CELEX: 31990L0676
Language: en
Date: 1990-12-13 00:00:00
Title: Council Directive 90/676/EEC Of 13 December 1990 amending Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products

Avis juridique important

|

31990L0676

Council Directive 90/676/EEC Of 13 December 1990 amending Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products  

Official Journal L 373 , 31/12/1990 P. 0015 - 0025 Finnish special edition: Chapter 13 Volume 20 P. 0044  Swedish special edition: Chapter 13 Volume 20 P. 0044 

 COUNCIL DIRECTIVE    of 13 December 1990    amending Directive 81/851/EEC on the approximation   of the laws of the Member States relating to   veterinary medicinal products     ( 90/676/EEC )    THE COUNCIL OF THE EUROPEAN COMMUNITIES ,    Having regard to the Treaty establishing the   European Economic Community , and in particular   Article 100a thereof ,    Having regard to the proposal from the Commission (1) ,    In cooperation with the European Parliament (2) ,    Having regard to the opinion of the Economic and   Social Committee (3) ,    Whereas Article 23/2 of Council Directive 81/851/EEC (4)   provides that the Commission should submit to the Council a   proposal containing appropriate measures leading   towards the elimination of any remaining barriers to trade   or to the tree movement of veterinary medicinal   products not late ; than four years after the   implementation of the abovementioned Directive .    Whereas the Directives on the approximation of   laws relating to veterinary medicinal products must   be adapted to scientific progress and improved to take   account of the experience acquired since their adoption ;    Whereas it is necessary from the point of view of   public health and the free movement of veterinary   medicinal products for the competent authorities to have   at their disposal all useful information on authorized   veterinary medicinal products in the form of approved   summaries of the characteristics of products ;    Whereas the approximation of laws brought about in this   connection must enable a veterinary medicinal product ,   manufactured and placed on the market in one   Member State on the basis of harmonized provisions ,   to be allowed into the other Member States ,   taking due consideration of the initial   authorization , save in exceptional cases submitted   for an opinion to the Committee for Veterinary   Medicinal Products set up by Directive 81/851/EEC ;    Whereas the system for package inserts accompanying   veterinary medicinal products should be improved ;    Whereas it is advisable to stipulate more precisely   the cases in which the results of pharmacological and   toxicological tests or clinical trials do not have   to be provided with a view to obtaining authorization   for a veterinary medicinal product which is   essentially similar to an innovative product , while   ensuring that innovative firms are not placed at a   disadvantage , whereas , however , there are   reasons of public policy for not repeating tests   carried out on animal , without overriding   cause ;    Whereas the guarantees of the quality of veterinary   medicinal products manufactured within the Community   should be maintained by requiring compliance with the   principles of good manufacturing practice for   medicinal products irrespective of the final   destination of the products ;    Whereas the Commission should be empowered to define in   detail principles of good manufacturing practice for   veterinary medicinal products in close cooperation   with the Committee for Adaptation to Technical   Progress of the Directives on the Removal of   Technical Barriers to Trade in the Veterinary   Medicinal Products Sector established by   Article 2b of Council Directive 81/852/EEC of   26 September 1981 on the approximation of the laws   of the Member States relating to analytical ,   pharmacotoxicological and clinical standards   and protocols in respect of the testing of veterinary   medicinal products (5) , as amended by Directive   87/20/EEC (6) ;    Whereas measures should be taken to improve the   provision of information for third countries   about the conditions of use of veterinary medicinal   products within the Member States and the Community ;    Whereas measures should also be taken to ensure   that distributors of veterinary medicinal   products are authorized by Member States and   maintain adequate records ,    HAS ADOPTED THIS DIRECTIVE :    Article 1    Directive 81/851/EEC is hereby amended as follows :    1 . Article 1 ( 5 ) is replaced by the following :     " 5 . Member States shall take all mea ires   necessary to ensure that only persons empowered   under their national legislation in force possess   or have under their control veterinary medicinal   products or substances which may be used as veterinary   medicinal products that have anabolic , anti-infectious ,   anti-parasitic , anti-inflammatory , hormonal or   psychotropic properties .    