-parasitic, anti-inflammatory hormonal or psychotropic properties unless his or her name and the substance are entered in the Register (“register of bulk animal remedies”).
- (2) A person whose name is entered in the register of bulk animal remedies —
- (a) shall keep a record available for inspection by an authorised officer for at least five years detailing, in chronological order, quantities of each substance imported, acquired, manufactured, sold, supplied or used as, or for the production of, an animal remedy,
- (b) shall make returns to the Minister as and when and in a form that the Minister directs, and
- (c) shall not sell or supply a substance unless the outer container bears a label indicating the commercial name or scientific name of the substance, the name and address of the manufacturer and, if the substance is sold or supplied in bulk the name and address of the consignee.
- (3)
- (a) Paragraph (1) does not apply to the sale or supply of a substance if the sale or supply is by -
- (i) a pharmacist,
- (ii) a registered veterinary practitioner,
- (iii) a registered medical practitioner, or
- (iv) a registered dentist.
- (b) Paragraph (1) does not apply to the manufacture or wholesale supply of an animal remedy or a medicinal product if the person is lawfully entitled (otherwise than by reference to this Regulation) to manufacture, sell or supply the animal remedy or medicinal product.
PART II AUTHORISATION OF AN ANIMAL REMEDY
Requirement for an animal remedies authorisation
4.
4. (1) Without prejudice to Regulation 18,19 and 21, a person shall not import, possess sell or supply an animal remedy, unless there is in force an animal remedies authorisation.
- (2) Paragraph (1) does not apply to a homeopathic animal remedy (other than an immunological homeopathic animal remedy) which, on or before 31 December 1993 was registered under the Animal Remedies (Registration of Manufacturers, Importers and Wholesalers) Regulations 1980 ( S.I No 115 of 1980 ).
- (3)
- (a) The Board may, on application, determine that a substance does not come within the terms of the Directive.
- (b) An application under this paragraph shall be made in a form, be accompanied by any material and contain any particulars that the Board specifies.
- (c) If the Board proposes to refuse an application under this paragraph, it shall -
- (i) notify the applicant in writing of the proposal and of the reasons therefor, and that he or she may make representation to the Board in relation to the proposal within 14 days of notification,
- (ii) consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and
- (iii) notify the applicant of the decision and the reasons therefor.
- (4) If the Board determines in accordance with paragraph (3)(a) that a substance does not come within the terms of the Directive, it shall notify the applicant and forward a copy to the Minister.
Application for a veterinary product authorisation
5.
5. (1) An application for a veterinary product authorisation shall be made to the Board and shall -
- (a) be in a form and contain the information that the Board requires and be accompanied by the particulars and documents specified in the first subparagraph of Article 12(3) and in Article 14 of the Directive and Annex 1 to the Directive, and
- (b) if the documents and particulars which relate to matters referred to in point (j of the first subparagraph of Article 12(3) of the Directive are accompanied by detailed and critical summaries, these summaries shall be drafted and signed by experts with the requisite qualifications as specified in Article 15(1) and (3) of the Directive.
- (2) If an application for a veterinary product authorisation is made in respect of an animal remedy authorised, or under examination, by the competent authority in another Member State, the Board may not consider the application unless it is satisfied that the first subparagraph of Article 32(1) of the Directive has been complied with.
- (3) If the Board decides not to consider an application to which paragraph (2) applies, it shall inform the applicant.
- (4)
- (a) The Board may not consider an application for a veterinary product authorisation in respect of an animal remedy intended for administration to a food producing animal unless six months has elapsed since the lodgement of a valid application for the establishment of a maximum residue limit with the Agency.
- (b) Subparagraph (a) does not apply to an animal remedy containing a pharmacologically active substance not listed in Annexes I, II or III to Regulation (EEC) No 2377/90 intended for administration to equidae, not intended for use as food for human consumption in accordance with the European Communities (Equine Stud Book and Competition) Regulations 2004 ( S.I. No 399 of 2004 ).
- (5) The Board may not consider an application for a veterinary product authorisation unless the applicant is established in a Member State.
Examination of an application for a veterinary product authorisation.
6.
6. (1) In examining an application for a veterinary product authorisation, the Board shall take into consideration such criteria as it considers relevant to comply with Articles 12 to 13(d) of the Directive and in particular, information supplied by the applicant relating to -
- (a) the quality, safety and efficacy of the animal remedy,
- (b) the proposed indications, sales presentation, labelling and where appropriate package leaflet relating to the animal remedy, and
- (c) the measures, in the case of an animal remedy to be imported from a third country, to ensure that the animal remedy is produced to an equivalent standard to those applicable in the European Community, and an inspection of the manufacturing facility by the Board may be required.
