DIRECTIVE 2004/28/EC OF THE EUROPEAN...

DIRECTIVE 2004/28/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 31 March 2004

amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THEEUROPEAN UNION,

Having regard to the Treaty establishing the EuropeanCommunity, and in particular Article 95 and Article152(4)(b) thereof,

Having regard to the proposal of the Commission (1),

Having regard to the Opinion of the European Economic andSocial Committee (2),

After consulting the Committee of the Regions,

Acting in accordance with the procedure referred to in Article251 of the Treaty (3),

Whereas:

(1) Directive 2001/82/EC of the European Parliament and ofthe Council of 23 October 2001 on the Communitycode relating to veterinary medicinal products (4)codified and consolidated previous Community legis-lation on veterinary medicinal products in a single textin the interests of clarity and rationalisation.

(2) The Community legislation so far adopted has made amajor contribution to the achievement of the objectiveof free and safe movement of veterinary medicinalproducts and the elimination of obstacles to trade insuch products. However, in the light of the experiencegained, it has become clear that new measures arenecessary to eliminate the remaining obstacles to freemovement.

(3) It is therefore necessary to align national laws, regu-lations and administrative provisions that contain

differences with regard to the basic principles in order topromote the operation of the internal market withoutadversely affecting public health.

(4) The main purpose of any regulation on the manufactureand distribution of veterinary medicinal products shouldbe to safeguard animal health and welfare as well aspublic health. The legislation on marketing authoris-ations for veterinary medicinal products, and thecriteria governing the granting of authorisations, aresuch as to strengthen the protection of public health.That aim should, however, be achieved by means thatdo not hinder the development of the pharmaceuticalindustry or trade in veterinary medicinal products withinthe Community.

(5) Article 71 of Council Regulation (EEC) No 2309/93 of22 July 1993 laying down Community procedures forthe authorisation and supervision of medicinal productsfor human and veterinary use and establishing aEuropean Agency for the Evaluation of MedicinalProducts (5) provided that, within six years of its entryinto force, the Commission was required to publish ageneral report on the experience acquired as a result ofthe operation of the marketing authorisation procedureslaid down in that Regulation and in other Communitylegal provisions.

(6) In the light of the Commission's report on theexperience acquired, it has proved necessary toimprove the operation of the marketing authorisationprocedures for veterinary medicinal products in theCommunity.

(7) Particularly as a result of scientific and technical progressin the field of animal health, the definitions and scope ofDirective 2001/82/EC should be clarified in order toachieve high standards for the quality, safety andefficacy of veterinary medicinal products. In order totake account both of the emergence of new therapiesand of the growing number of so-called ‘borderline’products between the medicinal product sector andother sectors, the definition of ‘medicinal product’should be modified so as to avoid any doubt as to theapplicable legislation when a product, whilst fully fallingwithin the definition of a medicinal product, may alsofall within the definition of other regulated products.Also, in view of the characteristics of pharmaceuticallegislation, provision should be made for such legislationto apply. With the same objective of clarifyingsituations, where a given product comes under the defi-

ENL 136/58 Official Journal of the European Union 30.4.2004

(1) OJ C 75 E, 26.3.2002, p. 234.(2) OJ C 61, 14.3.2003, p. 1.(3) Opinion of the European Parliament of 23 October 2002 (OJ C

300 E, 11.12.2003, p. 390), Council Common Position of29 September 2003 (OJ C 297 E, 9.12.2003, p. 72), Position ofthe European Parliament of 17 December 2003 (not yet publishedin the Official Journal) and Council Decision of 11 March 2004.

(4) OJ L 311, 28.11.2001, p. 1.(5) OJ L 214, 24.8.1993, p. 1. Regulation repealed by Regulation (EC)

No 726/2004 (see p. 1 of this Official Journal).

nition of a veterinary medicinal product, but could alsofall within the definition of other regulated products, itis necessary, in cases of doubt and in order to ensurelegal certainty, to state explicitly which provisions haveto be complied with. Where a product comes clearlyunder the definition of other product categories, inparticular food, feed, feed additives or biocides, thisDirective should not apply. It is also appropriate toimprove the consistency of the terminology of phar-maceutical legislation.

(8) The veterinary medicinal products sector has a numberof very specific features. Veterinary medicinal productsfor food-producing animals may be authorised only onconditions that guarantee that the foodstuffs producedwill be harmless to consumers as regards any residues ofsuch medicinal products.

(9) The costs of research and development to meetincreased requirements as regards the quality, safetyand efficacy of veterinary medicinal products areleading to a gradual reduction in the range ofproducts authorised for the species and indicationsrepresenting smaller market sectors.

(10) The provisions of Directive 2001/82/EC also need,therefore, to be adapted to the specific features of thesector, particularly to meet the health and welfare needsof food-producing animals on terms that guarantee ahigh level of consumer protection, and in a contextthat provides adequate economic interest for theveterinary medicinal products industry.

(11) In certain circumstances, particularly where certain typesof pets are concerned, the need to obtain a marketingauthorisation for a veterinary medicinal product inaccordance with Community provisions is clearly dispro-portionate. Moreover, the absence of authorisation tomarket an immunological product in the Communityshould not be an obstacle to international movementsof certain live animals for the purpose of which bindinghealth measures have to be taken. The provisions on theauthorisation or use of such medicinal products to takeaccount of measures to combat certain infectious animaldiseases at Community level also need to be adapted.

(12) Evaluation of the operation of market authorisationprocedures has revealed the need to revise, in particular,the mutual-recognition procedure in order to improvethe opportunities for cooperation between MemberStates. This cooperation process should be formalisedby setting up a coordination group for this procedureand by defining its operation so as to settle

disagreements within the framework of a revised decen-tralised procedure.

(13) With regard to referrals, the experience acquired revealsthe need for an appropriate procedure, particularly inthe case of referrals relating to an entire therapeuticclass or to all veterinary medicinal products containingthe same active substance.

(14) Marketing authorisation for veterinary medicinalproducts should be limited initially to five years. Afterthis first renewal, the marketing authorisation shouldnormally be valid for an unlimited period. Furthermore,any authorisation not used for three consecutive years,that is to say, one which has not led to the placing onthe market of a veterinary medicinal product in theMember States concerned during that period, shouldbe considered invalid, in order, in particular, to avoidthe administrative burden of maintaining such authoris-ations. However, exemptions from this rule should begranted when these are justified on public or animalhealth grounds.

(15) Biological medicinal products similar to a referencemedicinal product do not usually meet all the conditionsto be considered as a generic medicinal product mainlydue to manufacturing process characteristics, rawmaterials used, molecular characteristics and therapeuticmodes of action. When a biological product does notmeet all the conditions to be considered as a genericmedicinal product, the results of appropriate testsshould be provided in order to fulfil the requirementsrelated to safety (pre-clinical tests) or to efficacy (clinicaltests) or to both.

(16) The criteria of quality, safety and efficacy should enablethe risk-benefit balance of all veterinary medicinalproducts to be assessed both when they are placed onthe market and at any other time the competentauthority deems this appropriate. In this connection, itis necessary to harmonise and adapt the criteria forrefusal, suspension and revocation of marketing author-isations.

(17) In the veterinary sector, if no medicinal product hasbeen authorised for a given species or a givendisorder, the possibility of using other existingproducts should be made a straightforward matter, butwithout prejudicing consumer health in the case ofmedicinal products intended for administration to food-producing animals. In particular, medicinal productsshould be used only under conditions that guaranteethat the foodstuffs produced will be harmless toconsumers as regards any residues of medicinalproducts.

EN30.4.2004 Official Journal of the European Union L 136/59

(18) There is also a need to stimulate the interest of theveterinary pharmaceuticals industry in certain marketsegments in order to encourage the development ofnew veterinary medicinal products. The period ofadministrative data-protection vis-a-vis generics shouldbe harmonised.

(19) There is also a need to clarify the obligations of, anddivision of responsibilities between, the applicant for amarketing authorisation, the holder of a marketing auth-orisation and the competent authorities in charge ofmonitoring the quality of foodstuffs, particularlythrough compliance with the provisions on the use ofveterinary medicinal products. In addition, in order tofacilitate the testing of new medicinal products whileguaranteeing a high level of protection for consumers,sufficiently long withdrawal periods should be laid downfor foodstuffs that animals involved in tests mightproduce.

(20) Without prejudice to the provisions aimed at guaran-teeing consumer protection, the specific characteristicsof homeopathic veterinary medicinal products, andparticularly their use in organic farming, should betaken into account by establishing a simplifiedprocedure for registration on terms defined in advance.

(21) In order to increase the information available to usersand to improve consumer protection in the case of food-producing animals, the provisions on the labelling ofveterinary medicinal products and the accompanyingpackage leaflet should be strengthened. The requirementthat a veterinary medicinal product may only bedispensed after a veterinary prescription has beenmade out should, as a general principle, be extendedto all medicinal products for food-producing animals.However, it should be possible to grant exemptions,where appropriate. The administrative procedures forsupplying medicinal products for pets, on the otherhand, should be simplified.

(22) The quality of veterinary medicinal products manu-factured or available in the Community should beguaranteed by requiring that the active substances usedin their composition comply with the principles of goodmanufacturing practice. It has proved necessary toreinforce the Community provisions on inspectionsand to compile a Community register of the results ofthose inspections. The provisions for the official releaseof batches of immunological medicinal products shouldbe reviewed in order to take account of theimprovement of the general system for monitoring thequality of medicinal products and to reflect technicaland scientific progress, and also in order to makemutual recognition fully effective.

(23) The environmental impact should be studied andconsideration should be given on a case-by-case basisto specific provisions seeking to limit it.

(24) Pharmacovigilance and, more generally, marketsurveillance and sanctions in the event of failure tocomply with the provisions should be stepped up. Inthe field of pharmacovigilance, account should betaken of the facilities offered by new information tech-nologies to improve exchanges between Member States.

(25) The measures necessary for the implementation of thisDirective should be adopted in accordance with CouncilDecision 1999/468/EC of 28 June 1999 laying downthe procedures for the exercise of implementingpowers conferred on the Commission (1).

(26) Directive 2001/82/EC should be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2001/82/EC shall be amended as follows:

1) Article 1 shall be amended as follows:

(a) point 1 shall be deleted;

(b) point 2 shall be replaced by the following:

‘2. Veterinary medicinal product:

(a) any substance or combination of substancespresented as having properties for treating orpreventing disease in animals; or

(b) any substance or combination of substanceswhich may be used in or administered toanimals with a view either to restoring,correcting or modifying physiologicalfunctions by exerting a pharmacological,immunological or metabolic action, or tomaking a medical diagnosis.’;

(c) point 3 shall be deleted;


(1) OJ L 184, 17.7.1999, p. 23.

(d) points 8, 9 and 10 shall be replaced by the following:

‘8. Homeopathic veterinary medicinal product:

Any veterinary medicinal product prepared fromsubstances called homeopathic stocks inaccordance with a homeopathic manufacturingprocedure described by the European Phar-macopoeia or, in the absence thereof, by the phar-macopoeias currently used officially in MemberStates. A homeopathic veterinary medicinalproduct may contain a number of principles.

9. Withdrawal period:

The period necessary between the last adminis-tration of the veterinary medicinal product toanimals, under normal conditions of use and inaccordance with the provisions of this Directive,and the production of foodstuffs from suchanimals, in order to protect public health byensuring that such foodstuffs do not containresidues in quantities in excess of the maximumresidue limits for active substances laid downpursuant to Regulation (EEC) No 2377/90.