Member States shall maintain a register of producers   and dealers permitted to be in possession of active   substances which may be used in the manufacture of   veterinary medicinal products having the properties   referred to in the first subparagraph . Such persons must   maintain detailed records of all dealings in substances   which may be used in the manufacture of veterinary   medicinal products and keep these records available for   inspection by the competent authorities for a period   of at least three years .    Any amendments to be made to the list of substances   referred to in the first subparagraph shall be adopted in   accordance with the procedure referred to in Article 2c   of Directive 81/852/EEC (*) as amended by Directive   87/20/EEC (**) .    (*) OJ No L 317 , 6 . 11 . 1981 , p. 16 .    (**) OJ No L 15 , 17 . 1 . 1987 , p. 34 .    2 . The following subparagraph is added to Article 2   ( 1 ) :     " This Directive shall apply to veterinary medicinal   products used in order to produce active or passive   immunity or to diagnose the state of immunity , in   accordance with the provisions of Directive   90/676/EEC (***) which widens the scope of this   Directive .    (***) OJ No L 373 , 31 . 12 . 1990 , p. 15 . "    3 . The second and fourth indents of Article 2   ( 2 ) are deleted .    4 . Article 4 is replaced by the following :     " Article 4    1 . No veterinary medicinal product may be placed   on the market in a Member State unless authorization   has previously been granted by the competent authority   of that Member State .    However , where the health situation so requires ,   a Member State may authorize the placing on the market   or administration to animals of veterinary medicinal   products which have been authorized by another   Member State in accordance with this Directive .    In the event of a serious disease epidemic the States may   provissionally allow the use of immunological   veterinary medicinal products without an   authorization for placing on the market , in the   absence of a suitable medicinal product and after   informing the Commission of the detailed conditions of use .    2 . A Member State shall not authorize the placing   on the market of a veterinary medicinal product   intended for administration to food-producing   animals whose flesh or products are intended for human   consumption , unless :     ( a ) the active substance or substances capable of   pharmacological action contained in the veterinary   medicinal product were authorized for use in other   veterinary medicinal products in the Member State   concerned on the date of entry into force of   Council Regulation ( EEC ) No 2377/90 of   26 June 1990 laying down a Community procedure   for the fixing of maximum levels of residues of   veterinary medicinal products in foodstuffs   of animal origin (*) ;     ( b ) the active substance or substances capable of   pharmacological action is or are   mentioned in Annex I , II or III to the aforementioned   Regulation .    3 . No veterinary medicinal product may be   administered to animals unless the authorization   referred to above has been issued , except for the tests of   veterinary medicinal products referred to in point 10 of   Article 5 which have been accepted by the competent   national authorities , following notification or   authorization , in accordance with the national   rules in force .    The Member States shall permit the placing on the   market of foodstuffs obtained from animals treated   during these tests only if they are satisfied that the   foodstuffs do not contain residues which may present a   risk for human health .    Without prejudice to stricter Community or national   rules relating to dispensing veterinary medicinal   products and to protect human and animal health , a   prescription shall be required for dispensing to the   public the following veterinary medicinal products ;     ( a ) those products subject to official restrictions on   supply or use , such as :     - the restrictions resulting from the   implementation of the relevant United Nations   conventions on narcotic and psychotropic   substances ,     - the restrictions on the use of veterinary   medicinal products resulting from Community law ;     ( b ) those products in respect of which special   precautions must be taken by the veterinarian in   order to avoid any unnecessary risk to :     - the target species ,     - the person administering the products to the   animal ,     - the consumer of foodstuffs obtained from the   treated animal ,     - the environment ;     ( c ) those products intended for treatments or   pathological processes which require a precise   prior diagnosis or the use of which may cause   effects which impede or interfere with subsequent   diagnostic or therapeutic measures ;     ( d ) magistral formulae intended for animals .    In addition , a prescription shall be required   for new veterinary medicinal products containing   an active ingredient which has been authorized for use   in a veterinary medicinal product for less than five   years unless , having regard to the information   and particulars provided by the applicant , or   experience acquired in the practical use of the   product , the competent authorities are satisfied   that none of the criteria referred to in ( a ) to   ( d ) of the third subparagraph apply .    