- (2) The Board may require an applicant to furnish, without charge, a sample of an animal remedy, its starting materials, active substances, intermediate product, reference standard or other constituent material for testing by a laboratory designated by the Board.
- (3) The Board may (to verify the analytical detection methods proposed by the applicant for the carrying out of checks for residues of an animal remedy in food producing animals or, in the flesh or produce of those animals) consult with experts it considers appropriate, and may require the applicant to supply sufficient quantities of a substance or other material it considers necessary.
- (4) If the Board requires further information as specified in Article 23(4) of the Directive, the time limit referred to in Regulation 10(2) is suspended until the information required is supplied to the satisfaction of the Board.
- (5) The Board shall, when determining an application for a veterinary product authorisation, comply with the Council Directives within the meaning of the Regulations of 1998.
Authorisation of an animal remedy referred to in Articles 13, 13a-d of the Directive (‘generics’, ‘bibliographics’ etc.).
7.
7. (1) Notwithstanding Regulation 5(1) and without prejudice to the Patents Act 1992 (No. 1 of 1992), if an applicant can demonstrate to the satisfaction of the Board -
- (a) that the animal remedy is a generic animal remedy, and
- (b) the reference animal remedy, is or was authorised for not less than 8 years,
he or she need not provide the results of safety and residue tests or of pre-clinical and clinical trials referred to and in accordance with Annex I to the Directive.
- (2) If a reference animal remedy is authorised in another Member State, the applicant shall identify the Member State and the Board shall request the competent authority of that Member State to transmit confirmation that the animal remedy is or has been authorised together with the full composition of the animal remedy and any other relevant information.
- (3) For the purposes of paragraph (1) -
- (a) different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, and
- (b) if salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of a substance, in the opinion of the Board, differ significantly from those in the reference animal remedy, the applicant shall provide additional information as specified in Article 13(2)(b) of the Directive.
- (4) If, in the opinion of the Board, an animal remedy is not a generic animal remedy, or if bio-equivalence cannot be demonstrated through bio-availability studies or in the case of changes to an active substance, therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference animal remedy, the applicant shall provide results of appropriate safety and residue tests and pre-clinical tests or clinical trials in accordance with Annex I to the Directive.
- (5) If, in the opinion of the Board, a biological animal remedy does not meet in full the definition of a generic animal remedy, owing to, in particular, differences relating to raw materials or differences between the manufacturing processes of the biological animal remedy and the reference biological animal remedy, the applicant shall comply with Article 13(4) of the Directive.
- (6)
- (a) An applicant need not provide the results of safety and residue tests or of pre-clinical and clinical trials referred to and in accordance with Annex I to the Directive, if he or she can satisfy the Board, on the basis of appropriate scientific literature, that the active substances in the animal remedy have been present in an authorised animal remedy meeting the requirements of Annex 1 to the Directive, for at least 10 years.
- (b) The use of scientific literature referred to in subparagraph (a) shall be justified to the satisfaction of the Board, by the experts referred to in Regulation 5(1)(b).
- (c) For the purposes of subparagraph (a), the Board may accept the assessment report published by the Agency as appropriate scientific literature following the evaluation of an application for the establishment of a maximum residue limit pursuant to Regulation (EEC) No 2377/90.
- (7) Notwithstanding paragraph (1), an application for a veterinary product authorisation in respect of an animal remedy containing two or more active substances, each having been used in an authorised animal remedy, but not previously used in combination in an authorised animal remedy shall, as may be required by the Board, be accompanied by the results of: -
- (a) safety and residue tests relating to the combination, and
- (b) new pre-clinical tests or new clinical trials, relating to the combination that fulfils the requirements of Article 12 (3) (j) of the Directive.
- (8) Notwithstanding paragraph (1), if an application is made for a veterinary product authorisation in respect of an immunological animal remedy, in exceptional circumstances, the Board may, if it receives a duly substantiated case from the applicant on the basis of Article 13(d) of the Directive and following consultation with the Minister, exempt the applicant from the requirements of Article 12(3)(j) of the Directive in relation to field trials on a target species.
- (9)
- (a) Notwithstanding Regulation 10(2), the Board shall not issue a veterinary product authorisation in respect of a generic animal remedy authorised pursuant to paragraph (1) until 10 years have elapsed from the date of the grant of a marketing authorisation for the reference animal remedy.
- (b) Notwithstanding subparagraph (a), in the case of an application for an animal remedy for fish or bees or other species designated in accordance with Article 89(2) of the Directive, the Board shall not issue a veterinary product authorisation until thirteen years have elapsed from the date of the grant of a marketing authorisation for the reference animal remedy.
