CELEX: 51988PC0779(02)
Language: en
Date: 1989-02-09
Title: PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVE 81/851/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO VETERINARY MEDICINAL PRODUCTS

10. 3. 89                             Official Journal of the European Communities                             No C 61/11
              Proposal for a Council Directive amending Directive 81/8 51 / E E C on the approximation of the
                           laws of the Member States relating to veterinary medicinal products
                                              COM(88) 779 final — SYN 189
                                    (Submitted by the Commission on 10 January 1989)
                                                       (89/C 61/08)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                        Whereas it is advisable to stipulate more precisely the
                                                                cases in which the results of pharmacological and toxico-
                                                                logical tests or clinical trials do not have to be provided
Having regard to the Treaty establishing the European
                                                                with a view to obtaining authorization for a veterinary
Economic Community, and in particular Article 100A
                                                                medicinal product which is essentially similar to an inno-
thereof,                                                        vative product, while ensuring that innovative firms are
                                                                not placed at a disadvantage; whereas, however, there
Having regard to the proposal from the Commission,              are reasons of public policy for not repeating tests
                                                                carried out on animals without over-riding cause;
In cooperation with the European Parliament,                    Whereas the guarantees of the quality of veterinary
                                                                medicinal products manufactured within the Community
                                                                should be maintained by requiring compliance with the
Having regard to the opinion of the Economic and                principles of good manufacturing practice for medicinal
Social Committee,                                               products irrespective of the final destination of the
                                                                products;
Whereas Article 23 (2) of Council                 Directive
81/8 51/EEC ( l ) provides that the Commission should           Whereas the Commission should be empowered to
submit to the Council a proposal containing appropriate         define in detail the principles of good manufacturing
measures leading towards the elimination of any                 practice for veterinary medicinal products in close
remaining barriers to trade or to the free movement of          cooperation with the Committee for Adaptation to
veterinary medicinal products not later than four years         Technical Progress of the Directive on the Removal of
after the implementation of the abovementioned                  Technical Barriers to Trade in the Veterinary Medicinal
Directive;                                                      Products Sector established by Article 2c of Council
                                                                Directive 81/852/EEC of 28 September 1981 on the
                                                                approximation of the laws of the Member States relating
Whereas the Directives on the approximation of laws             to analytical, pharmaco-toxicological and clinical
relating to veterinary medicinal products must be               standards and protocols in respect of the testing of
adapted to scientific progress and improved to take             veterinary medicinal products (2), as amended by
account of the experience acquired since their adoption;        Directive 87/20/EEC ( 3 );
                                                                Whereas measures should be taken to improve the
Whereas it is necessary, from the point of view of public       provision of information for third countries about the
health and the free movement of veterinary medicinal            conditions of use of veterinary medicinal products within
products, for the competent authorities to have at their        the Member States and the Community;
disposal all useful information on authorized veterinary
medicinal products in the form of approved summaries            Whereas measures should be taken to ensure that
of the characteristics of products;                             distributors of veterinary medicinal products are auth-
                                                                orized by Member States and maintain adequate records,
Whereas the approximation of laws brought about in this
connection must enable a veterinary medicinal product,          HAS ADOPTED THIS DIRECTIVE:
manufactured and marketed in one Member State on the
basis of harmonized provisions, to be allowed into                                         Article 1
another Member State, taking due consideration of the
initial authorization, save in exceptional cases submitted      Directive 81/851/EEC is hereby amended as follows:
for a binding opinion to the Committee for Veterinary
Medicinal Products set up by Directive 81/851 / E E C ;           1. In Article 1 (2), the first indent is replaced by the
                                                                     following:
Whereas the system for leaflets accompanying veterinary              '— "veterinary medicinal product" means            any
medicinal products should be improved;                                    medicinal product intended for animals.
                                                                O OJ No L 317, 6. 11. 1981, p. 16.
(') OJ No L 317, 6. 11. 1981, p. 1.                             O OJ No L 15, 17. 1. 1987, p. 34.
 ---pagebreak--- No C 61/12                              Official Journal of the European Communities                                10. 3. 89
          However products or substances which are                    — veterinary medicinal products authorized for use
          intended for long-term use by oral adminis-                      in the Member State concerned in accordance
          tration to healthy animals for nutritional                       with the provisions of this Directive for use in
          purposes shall not be considered as veterinary                   another animal species',
          medicinal products.'