4 . However , where there exists no authorized   medicinal product for a condition , Member States may   exceptionally , in particular in order to avoid   causing unacceptable suffering to the animals   concerned , permit the administration by a veterinarian   or under his her direct personal responsibility to   an animal or to a small number of animals on a particular   holding (*) :     ( a ) of a veterinary medicinal product authorized   in the Member State concerned for use in another animal   species , or for another condition in the same   species ; or     ( b ) if there is no product such as referred to in   point ( a ) , of a medicinal product authorized for   use in the Member State concerned in human   beings in accordance with Directive 65/65/EEC   of 26 January 1965 ; or     ( c ) if there is no product such as referred to in   point ( b ) and within the limits of the law of the   Member State concerned , of a veterinary medicinal   product prepared extemporaneously by a person   authorized to do so under national legislation in   accordance with the terms of a veterinary   prescription ,    provided that the medicinal product , where   administered to animals whose flesh or products are   intended for human consumption , contains only   substances to be found in a veterinary medicinal   product authorized for such animals in the Member   State concerned and that in the case of food-producing   animals the veterinarian responsible specifies an   appropriate withdrawal period to ensure that food   produced from the treated animals does not contain   residues harmful to consumers .    Unless the product used indicates a withdrawal   period for the species concerned , the specified   withdrawal period shall not be less than :    7 days : eggs ,    7 days : milk ,    28 days : meat from poultry and mammals including fat   and offal ,    500 degree days : meat from fish .    The veterinarian shall keep adequate records of   the date of examination of the animals , details of   the owner , the number of animals treated , the   diagnosis , the medicinal products prescribed , the   dosages administered , the duration of treatment and the   withdrawal periods recommended , and make these   records available for inspection by the competent   authorities for a period of at least three years .   This requirement may be extended by the Member States   to animals whose flesh or products are not intended for   human consumption .    5 . Notwithstanding paragraph 3 , Member States shall   ensure that veterinarians providing services in   another Member State can take with them and   administer to animals small quantities of ready-made   veterinary medicinal products not exceeding daily   requirements other than immunological veterinary   medicinal products which are not authorized for use in   the Member State in which the services are provided   ( host Member State ) , providing that the following   conditions are satisfied :     ( a ) the authorization to place the product on the   market provided for in paragraph 1 has been   issued by the competent authorities of the Member   State in which the veterinarian is established ;     ( b ) the veterinary medicinal products are   transported by the veterinarian in the original   manufacturer's packaging ;     ( c ) the veterinary medicinal products intended for   administration to food-producing animals have   the same qualitative and quantitative composition   in terms of active principles as the medicinal   products authorized in accordance with   paragraph 1 in the host Member State ;     ( d ) a veterinarian providing services in another   Member State shall acquaint himself with the good   veterinary practices applied in that Member State .   He shall ensure that the withdrawal period   specified on the labelling of the veterinary   medicinal product concerned is complied with ,   unless he could reasonably be expected to know   that a longer withdrawal period should be   specified to comply with these good veterinary   practices ;     ( 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   this is permissible on the basis of the rules of the   host Member State ; in this case he shall , however ,   supply only in relation to animals under his care   and only the minimum quantities of veterinary   medicinal product necessary to complete the   treatment of animals concerned on that occasion ;     ( f ) the veterinarian shall be required to keep   detailed records of the animals treated , the diagnosis ,   the veterinary medicinal products administered , the   dosage administered , the duration of treatment   and the withdrawal period applied . These records   shall be available for inspection by the competent   authorities of the host State for a period of at least   three years ;     ( g ) the overall range and quantity of veterinary   medicinal products carried by the veterinarian   shall not exceed that generally required for the   daily needs of good veterinary practice .    