- (c) Notwithstanding subparagraphs (a) and (b), in the case of an reference animal remedy containing a new active substance -
- (i) intended for administration to a food producing species, and
- (ii) that was not authorised, by 30 April 2004,
the Board shall not issue a veterinary product authorisation in respect of a generic animal remedy for an additional food producing species unless the periods specified in Article 13(5) of the Directive have elapsed.
- (d) Subparagraph (c) only applies when -
- (i) the extension to the veterinary product authorisation referred to in subparagraph (c) is granted within five years of the grant of the original marketing authorisation for the reference animal remedy, and
- (ii) the veterinary product authorisation holder is the person who applied to the Agency for the maximum residue limit for the active substance in the reference animal remedy for the species concerned.
- (10) If a person, having availed of paragraph (6)(a), submits new residue studies and clinical trials, with a view to obtaining a veterinary product authorisation in respect of a further food-producing species, another person shall not use the studies or trials in an application for a generic animal remedy for a period of three years thereafter.
- (11) The Board, having obtained permission in writing from the holder of a veterinary product authorisation, may take into account data referred to in Article 13c of the Directive when examining another application for a veterinary product authorisation for an animal remedy having the same qualitative and quantitative composition in active substances and the same pharmaceutical form.
- (12) This Regulation applies only to a reference animal remedy for which an application for a marketing authorisation is submitted after 30 October 2005.
- (13) In this Regulation -
“authorised”, in relation to an animal remedy, means authorised in the State, in another Member State or in accordance with Regulation (EC) No. 726/2004;
“generic animal remedy” means an animal remedy which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form (which includes various immediate-release oral pharmaceutical forms) as the reference animal remedy and whose bioequivalence with the reference animal remedy has been demonstrated by bioavailability studies where appropriate;
“reference animal remedy” has the meaning assigned to a reference medicinal product by Article 13.2 (a) of the Directive.
Authorisation of a homeopathic animal remedy
8.
8. (1) An application for a veterinary product authorisation for a homeopathic animal remedy shall comply with Regulation 5.
- (2)
- (a) Notwithstanding paragraph (1) and without prejudice to Regulation (EEC) No 2377/90, an application for registration of a homeopathic animal remedy (other than an immunological homeopathic animal remedy) in respect of which it has been demonstrated to the satisfaction of the Board that it -
- (i) is to be administered by a route described in the European Pharmacopoeia or in the absence thereof, in the official pharmacopoeias used in a Member State,
- (ii) contains no specific therapeutic indications, and
- (iii) has, in the opinion of the Board, a sufficient degree of dilution and in particular, does not contain more than one part per 10 000 of the mother tincture,
is subject to Article 17(2) of the Directive.
- (b) An application for registration of a homeopathic animal remedy to which subparagraph (a) refers shall be made to the Board and be in such form as the Board may require and be accompanied by the particulars and documents specified in Article 18 of the Directive.
- (c) Notwithstanding subparagraphs (a) and (b), Regulation 6 applies to an application under this paragraph with the exception of requirements in relation to efficacy.
Mutual recognition
9.
9. The Board shall comply with Articles 32 to 41 of the Directive in so far as these Articles apply to the Board and may act as a reference or concerned member state (within the meaning of those Articles).
Decision etc. on an application
10.
10. (1) The Board may grant a veterinary product authorisation or registration, arising from an application under Regulations 5, 7, 8 or 9, refuse an application, attach conditions to a veterinary product authorisation or registration, revoke or vary a condition, or suspend or revoke a veterinary product authorisation or registration.
- (2) Subject to Regulations 6(4) and 9, the Board shall, within 210 days of the receipt of a valid application, notify the applicant of its decision.
- (3) The Board may, following consultation with the applicant, grant a veterinary product authorisation subject to annual review and subject to the holder undertaking to meet specific obligations, including—
- (a) introduction of specific procedures, in particular, concerning the safety of the animal remedy, and
- (b) notification to the Board of all incidents relating to use of the animal remedy.
- (4) The Board, except in the case of a homeopathic animal remedy referred to in Regulation 8(2), shall comply with Article 25 of the Directive.
- (5) The Board shall specify the manner in which an animal remedy shall be packaged presented and labelled and the particulars which shall appear on the label, container or package leaflet.
- (6) For the purposes of paragraph (5) and without prejudice to Regulation 8(2), the form of label or package leaflet shall comply with the Directive and Schedule 2 and include any particulars specified by the Board for the purpose of safety or health protection including any special precautions for use or other warnings resulting from clinical and pharmacological trials, or, from experience gained during the use of the animal remedy and, in particular, matters arising as a result of pharmacovigilance reports.