10. Adverse reaction:

A reaction to a veterinary medicinal productwhich is harmful and unintended and whichoccurs at doses normally used in animals for theprophylaxis, diagnosis or treatment of disease orto restore, correct or modify a physiologicalfunction.’;

(e) the following point shall be inserted:

‘17a. Representative of the marketing authorisation holder:

The person, commonly known as localrepresentative, designated by the marketingauthorisation holder to represent him in theMember State concerned.’;

(f) point 18 shall be replaced by the following:

‘18. Agency:

The European Medicines Agency established byRegulation (EC) No 726/2004 (*);

___________(*) OJ L 136, 30.4.2004, p. 1.’;

(g) point 19 shall be replaced by the following:

‘19. Risks relating to use of the product:

— any risk relating to the quality, safety andefficacy of the veterinary medicinal productsas regards animal or human health;

— any risk of undesirable effects on theenvironment.’;

(h) the following points shall be added:

‘20. Risk/benefit balance:

An evaluation of the positive therapeutic effectsof the veterinary medicinal product in relation tothe risks as defined above.

21. Veterinary prescription:

Any prescription for a veterinary medicinalproduct issued by a professional personqualified to do so in accordance with applicablenational law.

22. Name of veterinary medicinal product:

The name, which may be either an inventedname not liable to confusion with the commonname, or a common or scientific name accom-panied by a trademark or the name of themarketing authorisation holder.

23. Common name:

The international non-proprietary name recom-mended by the World Health Organisation, or,if one does not exist, the usual common name.

24. Strength:

The content of active substances, expressedquantitatively per dosage unit, per unit ofvolume or weight according to the dosage form.

25. Immediate packaging:

The container or any other form of packagingthat is in direct contact with the medicinalproduct.

26. Outer packaging:

The packaging into which is placed theimmediate packaging.

27. Labelling:

Information on the immediate or outerpackaging.

28. Package leaflet:

The leaflet containing information for the userthat accompanies the medicinal product.’;


2) Articles 2 and 3 shall be replaced by the following:

‘Article 2

1. This Directive shall apply to veterinary medicinalproducts, including pre-mixes for medicated feedingstuffs,intended to be placed on the market in Member States andprepared industrially or by a method involving anindustrial process.

2. In cases of doubt, where, taking into account all itscharacteristics, a product may fall within the definition ofa “veterinary medicinal product” and within the definitionof a product covered by other Community legislation, theprovisions of this Directive shall apply.

3. Notwithstanding paragraph 1, this Directive shallalso apply to active substances used as starting materialsto the extent set out in Articles 50, 50a, 51 and 80 andadditionally to certain substances that may be used asveterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal orpsychotropic properties to the extent set out in Article 68.

Article 3

1. This Directive shall not apply to:

(a) medicated feedingstuffs as defined in Council Directive90/167/EEC of 26 March 1990 laying down theconditions governing the preparation, placing on themarket and use of medicated feedingstuffs in theCommunity (*);

(b) inactivated immunological veterinary medicinalproducts which are manufactured from pathogensand antigens obtained from an animal or animalsfrom a holding and used for the treatment of thatanimal or the animals of that holding in the samelocality;

(c) veterinary medicinal products based on radio-activeisotopes;

(d) any additives covered by Council Directive70/524/EEC of 23 November 1970 concerningadditives in feedingstuffs (**) where they are incor-porated in animal feedingstuffs and supplementaryanimal feedingstuffs in accordance with that Directive;and

(e) without prejudice to Article 95, medicinal products forveterinary use intended for research and developmenttrials.

However, medicated feedingstuffs referred to insubparagraph (a) may be prepared only from pre-mixesthat have been authorised under this Directive.

2. Except for the provisions on the possession,prescription, dispensing and administration of veterinarymedicinal products, this Directive shall not apply to:

(a) any medicinal product prepared in a pharmacy inaccordance with a veterinary prescription for an indi-vidual animal or a small group of animals, commonlyknown as the magistral formula; and

(b) any medicinal product prepared in a pharmacy inaccordance with the prescriptions of a pharmacopoeiaand intended to be supplied directly to the end-user,commonly known as the officinal formula.

___________(*) OJ L 92, 7.4.1990, p. 42.

(**) OJ L 270, 14.12.1970, p. 1. Directive as last amendedby Regulation (EC) No 1756/2002 (OJ L 265,3.10.2002, p. 1).’;

3) Article 4(2) shall be replaced by the following:

‘2. In the case of veterinary medicinal products intendedsolely for aquarium fish, cage birds, homing pigeons,terrarium animals, small rodents, and ferrets and rabbitskept exclusively as pets, Member States may permitexemptions, in their territory, from the provisions inArticles 5 to 8, provided that such products do notcontain substances the use of which requires veterinarycontrol and that all possible measures are taken toprevent unauthorised use of the products for otheranimals.’;

4) Articles 5 and 6 shall be replaced by the following:

‘Article 5

1. No veterinary medicinal product may be placed onthe market of a Member State unless a marketing author-isation has been granted by the competent authorities ofthat Member State in accordance with this Directive or amarketing authorisation has been granted in accordancewith Regulation (EC) No 726/2004.

When a veterinary medicinal product has been granted aninitial authorisation in accordance with the firstsubparagraph, any additional species, strengths, phar-maceutical forms, administration routes, presentations, aswell as any variations and extensions, shall also be grantedan authorisation in accordance with the first subparagraphor be included in the initial marketing authorisation. Allthese marketing authorisations shall be considered asbelonging to the same global marketing authorisation, inparticular for the purpose of the application of Article13(1).

2. The marketing authorisation holder shall beresponsible for the marketing of the medicinal product.The designation of a representative shall not relieve themarketing authorisation holder of his legal responsibility.


Article 6

1. A veterinary medicinal product may not be thesubject of a marketing authorisation for the purpose ofadministering it to one or more food-producing speciesunless the pharmacologically active substances which itcontains appear in Annexes I, II or III to Regulation(EEC) No 2377/90.

2. If an amendment to the Annexes to Regulation (EEC)No 2377/90 so warrants, the marketing authorisationholder or, where appropriate, the competent authoritiesshall take all necessary measures to amend or revoke themarketing authorisation within 60 days of the date onwhich the amendment to the Annexes to that Regulationwas published in the Official Journal of the European Union.

3. By way of derogation from paragraph 1, a veterinarymedicinal product containing pharmacologically activesubstances not included in Annexes I, II or III to Regu-lation (EEC) No 2377/90 may be authorised for particularanimals of the equidae family that have been declared, inaccordance with Commission Decision 93/623/EEC of20 October 1993 establishing the identificationdocument (passport) accompanying registered equidae (*)and Commission Decision 2000/68/EC of 22 December1999 amending Decision 93/623/EEC and establishingthe identification of equidae for breeding andproduction (**), as not being intended for slaughter forhuman consumption. Such veterinary medicinal productsshall neither include active substances that appear inAnnex IV to Regulation (EEC) No 2377/90 nor beintended for use in the treatment of conditions, asdetailed in the authorised Summary of Product Charac-teristics, for which a veterinary medicinal product is auth-orised for animals of the equidae family.

___________(*) OJ L 298, 3.12.1993, p. 45. Decision as amended by

Commission Decision 2000/68/EC (OJ L 23,28.1.2000, p. 72).

(**) OJ L 23, 28.1.2000, p. 72.’;

5) Article 8 shall be replaced by the following:

‘Article 8

In the event of serious epizootic diseases, Member Statesmay provisionally allow the use of immunologicalveterinary medicinal products without a marketing auth-orisation, in the absence of a suitable medicinal productand after informing the Commission of the detailedconditions of use.

The Commission may avail itself of the option set out inthe first paragraph when explicit provision is made forthat option under Community rules concerning certainserious epizootic diseases.

If an animal is being imported from, or exported to, athird country and is thereby subject to specific binding

health rules, a Member State may permit the use, for theanimal in question, of an immunological veterinarymedicinal product that is not covered by a marketingauthorisation in the Member State in question but is auth-orised under the legislation of the third country. MemberStates shall take all appropriate measures concerning thesupervision of the importation and the use of such immu-nological products.’;

6) Articles 10 to 13 shall be replaced by the following:

‘Article 10

1. Member States shall take the necessary measures toensure that, if there is no authorised veterinary medicinalproduct in a Member State for a condition affecting a nonfood-producing species, by way of exception, the veter-inarian responsible may, under his/her direct personalresponsibility and in particular to avoid causing unac-ceptable suffering, treat the animal concerned with:

(a) a veterinary medicinal product authorised in theMember State concerned under this Directive orunder Regulation (EC) No 726/2004 for use withanother animal species, or for another condition inthe same species; or

(b) if there is no product as referred to in point (a), either:

(i) a medicinal product authorised for human use inthe Member State concerned in accordance withDirective 2001/83/EC of the European Parliamentand of the Council or under Regulation (EC)No 726/2004, or

(ii) in accordance with specific national measures, aveterinary medicinal product authorised inanother Member State in accordance with thisDirective for use in the same species or inanother species for the condition in question orfor another condition; or

(c) if there is no product as referred to in subparagraph(b), and within the limits of the law of the MemberState concerned, a veterinary medicinal productprepared extemporaneously by a person authorisedto do so under national legislation in accordancewith the terms of a veterinary prescription.

The veterinarian may administer the medicinal productpersonally or allow another person to do so under theveterinarian's responsibility.

2. By way of derogation from Article 11, the provisionsof paragraph 1 of this Article shall also apply to thetreatment by a veterinarian of an animal belonging tothe equidae family provided that it has been declared, inaccordance with Commission Decisions 93/623/EEC and2000/68/EC, as not being intended for slaughter forhuman consumption.


3. By way of derogation from Article 11, and inaccordance with the procedure referred to in Article89(2), the Commission shall establish a list of substancesessential for the treatment of equidae and for which thewithdrawal period shall be not less than six monthsaccording to the control mechanisms laid down inCommission Decisions 93/623/EEC and 2000/68/EC.

Article 11

1. Member States shall take the necessary measures toensure that, if there is no authorised veterinary medicinalproduct in a Member State for a condition affecting afood-producing species, by way of exception, the veter-inarian responsible may, under his direct personal respon-sibility and in particular to avoid causing unacceptablesuffering, treat the animals concerned on a particularholding with:

(a) a veterinary medicinal product authorised in theMember State concerned under this Directive orunder Regulation (EC) No 726/2004 for use withanother animal species, or for another condition inthe same species; or

(b) if there is no product as referred to in point (a), either:

(i) a medicinal product for human use authorised inthe Member State concerned in accordance withDirective 2001/83/EC or under Regulation (EC)No 726/2004, or

(ii) a veterinary medicinal product authorised inanother Member State in accordance with thisDirective for use in the same species or inanother food-producing species for the conditionin question or for another condition; or

(c) if there is no product as referred to in subparagraph(b), and within the limits of the law of the MemberState concerned, a veterinary medicinal productprepared extemporaneously by a person authorisedto do so under national legislation in accordancewith the terms of a veterinary prescription.

The veterinarian may administer the medicinal productpersonally or allow another person to do so under theveterinarian's responsibility.