5 . Article 5 is replaced by the following :     " Article 5    For the purpose of obtaining the authorization for   placing a product on the market provided for in   Article 4 , the person responsible for placing the   product on the market shall lodge an application with   the competent authority of the Member State .    The following particulars and documents shall   accompany such application :    1 . name or business name and permanent address   or registered place of business of the person   responsible for placing the product on the market   and , if different , of the manufacturer or   manufacturers involved and of the sites of   manufacture ;    2 . name of the veterinary medicinal product   ( brand name , non-proprietary name , whith or   without a trademark , or name of the manufacturer or   scientific name or formula , with or without a   trademark , or the name of the manufacturer ) ;    3 . qualitative and quantitative particulars of all   the constituents of the veterinary medicinal product ,   using the usual terminology but not empirical   chemical formula and giving the international   non-proprietary name recommended by the   World Health Organization , where such a name   exists ;    4 . description of the method of preparation ;    5 . therapeutic indications , contra-indications and   side-effects ;    6 . dosage for the various species of animal for which   the veterinary medicinal product is intended , its   pharmaceutical form , method and route of   administration and proposed shelf life ;    7 . if applicable , explanations of the precautionary   and safety measures to be taken when the product   is stored , when it is administered to animals and   when waste therefrom is disposed of , together   with an indication of any potential risks the   medicinal product might pose to the environment   and the health of humans , animals or plants ;    8 . indication of the withdrawal period necessary   between the last administration of the veterinary   medicinal product to animals under normal   conditions of use and the production of foodstuffs   from such animals in order to ensure that such   foodstuffs do not contain residues in   quantities in excess of the maximum limits laid down .   Where necessary , the applicant shall propose and   justify a tolerance level for residues which may be   accepted in foodstuffs without risk for the consumer ,   together with routine analysis methods which   could by used by the competent authorities to   trace residues ;    9 . description of the control testing methods   employed by the manufacturer qualitative and   quantitative analysis of the constituents and the   finished product , specific tests , e.g. sterility tests ,   test for the presence of pyrogens , for the presence   of heavy metals , stability tests , biological and   toxicity tests , tests on intermediate products ) ;    10 . results of :     - physico-chemical , biological or microbiological   tests ,     - toxicological and pharmacological tests ,     - clinical trials .    However , and without prejudice to the law   relating to the protection of industrial and   commercial property :     ( a ) the applicant shall not be required to   provide the results of toxicological and   pharmacological tests and clinical trials if he   can demonstrate :     ( i ) either that the veterinary medicinal   product is essentially similar to a medicinal   product authorized in the Member State   concerned by the application and that the person   responsible for placing the original   veterinary medicinal product on the market has   agreed that the toxicological , pharmacological or   clinical references contained in the file   on the original veterinary medicinal product may   be used for the purpose of examining the   application in question ;     ( ii ) or by detailed references to the scientific   literature presented in accordance with   the second paragraph of Article 1 of Directive   81/852/EEC , as amended by Directive 87/20/EEC ,   that the constituent or constituents of the veterinary   medicinal product have a well-established medicinal use ,   with recognized efficacy and an acceptable   level of safety ;     ( iii ) or that the veterinary medicinal product   is essentially similar to a product which   has been authorized within the Community ,   in accordance with Community provisions in   force , for not less than six years and is marketed in the   Member State for which the application is made ;   this period shall be extended to 10 years in the   case of high-technology medicinal products   appearing on the list in Part A of the Annex to Directive   87/22/EEC (*) or of a medicinal product appearing   on the list in Part B of the Annex to that   Directive for which the procedure laid down in   Article 2 of that Directive has been followed .   