- (7) Without prejudice to paragraph (1), -
- (a) the Board shall, as a condition of a veterinary product authorisation or registration, designate the route of sale for an animal remedy in accordance with Part II of Schedule 1, and
- (b) the route of sale (for which purpose the symbols set out in Part IV of Schedule 2 may be used) shall appear on the container, label and package leaflet relating to the animal remedy.
- (8) If the Board proposes to refuse an application, it shall -
- (a) notify the applicant in writing of the proposal and of the reasons therefor, and that he or she may make representation to the Board in relation to the proposal within 30 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 concerned of the decision and the reasons for the decision.
- (9) The Board shall refuse an application if, in its opinion -
- (a) the risk-benefit balance of the animal remedy is unfavourable under the proposed conditions of use,
- (b) the animal remedy has no therapeutic effect or the applicant has not provided sufficient proof of such effect in the species of animal to be treated,
- (c) the qualitative or quantitative composition of the animal remedy is not as stated,
- (d) the withdrawal period recommended by the applicant is not long enough to ensure that a foodstuff obtained from an animal does not contain residues which exceed those prescribed by Council Regulation (EEC) No 2377/90, or other instrument of Community Law, or a limit prescribed by regulations made under the Act, or which might constitute a health hazard to a consumer of produce from an animal,
- (e) the labelling or package leaflet proposed by the applicant for the animal remedy does not comply with the Directive or these Regulations,
- (f) the animal remedy is, or is to be, offered for sale or supply for a use that is unlawful,
- (g) the animal remedy consists of, or contains, a substance the administration of which to the particular class or classes of animal for which the animal remedy is intended, is unlawful,
- (h) the animal remedy consists of or contains a substance to which Regulation 3(1 of the Regulations of 1998 applies,
- (i) such action is necessary to protect public health, animal health or the environment,
- (j) the animal remedy is not manufactured in accordance with the principles and guidelines referred to in Article 50(f) of the Directive,
- (k) a request by the Board for further particulars, to enable compliance with the Directive to be considered, has not been complied with, within the time specified, or
- (l) the application does not comply with Regulation 5.
- (10) For the purposes of paragraph (9)(a), in the case of an animal remedy intended for zootechnical use, the Board shall have particular regard to the benefits for animal health and welfare and consumer safety.
- (11) An animal remedy is considered to have no therapeutic effect unless it can be shown that it produces the appropriate therapeutic effect for the condition to be treated in the species of animal for which the treatment is intended.
- (12)
- (a) Subject to paragraph (9) and without prejudice to subparagraph (b), the Board shall not grant a veterinary product authorisation or a registration in respect of an animal remedy intended for administration to a food producing animal unless each substance capable of pharmacological action contained in the animal remedy is mentioned in Annex I, II or III to Regulation (EEC) No. 2377/90.
- (b) Notwithstanding subparagraph (a), the Board may authorise an animal remedy containing a substance not listed in Annexes I, II or III to Regulation (EEC) No 2377/90 for administration to equidae which are not intended for use as food for human consumption in accordance with European Communities (Equine Stud Book and Competition) Regulations 2004 ( S.I. No 399 of 2004 ).
- (c) Subparagraph (b) does not apply -
- (i) to an animal remedy containing a substance listed in Annex IV to Regulation (EEC) No 2377/90, or
- (ii) if an animal remedies authorisation has issued in respect of an animal remedy for treatment of the same condition in equidae.
Validity of a veterinary product authorisation
11.
11. (1) Without prejudice to Regulations 10(3) and 12, a veterinary product authorisation is, unless previously revoked, valid for five years, commencing on the date of the grant of the authorisation.
- (2)
- (a) A veterinary product authorisation may be renewed by the Board on the basis of an application made by the holder.
- (b) An application for renewal of a veterinary product authorisation shall be made in a form, be accompanied by any material and contain any particulars that the Board specifies and, in particular, the information specified in the second subparagraph of Article 28(2) of the Directive and be submitted no later than six months before expiry of the authorisation which it is to replace.
- (3) If application for renewal of a veterinary product authorisation is made no later than six months before the expiry date, that veterinary product authorisation remains in force until determination of the application.
- (4) Without prejudice to Regulation 10(1), a veterinary product authorisation, if renewed, is subject to these Regulations, valid for an unlimited period, unless the Board considers at the time of the grant of a first renewal, on the basis of pharmacovigilance information, that the validity should be limited to one additional five year period following which the Board shall, if it considers it appropriate to do so, renew the authorisation for an unlimited period.
- (5)
- (a) If an animal remedy in respect of which a veterinary product authorisation has been issued by the Board -
- (i) is not placed on the market in the State within three years from the date of authorisation, or
- (ii) is not marketed in the State for a period of three consecutive years,
the authorisation ceases to be valid on the day following expiry of the three year period.