2. Paragraph 1 shall apply provided that pharmaco-logically active substances included in the medicinalproduct are listed in Annex I, II or III to Regulation(EEC) No 2377/90, and that the veterinarian specifies anappropriate withdrawal period.

Unless the medicinal product used indicates a withdrawalperiod for the species concerned, the specified withdrawalperiod shall not be less than:

— 7 days for eggs,

— 7 days for milk,

— 28 days for meat from poultry and mammals includingfat and offal,

— 500 degree-days for fish meat.

However, these specific withdrawal periods may bemodified in accordance with the procedure referred to inArticle 89(2).

3. With regard to homeopathic veterinary medicinalproducts in which active principles figure in Annex II toRegulation (EEC) No 2377/90, the withdrawal periodreferred to in the second subparagraph of paragraph 2shall be reduced to zero.

4. When a veterinarian has recourse to the provisionsof paragraphs 1 and 2 of this Article, he shall keepadequate records of the date of examination of theanimals, details of the owner, the number of animalstreated, the diagnosis, the medicinal products prescribed,the doses administered, the duration of treatment and thewithdrawal periods recommended, and shall make theserecords available for inspection by the competent auth-orities for a period of at least five years.

5. Without prejudice to the other provisions of thisDirective, Member States shall take all necessarymeasures concerning the import, distribution, dispensingof and information on the medicinal products which theypermit for administration to food-producing animals inaccordance with paragraph 1(b)(ii).

Article 12

1. For the purposes of obtaining a marketing author-isation in respect of a veterinary medicinal product,otherwise than under the procedure established by Regu-lation (EC) No 726/2004, an application shall be lodgedwith the competent authority of the Member Stateconcerned.

In the case of veterinary medicinal products which areintended for one or more food-producing species butwhose pharmacologically active substances have not yetbeen included, for the species in question, in Annexes I,II or III to Regulation (EEC) No 2377/90, a marketingauthorisation may not be applied for until after a validapplication has been made for the establishment ofmaximum residue limits in accordance with that Regu-lation. At least six months shall elapse between a validapplication for the establishment of maximum residuelimits and an application for a marketing authorisation.


However, in the case of veterinary medicinal productsreferred to in Article 6(3), a marketing authorisationmay be applied for without a valid application inaccordance with Regulation (EEC) No 2377/90. All thescientific documentation necessary for the demonstrationof the quality, safety and efficacy of the veterinarymedicinal product, as provided for in paragraph 3, shallbe submitted.

2. A marketing authorisation may only be granted toan applicant established in the Community.

3. The application for marketing authorisation shallinclude all the administrative information and scientificdocumentation necessary for demonstrating the quality,safety and efficacy of the veterinary medicinal product inquestion. The file shall be submitted in accordance withAnnex I and shall contain, in particular, the followinginformation:

(a) name or business name and permanent address orregistered place of business of the person responsiblefor placing the product on the market and, ifdifferent, of the manufacturer or manufacturersinvolved and of the sites of manufacture;

(b) name of veterinary medicinal product;

(c) qualitative and quantitative particulars of all theconstituents of the veterinary medicinal product,including its international non-proprietary name(INN) recommended by the WHO, where an INNexists, or its chemical name;

(d) description of the method of manufacture;

(e) therapeutic indications, contra-indications and adversereactions;

(f) dosage for the various species of animal for which theveterinary medicinal product is intended, its phar-maceutical form, method and route of administrationand proposed shelf life;

(g) reasons for any precautionary and safety measures tobe taken when storing the veterinary medicinalproduct, administering it to animals and disposingof waste, together with an indication of potentialrisks that the veterinary medicinal product mightpose to the environment, to human and animalhealth and to plants;

(h) indication of the withdrawal period in the case ofmedicinal products intended for food-producingspecies;

(i) description of the testing methods employed by themanufacturer;

(j) results of:

— pharmaceutical (physico-chemical, biological ormicrobiological) tests,

— safety tests and residue tests,

— pre-clinical and clinical trials;

— tests assessing the potential risks posed by themedicinal product for the environment. Thisimpact shall be studied and consideration shallbe given on a case-by-case basis to specificprovisions seeking to limit it.

(k) a detailed description of the pharmacovigilancesystem and, where appropriate, the risk managementsystem that the applicant will put in place;

(l) a summary in accordance with Article 14 of theproduct characteristics, a mock-up of the immediatepackaging and the outer packaging of the veterinarymedicinal product, together with the package leaflet,in accordance with Articles 58 to 61;

(m) a document showing that the manufacturer is auth-orised in his own country to produce veterinarymedicinal products;

(n) copies of any marketing authorisation obtained inanother Member State or in a third country for therelevant veterinary medicinal product, together with alist of those Member States in which an applicationfor authorisation submitted in accordance with thisDirective is under examination. Copies of thesummary of the product characteristics proposed bythe applicant in accordance with Article 14 orapproved by the competent authority of theMember State in accordance with Article 25 andcopies of the package insert proposed, details of anydecision to refuse authorisation, whether in theCommunity or a third country and the reasons forthat decision. All this information shall be updatedon a regular basis;

(o) proof that the applicant has the services of a qualifiedperson responsible for pharmacovigilance and has thenecessary means for the notification of any adversereaction suspected of occurring either in theCommunity or in a third country;

(p) in the case of veterinary medicinal products intendedfor one or more food-producing species andcontaining one or more pharmacologically activesubstances not yet included, for the species inquestion, in Annexes I, II or III to Regulation (EEC)No 2377/90, a document certifying that a validapplication for the establishment of maximumresidue limits has been submitted to the Agency inaccordance with the aforementioned Regulation.

The documents and particulars relating to the results ofthe tests referred to in point (j) of the first subparagraphshall be accompanied by detailed and critical summaries,drawn up as specified in Article 15.


Article 13

1. By way of derogation from point (j) of the firstsubparagraph of Article 12(3), and without prejudice tothe law relating to the protection of industrial andcommercial property, the applicant shall not be requiredto provide the results of the safety and residue tests or ofthe pre-clinical and clinical trials if he can demonstratethat the medicinal product is a generic of a referencemedicinal product which is or has been authorised underArticle 5 for not less than eight years in a Member State orthe Community.

A generic veterinary medicinal product authorisedpursuant to this provision shall not be placed on themarket until ten years have elapsed from the initial auth-orisation of the reference product.

The first subparagraph shall also apply when the referencemedicinal product was not authorised in the Member Statein which the application for the generic medicinal productis submitted. In this case, the applicant shall indicate in theapplication the Member State in which the referencemedicinal product is or has been authorised. At therequest of the competent authority of the Member Statein which the application is submitted, the competentauthority of the other Member State shall transmit,within a period of one month, confirmation that thereference medicinal product is or has been authorisedtogether with the full composition of the referenceproduct and if necessary other relevant documentation.

However, the ten-year period provided for in the secondsubparagraph shall be extended to 13 years in the case ofveterinary medicinal products for fish or bees or otherspecies designated in accordance with the procedurereferred to in Article 89(2).

2. For the purposes of this Article:

(a) “reference medicinal product” shall mean a productauthorised within the meaning of Article 5 inaccordance with the provisions of Article 12;

(b) “generic medicinal product” shall mean a medicinalproduct which has the same qualitative and quanti-tative composition in active substances and the samepharmaceutical form as the reference medicinalproduct, and whose bioequivalence with thereference medicinal product has been demonstratedby appropriate bioavailability studies. The differentsalts, esters, ethers, isomers, mixtures of isomers,complexes or derivatives of an active substance shallbe considered to be the same active substance, unlessthey differ significantly in properties with regard tosafety and/or efficacy. In such cases, additionalinformation intended to provide proof of the safetyand/or efficacy of the various salts, esters or derivativesof an authorised active substance must be supplied bythe applicant. The various immediate-release oral phar-

maceutical forms shall be considered to be one and thesame pharmaceutical form. Bioavailability studies neednot be required of the applicant if he can demonstratethat the generic medicinal product meets the relevantcriteria as defined in the appropriate detailedguidelines.

3. In cases where the veterinary medicinal product doesnot fall under the definition of a generic medicinal productset out in paragraph 2(b) or where bio-equivalence cannotbe demonstrated through bioavailability studies or in thecase of changes to the active substance(s), therapeutic indi-cations, strength, pharmaceutical form or route of admin-istration vis-à-vis the reference medicinal product, theresults of the appropriate safety and residue tests andpre-clinical tests or clinical trials shall be provided.

4. Where a biological veterinary medicinal productwhich is similar to a reference biological veterinarymedicinal product does not meet the conditions in thedefinition of generic medicinal products, owing to, inparticular, differences relating to raw materials or inmanufacturing processes of the biological veterinarymedicinal product and the reference biological veterinarymedicinal product, the results of appropriate pre-clinicaltests or clinical trials relating to these conditions must beprovided. The type and quantity of supplementary data tobe provided must comply with the relevant criteria statedin Annex I and the related detailed guidelines. The resultsof other tests and trials from the reference medicinalproduct's dossier shall not be provided.

5. In the case of veterinary medicinal products intendedfor one or more food-producing species and containing anew active substance that has not been authorised in theCommunity by 30 April 2004 the ten-year periodprovided for in the second subparagraph of paragraph 1shall be extended by one year for each extension of themarketing authorisation to another food-producingspecies, if it is authorised within the five years followingthe granting of the initial marketing authorisation.

This period shall not, however, exceed a total of 13 years,for a marketing authorisation for four or more food-producing species.

The extension of the ten-year period to 11, 12, or 13years for a veterinary medicinal product intended for food-producing species shall be granted only if the marketingauthorisation holder also originally applied for deter-mination of the maximum residue limits established forthe species covered by the authorisation.

6. Conducting the necessary studies, tests and trialswith a view to the application of paragraphs 1 to 5 andthe consequential practical requirements shall not beregarded as contrary to patent-related rights or tosupplementary-protection certificates for medicinalproducts.’;


7) the following Articles shall be inserted:

‘Article 13a

1. By way of derogation from point (j) of the firstsubparagraph of Article 12(3), and without prejudice tothe law on the protection of industrial and commercialproperty, the applicant shall not be required to providethe results of safety and residue tests or of pre-clinical testsor clinical trials if he can demonstrate that the activesubstances of the veterinary medicinal product have beenin well-established veterinary use within the Communityfor at least ten years, with recognised efficacy and anacceptable level of safety in terms of the conditions setout in Annex I. In that event, the applicant shall provideappropriate scientific literature.

2. The assessment report published by the Agencyfollowing the evaluation of an application for the estab-lishment of maximum residue limits in accordance withRegulation (EEC) No 2377/90 may be used in an appro-priate manner as literature, particularly for the safety tests.

3. If an applicant makes use of scientific literature toobtain authorisation for a food-producing species, andsubmits, in respect of the same medicinal product andwith a view to obtaining authorisation for another food-producing species, new residue studies in accordance withRegulation (EEC) No 2377/90, together with furtherclinical trials, it shall not be permissible for a third partyto use such studies or such trials pursuant to Article 13,for a period of three years from the grant of the author-isation for which they were carried out.

Article 13b

In the case of veterinary medicinal products containingactive substances used in the composition of authorisedveterinary medicinal products but not hitherto used incombination for therapeutic purposes, the results ofsafety and residue tests, if necessary, and new pre-clinicaltests or new clinical trials relating to that combinationshall be provided in accordance with point (j) of the firstsubparagraph of Article 12(3), but it shall not be necessaryto provide scientific references relating to each individualactive substance.