                                                                      — medicinal products which have been authorized
 2. Article 1 (5) is replaced by the following:                            for use in the Member State concerned in
                                                                           human beings in accordance with the provisions
    '5.     Member States shall take all necessary                         of Council Directive 65/65/EEC of 26 January
    measures to ensure that no person shall have on his                     1965 on the approximation of provisions laid
    premises or under his control any substance which                      down by law, regulation or administrative action
    may be used as a veterinary medicinal product unless                   relating to proprietary medicinal products ('),
    expressly authorized under the legislation of the
    Member State concerned.                                           which have been prescribed by a veterinarian,
                                                                      provided that the animals to be treated have been
    For the purposes of implementing this provision,                  examined by the veterinarian personally and the
    Member States shall maintain a register of producers              veterinarian concludes that there is no authorized
    and dealers and other persons who are permitted to                therapy which will be effective for the treatment of
    be in possession of active substances which may be                the animals concerned. The veterinarian shall be
    used in the manufacture of veterinary medicinal                   required to maintain adequate records of the date of
    products which are available only on veterinary pre-              examination of the animals, the clinical diagnosis,
    scription. Such persons shall be required to maintain             the medicinal products prescribed, the dosages
    detailed records of all dealings in active substances             administered, the duration of treatment and the
    which may be used in the manufacture of veterinary                withdrawal periods recommended, and to make
    medicinal products and to make these records                      these records available for inspection by the
    available for inspection by the competent authorities             competent authorities for a period of at least three
    for a period of at least three years.                             years.
    Before the date of implementation of this Directive,
    Member       States    shall   communicate      to    the         Where the administration of such medicinal products
    Commission a list of the veterinary medicinal                     to food-producing animals is permitted, the veter-
    products which are available without veterinary pre-              inarian shall be responsible for ensuring that the
    scription.'                                                       withdrawal period applied is sufficient to ensure that
                                                                      foodstuffs derived from treated animals do not
                                                                      contain any residues which might constitute a health
 3. In Article 2, the fourth indent of paragraph 2 is                 hazard for the consumer.
    deleted.
                                                                      4.     Notwithstanding paragraph 2, Member States
 4. Article 4 is replaced by the following:                           shall ensure that veterinarians providing services in
                                                                      another Member State can take with them and
     'Article 4                                                       administer to animals under their direct care small
                                                                      quantities of veterinary medicinal products other
    1.     N o veterinary medicinal product may be
                                                                      than immunological veterinary medicinal products
    marketed in a Member State unless authorization
                                                                      which are not authorized for use in the Member
    has previously been granted by the competent
                                                                      State in which the services are provided (host
    authority of that Member State.
                                                                      Member State), providing that the following
                                                                      conditions are satisfied:
    2.     No veterinary medicinal product may be
    administered to animals unless the authorization
    referred to above has been issued, except for the                 (a) The marketing authorization provided for in
    tests of veterinary medicinal products referred to in                 paragraph 1 has been granted by the competent
    point 10 of Article 5 which have been notified to or                  authorities of the Member State in which the
                                                                          veterinarian is established.
    approved by the competent national authorities in
    accordance with the national rules in force.
                                                                      (b) The veterinary medicinal products are trans-
    3.     However Member States may permit veterinary                    ported by the veterinarian in the original manu-
    medicinal products prepared extemporaneously by a                     facturer's packaging.
    veterinarian or in a pharmacy in accordance with the
    terms of a veterinary prescription or an official                 (c) In the case of veterinary medicinal products
    formula to be administered to a particular animal or                  intended for administration to food-producing
    a small number of animals by a veterinarian or under                   animals, the products carried have the same
    his direct personal responsibility.                                    qualitative and quantitative composition in terms
                                                                           of active principles as products authorized in
    Moreover, Member States may permit the adminis-                        accordance with paragraph 1 for use in the host
    tration to animals of:                                                 Member State.
 ---pagebreak--- 10. 3. 89                                Official Journal of the European Communities                              No C 61/13
    (d) Prior to the administration of the products to                  4. Description of the method of preparation.
         animals, the veterinarian shall be required to
         ascertain the conditions for use of the corre-
         sponding veterinary medicinal products in the                  5. Therapeutic indications, contra-indications and
         host Member State, including the withdrawal                        side-effects.
         period, and the veterinarian shall be required to
         take all measures incumbent upon him to ensure
                                                                        6. Dosage for the various species of animal for
         that the rules applying in the host Member State
                                                                           which the veterinary medicinal               products
         are complied with.
                                                                            intended, its pharmaceutical form, method and
                                                                           route of administration and proposed shelf life.