- (b) This paragraph does not apply if the Board is satisfied that the validity of the authorisation should be continued, in particular, on public or animal health grounds.
Certain obligations of a marketing authorisation holder
12.
12. (1) The holder of an animal remedies authorisation shall, at the request of the Board, supply, within the period specified by the Board, data which the Board considers appropriate in order to demonstrate that the risk-benefit balance of the animal remedy remains favourable.
- (2)
- (a) The holder of an animal remedies authorisation shall take all reasonable steps to ensure that he or she takes account of ongoing scientific progress as regards the manufacturing and control methods specified in Articles 12(3)(d) and (i) of the Directive for the purposes of compliance with Article 27 of the Directive.
- (b) The holder of an animal remedies authorisation shall submit for the approval of the Board changes to the methods referred to in subparagraph (a).
- (3) The holder of an animal remedies authorisation shall immediately provide to the Board new information relating to an animal remedy which would give rise to an amendment to the particulars or documents furnished for the purposes of Regulations 5 and 7 and in particular, -
- (a) new information which would affect the risk-benefit balance of the animal remedy,
- (b) prohibitions or restrictions placed on the marketing of an animal remedy in another State or jurisdiction, and
- (c) serious unexpected adverse reactions arising out of the administration of the animal remedy.
- (4) The holder of an animal remedies authorisation shall submit for the approval of the Board amendments to the particulars or documents referred to in paragraph (3)(a).
- (5) The holder of an animal remedies authorisation shall, on request, make available to the Board or an authorised officer -
- (a) a quantity of a substance as may be necessary to carry out routine checks for the presence of residues of an animal remedy, and
- (b) technical expertise to facilitate implementation of an analytical method for detecting residues of an animal remedy,
in a food producing animal or in the flesh or produce of a food producing animal.
- (6) The holder of an animal remedies authorisation shall maintain for at least five years records of all undesirable effects observed in animals or humans arising out of the administration of the animal remedy, and shall make them available to the Board on request and shall have arrangements in place to comply with the pharmacovigilance requirements specified in Regulation 13.
- (7) The holder of an animal remedies authorisation shall inform the Board of -
- (a) the date an animal remedy is placed on the market in the State, and
- (b) the date an animal remedy is to cease to be placed on the market in the State and the reasons for this action at least two months in advance of the proposed withdrawal date, except where the applicant demonstrates exceptional circumstances, to the satisfaction of the Board.
- (8) The holder of an animal remedies authorisation shall, at the request of the Board furnish details of sale or supply of an animal remedy and data in his or her possession relating to prescriptions of the animal remedy.
- (9) (a)The holder of an animal remedies authorisation, or a person carrying out activities on his or her behalf, shall maintain a system designed to ensure, in accordance with Article 95a of the Directive, that an animal remedy sold or supplied by him or her, in the State which is unused or reaches its expiry date is disposed of lawfully.
- (b) For the purposes of subparagraph (a), the holder of an animal remedies authorisation or a person carrying out activities on his or her behalf shall put in place the necessary arrangements with -
- (i) the holder of an animal remedies wholesaler's licence,
- (ii) a registered veterinary practitioner,
- (iii) a pharmacist,
- (iv) the holder of an animal remedies merchant's licence, or
- (v) a person registered in accordance with Regulation 33,
to whom he or she sells or supplies an animal remedy, with a view to receiving animal remedies referred to in sub-paragraph (a) from those persons having been returned to them.
- (10) Without prejudice to Regulation 8(2), the holder of an animal remedies authorisation shall not sell or supply an animal remedy unless and until the package and label comply with Schedule 2 and the veterinary product authorisation.
- (11) A person shall not remove or alter a label or package leaflet prescribed by these Regulations unless authorised by the Board.
- (12) 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.
- (13)
- (a) In the case of an immunological animal remedy, the holder of an animal remedies authorisation shall, -
- (i) if requested by the Board, submit copies of control reports referred to in Article 81(2) of the Directive, and
- (ii) if the Board considers it necessary for the purposes of Article 82(1 of the Directive, submit samples of batches of bulk product or an immunological animal remedy before the product is placed on the market in the State.
- (b) If subparagraph (a)(ii) applies, the Board shall comply with the second sub-paragraph of Article 82(2), and 82(5) of the Directive.
- (14) This Regulation is in addition to and not in substitution for any other obligation imposed on a holder of an animal remedies authorisation by these Regulations or by an animal remedies authorisation.
Pharmacovigilance
13.
13. (1) The Board shall maintain and implement a pharmacovigilance system in accordance with Title VII of the Directive.