Article 13c

After the marketing authorisation has been granted, themarketing authorisation holder may allow use to bemade of the pharmaceutical, safety and residues,pre-clinical and clinical documentation contained in thefile for the veterinary medicinal product with a view toexamining a subsequent application for a veterinarymedicinal product having the same qualitative and quanti-tative composition in active substances and the same phar-maceutical form.

Article 13d

By way of derogation from point (j) of the firstsubparagraph of Article 12(3), and in exceptional circum-stances with respect to immunological veterinarymedicinal products, the applicant shall not be requiredto provide the results of certain field trials on the targetspecies if these trials cannot be carried out for dulysubstantiated reasons, in particular on account of otherCommunity provisions.’;


‘Article 14

The summary of the product characteristics shall contain,in the order indicated below, the following information:

1) name of the veterinary medicinal product followed bythe strength and the pharmaceutical form;

2) qualitative and quantitative composition in terms ofthe active substances and constituents of the excipient,knowledge of which is essential for proper adminis-tration of the medicinal product. The usual commonname or chemical description shall be used;

3) pharmaceutical form;

4) clinical particulars:

4.1. target species,

4.2. indications for use, specifying the target species,

4.3. contra-indications,

4.4. special warnings for each target species,

4.5. special precautions for use, including specialprecautions to be taken by the person adminis-tering the medicinal product to the animals,

4.6. adverse reactions (frequency and seriousness),

4.7. use during pregnancy, lactation or lay,

4.8. interaction with other medicinal products andother forms of interaction,

4.9. amounts to be administered and administrationroute,

4.10. overdose (symptoms, emergency procedures,antidotes), if necessary,

4.11. withdrawal periods for the various foodstuffs,including those for which the withdrawalperiod is zero;


5) pharmacological properties:

5.1. pharmacodynamic properties,

5.2. pharmacokinetic particulars;

6) pharmaceutical particulars:

6.1. list of excipients,

6.2. major incompatibilities,

6.3. shelf life, when necessary after reconstitution ofthe medicinal product or when the immediatepackaging is opened for the first time,

6.4. special precautions for storage,

6.5. nature and composition of immediatepackaging,

6.6. special precautions for the disposal of unusedveterinary medicinal products or wastematerials derived from the use of suchproducts, if appropriate;

7) marketing authorisation holder;

8) marketing authorisation number(s);

9) date of the first authorisation or date of renewal ofthe authorisation;

10) date of revision of the text.

For authorisation under Article 13, those parts of thesummary of product characteristics of the referencemedicinal product referring to indications or dosageforms which were still covered by patent law at the timewhen a generic medicine was marketed need not beincluded.

Article 15

1. Applicants shall ensure that the detailed and criticalsummaries referred to in the second subparagraph ofArticle 12(3) are drafted and signed by persons with therequisite technical or professional qualifications, set out ina brief curriculum vitae, before being submitted to thecompetent authorities.

2. Persons with the technical or professional qualifi-cations referred to in paragraph 1 shall justify any usemade of the scientific literature referred to in Article13a(1) in accordance with the conditions set out inAnnex I.

3. A brief curriculum vitae of the persons referred to inparagraph 1 shall be appended to the detailed criticalsummaries.

Article 16

1. Member States shall ensure that homeopathicveterinary medicinal products manufactured and placedon the market within the Community are registered orauthorised in accordance with Articles 17, 18 and 19,except where such veterinary medicinal products arecovered by a registration or authorisation granted inaccordance with national legislation on or before31 December 1993. In the case of homeopathicmedicinal products registered in accordance with Article17, Article 32 and Article 33(1) to (3) shall apply.

2. Member States shall establish a simplified registrationprocedure for the homeopathic veterinary medicinalproducts referred to in Article 17.

3. By way of derogation from Article 10, homeopathicveterinary medicinal products may be administered tonon-food producing animals under the responsibility of aveterinarian.

4. By way of derogation from Article 11(1) and (2),Member States shall permit the administration of homeo-pathic veterinary medicinal products intended for food-producing species the active constituents of whichappear in Annex II to Regulation (EEC) No 2377/90under the responsibility of a veterinarian. Member Statesshall take appropriate measures to control the use ofveterinary homeopathic medicinal products registered orauthorised in another Member State in accordance withthis Directive for use in the same species.’;


(a) paragraph 1 shall be replaced by the following:

‘1. Without prejudice to the provisions of Regu-lation (EEC) No 2377/90 on the establishment ofmaximum residue limits of pharmacologically activesubstances intended for food-producing animals, onlyhomeopathic veterinary medicinal products whichsatisfy all of the following conditions may be subjectto a special, simplified registration procedure:

(a) they are administered by a route described in theEuropean Pharmacopoeia or, in the absencethereof, by the pharmacopoeias currently usedofficially in Member States;

(b) no specific therapeutic indication appears on thelabelling of the veterinary medicinal product or inany information relating thereto;

(c) there is a sufficient degree of dilution to guaranteethe safety of the medicinal product. In particular,the medicinal product shall not contain more thanone part per 10 000 of the mother tincture.


If it appears justified in the light of new scientificevidence, points (b) and (c) of the first subparagraphmay be adapted in accordance with the procedurereferred to in Article 89(2).

At the time of registration, Member States shalldetermine the classification for the dispensing of themedicinal product.’;

(b) paragraph 3 shall be deleted;


(a) the third indent shall be replaced by the following:

‘— manufacturing and control file for each phar-maceutical form and a description of the methodof dilution and potentisation,’;

(b) the sixth indent shall be replaced by the following:

‘— one or more mock-ups of the outer packaging andimmediate packaging of the medicinal products tobe registered,’;

(c) the following eighth indent shall be added:

‘— proposed withdrawal period together with allrequisite justification.’;


‘Article 19

1. Homeopathic veterinary medicinal products otherthan those referred to in Article 17(1) shall be authorisedin accordance with Articles 12, 13a, 13b, 13c, 13d and14.

2. A Member State may introduce or retain on itsterritory specific rules for the safety tests and pre-clinicaland clinical trials of homeopathic veterinary medicinalproducts intended for pet species and non-food-producingexotic species other than those referred to in Article 17(1),in accordance with the principles and characteristics ofhomeopathy as practised in that Member State. In thiscase, the Member State concerned shall notify theCommission of the specific rules in force.’;

12) Articles 21, 22 and 23 shall be replaced by the following:

‘Article 21

1. Member States shall take all appropriate measures toensure that the procedure for granting a marketing auth-orisation for a veterinary medicinal product is completedwithin a maximum of 210 days after the submission of avalid application.

Applications for marketing authorisations for the sameveterinary medicinal product in two or more MemberStates, shall be submitted in accordance with Articles 31to 43.

2. Where a Member State notes that another marketingauthorisation application for the same medicinal productis being examined in another Member State, the MemberState concerned shall decline to assess the application andshall advise the applicant that Articles 31 to 43 apply.

Article 22

Where a Member State is informed, in accordance withpoint (n) of Article 12(3), that another Member State hasauthorised a veterinary medicinal product which is thesubject of an application for authorisation in theMember State concerned, that Member State shall rejectthe application unless it was submitted in compliancewith Articles 31 to 43.

Article 23

In order to examine the application submitted pursuant toArticles 12 to 13d, Member States' competent authorities:

1) shall check that the documentation submitted insupport of the application complies with Articles 12to 13d and ascertain whether the conditions for theissue of the marketing authorisation have been fulfilled;

2) may submit the medicinal product, its starting materialsand if necessary intermediate products or otherconstituent materials for testing by an OfficialMedicines Control Laboratory or a laboratory that aMember State has designated for that purpose, inorder to ensure that the testing methods employed bythe manufacturer and described in the applicationdocuments, in accordance with point (i) of the firstsubparagraph of Article 12(3), are satisfactory;

3) may similarly check, in particular through consultationof a national or Community reference laboratory, thatthe analytical method used for detecting residuespresented by the applicant for the purposes of Article12(3)(j), second indent is satisfactory;

4) may, where appropriate, require the applicant toprovide further information as regards the items listedin Articles 12, 13a, 13b, 13c and 13d. Where thecompetent authorities take this course of action, thetime-limits specified in Article 21 shall be suspendeduntil the further data required have been provided.Similarly, these time-limits shall be suspended for anyperiod which the applicant may be given to provideoral or written explanations.’;


‘Article 25

1. When granting a marketing authorisation, thecompetent authority shall inform the holder of thesummary of product characteristics that it has approved.


2. The competent authority shall take all necessarymeasures to ensure that information concerning theveterinary medicinal product, and in particular thelabelling and package leaflet, is in conformity with thesummary of product characteristics approved when themarketing authorisation was granted or subsequently.

3. The competent authority shall make the marketingauthorisation publicly available without delay, togetherwith the summary of product characteristics for eachveterinary medicinal product that it has authorised.

4. The competent authority shall draw up anassessment report and comments on the file as regardsthe results of the pharmaceutical, safety and residue testsand the pre-clinical and clinical trials of the veterinarymedicinal product concerned. The assessment reportshall be updated whenever new information becomesavailable which is of importance for the evaluation ofthe quality, safety or efficacy of the veterinary medicinalproduct concerned.

The competent authority shall make the assessment reportand its reasons for the opinion publicly available withoutdelay, after deleting any information of a commerciallyconfidential nature.’;



‘1. The marketing authorisation may require theholder to indicate on the immediate packagingand/or the outer wrapping and the package leaflet,where the latter is required, other particularsessential for safety or health protection, includingany special precautions relating to use and any otherwarnings resulting from the clinical and pharmaco-logical trials prescribed in Article 12(3)(j) and inArticles 13 to 13d or from experience gained duringthe use of the veterinary medicinal product once it hasbeen marketed.’.


(c) paragraph 3 shall be replaced by the following:

‘3. In exceptional circumstances, and followingconsultation with the applicant, the authorisationmay be granted subject to a requirement for theapplicant to introduce specific procedures, in particularconcerning the safety of the veterinary medicinalproduct, notification to the competent authorities ofany incident relating to its use, and action to be taken.Such authorisations may be granted only for objective,verifiable reasons. Continuation of the authorisationshall be linked to the annual reassessment of theseconditions.’;


(a) paragraphs 2 and 3 shall be replaced by the following:

‘2. The competent authority may require theapplicant or the marketing authorisation holder toprovide sufficient quantities of the substances toenable controls to be made on the identification ofthe presence of residues of the veterinary medicinalproducts in question.

At the competent authority's request, the marketingauthorisation holder shall provide his technicalexpertise to facilitate the implementation of theanalytical method for detecting residues of theveterinary medicinal products in the nationalreference laboratory designated under CouncilDirective 96/23/EC of 29 April 1996 on measures tomonitor certain substances and residues thereof in liveanimals and animal products (*).

3. The authorisation holder shall immediatelysupply the competent authority with any newinformation that might entail the amendment of theparticulars or documents referred to in Articles 12(3),13, 13a, 13b and 14 or Annex I.

In particular, he shall immediately inform thecompetent authority of any prohibition or restrictionimposed by the competent authorities of any countryin which the veterinary medicinal product is placed onthe market and of any other new information whichmight influence the assessment of the benefits andrisks of the veterinary medicinal product concerned.