    (e) The veterinarian shall not furnish any veterinary
         medicinal product to the owner or keeper of the
         animals treated in the host Member State unless                7. If applicble, reasons for any precautionary and
         this is permissible on the basis of Community                     safety measures to be taken for the storage of
         law or the law of the Member State concerned.                     the product, during its administration to
                                                                           animals, and for the disposal of waste products,
    (f) The veterinarian shall be required to keep                         together with an indication of any potential risks
         detailed records of the animals treated, the                      presented by the product to the environment and
         clinical diagnosis, the veterinary medicinal                      the health of humans, animals or plants.
         products administered, the dosage administered,
         the duration of treatment and the withdrawal
         period applied. These records shall be available               8. Indication of the withdrawal period necessary
         for inspection by the competent authorities for a                 between the last administration of the veterinary
         period of at least three years.                                   medicinal product to animals under normal
                                                                           conditions of use and the production of food-
    (g) The overall range and quantity of veterinary                       stuffs from such animals in order to ensure that
         medicinal products carried by the veterinarian                    such foodstuffs do not contain any residues
         shall not exceed that generally required by good                  which might constitute a health hazard to the
         veterinary practice.                                              consumer. Where necessary, and in particular in
                                                                           the case of veterinary medicinal products
         (') OJ No 22, 9. 2. 1965, p. 369/65.'                             containing an active substance not previously
                                                                           used in veterinary medicine, which are the
                                                                           subject of a request for marketing authorization
 5. Article 5 is replaced by the following:
                                                                           in the Member States concerned for the first
                                                                           time, the applicant shall propose and justify a
    'Article 5                                                             tolerance level for residues which may be
    For the purpose of obtaining the authorization                         accepted in foodstuffs without risk for the
    provided for in Article 4, the person responsible for                  consumer, together with appropriate validated
    marketing shall lodge an application with the                          analytical detection methods.
    competent authority of the Member State.
                                                                        9. Description of the control testing methods
    The following particulars and documents shall be
                                                                           employed by the manufacturer (qualitative and
    provided by the applicant:
                                                                           quantitative analysis of the constituents and the
      1. Name or corporate name and permanent address                      finished product, specific tests, e.g. sterility tests,
         or registered place of business of the person                     test for the presence of pyrogens, for the
         responsible for marketing and, if different, of                   presence of heavy metals, stability tests, bio-
         the manufacturer or manufacturers involved and                    logical and toxicity tests, tests on intermediate
         of the sites where manufacturing operations are                   products).
         carried out.
     2. Name of the veterinary medicinal product                       10. Results of:
         (brand name, non-proprietary name, with or                        — physico-chemical,     biological    or   microbio-
         without a trademark or name of the manu-                               logical tests,
         facturer; scientific name or formula, with or                     — toxicological and pharmacological tests,
         without a trademark or name of the manu-
                                                                           — clinical trials.
         facturer).
     3. Qualitative and quantitative particulars of all the                However, and without prejudice to the law
         constituents of the veterinary medicinal product,                 relating to the protection of industrial and
         using the usual terminology but not empirical                     commercial property:
         chemical formula and giving the international
         non-proprietary name recommended by the
         World Health Organization, if such a name                         (a) The applicant shall not be required to
         exists.                                                                 provide the results of toxicological and
 ---pagebreak--- No C 61/14                             Official Journal of the European Communities                                   10. 3. 89
           pharmacological tests and clinical trials if he         6. The following Article 5a is inserted:
           can demonstrate:
             (i) either that the veterinary medicinal                  'Article 5a
                 product is essentially similar to a
                                                                      The summary of the product characteristics referred
                 product authorized in the country
                                                                      to in point 11 of the second paragraph of Article 5
                 concerned by the application and that
                                                                      shall contain the following information:
                 the person responsible for the marketing
                 of the original veterinary medicinal                 1. Name of the veterinary medicinal product,
                 product has consented to the toxico-
                 logical, pharmacological or clinical                 2. Qualitative and quantitative composition in terms
                 references contained in the file on the                  of the active ingredients and constituents of the
                 original veterinary medicinal product                    excipient, knowledge of which is essential for
                 being used for the purpose of examining                  proper administration of the medicinal product;
                 the application in question,                             the international non-proprietary names re-
           (ii) or by detailed references to the                          commended by the World Health Organization
                 scientific    literature    presented    in              shall be used, where such names exist, or failing
                 accordance with the second paragraph                     this, the usual common name or chemical
                 of Article 1 of Directive 81/852/EEC                     description.
                 that the constituent or constituents of
                                                                      3. Pharmaceutical form.
                 the veterinary medicinal product have a
                 well established medicinal use, with                 4. Pharmacological properties and, in so far as this
                 recognized efficacy and an acceptable                    information is useful for therapeutic purposes,
                 level of safety,                                         pharmacokinetic particulars.