- (2)
- (a) If, as a result of evaluation of a report under this Regulation, the Board considers that an animal remedies authorisation should be: -
- (i) revoked, varied or suspended,
- (ii) restricted as to the indications or availability,
- (iii) varied as to the posology, or
- (iv) varied by the addition of a contra-indication or precautionary measure,
it shall inform the Minister, the Agency, the appropriate authorities in other member states and the holder of the animal remedies authorisation (who shall be afforded an opportunity to make representations within a period as may be fixed by the Board) forthwith.
- (b) An animal remedies authorisation shall not be revoked, varied or suspended until the representations, if any, of the holder of the animal remedies authorisation have been considered.
- (c) Notwithstanding sub-paragraph (b), in case of urgency if public or animal health is threatened, the Board may suspend the distribution, sale and supply of an animal remedy.
- (3)
- (a) The holder of an animal remedies authorisation shall have permanently and continuously at his or her disposal an appropriately qualified person responsible for pharmacovigilance, (“qualified person for pharmacovigilance”).
- (b) A qualified person for pharmacovigilance shall reside in a member state and is responsible for carrying out the functions referred to in Article 74 of the Directive.
- (4) The holder of an animal remedies authorisation shall comply with Article 75 of the Directive and shall furnish the reports required by and in accordance with that Article.
- (5) Notwithstanding paragraph (4), the Board may, at the request of the holder of an animal remedies authorisation, amend the periods referred to in Article 75 of the Directive.
- (6)
- (a) The holder of an animal remedies authorisation shall not release to the general public information to which this Regulation relates without giving prior or simultaneous notification to the Board.
- (b) If information relating to adverse reactions is released to the general public, the holder of the animal remedies authorisation shall present the information in a manner that is objective and not misleading.
- (7)
- (a) The holder of an animal remedies wholesaler's licence, an animal remedies merchant's licence or a person registered under Regulation 33, a registered veterinary practitioner or a pharmacist shall report suspected serious or unexpected adverse reactions and human adverse reactions which are reported to him or her, or, which otherwise come to his or her attention, to the Board or the holder of the animal remedies authorisation.
- (b) In the case of an adverse reaction referred to in subparagraph (a), the report shall be made at the earliest opportunity and not later than 15 days following receipt of the information.
- (c) The Board may prescribe the form in which a report under this paragraph is made.
- (8) A person who sells or supplies an animal remedy shall notify the Board of any action taken by him or her to -
- (a) suspend the sale or supply, or
- (b) recall,
an animal remedy together with the reasons for the action if it concerns the efficacy or safety (including the protection of public health) of the animal remedy.
- (9) In this Regulation: —
“adverse reaction” means a reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or modification of physiological function;
“human adverse reaction” means a reaction which is noxious and unintended and which occurs in a human being following exposure to an animal remedy;
“qualified person for pharmacovigilance” means a person who as a result of professional qualification, and, or, education and training is competent to discharge the responsibilities prescribed by this Regulation;
“serious adverse reaction” means an adverse reaction which is fatal, life threatening, lesion producing, disabling, incapacitating or which results in permanent or prolonged symptoms in the animals treated and includes a human adverse reaction;
“serious unexpected adverse reaction” means an adverse reaction which is both serious and unexpected;
“unexpected adverse reaction” means an adverse reaction, the nature severity or outcome of which is not consistent with the summary of the product characteristics.
Suspension, revocation or variation of a veterinary product authorisation
14.
14. (1) Without prejudice to the generality of these Regulations, the Board shall suspend, revoke or vary a veterinary product authorisation if it is of the opinion that a circumstance referred to in Article 83(1) of the Directive applies or if an undertaking given under Regulation 10(3) has not been honoured or fulfilled.
- (2) Without prejudice to Regulation 10(1), the Board may suspend, revoke or vary a veterinary product authorisation if it is of the opinion that -
- (a) a circumstance referred to in Article 83(2) of the Directive applies,
- (b) the animal remedy is not manufactured in accordance with the principles and guidelines referred to in Article 50(f) of the Directive,
- (c) the animal remedy is not labelled in accordance with the veterinary product authorisation, or
- (d) the animal remedy is not manufactured to the specification of the animal remedies authorisation.
- (3) The Board may modify or annul a suspension, revocation or variation.
- (4) A person shall not sell or supply an animal remedy to which a suspension or revocation under paragraph (1) or (2) relates (including a suspension or revocation subject to representation under paragraph (6)).
- (5) Without prejudice to paragraph (6), if the Board proposes to suspend, revoke or vary a veterinary product authorisation, it shall -
- (a) notify the holder in writing of the proposal and of the reasons therefor, and that he or she may make representation to the Board in relation to the proposal within 7 days of the date of the notification,
- (b) consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and
- (c) notify the holder of the decision and the reasons therefor,
and the suspension, revocation or variation (under this paragraph) shall not have effect until the Board issues a notification of its decision in accordance with subparagraph (c).