In order to permit continuous assessment of the risk-benefit balance, the competent authority may at anytime ask the marketing authorisation holder to forwarddata demonstrating that the risk-benefit balanceremains favourable.

___________(*) OJ L 125, 23.5.1996, p. 10. Directive as amended

by Regulation (EC) No 806/2003 (OJ L 122,16.5.2003, p. 1).’;



‘5. The marketing authorisation holder shallimmediately inform the competent authorities, with aview to authorisation, of any alteration which heproposes to make to the particulars or documentsreferred to in Articles 12 to 13d.’;


16) the following Article shall be inserted:

‘Article 27a

After a marketing authorisation has been granted, theholder of the authorisation shall inform the competentauthority of the authorising Member State of the date ofthe actual placing on the market of the veterinarymedicinal product in that Member State, taking intoaccount the various presentations authorised.

The holder shall also notify the competent authority if theproduct ceases to be placed on the market of the MemberState, either temporarily or permanently. Such notificationshall, otherwise than in exceptional circumstances, bemade no less than two months before the interruptionin the placing on the market of the product.

Upon request by the competent authority, particularly inthe context of pharmacovigilance, the marketing author-isation holder shall provide the competent authority withall data relating to the volume of sales of the veterinarymedicinal product, and any data in his possession relatingto the volume of prescriptions.’;


‘Article 28

1. Without prejudice to paragraphs 4 and 5, amarketing authorisation shall be valid for five years.

2. The authorisation may be renewed after five years onthe basis of a re-evaluation of the risk-benefit balance.

To this end, the marketing authorisation holder shallsubmit a consolidated list of all documents submitted inrespect of quality, safety and efficacy, including allvariations introduced since the marketing authorisationwas granted, at least six months before the marketingauthorisation ceases to be valid in accordance withparagraph 1. The competent authority may require theapplicant to submit the listed documents at any time.

3. Once renewed, the marketing authorisation shall bevalid for an unlimited period, unless the competentauthority decides, on justified grounds relating to phar-macovigilance, to proceed with one additional five-yearrenewal in accordance with paragraph 2.

4. Any authorisation that is not followed within threeyears of its granting by the actual placing on the market ofthe authorised veterinary medicinal product in the auth-orising Member State shall cease to be valid.

5. When an authorised veterinary medicinal productpreviously placed on the market in the authorisingMember State is no longer actually present on themarket in that Member State for a period of threeconsecutive years, the authorisation granted for thatveterinary medicinal product shall cease to be valid.

6. The competent authority may, in exceptional circum-stances, and on human or animal health grounds, grantexemptions from paragraphs 4 and 5. Such exemptionsshall be duly justified.’;


‘Article 30

The marketing authorisation shall be refused if the filesubmitted to the competent authorities does not complywith Articles 12 to 13d and Article 15.

The authorisation shall also be refused if, after exam-ination of the documents and particulars listed inArticles 12 and 13(1), it is clear that:

(a) the risk-benefit balance of the veterinary medicinalproduct is, under the authorised conditions of use,unfavourable; when the application concerns aveterinary medicinal product for zootechnical use,particular regard shall be had to the benefits foranimal health and welfare and to consumer safety; or

(b) the product has no therapeutic effect or the applicanthas not provided sufficient proof of such effect asregards the species of animal which is to be treated; or

(c) its qualitative or quantitative composition is not asstated; or

(d) the withdrawal period recommended by the applicantis not long enough to ensure that foodstuffs obtainedfrom the treated animal do not contain residues whichmight constitute a health hazard to the consumer, or isinsufficiently substantiated; or

(e) the labelling or the package leaflet proposed by theapplicant does not comply with this Directive; or

(f) the veterinary medicinal product is offered for sale fora use prohibited under other Community provisions.

However, when a Community legislative framework is inthe course of being adopted, the competent authority mayrefuse authorisation for a veterinary medicinal productwhere such action is necessary for the protection ofpublic health, consumer or animal health.


The applicant or marketing authorisation holder shall beresponsible for the accuracy of documents and datasubmitted.’;

19) the title of Chapter 4 shall be replaced by the following:

‘CHAPTER 4

Mutual recognition procedure and decentralisedprocedure’;


‘Article 31

1. A coordination group shall be set up for the exam-ination of any question relating to marketing authorisationof a veterinary medicinal product in two or more MemberStates in accordance with the procedures laid down in thisChapter. The Agency shall provide the secretariat of thiscoordination group.

2. The coordination group shall be composed of onerepresentative per Member State appointed for a renewableperiod of three years. Members of the group may arrangeto be accompanied by experts.

3. The coordination group shall draw up its own rulesof procedure, which shall enter into force after afavourable opinion has been given by the Commission.These rules of procedure shall be made public.

Article 32

1. With a view to the granting of a marketing author-isation for a veterinary medicinal product in more thanone Member State, the applicant shall submit anapplication based on an identical dossier in thoseMember States. The dossier shall contain all the adminis-trative information and scientific and technical documen-tation described in Articles 12 to 14. The documentssubmitted shall include a list of Member Statesconcerned by the application.

The applicant shall request one Member State to act asreference Member State and to prepare an assessmentreport in respect of the veterinary medicinal product inaccordance with paragraphs 2 or 3.

Where appropriate, the assessment report shall contain anevaluation for the purposes of Article 13(5) or Article13a(3).

2. If the veterinary medicinal product has alreadyreceived a marketing authorisation at the time ofapplication, the concerned Member States shall recognisethe marketing authorisation granted by the reference

Member State. To this end, the marketing authorisationholder shall request the reference Member State either toprepare an assessment report in respect of the veterinarymedicinal product or, if necessary, to update any existingassessment report. The reference Member State shallprepare or update the assessment report within 90 daysof receipt of a valid application. The assessment reporttogether with the approved summary of product charac-teristics, labelling and package leaflet shall be forwarded tothe concerned Member States and the applicant.

3. If the veterinary medicinal product has not receivedauthorisation by the time of application, the applicantshall request the reference Member State to prepare adraft assessment report and drafts of the summary ofproduct characteristics, labelling and package leaflet. Thereference Member State shall prepare these drafts within120 days of the receipt of a valid application and shallsend them to the concerned Member States and theapplicant.

4. Within 90 days after receipt of the documentsreferred to in paragraphs 2 and 3, the Member Statesconcerned shall approve the assessment report, thesummary of product characteristics, the labelling and thepackage leaflet and inform the reference Member Stateaccordingly. The reference Member State shall record theagreement of all parties, close the procedure and informthe applicant accordingly.

5. Each Member State in which an applicationfollowing paragraph 1 has been submitted shall adopt adecision in conformity with the approved assessmentreport, summary of product characteristics, labelling andpackage leaflet within 30 days after acknowledgement ofthe agreement.

Article 33

1. If a Member State cannot, within the period allowedin Article 32(4), agree with the assessment report,summary of product characteristics, labelling andpackage leaflet on grounds of a potential serious risk tohuman or animal health or to the environment, a detailedstatement of the reasons shall be provided to the referenceMember State, the other Member States concerned and theapplicant. The points of disagreement shall be referredwithout delay to the coordination group.

If a Member State to which an application has beensubmitted invokes the reasons referred to in Article71(1), it shall no longer be regarded as a Member Stateconcerned by this Chapter.

2. The Commission shall adopt guidelines defining apotential serious risk for human or animal health or forthe environment.


3. Within the coordination group, all Member Statesreferred to in paragraph 1 shall use their best endeavoursto reach agreement on the action to be taken. They shallprovide the applicant with the opportunity to make hispoint of view known orally or in writing. If, within 60days of the communication of the reasons fordisagreement to the coordination group the MemberStates reach an agreement, the reference Member Stateshall record the agreement, close the procedure andinform the applicant accordingly. Article 32(5) shall apply.

4. If within the period of 60 days the Member Statesfail to reach an agreement, the Agency shall beimmediately informed with a view to application of theprocedure laid down in Articles 36, 37 and 38. TheAgency shall be provided with a detailed description ofthe matters on which agreement could not be reachedand the reasons for the disagreement. The applicant shallbe provided with a copy of this information.

5. As soon as the applicant has been informed that thematter has been referred to the Agency, he shall forthwithforward to the Agency a copy of the information anddocuments referred to in the first subparagraph ofArticle 32(1).

6. In the case referred to in paragraph 4, the MemberStates that have approved the assessment report, summaryof product characteristics, labelling and package leaflet ofthe reference Member State may, on request by theapplicant, grant a marketing authorisation for theveterinary medicinal product without waiting for theoutcome of the procedure laid down in Article 36. Inthat case, the authorisation granted shall be withoutprejudice to the outcome of that procedure.

Article 34

1. If two or more applications submitted in accordancewith Articles 12 to 14 have been made for marketingauthorisation for a particular veterinary medicinalproduct and Member States have adopted divergentdecisions concerning the authorisation of that veterinarymedicinal product, or suspension or revocation of author-isation, a Member State, or the Commission, or themarketing-authorisation holder may refer the matter tothe Committee for Medicinal Products for VeterinaryUse, hereinafter referred to as “the Committee”, for theapplication of the procedure laid down in Articles 36,37 and 38.

2. With a view to promoting the harmonisation ofveterinary medicinal products authorised in theCommunity, and to strengthening the efficiency of theprovisions of Articles 10 and 11, Member States shallsend to the coordination group, no later than 30 April2005, a list of veterinary medicinal products for which aharmonised summary of product characteristics should beprepared.

The coordination group shall agree on a list of medicinalproducts, on the basis of proposals sent by Member States,and shall forward the list to the Commission.

The medicinal products on the list shall be subject to theprovisions in paragraph 1 in accordance with a timetableestablished in cooperation with the Agency.

The Commission, acting in collaboration with the Agency,and taking into consideration the views of the interestedparties, shall agree the final list and timetable.

Article 35

1. Member States or the Commission or the applicantor marketing authorisation holder shall, in specific caseswhere the interests of the Community are involved, referthe matter to the Committee for the application of theprocedure laid down in Articles 36, 37 and 38 before adecision is reached on a request for a marketing author-isation or on the suspension or withdrawal of an author-isation, or on any other variations to the terms of amarketing authorisation which appear necessary, so as totake account in particular of the information collected inaccordance with Title VII.

The Member State concerned or the Commission shallclearly identify the question which is referred to theCommittee for consideration and shall inform theapplicant or the marketing authorisation holder.

The Member State and the applicant or the marketingauthorisation holder shall forward to the Committee allavailable information relating to the matter in question.

2. Where the referral to the Committee concerns arange of medicinal products or a therapeutic class, theAgency may limit the procedure to specific parts of theauthorisation.

In that case, Article 39 shall apply to those medicinalproducts only if they are covered by the marketing auth-orisation procedure referred to in this Chapter.

Article 36

1. When reference is made to the procedure laid downin this Article, the Committee shall consider the matterconcerned and shall issue a reasoned opinion within 60days of the date on which the matter was referred to it.

However, in cases submitted to the Committee inaccordance with Articles 34 and 35, this period may beextended by the Committee for a further period of up to90 days, taking into account the views of the marketingauthorisation holders concerned.


In an emergency, and on a proposal from its Chairman,the Committee may agree to a shorter deadline.

2. In order to consider the matter, the Committee shallappoint one of its members to act as rapporteur. TheCommittee may also appoint independent experts toadvise it on specific questions. When appointing suchexperts, the Committee shall define their tasks andspecify the time limit for the completion of these tasks.