           (iii) or that the veterinary medicinal product
                 is essentially similar to a product which            5. Clinical particulars:
                 has been         authorized    within   the              5.0.   target species,
                 Community, in accordance with the
                                                                          5.1.   therapeutic indications, specifying the target
                 Community provisions in force, for not
                                                                                 species,
                 less than ten years and is marketed in
                 the Member State for which the                           5.2.   contra-indications,
                 application is made.                                     5.3.   undesirable      effects   (frequency      and
                                                                                 seriousness),
       (b) In the case of new veterinary medicinal
                                                                          5.4.   special precautions for use,
           products containing known constituents not
           hitherto used in combination for therapeutic                   5.5.   use during pregnancy and lactation,
           purposes, the results of toxicological and of                  5.6.   interaction with other medicaments         and
           pharmacological tests and of clinical trials                          other forms of interaction,
           relating to that combination must be
           provided, but it shall not be necessary to                     5.7.   posology and method of administration,
           provide references relating to each individual                 5.8.   overdose     (symptoms, emergency         pro-
           constituent.                                                          cedures, antidotes) (if necessary),
                                                                          5.9.   special warnings for each target species,
   11. A summary in accordance with Article 5a of the                     5.10. withdrawal periods,
       product characteristics, one or more specimens
       or mock-ups of the sales presentation of the                       5.11. special safety precautions to be taken by the
       veterinary medicinal product together with a                              person administering the product to
       package insert where one is to be enclosed.                               animals.
                                                                      6. Pharmaceutical particulars:
   12. A document showing that the manufacturer is                        6.1.   Incompatibilities (major),
       authorized in his own country to produce
       veterinary medicinal products.                                     6.2.   shelf life, when necessary after recon-
                                                                                 stitution of the product or when the
                                                                                 container is opened for the first time,
   13. Any marketing authorization for the relevant
       veterinary medicinal product which may have                         6.3.  special precautions for storage,
       been obtained in another Member State or in a                       6.4.  nature and contents of container,
       third country together with a list of those
                                                                           6.5.  name or style and permanent address or
       countries to which an application for marketing
                                                                                  registered place of business of the holder of
       authorization has been made and an explanation
                                                                                  the marketing authorization,
       of the reasons for which any Member State or
       third country has refused to grant authorization                    6.6.   special precautions for the disposal of
       for the veterinary medicinal product concerned.'                           unused product or waste materials, if any.'
 ---pagebreak--- 10. 3. 89                                 Official Journal of the European Communities                               N o C 61/15
 7. The following Article 5b is inserted:                                 3.     The person responsible for marketing shall be
                                                                          required to maintain records of all reported
      'Article 5b                                                         suspected adverse reactions arising in animals and
                                                                          human beings. For the purpose of this provision, a
     When the marketing authorization referred to in
                                                                          failure of the veterinary medicinal product to achieve
     Article 4 (1) is issued, the person responsible for
                                                                         the expected therapeutic effect shall be considered
     placing that product on the market shall be
                                                                          an adverse reaction. These records shall be kept for
     informed, by the competent authorities of the
                                                                          at least five years and shall be made available to the
     Member State concerned, of the summary of the
                                                                         competent authorities upon request.
     product characteristics as approved by them. The
     competent authorities shall take all necessary
                                                                         4.     The person responsible for marketing shall
     measures to ensure that the information given in the
                                                                         immediately inform the competent authorities, with a
     summary is in conformity with that accepted when
                                                                         view to authorization, of any alteration he proposes
     the     marketing     authorization      is   issued    or
                                                                         to make to the particulars and documents referred to
     subsequently.'                                                      in Article 5.'
 8. The last paragraph of Article 7 is amended as
     follows:                                                       11. Chapter IV is replaced by the following:
     'The experts' detailed reports shall form a part of the             'CHAPTER IV
     documentation which the applicant shall lodge with
     the competent authorities. A brief curriculum vitae of              Committee for Veterinary Medicinal Products
     the expert shall be appended to each expert report.'