Furthermore , a Member State may also extend   this period to 10 years by a single Decision covering all   the products marketed in its territory where it   considers this necessary in the interest of public   health . Member States are at liberty not to   apply the abovementioned six-year period beyond the date   of expiry of a patent protecting the original   product ;     ( b ) in the case of new veterinary medicinal   products containing known constituents not   hitherto used in combination for therapeutic   purposes , the results of toxicological and   pharmacological tests and of clinical trials   relating to that combination must be provided ,   but it shall not be necessary to provide   references relating to each individual constituent :    11 . a summary in accordance with Article 5a of the   product characteristics , one or more specimens   or mock-aps of the sales presentation of the   veterinary medicinal product together with the   package insert referred to in Article 48 ( 1 ) ;    12 . a document showing that the manufacturer is   authorized in his own country to produce   veterinary medicinal products ;    13 . any authorization to place the relevant veterinary   medicinal product on the market which may have   been obtained in another Member State or in a   third country , together with a list of those   countries to which an application for   authorization to place the product on the market   has been made and explanation of the reasons for   which the Member State or third country has   refused to grant authorization for the veterinary   medicinal product concerned ;    14 . in the case of medicinal products containing new   active ingredients which are not mentioned in   Annex I , II or III to Regulation ( EEC )   No 2377/90 , a copy of the documents submitted   to the Commission in accordance with Annex V   to the Regulation .    (*) OJ No L 15 , 17 . 1 . 1987 , p. 38 . "    6 . The following Article is inserted :     " Article 5a    The summary of the product characteristics referred to   in point 11 of point 2 of the second paragraph of   Article 5 shall contain the following information :    1 . name of the veterinary medicinal product ;    2 . qualitative and quantitative composition in terms   of the active ingredients and constituents of the   excipient , knowledge of which is essential for   proper administration of the medicinal product ;   the international non-proprietary names   recommended by the World Health Organization   shall be used , where such names exist , or failing   this , the usual non-proprietary name or chemical   description ;    3 . pharmaceutical form ;    4 . pharmacological properties and , in so far as this   information is useful for therapeutic purposes ,   pharmacokinetic particulars ;    5 . clinical particulars :    5.0 target species ,    5.1 indications for use , specifying the target species ,    5.2 contra-indications ,    5.3 undesirable effects ( frequency and seriousness ) ,    5.4 special precautions for use ,    5.5 use during pregnancy and lactation ,    5.6 interaction with other medicaments and other   forms of interaction ,    5.7 posology and method of administration ,    5.8 overdose ( symptoms , emergency procedures ,   antidotes ) ( if necessary ) ,    5.9 special warnings for each target species ,    5.10 withdrawal periods ,    5.11 special precautions to be taken by the person   administering the product to animals ;    6 . pharmaceutical particulars :    6.1 incompatibilities ( major ) ,    6.2 shelf life , when necessary after reconstitution   of the product or when the container is   opened for the first time ,    6.3 special precautions for storage ,    6.4 nature and contents of container ,    6.5 name or style and permanent address or   registered place of business of the holder of   the authorization to place the product on the   market ,    6.6 special precautions for the disposal of unused   product or waste materials , if any . "    7 . The following Article is inserted :     " Article 5b    When the authorization to place the product on the   market , referred to in Article 4 ( 1 ) , is issued , the   person responsible for placing that product on the market   shall be informed , by the competent authorities of the   Member States concerned , of the summary of the   product characteristics as approved by them . The   competent authorities shall take all necessary measures   to ensure that the information given in the summary   is in conformity with that accepted when the   authorization to place the product on the market is   issued or subsequently . "    8 . The last sentence of Article 7 is replaced by the   following :     " The experts " detailed reports shall form part of the   documentation which the applicam shall lodge with the   competent authorities . A brief curriculum vitae of the   expert shall be appended to each report . "    9 . Article 9 ( 2 ) is replaced by the following :     " 2 . may submit the medicinal product , its active   principles and if necessary intermediate products   or other constituent materials for testing by a State   laboratory or by a laboratory designated for that   purpose , in order to ensure that the testing   methods employed by the manufacturer and   described in the application documents , in   accordance with point 9 of the second paragraph   of Article 5 , are satisfactory . "    10 . In Article 9 , the following point is added :     " 4 . may require the applicant to submit substances in   the quantities necessary to verify the analytical   detection method proposed by the applicant in   accordance with point 8 of the second paragraph   of Article 5 and to put it into effect as part of   routine checks to reveal the presence of residues of   the veterinary medicinal products concerned " .    