- (6) If the Board, for urgent public or animal health reasons, suspends or revokes a veterinary product authorisation it shall -
- (a) notify the holder in writing of the decision and the reasons therefor, and that he or she may (without prejudice to paragraph (4)) make representations to the Board in relation to the decision within 14 days of the date of the notification,
- (b) consider a representation duly made, and
- (c) confirm, modify or annul the decision and notify the holder of the decision and the reasons therefor.
Recall of an animal remedy
15.
15. (1) The Board may, by notice (“recall notice”), order the recall of an animal remedy or a batch of an animal remedy if it is of the opinion that -
- (a) a circumstance referred to in Article 84(1) of the Directive applies,
- (b) the animal remedy consists of or contains a substance the administration of which, to a class of animal for which the animal remedy is intended, is unlawful,
- (c) the animal remedy is not manufactured in accordance with the animal remedies authorisation or in accordance with the principles and guidelines referred to in Article 50(f) of the Directive, or
- (d) the animal remedy is not labelled in accordance with the animal remedies authorisation.
- (2) The Board may modify or annul a recall notice.
- (3) The Board may confine a recall notice to wholesaler or retailer level if it considers such action appropriate for the protection of animal or public health or environmental safety.
- (4) A person shall comply with a recall notice (including a notice subject to representation under paragraph (8)).
- (5) If a recall notice is issued by the Board, the marketing authorisation holder shall consult with and agree to a requirement or amendment notified by the Board regarding the text of a recall notice or to the publication of the notice.
- (6) Records of the recall of an animal remedy shall be available for inspection by an authorised officer of the Board.
- (7) Without prejudice to paragraph (8), if the Board proposes to issue a recall notice, it shall -
- (a) notify the holder in writing of the proposal and of the reasons therefor, and that he or she may make representation to the Board in relation to the proposal within 7 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 holder of the decision and the reasons therefor,
and the notice shall not have effect until the Board issues a notification of its decision in accordance with subparagraph (c).
- (8) If the Board, for urgent public or animal health reasons, issues a recall notice, it shall -
- (a) notify the holder in writing of the decision and the reasons therefor, and that he or she may (without prejudice to paragraph (4)) make representations to the Board in relation to the decision within 14 days of the date of the notification,
- (b) consider a representation duly made, and
- (c) confirm, modify or annul the decision and notify the holder of the decision and the reasons therefor.
PART 111 EXCEPTIONAL AUTHORISATION AND ADMINISTRATION OF AN ANIMAL REMEDY
Certain health situations
16.
16. (1) Notwithstanding Regulation 21, the Minister may, by licence -
- (a) if he or she considers that the health situation so requires, authorise the import, possession, sale or supply and administration of an animal remedy in respect of which there is not otherwise in force an animal remedies authorisation, if he or she is satisfied it is authorised in another Member State,
- (b) in exceptional circumstances, if he or she considers that the health situation so requires, if there is no appropriate animal remedy authorised within the State or in another Member State, authorise the manufacture, import, sale or supply and administration of an animal remedy pending consideration of an application for authorisation by the Board,
- (c) if he or she considers it appropriate to deal with a serious epizootic disease in accordance with Article 8 of the Directive, authorise the import possession, sale or supply and administration of an immunological animal remedy in respect of which there is not otherwise in force an animal remedies authorisation, or
- (d) in exceptional circumstances, if the animal concerned is to be exported to a third country, authorise the import, possession, sale or supply and administration, of an immunological animal remedy, authorised in that country.
- (2) A licence granted under this Regulation shall specify the route of sale of the animal remedy to which it relates in accordance with Schedule 1.
- (3) The Minister may not grant a licence under this Regulation if, following consultation with the Board, he or she is of the opinion that it is more appropriate that an application for a veterinary product authorisation be made to, and determined by, the Board.
- (4) This Regulation is in addition to and not in substitution for the Diseases of Animals Act 1966 (Control on Animal and Poultry Vaccines) Order 2002 ( S.I. No 528 of 2002 ) as amended.
Miscellaneous situations
17.
17. (1) Notwithstanding Regulation 21 and subject to this Regulation, the Minister may grant a licence to a person authorising the possession, manufacture, import, sale or supply of an animal remedy.
- (2) Without prejudice to the generality of paragraph (1), the Minister shall not grant a licence unless the applicant establishes to the satisfaction of the Minister that all of the animal remedy will be —
- (a) administered to animals in the course of a test or trial authorised by a licence granted under Regulation 20,
- (b) supplied to the Board or the Minister for the purpose of an application for an animal remedies authorisation,
- (c) supplied to a University or other institution concerned with higher education or scientific research or analysis for the purposes of such education or research or analysis,
- (d) used for in vitro or other studies or analysis not involving administration to animals, or
- (e) exported from the State.