                                                                        Article 16
 9. Point 2 of Article 9 is replaced by the following:
                                                                         1.     In order to facilitate the adoption of a common
    '2. may submit the medicinal product, its active prin-
                                                                        position by the Member States with regard to
         ciples and its necessary intermediate products or
                                                                         decisions on the issue of marketing authorizations
         other constituent materials for testing by a State
                                                                         and to promote thereby the free movement of
         laboratory or by a laboratory designated for that
                                                                        veterinary medicinal products, a Committee for
         purpose, in order to ensure that the control
                                                                        Veterinary Medicinal Products, hereinafter referred
         testing methods employed by the manufacturer
                                                                        to as "the Committee", is hereby set up. The
         and described in the application documents, in
                                                                        Committee shall consist of representatives of the
         accordance with point 9 of the second paragraph
                                                                        Member States and of the Commission.
         of Article 5, are satisfactory.'
                                                                        2.      The Committee's task shall be to examine, at
10. Article 14 is replaced by the following:                            the request of a Member State or the Commission
                                                                        and in accordance with Articles 17 to 22, questions
     'Article 14                                                        concerning the application of Articles 11, 36 and 49.
     1.    After an authorization has been issued, the
                                                                        3.      The Committee shall draw up its own rules of
    person responsible for placing the product on the
                                                                        procedure.
    market must, in respect of the control methods
    provided for in point 9 of the second paragraph of
    Article 5, take account of technical and scientific                 Article 17
    progress and introduce any changes that may be
    required to enable the veterinary medicinal product                  1.     In order to make it easier to obtain a marketing
    to be checked by means of generally accepted                        authorization in at least two other Member States
    scientific methods. These changes must be accepted                  taking into due consideration an authorization
    by the competent authorities of the Member States                   issued in one Member State in accordance with
    concerned.                                                          Article 4, the holder of the latter authorization may
                                                                        submit an application to the competent authorities of
    2.     The person responsible for marketing shall                   the Member States concerned together with the
    forthwith inform the competent authorities of any                   information and documents referred to in Articles 5,
    new information which might entail the amendment                    5a and 5b. He shall testify to its identity with the
    or further examination of the particulars and                       dossier accepted by the first Member State, spec-
    documents referred to in Article 5 or the approved                  ifying any additions it may contain, and shall certify
    summary of the product characteristics referred to in               that all the dossiers filed as part of this procedure
    Article 5b. In particular the person responsible for                are identical.
    marketing shall forthwith inform the competent
    authorities of any prohibition or restriction imposed               2.     The holder of the marketing authorization shall
    by the competent authorities of any country in which                notify the Committee of this application, inform it of
    the veterinary medicinal product is marketed and of                 the Member States concerned and send it a copy of
    any serious unexpected reaction occuring in animals                 this authorization. He shall also inform the Member
    or human beings.                                                    State which granted him the initial authorization and
 ---pagebreak--- No C 61/16                            Official Journal of the European Communities                                10. 3. 89
    notify it of any additions to the original dossier; that         In both cases, the person responsible for placing the
    State may require the applicant to provide it with all          veterinary medicinal product on the market shall be
    the particulars and documents necessary to enable it             informed of any decision of the Committee to apply
    to check the identity of the dossiers filed with the             the procedure laid down in Article 14.
    dossier on which it took its decision.
                                                                    Article 20
    3.    The holder of the marketing authorization shall           The competent authorities of Member States may, in
    notify the dates on which the dossiers were sent to             specific cases where the interests of the Community
   the Member States concerned. As soon as the                      are involved, refer the matter to the Committee
   Committee has noted that all the Member States                   before reaching a decision on a request for a
   concerned are in possession of the dossier, it shall             marketing authorization or on the suspension or
   forthwith inform all the Member States and the                   revocation of an authorization.
   applicant of the date on which the last Member State
   concerned received the dossier. The Member State(s)              Article 21
   concerned shall either grant the authorization valid
   for their markets within a period of 120 days of the              1.   The competent authorities shall draw up an
   aforementioned date, taking into due consideration               assessment report and comments on the dossier as
   the authorization issued within the meaning of                   regards the results of the analytical and toxico-phar-
   paragraph 1, or put forward a reasoned objection.                macological tests on, and clinical trials of, any
                                                                    veterinary medicinal products containing a new
                                                                    active substance which are the subject of a request
                                                                    for a marketing authorization in the Member States
   Article 18
                                                                    concerned for the first time.