3. Before issuing its opinion, the Committee shallprovide the applicant or the marketing authorisationholder with an opportunity to present written or oralexplanations within a time limit that it will specify.

The opinion of the Committee shall include the draftsummary of product characteristics and the drafts of thelabelling and package leaflet.

If it considers appropriate, the Committee may invite anyother person to provide information relating to the matterbefore it.

The Committee may suspend the time limit referred to inparagraph 1 to allow the applicant or the marketing auth-orisation holder to prepare the explanations.

4. The Agency shall forthwith inform the applicant orthe marketing authorisation holder when the opinion ofthe Committee is that:

— the application does not satisfy the criteria for author-isation, or

— the summary of product characteristics proposed bythe applicant or the marketing authorisation holderin accordance with Article 14 should be amended, or

— the authorisation should be granted subject toconditions, with regard to conditions consideredessential for the safe and effective use of the veterinarymedicinal product including pharmacovigilance, or

— a marketing authorisation should be suspended, variedor revoked.

Within 15 days after receipt of the opinion, the applicantor the marketing authorisation holder may notify theAgency in writing of his intention to request a re-exam-ination of the opinion. In that case, he shall forward to theAgency the detailed grounds for the request within 60days after receipt of the opinion.

Within 60 days following receipt of the grounds for therequest, the Committee shall re-examine its opinion inaccordance with the fourth subparagraph of Article62(1) of Regulation (EC) No 726/2004. The reasons forthe conclusion reached shall be annexed to the assessmentreport referred to in paragraph 5 of this Article.

5. Within 15 days after its adoption, the Agency shallforward the final opinion of the Committee to MemberStates, the Commission and the applicant or the marketingauthorisation holder, together with a report describing theassessment of the veterinary medicinal product and thereasons for its conclusions.

In the event of an opinion in favour of granting or main-taining a marketing authorisation, the followingdocuments shall be annexed to the opinion:

(a) a draft summary of the product characteristics, asreferred to in Article 14; where necessary this willreflect the differences in the veterinary conditions inMember States;

(b) any conditions affecting the authorisation within themeaning of paragraph 4;

(c) details of any recommended conditions or restrictionswith regard to the safe and effective use of theveterinary medicinal product; and

(d) drafts of the labelling and package leaflet.

Article 37

Within 15 days after receipt of the opinion, theCommission shall prepare a draft of the decision to betaken in respect of the application, taking into accountCommunity law.

In the event of a draft decision that envisages the grantingof a marketing authorisation, the documents referred to inthe second subparagraph of Article 36(5) shall be annexed.

If, exceptionally, the draft decision is not in accordancewith the opinion of the Agency, the Commission shall alsoannex a detailed explanation of the reasons for thedifferences.

The draft decision shall be forwarded to Member Statesand the applicant or marketing authorisation holder.’;




‘1. The Commission shall take a final decision inaccordance with, and within 15 days after the endof, the procedure referred to in Article 89(3).’;

(b) In paragraph 2, the second and third indents shall bereplaced by the following:

‘— Member States shall have 22 days to forward theirwritten observations on the draft decision to theCommission. However, if a decision has to betaken urgently, a shorter time-limit may be setby the Chairman according to the degree ofurgency involved. This time-limit shall not,otherwise than in exceptional circumstances, beshorter than 5 days,

— Member States shall have the option of submittinga written request that the draft decision bediscussed in a plenary meeting of the StandingCommittee.’;


‘3. A decision as referred to in paragraph 1 shall beaddressed to all Member States and communicated tothe marketing authorisation holder or the applicant forinformation. The concerned Member States and thereference Member State shall either grant orwithdraw marketing authorisation, or vary the termsof a marketing authorisation as necessary to complywith the decision within 30 days of its notification andshall refer to it. They shall inform the Commission andthe Agency accordingly.’;

22) in Article 39, the third subparagraph of paragraph 1 shallbe deleted;

23) in Article 42, paragraph 2 shall be replaced by thefollowing:

‘2. At least every ten years the Commission shallpublish a report on experience gained on the basis ofthe procedures provided for in this chapter and shallpropose any amendments necessary to improve theprocedures. The Commission shall submit this report tothe European Parliament and the Council.’;


‘Article 43

Articles 33(4), (5) and (6) and 34 to 38 shall not apply tothe homeopathic veterinary medicinal products referred toin Article 17.

Articles 32 to 38 shall not apply to the homeopathicveterinary medicinal products referred to in Article 19(2).’;

25) in Article 44, the following paragraph shall be added:

‘4. The Member State shall forward to the Agency acopy of the manufacturing authorisations referred to inparagraph 1. The Agency shall enter that information inthe Community database referred to in Article 80(6).’;

26) in Article 50, point (f) shall be replaced by the following:

‘(f) comply with the principles and the guidelines on goodmanufacturing practice for medicinal products and useas starting materials only active substances which havebeen manufactured in accordance with the detailedguidelines on good manufacturing practice forstarting materials.’;

27) the following Article shall be inserted:

‘Article 50a

1. For the purposes of this Directive, manufacturingactive substances for use as starting materials shallinclude the complete or partial manufacture or theimport of an active substance used as a starting material,as defined in Part 2, Section C of Annex I, and the variousprocesses of dividing up, packaging or presentation priorto its incorporation in a veterinary medicinal product,including repackaging or re-labelling, such as carried outby a starting material distributor.

2. Any amendments which may be necessary to adaptthe provisions of this Article to scientific and technicalprogress shall be adopted in accordance with theprocedure referred to in Article 89(2).’;

28) in Article 51, the following paragraphs shall be added:

‘The principles of good manufacturing practice as regardsthe manufacturing of active substances for use as startingmaterials as referred to in Article 50(f) shall be adopted inthe form of detailed guidelines.

The Commission shall also publish guidelines on the formand content of the authorisation referred to in Article44(1), the reports referred to in Article 80(3) and theform and content of the certificate of good manufacturingpractice referred to in Article 80(5).’;


‘1. Member States shall ensure that the qualified personreferred to in Article 52(1) fulfils the conditions of qualifi-cation referred to in paragraphs 2 and 3.’;


‘1. A person engaging, in a Member State, in theactivities of the person referred to in Article 52(1) onthe date on which Directive 81/851/EEC becameapplicable, without complying with the provisions ofArticle 53, shall be eligible to continue to engage inthose activities within the Community.’;


31) in Article 55, paragraph 1(b) shall be replaced by thefollowing:

‘(b) in the case of veterinary medicinal products comingfrom third countries, even if manufactured in theCommunity, each production batch imported hasundergone in a Member State a full qualitativeanalysis, a quantitative analysis of at least all theactive substances, and all the other tests or controlsnecessary to ensure the quality of veterinary medicinalproducts in accordance with the requirements of themarketing authorisation.’;


(a) paragraph 1 shall be amended as follows:

(i) The introductory wording shall be replaced by thefollowing:

‘Except in the case of the medicinal productsreferred to in Article 17(1), the competentauthority shall approve the immediate packagingand outer packaging of veterinary medicinalproducts. Packaging shall bear the followinginformation, which shall conform with theparticulars and documents provided pursuant toArticles 12 to 13d and the summary of productcharacteristics, and shall appear in legiblecharacters:’;

(ii) Points (a) and (b) shall be replaced by thefollowing:

‘(a) the name of the medicinal product, followedby its strength and pharmaceutical form. Thecommon name shall appear if the medicinalproduct contains only one active substanceand its name is an invented name;

(b) a statement of the active substances expressedqualitatively and quantitatively per unit oraccording to the form of administration fora particular volume or weight, using thecommon names;’;

(iii) Point (e) shall be replaced by the following:

‘(e) name or corporate name and permanentaddress or registered place of business ofthe marketing authorisation holder and,where appropriate, of the representativedesignated by the marketing authorisationholder;’;

(iv) Point (f) shall be replaced by the following:

‘(f) the species of animal for which the veterinarymedicinal product is intended; the methodand, if necessary, the route of administration.Space shall be provided for the prescribeddose to be indicated;’;

(v) Point (g) shall be replaced by the following:

‘(g) the withdrawal period for veterinarymedicinal products to be administered tofood-producing species, for all the speciesconcerned and for the various foodstuffsconcerned (meat and offal, eggs, milk,honey), including those for which the with-drawal period is zero;’;

(vi) Point (j) shall be replaced by the following:

‘(j) specific precautions relating to the disposal ofunused medicinal products or waste derivedfrom veterinary medicinal products, whereappropriate, as well as a reference to anyappropriate collection system in place;’;

(vii) Point (l) shall be replaced by the following:

‘(l) the words “For animal treatment only” or, inthe case of the medicinal products referred toin Article 67, the words “For animaltreatment only — to be supplied only onveterinary prescription”.’;

(b) the following paragraph shall be added:

‘5. In the case of medicinal products that have beengranted a marketing authorisation under Regulation(EC) No 726/2004, Member States may permit orrequire that the outer packaging bear additionalinformation concerning distribution, possession, saleor any necessary precautions, provided that suchinformation is not in infringement of Communitylaw or the terms of the marketing authorisation, andis not promotional.

This additional information shall appear in a box witha blue border to separate it clearly from theinformation referred to in paragraph 1.’;


(a) the introductory wording of paragraph 1 shall bereplaced by the following:

‘1. As regards ampoules, the particulars listed in thefirst paragraph of Article 58(1) shall be given on theouter package. On the immediate packaging, however,only the following particulars shall be necessary:’;

(b) paragraphs 2 and 3 shall be replaced by the following:

‘2. As regards small immediate packagingcontaining a single dose, other than ampoules, onwhich it is impossible to give the particularsmentioned in paragraph 1, the requirements ofArticle 58(1), (2) and (3) shall apply only to theouter package.

3. The particulars mentioned in the third and sixthindents of paragraph 1 shall appear on the outerpackage and on the immediate packaging of themedicinal products in the language or languages ofthe country in which they are placed on the market.’;



‘Article 60

Where there is no outer package, all the particulars whichshould feature on such a package pursuant to Articles 58and 59 shall be shown on the immediate packaging.’;



‘1. The inclusion of a package leaflet in thepackaging of veterinary medicinal products shall beobligatory unless all the information required by thisArticle can be conveyed on the immediate packagingand the outer packaging. Member States shall take allappropriate measures to ensure that the package leafletrelates solely to the veterinary medicinal product withwhich it is included. The package leaflet shall bewritten in terms that are comprehensible to thegeneral public and in the official language orlanguages of the Member State in which themedicinal product is marketed.

The first subparagraph shall not prevent the packageleaflet from being written in several languages,provided that the information given is identical in allthe languages.