11 . Article 14 is replaced by the following :     " Article 14    1 . After an authorization has been issued , the   person responsible for placing the product on the   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   progress and introduce any changes that may be   required to enable the veterinary medicinal product to   be checked by means of generally accepted scientific   methods . These changes must be approved by the   competent authorities of the Member States   concerned .    Upon request from the competent authorities , the   person responsible for placing the product on the   market shall also review the analytical detection   methods provided for in point 8 of the second   paragraph of Article 5 and propose any changes which   may be necessary to take account of scientific and   technical progress .    2 . The person responsible for placing the product on   the market shall forthwith inform the competent   authorities of any new information which might entail   the amendment of the particulars and documents   referred to in Article 5 or the approved summary of the   product characteristics referred to in Article 5b . In   particular , he shall forthwith inform the competent   authorities of any prohibition or restriction imposed by   the competent authorities of any country in which the   veterinary medicinal product is marketed and of any   serious unexpected reaction occuring in the animals   concerned or human beings .    3 . The person responsible for placing the product on   the market shall be required to maintain records of all   undesitable effects observed in animals or human   beings . The records so established shall be kept for at   least five years and shall be made available to the   competent authorities upon request .    4 . The person responsible for placing the product on   the market shall immediately inform the competent   authorities , with a view to authorization , of any   alteration he proposes to make to the particulars and   documents referred to in Article 5 . "    12 . Article 15 is replaced by the following :     " Article 15    Authorization shall be valid for five years and shall be   renewable for five year periods , on application by the   holder at least three months before the date of   expiry .    However , veterinary medicinal products which contain   active substances included in Annex III to Regulation   ( EEC ) No 2377/90 shall be authorized only for the   period for which a provisional tolerance has been   established and authorization may be extended if the   provisional tolerance is renewed . "    13 . Chapter IV of Directive 81/851/EEC is replaced by   the following :     " CHAPTER IV    Committee for Veterinary Medicinal Products    Article 16    1 . In order to facilitate the adoption of a common   position by the Member States with regard to decisions   on the issue of authorizations to place products on the   market and to promote thereby the free movement   of veterinary medicinal products , a Committee for   Veterinary Medicinal Products , hereinafter referred to   as " the Committee " and composed of representatives of   the Member States and of the Commission , is hereby set   up .    2 . The Committee's task shall be to examine , at the   request of a Member State or the Commission and   in accordance with Articles 17 to 22 , questions   concerning the application of Articles 11 , 36 and 49 .    3 . The Committee shall draw up its own rules of   procedure , which shall be published by the   Commission .    The rules of procedure shall provide for , in   particular :     - the publication of the names and qualifications of   the members of the Committee ;     - appropriate safeguards to ensure that the members   of the Committee discharge their responsabilities   with complete impartiality .    The Commission shall maintain available for public   inspection at its offices a register of all interests   relating to the pharmaceutical industry held by   members of the Committee and persons taking part in its   discussions .    Article 17    1 . In order to make it easier to obtain an   authorization to place a product on the market in at   least two other Member States taking into due   consideration an authorization issued in one Member   State in accordance with Article 4 , the holder of the   latter authorization may submit an application to the   competent authorities of the Member States concerned   together with the information and documents referred   to in Articles 5 , 5a and 5b .    