                                                                    2.    As soon as the notification referred to in
    1.    Where a Member State considers that it is
                                                                    Article 17 is received, the competent authorities shall
   unable to grant a marketing authorization, it shall
                                                                    immediately communicate to the Member States
   forward to the Committee and to the person
                                                                    concerned any assessment report accompanied by a
   responsible for placing the veterinary medicinal
                                                                    summary of the dossier relating to a particular
   product on the market its reasoned objection in
                                                                    veterinary medicinal product. This report shall also
   accordance with Article 11, within the time limits
                                                                    be communicated to the Committee where a matter
   stipulated in Article 17 (3).
                                                                    is referred to the Committee pursuant to Article 18.
                                                                    The assessment report shall also be forwarded to the
   2.     Upon the expiry of this period, the matter shall          other Member States concerned and to the
   be referred to the Committee and the procedure                   Committee as soon as a matter is referred to the
   referred to in Article 21 shall be applied.                      Committee under the procedure laid down in Article
                                                                    19. Any assessment report so forwarded shall remain
                                                                    confidential.
   3.     On receipt of the reasoned objection referred             The competent authorities shall bring the assessment
   to in paragraph 1, the person responsible for placing            report up to date as soon as it is in possession of
   the product on the market shall immediately send                 information which is of importance for the
   the Committee a copy of the particulars and                      evaluation of the balance between effectiveness and
   documents enumerated in Article 17(1).                           risk.
                                                                    Article 22
   Article 19
                                                                    1.    Where reference is made to the procedure
                                                                    described in this Article, the Committee shall
   If several applications submitted in accordance with             consider the matter concerned and issue a reasoned
   Articles 5 and 5a have been made for a marketing                 opinion within 60 days of the date on which the
   authorization for a particular veterinary medicinal              matter was referred to it.
   product, and one or more Member States have
                                                                    In the case referred to in Article 18 the person
   granted an authorization while one or more of the
                                                                    reponsible for placing the product on the market
   other Member States have refused it, one of the
                                                                    may, at his request, explain himself orally or in
   Member States concerned or the Commission may
                                                                    writing and provide additional information before
   refer the matter to the Committee for application of
                                                                    the Committee issues its opinion. The Committee
   the procedure referred to in Article 21.
                                                                    may extend the time limit referred to in the
                                                                    preceding paragraph to give the applicant time to
                                                                    explain himself orally or in writing.
   The same shall apply where one or more Member
   States have suspended or revoked a marketing auth-               In the case referred to in Article 19, the person
   orization while one or more Member States have not               responsible for placing the product on the market
   done so.                                                         may be asked to explain himself orally or in writing.
 ---pagebreak--- 10. 3. 89                             Official Journal of the European Communities                               N o C 61/17
    2.     The Committee's opinion shall concern the                 Where the manufacturer is not in possession of a
    grounds for the objection provided for in Article                 marketing authorization, he shall provide the auth-
     18(1) and the grounds on which the marketing auth-               orities responsible for establishing the certificate
    orization has been refused, suspended or withdrawn               referred to in the first paragraph with a declaration
    in the cases described in Article 19.                            explaining why no marketing authorization is
    The Committee shall immediately inform the                       available.'
    competent authorities and the person responsible for
    placing the product on the market of its opinion.
                                                                 14. In Article 27, the following is added:
    3.     The competent authorities shall implement the
    opinion of the Committee with 60 days of its receipt.            '(f) comply with the principles and the guidelines of
                                                                            good manufacturing practice for medicinal
    4.     Where an application for marketing authori-                     products laid down by Community law.'
    zation is submitted in respect of a product which is
    the subject of an opinion of the Committee and the
                                                                15. In Article 27, the following is added:
    competent authorities have reasons for not applying
    the opinion of the Committee, they shall forthwith
    request the Committee to reconsider its opinion, in              (g) maintain detailed records of all veterinary
    accordance with the procedure laid down in this                        medicinal products supplied by him to whole-
    Chapter.                                                               salers or, where this is permitted by the laws of
                                                                           the Member State concerned, to retailers, veteri-
                                                                           narians or farmers. The following information
    Article 23                                                             shall be recorded in respect of each transaction,
                                                                           whether or not it is made for payment:
    The Commission shall report to the Council and the
                                                                           — date,
    European Parliament every two years on the
    operation of the procedure laid down in this                           — name of the veterinary medicinal product
    Chapter.'                                                              — quantity supplied,
                                                                           — name and address of the recipient.