- (3) The Minister shall not grant a licence if, in his or her opinion —
- (a) the grant of the licence would prejudice public or animal health or trade in animals or animal products from the State, or
- (b) in the case of a licence authorising the manufacture of an animal remedy, the staff, premises, equipment, machinery or plant are not suitable to manufacture the animal remedy.
‘The cascade’
18.
18. (1) (a) Notwithstanding Regulations 4(1) and 40(2) and subject to this Regulation, if there is no authorised animal remedy for the treatment of a condition in a food producing animal and, in particular, to avoid unacceptable suffering to the animal, a registered veterinary practitioner may, under his or her direct responsibility, administer or prescribe (in accordance with Regulations 44 and 45)—
- (i) an animal remedy authorised in the State for another animal species or for another condition in the same species, or
- (ii) if there is no animal remedy to which sub-paragraph (i) refers -
- (I) a medicinal product authorised by the Board pursuant to Title III of Directive 2001/83/EC of the European Parliament and of the Council or authorised pursuant to Regulation (EC) 726/2004, or
- (II) an animal remedy imported in accordance with paragraph (5), authorised in another member state for administration in the same species, or in another species for the condition in question or for another condition,
- (iii) if there is no animal remedy or medicinal product to which either sub-paragraphs (i) or (ii) refers, an animal remedy prepared extemporaneously by —
- (I) a pharmacist in accordance with a veterinary prescription,
- (II) the registered veterinary practitioner, or
- (III) a person licensed to manufacture an animal remedy.
- (b) Subparagraph (a), applies only to the administration or prescription of -
- (i) in the case of a food producing animal, an animal remedy or medicinal product containing a substance listed in Annex I, II or III to Council Regulation (EEC) No 2377/90, and
- (ii) in the case of an equid, in addition, a substance designated in accordance with Article 10(3) of the Directive.
- (c) If a registered veterinary practitioner administers or prescribes an animal remedy in accordance with subparagraph (a), he or she shall specify an appropriate withdrawal period to ensure that food produced from the treated animal does not contain a residue which may be harmful for consumers of produce from a treated animal.
- (d) (i) If an animal remedy or medicinal product administered or prescribed in accordance with subparagraph (a) does not indicate a withdrawal period for the species of animal to be treated, the following withdrawal periods are mandatory unless a longer withdrawal period is specified in accordance with subparagraph (c) —
- (I) in the case of eggs from treated animals, 7 days,
- (II) in the case of milk from treated animals, 7 days,
- (III) in the case of meat, including fat & offal from poultry and mammals, 28 days,
- (IV) in the case of meat from fish, 500 degree days, or
- (V) in the case of meat from an equid, if subparagraph (b)(ii applies, at least 6 months.
- (ii) subparagraphs (c) and (d) (i) do not apply to a homeopathic animal remedy which contains an active substance listed in Annex II to Regulation (EEC) No 2377/90.
- (e) If a registered veterinary practitioner administers or prescribes an animal remedy in accordance with subparagraph (a), he or she shall keep a record detailing:-
- (i) the date of examination of the animal,
- (ii) the identification of the animal,
- (iii) the number of animals treated,
- (iv) the name and address of the owner or person in charge of the animals,
- (v) his or her diagnosis,
- (vi) details of the substance administered or prescribed and reasons for the choice of that substance,
- (vii) the dosage of the substance administered or prescribed,
- (viii) the duration of treatment, and
- (ix) the withdrawal period specified.
- (f) The records specified in subparagraph (e) shall be completed at the time of administration and shall be maintained at the premises of the veterinary practitioner for five years and be furnished on request for examination by an authorised officer.
- (g) This Regulation applies to the treatment of an individual animal or animals on a premises and does not provide for the general manufacture, sale, supply or administration of a substance to which subparagraph (a)(ii) or (iii) applies.
- (2)
- (a) Notwithstanding Regulations 4(1) and 40(2) and subject to this Regulation, if there is no authorised animal remedy for the treatment of a condition in a companion animal and, in particular, to avoid unacceptable suffering to the animal, a registered veterinary practitioner may, under his or her direct responsibility, administer, or prescribe —
- (i) an animal remedy authorised in the State for another animal species or for another condition in the same species, or
- (ii) if there is no animal remedy to which subparagraph (i) refers, -
- (I) a medicinal product authorised by the Board pursuant to Title III of Directive 2001/83/EC of the European Parliament and of the Council or authorised pursuant to Regulation (EC) 726/2004, or
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