He shall testify to its identity with the dossier   accepted by the first Member State , specifying any   additions it may contain , and shall certify that all   the dossiers filed as part of this procedure are   identical .    2 . The holder of the authorization to place a   product on the market shall notify the Committee of the   application , inform it of the Member States concerned   and send it a copy of the authorization . He shall also   inform the Member State which granted him the initial   authorization and notify it of any additions to the   original dossier ; that State may require the applicant to   provide it with all the particulars and documents   necessary to enable it to check the identity of the   dossiers filed with the dossier on which it took its   decision .    3 . The holder of the authorization to place a   product on the market shall notify the dates on which   the dossiers were sent to the Member States concerned ;   the latter shall immediately send an acknowledgement   of receipt of the dossier to the Committee and to the   person responsible for placing the product on the   market . As soon as the Committee has noted that all the   Member States concerned are in possession of the   dossier , it shall forthwith inform all the Member States   and the applicant of the date on which the last Member   State concerned received the dossier . The Member   States concerned shall either grant the authorization   valid for their markets within a period of 120 days of   the aforementioned date , taking into due consideration   the authorization issued in accordance with   paragraph 1 , or put forward a reasoned objection .    Article 18    1 . Where a Member State considers that it is unable   to grant an authorization to place a product on the   market , it shall forward to the Committee and to the   person responsible for placing the veterinary medicinal   product on the market its reasoned objection in   accordance with Article 11 , within the time limits   stipulated in Article 17 ( 3 ) .    2 . Upon the expiry of this period , the matter shall   be referred to the Committee and the procedure referred to   in Articles 21 and 22 shall be applied .    3 . On receipt of the reasoned objection referred   to in paragraph 1 , the person responsible for placing the   product on the market shall immediately send the   Committee a copy of the particulars and documents   referred to in Article 17 ( 1 ) .    Article 19    Where several applications submitted in accordance   with Articles 5 and 5a have been made for   authorization to place a particular veterinary medicinal   product on the market , and one or more Member States   have granted an authorization while one or more of the   other Member States have refused it , one of the   Member States concerned or the Commission or the   person responsible for placing the product on the   market may refer the matter to the Committee for   application of the procedure provided for in Articles 21   and 22 . The Member States will be informed each time   this procedure is invoked .    The same shall apply where one or more Member States   have suspended or revoked an authorization to place a   product on the market while one or more Member   States have not done so .    In both cases , the person responsible for placing the   veterinary medicinal product on the market shall be   informed of any decision of the Committee to apply the   procedure provided for in Article 22 .    Article 20    The competent authorities of Member States may , in   specific cases where the interests of the Community are   involved , refer the matter to the Committee before   reaching a decision on a request for authorization to   place a product on the market or on the suspension or   revocation of an authorization .    Article 21    1 . The competent authorities shall draw up an   assessment report and comments on the dossiers as   regards the result of the analytical and   toxico-pharmacological tests on , and clinical trials of ,   any veterinary medicinal products containing a new   active substance which are the subject of a request for   authorization to place the products on the market in the   Member States concerned for the first time .    2 . As soon as the notification referred to in   Article 17 is received , the competent authorities shall   immediately communicate to the Member States   concerned an assessment report , accompanied by a   summary of the dossier relating to an particular   veterinary medicinal product . This report shall also be   communicated to the Committee where a matter is   referred to the Committee pursuant to Article 18 .    The assessment report shall also be forwarded to the   other Member States concerned and to the Committee   as soon as a matter is referred to the Committee under   the procedure laid down in Article 19 . Any assessment   report so forwarded shall remain confidential .    The competent authorities shall bring the assessment   report up to date as soon as it is in possession of   information which is of importance for the evaluation   of the balance between effectiveness and risk .    