12. Article 24 (1) is replaced by the following:
                                                                           These records shall be available for inspection by
    '1.     Member States shall take all appropriate                       the competent authorities for a period of three
    measures to ensure that the manufacture of                             years.
    veterinary medicinal products is subject to the
    holding of an authorization. This manufacturing
    authorization shall be required notwithstanding that        16. The following Article 27a is inserted:
    the veterinary medicinal products manufactured are
    intended for export.'
                                                                      Article 27a
13. The following Article 24a is inserted:                           The principles and guidelines of good manufacturing
                                                                     practices for medicinal products referred to in
                                                                     Article 27 (f) should be adopted in the form of a
     'Article 24a
                                                                     Directive addressed to Member States in accordance
                                                                     with the procedure laid down in Article 2c of
    At the request of the manufacturer, the exporter or              Council Directive 81/852/EEC, after taking into
    the authorities of an importing third country,                   consideration the specific nature of veterinary
    Member States shall certify that a manufacturer of               medicinal products; detailed guidelines shall be
    veterinary medicinal products is in possession of the            published by the Commission and revised as appro-
    authorization referred to in Article 24. When issuing            priate to take into consideration scientific and
    such certificates, Member States shall comply with               technical progress.'
    the following conditions:
    1. Member States shall have regard to the prevailing        17. In Article 34:
        administrative arrangements of the World Health
        Organization.
                                                                     — The first paragraph is replaced by the following:
    2. For veterinary medicinal products intended for                     'The competent authority of the Member State
        export which are already authorized on their                      concerned shall ensure by means of repeated
        territory, they shall supply the summary of the                   inspection that the legal requirements relating to
        product characteristics as approved in accordance                 veterinary medicinal products are complied with.'
        with Article 5b or, in the absence thereof, an
        equivalent document.                                         — The following third paragraph is added:
 ---pagebreak--- No C 61/18                             Official Journal of the European Communities                                 10. 3. 89
        'The officials     representing the competent                 7.   The withdrawal period, even if this is nil, in the
        authority shall report after each of the                           case of veterinary medicinal products admin-
        inspections mentioned in the first paragraph on                    istered to food-producing animals.
        whether the manufacturer complies with the
        principles and guidelines of good manufacturing               8.   Expiry date, in plain language.
        practice laid down by Community law. The
        manufacturer shall be informed of the content of              9a. Special precautions for disposal       of   unused
        such reports and shall be entitled to request a                    product or waste material, if any.'
        second inspection.'
                                                                 21. In Article 48, the first paragraph is replaced by the
18. In Article 39, the following second paragraph is                 following:
    added:
                                                                     'The inclusion of a package insert in the packaging
    'Upon reasoned request, Member States shall                      of veterinary medicinal products shall be obligatory
    forthwith communicate the reports referred to in the             unless all the information required by this Article can
    third paragraph of Article 34 to the competent auth-             be conveyed on the packaging itself. Member States
    orities of another Member State. If, after considering           shall take all appropriate measures to ensure that the
    the reports, the Member State receiving the reports              information included on a package insert of a
    considers that it cannot accept the conclusions                  veterinary medicinal product relates solely to the
    reached by the competent authority of the Member                 veterinary medicinal product concerned.'
    State in which the report was established, it shall
    inform the competent authority concerned of its
                                                                 22. In the second paragraph of Article 48, point (e) is
    reasons and may request further information. In the
                                                                     replaced by the following and the following point
    case of prolonged disagreement between Member
                                                                     (h) is added:
    States, the Member State(s) shall inform the
    Commission.'
                                                                     '(e) the withdrawal period, even if this is nil, in the
                                                                          case of veterinary medicinal products admin-
                                                                          istered to food-producing animals:
19. Article 42 becomes Article 42(1) and the following
    paragraphs are added:
    '2.    The person responsible for the marketing of a              (h) special precautions for the disposal of unused
    veterinary medicinal product shall be obliged to                      product or waste materials, if any.'
    notify the Member States forthwith of any action
    taken by him to suspend the marketing of a product
                                                                 23. The final paragraph of Article 48 is deleted.
    or to withdraw a product from the market, together
    with the reasons for such action. Member States
    shall ensure that this information is brought to the         24. The following Chapter VIII is inserted:
    attention of the Committee forthwith.