Competent authorities may exempt labels and packageleaflets for specific veterinary medicinal products fromthe obligation for certain particulars to appear and forthe leaflet to be in the official language or languages ofthe Member State in which the product is placed onthe market, when the product is intended to be admin-istered only by a veterinarian.’;

(b) paragraph 2 shall be amended as follows:


‘2. The competent authorities shall approvepackage leaflets. Leaflets shall contain at least thefollowing information, in the order indicated,which shall conform to the particulars anddocuments provided pursuant to Articles 12 to13d and the approved summary of product charac-teristics:’;

(ii) Points (a) and (b) shall be replaced by thefollowing:

‘(a) name or corporate name and permanentaddress or registered place of business of themarketing authorisation holder and of themanufacturer and, where appropriate, of therepresentative of the marketing authorisationholder;

(b) name of the veterinary medicinal productfollowed by its strength and pharmaceutical

form. The common name shall appear if theproduct contains only one active substance andits name is an invented name. Where themedicinal product is authorised according tothe procedure provided for in Articles 31 to43 under different names in the Member Statesconcerned, a list of the names authorised ineach Member State;’;

(c) paragraph 3 shall be deleted;


‘Article 62

Where the provisions of this Title are not observed and aformal notice addressed to the person concerned has beenineffectual, Member States' competent authorities maysuspend or revoke the marketing authorisation.’;

37) Article 64(2) shall be amended as follows:

(a) the introductory wording shall be replaced by thefollowing:

‘2. In addition to the clear mention of the words“homeopathic veterinary medicinal product withoutapproved therapeutic indications”, the labelling and,where appropriate, package leaflet for the homeo-pathic veterinary medicinal products referred to inArticle 17(1) shall bear the following informationand no other information:’;

(b) the first indent shall be replaced by the following:

‘— the scientific name of the stock or stocks followedby the degree of dilution, using the symbols of thepharmacopoeia used in accordance with point (8)of Article 1. If the homeopathic veterinarymedicinal product is composed of more thanone stock, the labelling may mention aninvented name in addition to the scientificnames of the stocks,’;

38) the title of Title VI shall be replaced by the following:

‘TITLE VI

POSSESSION, DISTRIBUTION AND DISPENSING OFVETERINARY MEDICINAL PRODUCTS’;


(a) the following paragraph shall be inserted:

‘3a. The holder of a distribution authorisation shallhave an emergency plan guaranteeing the effectiveimplementation of any recall operation ordered bythe competent authorities or undertaken in coop-eration with the manufacturer of the medicinalproduct in question or the holder of the marketingauthorisation.’;


(b) the following paragraph shall be inserted:

‘5. Any distributor, not being the marketing auth-orisation holder, who imports a product from anotherMember State shall notify the marketing authorisationholder and the competent authority in the MemberState to which the product will be imported of hisintention to import it. In the case of products whichhave not been granted an authorisation pursuant toRegulation (EC) No 726/2004, the notification to thecompetent authority shall be without prejudice toadditional procedures provided for in the legislationof that Member State.’;




‘Any person permitted under paragraph 1 tosupply veterinary medicinal products shall berequired to keep detailed records for veterinarymedicinal products that may be supplied only onprescription, the following information beingrecorded in respect of each incoming or outgoingtransaction:’;

(ii) The third subparagraph shall be replaced by thefollowing:

‘These records shall be available for inspection bythe competent authorities for a period of fiveyears.’;

(b) paragraph 3 shall be replaced by the following:

‘3. Member States may permit the supply on theirterritory of veterinary medicinal products for food-producing animals for which a veterinary prescriptionis required by or under the supervision of a personregistered for this purpose who provides guaranteeswith respect to qualifications, record-keeping andreporting in accordance with national law. MemberStates shall notify the Commission of relevantprovisions of national law. This provision shall notapply to the supply of veterinary medicinal productsfor the oral or parenteral treatment of bacterialinfections.’;

(c) paragraph 4 shall be deleted;


(a) the first paragraph shall be amended as follows:


‘Without prejudice to stricter Community ornational rules relating to dispensing veterinarymedicinal products and serving to protect humanand animal health, a veterinary prescription shallbe required for dispensing to the public thefollowing veterinary medicinal products:’;

(ii) The following point shall be inserted:

‘(aa) veterinary medicinal products for food-producing animals.

However, Member States may grantexemptions from this requirementaccording to criteria established inaccordance with the procedure referred toin Article 89(2).

Member States may continue to applynational provisions until either:

(i) the date of application of the decisionadopted in accordance with the firstsubparagraph; or

(ii) 1 January 2007, if no such decision hasbeen adopted by 31 December 2006;’;

(iii) The third indent of point (b) shall be deleted;

(iv) Point (d) shall be replaced by the following:

‘(d) official formula, within the meaning of Article3(2)(b), intended for food-producing animals.’;

(b) the second paragraph shall be replaced by thefollowing:

‘Member States shall take all necessary measures toensure that, in the case of medicinal productssupplied only on prescription, the quantity prescribedand supplied shall be restricted to the minimumamount required for the treatment or therapyconcerned.

In addition, a prescription shall be required for newveterinary medicinal products containing an activesubstance that has been authorised for use in aveterinary medicinal product for fewer than five years.’;

42) the first paragraph of Article 69 shall be replaced by thefollowing:

‘Member States shall ensure that the owners or keepers offood-producing animals can provide proof of purchase,possession and administration of veterinary medicinalproducts to such animals for five years after their adminis-tration, including when the animal is slaughtered duringthe five-year period.’;


43) the introductory wording of Article 70 shall be replacedby the following:

‘By way of derogation from Article 9 and withoutprejudice to Article 67, Member States shall ensure thatveterinarians providing services in another Member Statecan take with them and administer to animals smallquantities of veterinary medicinal products not exceedingdaily requirements other than immunological veterinarymedicinal products which are not authorised for use inthe Member State in which the services are provided (here-inafter: “host Member State”), provided that the followingconditions are satisfied:’;

44) the following subparagraph shall be added to Article 71(1):

‘The Member State may also invoke the provisions of thefirst subparagraph in order to withhold marketing author-isation in accordance with a decentralised procedure asprovided for in Articles 31 to 43.’;


‘2. Member States may impose specific requirements onveterinary practitioners and other health-care professionalsin respect of the reporting of suspected serious or unex-pected adverse reactions and human adverse reactions.’;


(a) the first paragraph shall be replaced by the following:

‘In order to ensure the adoption of appropriate andharmonised regulatory decisions concerning theveterinary medicinal products authorised within theCommunity, having regard to information obtainedabout suspected adverse reactions to veterinarymedicinal products under normal conditions of use,Member States shall administer a veterinary phar-macovigilance system. This system shall be used tocollect information useful in the surveillance ofveterinary medicinal products, with particularreference to adverse reactions in animals and inhuman beings relating to the use of veterinarymedicinal products, and to evaluate such informationscientifically.’;

(b) after the second paragraph, the following paragraphshall be inserted:

‘Member States shall ensure that suitable informationcollected within this system is communicated to otherMember States and the Agency. This information shallbe recorded in the database referred to in point (k) ofthe second subparagraph of Article 57(1) of Regulation(EC) No 726/2004 and shall be permanently accessibleto all Member States and without delay to the public.’;

47) The following article shall be inserted:

‘Article 73a

The management of funds intended for activitiesconnected with pharmacovigilance, the operation ofcommunication networks and market surveillance shallbe under the permanent control of the competent auth-orities in order to guarantee their independence.’

48) The introductory wording of the second paragraph ofArticle 74 shall be replaced by the following:

‘That qualified person shall reside in the Community andshall be responsible for the following:’;


‘Article 75

1. The marketing authorisation holder shall maintaindetailed records of all suspected adverse reactionsoccurring within the Community or in a third country.

Save in exceptional circumstances, these reactions shall becommunicated electronically in the form of a report inaccordance with the guidelines referred to in Article 77(1).

2. The marketing authorisation holder shall record allsuspected serious adverse reactions and human adversereactions relating to the use of veterinary medicinalproducts that are brought to his attention, and reportthem promptly to the competent authority of theMember State on whose territory the incident occurred,and no later than 15 days following receipt of theinformation.

The marketing authorisation holder shall also record allsuspected serious adverse reactions and human adversereactions related to the use of veterinary medicinalproducts of which he can reasonably be expected tohave knowledge, and report them promptly to thecompetent authority of Member State on whose territorythe incident occurred, and no later than 15 days followingreceipt of the information.

3. The marketing authorisation holder shall ensure thatall suspected serious unexpected adverse reactions, humanadverse reactions and any suspected transmission via aveterinary medicinal product of any infectious agentoccurring on the territory of a third country arereported promptly in accordance with the guidelinesreferred to in Article 77(1), so that they are available tothe Agency and the competent authorities of the MemberStates in which the veterinary medicinal product is auth-orised, and no later than 15 days following the receipt ofthe information.


4. By way of derogation from paragraphs 2 and 3, inthe case of veterinary medicinal products which arecovered by Directive 87/22/EEC, have benefited from theauthorisation procedures under Articles 31 and 32 of thisDirective or have been the subject of the proceduresprovided for in Articles 36, 37 and 38 of this Directive,the marketing authorisation holder shall additionallyensure that all suspected serious adverse reactions andhuman adverse reactions occurring in the Communityare reported in such a way so as to be accessible to thereference Member State or a competent authoritydesignated as reference Member State. The referenceMember State shall assume responsibility for the analysisand follow-up of any such adverse reactions.

5. Unless other requirements have been laid down as acondition for the granting of the marketing authorisationor subsequently as indicated in the guidelines referred to inArticle 77(1), reports of all adverse reactions shall besubmitted to the competent authorities in the form of aperiodic safety update report, immediately upon request orat least every six months after authorisation until theplacing on the market. Periodic safety update reportsshall also be submitted immediately upon request or atleast every six months during the first two yearsfollowing the initial placing on the market and once ayear for the following two years. Thereafter, the reportsshall be submitted at three-yearly intervals, or immediatelyupon request.

The periodic safety update reports shall include a scientificevaluation of the risk-benefit balance of the veterinarymedicinal product.

6. Amendments to paragraph 5 may be adopted inaccordance with the procedure referred to in Article89(2) in the light of the experience gained from itsoperation.

7. Following the granting of a marketing authorisation,the holder of such authorisation may request theamendment of the periods referred to in paragraph 5 ofthis Article in accordance with the procedure laid down byCommission Regulation (EC) No 1084/2003 (*).

8. The holder of a marketing authorisation may notcommunicate information relating to pharmacovigilanceconcerns to the general public in relation to its authorisedveterinary medicinal product without giving prior orsimultaneous notification to the competent authority.

In any case, the marketing authorisation holder shallensure that such information is presented objectively andis not misleading.

Member States shall take the necessary measures to ensurethat a marketing authorisation holder who fails todischarge these obligations is subject to effective,proportionate and dissuasive penalties.

___________(*) OJ L 159, 27.6.2003, p. 1.’;

50) Article 76(1) shall be replaced by the following:

‘1. The Agency, in collaboration with Member Statesand the Commission, shall set up a data-processingnetwork to facilitate the exchange of pharmacovigilanceinformation regarding veterinary medicinal productsmarketed in the Community in order to allow thecompetent authorities to share the information at thesame time.’;

51) in Article 77(1), the second subparagraph shall be replacedby the following:

‘In accordance with those guidelines, the marketing auth-orisation holder shall use internationally agreed veterinarymedical terminology for the transmission of reports onadverse reactions.

The Commission shall publish the guidelines, which shalltake account of international harmonisation work achievedin the field of pharmacovigilance.’;



‘2. If urgent action is necessary for protectinghuman or animal health, the Member Stateconcerned may suspend the marketing authorisationof a veterinary medicinal product, provided that theAgency, the Commission and the other Member Statesare informed on the following working day at thelatest.’;

(b) the following paragraph shall be added:

‘3. When the Agency is informed in accordancewith paragraphs 1 or 2, it shall give its opinion assoon as possible, according to the urgency of thematter.

On the basis of this opinion, the Commission mayrequest all Member States in which the veterinarymedicinal is marketed to take temporary measuresimmediately.

Final measures shall be adopted in accordance with theprocedure referred to in Article 89(3).’;




‘1. The competent authority of the Member Stateconcerned shall ensure, by means of repeatedinspections and, if necessary, unannouncedinspections, and where appropriate, by asking anOfficial Medicines Control Laboratory or a laboratorydesignated for that purpose to conduct tests onsamples, that the legal requirements relating toveterinary medicinal products are complied with.

The competent authority may also carry out unan-nounced inspections at the premises of manufacturersof active substances used as starting materials forveterinary medicinal products, and of the premises ofthe marketing authorisation holder whenever itconsiders that there are grounds for suspectingnon-compliance with the provisions of Article 51.Such inspections may also be carried out at therequest of another Member State, the Commission orthe Agency.

In order to verify whether the data submitted in orderto obtain a conformity certificate comply with themonographs of the European Pharmacopoeia, the stan-dardisation body for nomenclatures and quality normswithin the meaning of the Convention relating to theelaboration of a European Pharmacopoeia (*)(European Directorate for the Quality of Medicines)may ask the Commission or the Agency to requestsuch an inspection when the starting materialconcerned is the subject of a European Pharmacopoeiamonograph.

The competent authority of the Member Stateconcerned may carry out inspections of startingmaterial manufacturers at the manufacturer's ownrequest.

Such inspections shall be carried out by authorisedrepresentatives of the competent authority who shallbe empowered to:

(a) inspect manufacturing or trading establishmentsand any laboratories entrusted by the holder ofthe manufacturing authorisation with the task ofcarrying out control tests pursuant to Article 24;

(b) take samples including with a view to an inde-pendent analysis by an Official Medicines ControlLaboratory or by a laboratory designated for thatpurpose by a Member State;

(c) examine any documents relating to the object ofthe inspection, subject to the provisions in force inthe Member States on 9 October 1981 placingrestrictions on these powers with regard to thedescription of the manufacturing method;

(d) inspect the premises, records and documents ofmarketing authorisation holders or any firms

performing the activities described in Title VII,and in particular Articles 74 and 75 thereof, onbehalf of a marketing authorisation holder.

___________(*) OJ L 158, 25.6.1994, p. 19.’;

(b) paragraph 3 shall be replaced by the following:

‘3. The authorised representatives of the competentauthority shall report after each of the inspectionsmentioned in paragraph 1 on whether the principlesand guidelines on good manufacturing practicereferred to in Article 51 or, where appropriate, therequirements set out in Title VII, are being compliedwith. The inspected manufacturer or market author-isation holder shall be informed of the content ofsuch reports.’;

(c) the following paragraphs shall be added:

‘4. Without prejudice to any arrangements whichmay have been concluded between the Communityand a third country, a Member State, the Commissionor the Agency may require a manufacturer establishedin a third country to undergo an inspection as referredto in paragraph 1.

5. Within 90 days after an inspection as referred toin paragraph 1, a certificate of good manufacturingpractice shall be issued to the manufacturer if theinspection established that the manufacturer inquestion is complying with the principles andguidelines on good manufacturing practice asprovided for by Community law.

In the event of an inspection carried out at the requestof the European Pharmacopoeia, a certificate ofcompliance with the monograph shall be issued, ifappropriate.

6. Member States shall enter the certificates of goodmanufacturing practice which they issue in aCommunity database managed by the Agency onbehalf of the Community.

7. If the outcome of the inspection as referred to inparagraph 1 is that the manufacturer does not complywith the principles and guidelines of good manufac-turing practice as provided for by Community legis-lation, the information shall be entered in theCommunity database as referred to in paragraph 6.’;


‘Article 82

1. Where it considers it necessary for reasons of humanor animal health, a Member State may require themarketing authorisation holder for an immunologicalveterinary medicinal product to submit samples ofbatches of the bulk product and/or veterinary medicinalproduct for control by an Official Medicines ControlLaboratory before the product is put into circulation.


2. On request by the competent authorities, themarketing authorisation holder shall promptly supply thesamples referred to in paragraph 1, together with thereports of the control referred to in Article 81(2).

The competent authority shall inform all the otherMember States in which the veterinary medicinalproduct is authorised as well as the European Directoratefor the Quality of Medicines of its intention to controlbatches or the batch in question.

In such cases, the competent authorities of anotherMember State shall not apply the provisions ofparagraph 1.

3. After studying the control reports referred to inArticle 81(2), the laboratory responsible for the controlshall repeat, on the samples provided, all the testscarried out by the manufacturer on the finished product,in accordance with the relevant provisions shown in thedossier for marketing authorisation.

The list of tests to be repeated by the laboratoryresponsible for the control shall be restricted to justifiedtests, provided that all Member States concerned, and ifappropriate the European Directorate for the Quality ofMedicines, agree to this.

For immunological veterinary medicinal products auth-orised under Regulation (EC) No 726/2004, the list oftests to be repeated by the control laboratory may bereduced only after agreement by the Agency.

4. All Member States concerned shall recognise theresults of the tests.

5. Unless the Commission is informed that a longerperiod is necessary to conduct the tests, Member Statesshall ensure that this control is completed within 60days of receipt of the samples.

The competent authority shall notify the other MemberStates concerned, the European Directorate for theQuality of Medicines, the marketing authorisation holderand, if appropriate, the manufacturer, of the results of thetests within the same period of time.

If a competent authority concludes that a batch of aveterinary medicinal product is not in conformity withthe control report of the manufacturer or the specifi-cations provided for in the marketing authorisation, itshall take all the necessary measures vis-a-vis themarketing authorisation holder and the manufacturer,where appropriate, and shall inform accordingly theother Member States in which the veterinary medicinalproduct is authorised.’;



(i) The introductory words shall be replaced by thefollowing:

‘Member States' competent authorities shallsuspend, revoke, withdraw or vary marketingauthorisations when it is clear that:’;

(ii) Point (a) shall be replaced by the following:

‘(a) the risk-benefit assessment of the veterinarymedicinal product is, under the authorisedconditions of use, unfavourable, particularregard being had to the benefits for animalhealth and welfare and to consumer safety,when the authorisation concerns a veterinarymedicinal product for zootechnical use;’;

(iii) The second subparagraph of point (e) shall bedeleted;

(iv) Point (f) shall be replaced by the following:

‘(f) information given in the applicationdocuments pursuant to Articles 12 to 13dand 27 is incorrect;’;

(v) Point (h) shall be deleted;

(vi) The following second subparagraph shall beadded:

‘However, when a Community legislativeframework is in the course of being adopted, thecompetent authority may refuse authorisation fora veterinary medicinal product where such actionis necessary for the protection of public health,consumer and animal health.’;

(b) paragraph 2 shall be amended as follows:

(i) The introductory words shall be replaced by thefollowing:

‘Marketing authorisations may be suspended,revoked, withdrawn or varied when it is estab-lished that:’;

(ii) Point (a) shall be replaced by the following:

‘(a) the particulars supporting the application, asprovided for in Articles 12 to 13d, have notbeen amended in accordance with Article27(1) and (5);’;


56) in Article 84, point (a) of paragraph 1 shall be replaced bythe following:

‘(a) it is clear that the risk-benefit assessment of theveterinary medicinal product is, under the authorisedconditions of use, unfavourable, particular regardbeing had to the benefits for animal health andwelfare and to the safety and health benefits for theconsumer, when the authorisation concerns aveterinary medicinal product for zootechnical use.’;

57) in Article 85, the following paragraph shall be added:

‘3. Member States shall prohibit the advertising to thegeneral public of veterinary medicinal products that:

(a) in accordance with Article 67, are available onveterinary prescription only; or

(b) contain psychotropic drugs or narcotics, such as thosecovered by the United Nations Conventions of 1961and 1971.’;

58) in Article 89, paragraphs 2 and 3 shall be replaced by thefollowing:

‘2. Where reference is made to this paragraph, Articles5 and 7 of Decision 1999/468/EC shall apply, havingregard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Articles4 and 7 of Decision 1999/468/EC shall apply, havingregard to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision1999/468/EC shall be set at one month.

4. The Standing Committee shall adopt its rules ofprocedure. These rules of procedure shall be made public.’;


‘Article 90

Member States shall take all necessary measures to ensurethat the competent authorities concerned communicatethe appropriate information to each other, particularlyregarding compliance with the requirements adopted forthe authorisations referred to in Article 44, for thecertificates referred to in Article 80(5) or for authorisationto place products on the market.

Upon reasoned request, Member States shall forthwithcommunicate the reports referred to in Article 80(3) tothe competent authorities of another Member State.

The conclusions reached following an inspection asreferred to in Article 80(1) carried out by the inspectors

of the Member State concerned shall be valid for theCommunity.

However, by way of exception, if a Member State has notbeen able, for serious reasons of human or animal health,to accept the conclusions of an inspection as referred to inArticle 80(1), that Member State shall forthwith inform theCommission and the Agency. The Agency shall inform theMember States concerned.

When the Commission is informed of such seriousreasons, it may, after consulting the Member Statesconcerned, ask the inspector of the competent supervisoryauthority to carry out a new inspection; the inspector maybe accompanied by two other inspectors from MemberStates that are not parties to the disagreement.’;

60) in Article 94, the third subparagraph shall be replaced bythe following:

‘Decisions to grant or revoke a marketing authorisationshall be made publicly available.’;


‘Article 95

Member States shall not permit foodstuffs for humanconsumption to be taken from test animals unless thecompetent authorities have established an appropriatewithdrawal period. The withdrawal period shall either:

(a) be at least as laid down in Article 11(2), including,where appropriate, a safety factor reflecting thenature of the substance being tested; or

(b) if maximum residue limits have been established bythe Community in accordance with Regulation (EEC)No 2377/90, ensure that this maximum limit will notbe exceeded in foodstuffs.’;

62) the following articles shall be inserted:

‘Article 95a

Member States shall ensure that appropriate collectionsystems are in place for veterinary medicinal productsthat are unused or expired.

Article 95b

When a veterinary medicinal product is to be authorisedin accordance with Regulation (EC) No 726/2004 and theScientific Committee in its opinion refers to recommendedconditions or restrictions with regard to the safe andeffective use of the veterinary medicinal product asprovided for in Article 34(4)(d) of that Regulation, adecision addressed to Member States shall be adopted inaccordance with the procedure laid down in Articles 37and 38 of this Directive, for the implementation of thoseconditions or restrictions.’


Article 2

The periods of protection provided for in Article 1, point 6,which amends Article 13 of Directive 2001/82/EC, shall notapply to reference medicinal products for which an applicationfor authorisation has been submitted before the date of trans-position referred to in Article 3 first paragraph.

Article 3

Member States shall bring into force the laws, regulations andadministrative provisions necessary to comply with thisDirective by 30 October 2005 at the latest. They shallimmediately inform the Commission thereof.

When Member States adopt these measures, they shall containa reference to this Directive or shall be accompanied by suchreference on the occasion of their official publication. Themethods of making such reference shall be laid down by theMember States.

Article 4

This Directive shall enter into force on the day of its publi-cation in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

Done at Strasbourg, 31 March 2004.

For the European Parliament

The President

P. COX

For the Council

The President

D. ROCHE


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