                                                                     'CHAPTER VIII
    3.     Member States shall ensure that appropriate
    information about actions taken pursuant to para-                Distribution of veterinary medicinal products
    graphs 1 and 2 which may effect the protection of
    health in third countries is forthwith brought to the            Article 51
    attention of the relevant international organizations,
    with a copy to the Committee.'                                    1.    Member States shall take all appropriate
                                                                     measures to ensure that wholesale dealing in
                                                                     veterinary medicinal products is subject to the
20. In the first paragraph of Article 43, points 2, 7 and 8          holding of an authorization and to ensure that the
    are replaced by the following, and the following                 time taken for the procedure for granting this auth-
    point 9a is inserted:                                            orization does not exceed 90 days from the date on
                                                                     which the competent authority receives the
                                                                     application.
    '2.   A statement of the active ingredients expressed
          qualitatively and quantitatively per dosage unit
          or according to the form of administration for a           2.     In order to obtain the authorization referred to
          particular volume or weight, using the interna-            in paragraph 1, the applicant shall have at his
          tional non-proprietary names recommended by                disposal suitable and sufficient premises complying
          the World Health Organization, where such                  with the legal requirements laid down in the
          names exist, or where no such names exist, the              Member State concerned as regards the storage and
          usual common names.                                        handling of products.
 ---pagebreak--- 10. 3. 89                              Official Journal of the European Communities                            N o C 61/19
    3.     The holder of the authorization referred to in             At least one a year, a detailed audit shall be carried
    paragraph 1 shall be required to maintain detailed                out, and incoming and outgoing supplies shall be
    records. The following information shall be recorded              reconciled with supplies currently held in stock and
    in respect of each incoming or outgoing transaction:              any discrepancies recorded.
    (a) date;                                                         These records shall be available for inspection by the
    (b) name of the veterinary medicinal product;                     competent authorities for a period of three years.
    (c) name of the manufacturer;                                     However, Member States may dispense retailers of
    (d) manufacturers batch number, expiry date;                      veterinary medicinal products from the obligation to
                                                                      maintain detailed records in respect of products
    (e) quantity received or supplied;                                supplied by them in small transactions for the
    (f) name and address of the supplier or recipient.                treatment of companion animals such as cats, dogs,
                                                                      aquarium fish, cage birds, homing pigeons, terrarium
    At least once a year, a detailed audit shall be carried           animals and small rodents provided that such
    out, and incoming and outgoing supplies shall be                  products do not contain substances the use of which
    reconciled with supplies currently held in stock and              requires veterinary control and all possible measures
    any discrepancies recorded.                                       have been taken to prevent the unauthorized use of
                                                                      the products for other animals.
    These records shall be available for inspection by the
    competent authorities for a period of three years.
                                                                      Article 53
    4.     Member States shall take all appropriate                   Where, in accordance with the legislation of a
    measures to ensure that wholesalers supply                        Member State, a person responsible for marketing a
    veterinary medicinal products only to persons                     veterinary medicinal product is permitted to supply
    permitted to carry out retail activities in accordance            samples of the product directly to a veterinarian or
    with the provisions of Article 52, or to other persons            other authorized person, the veterinarian or other
    who are lawfully permitted to receive veterinary                  authorized person shall be required to maintain the
    medicinal products from wholesalers.                              records referred to in Article 52 (2) in respect of
                                                                      medicines received and subsequently supplied by
                                                                      him, whether or not such supply is made for
    Article 52
                                                                      payment.'
    1.     Member States shall take all appropriate
    measures to ensure that the retail supply of                  25. Chapter VIII becomes Chapter IX and Articles 51,
    veterinary medicinal products is conducted only by                52 and 53 become Articles 54, 55 and 56
    persons who are expressly permitted to carry out                  respectively.
    such operations by the legislation of the Member
    State concerned.
                                                                                           Article 2
    2.     Any retailer of veterinary medicinal products          1.    Member States shall take the necessary measures to
    shall be required to maintain detailed records. The           comply with this Directive not later than 1 January 1992.
    following information shall be recorded in respect of        They shall forthwith inform the Commission thereof.
    each incoming or outgoing transaction:
                                                                  2.    Requests for marketing authorization lodged from
    (a) date;
                                                                  the date set out in paragraph 1 must comply with the
    (b) name of the veterinary medicinal product;                 provisions of this Directive.
    (c) name of the manufacturer;
                                                                  3.    Within four years of the date set out in paragraph
    (d) manufacturers batch number, expiry date;                  1, Article 1 where relevant, shall be progressively
    (e) quantity received or supplied;                            extended to existing veterinary medicinal products.
    (f) name and address of the supplier or recipient;
                                                                                           Article 3
    (g) name and address of the prescribing veterinarian
         if any, date of prescription.                            This Directive is addressed to the Member States.