Article 22    1 . Where reference is made to the procedure   described in this Article , the Committee shall consider   the matter concerned and issue a reasoned opinion   within 60 days of the date on which the matter was   referred to it .    In the case referred to in Article 18 , the person   responsible for placing the product on the market may ,   at his request , provide an oral or written explanation   and provide additional information before the   Committee issues its opinion . The Committee may   extend the time limit referred to in the preceding   paragraph to give the applicant time to provide an oral   or written explanation .    In the case referred to in Article 19 , the person   responible for placing the product on the market may be   asked to provide an oral or written explanation .    2 . The Committee's opinion shall concern the   grounds for the objection provided for in Article 18 ( 1 )   and the grounds on which the authorization to place the   product on the market has been refused , suspended or   withdrawn in the cases described in Article 19 .    The Committee shall immediately inform the Member   States concerned and the person responsible for placing   the product on the market of its opinion or of the   opinions of its members where the latter differ .    3 . The Member State or States concerned shall   decide on the action to be taken further to the   Committee's opinion within 60 days of the notification   referred to in paragraph 2 . They shall immediately   inform the Committee of their decision .    Article 23    The Commission shall report to the Council every two   years on the operation of the procedure laid down in   this Chapter . "    14 . Article 24 ( 1 ) is replaced by the following :     " 1 . Member States shall take all appropriate   measures to ensure that the manufacture of veterinary   medicinal products is subject to the holding of an   authorization . This manufacturing authorization shall   likewise be required for veterinary medicinal products   intended for export . "    15 . The following is added to Article 24 ( 3 ) :     " Member States shall take all appropriate measures to   ensure that veterinary medicinal products brought into   their territory form a third country and destined for   another Member State are accompanied by a copy of   the authorization referred to in paragraph 1 . "    16 . The following Article is inserted :     " Article 24a    At the request of the manufacturer of veterinary   medicinal products , the exporter thereof or the   authorities of an importing third country . Member   States shall certify that such manufacturer is in   possession of the authorization referred to in   Article 24 . When issuing such certificates . Member   States shall comply with the following conditions :    1 . Member States shall have regard to the prevailing   administrative arrangements of the World Health   Organization ;    2 . for veterinary medicinal products intended for   export which are already authorized in their   territory , they shall supply the summary of the   product characteristics as approved in accordance   with Article 5b or , in the absence thereof , an   equivalent document .    Where the manufacturer is not in possession of an   authorization to place the product on the market , he   shall provide the authorities responsible for   establishing the certificate referred to in the first   paragraph with a declaration explaining why such   authorization is not available . "    17 . In Article 27 , the following is added :     " ( f ) comply with the principles and the guidelines of   good manufacturing practice for medicinal products   laid down by Community law ;     ( g ) keep detailed records of all veterinary medicinal   products supplied by him , including samples , in   accordance with the laws of the countries of   destination . The following information at least   shall be recorded in respect of each transaction ,   whether or not it is made for payment :     - date ,     - name of the veterinary medicinal product ,     - quantity supplied ,     - name and address of the recipient ,     - batch number .    These records shall be available for inspection by   the competent authorities for a period of at least   three years . "    18 . The following Article is inserted :     " Article 27a    The principles and guidelines of good manufacturing   practice for veterinar , medicinal products referred to in   Article 27 ( f ) shall be adopted in the form of a Directive   addressed to the Member States in accordance with the   procedure laid down in Article 2c of Directive   81/852/EEC , taking account of the specific nature of   the veterinary medicinal product . Detailed guidelines   shall be published by the Commission and revised as   appropriate to take account of scientific and technical   progress . "    19 . Article 34 is hereby amended as follows :     ( a ) The first paragraph is replaced by the following :     " The competent authority of the Member State   concerned shall ensure by means of repeated   inspection that the legal requirements relating to   veterinary medicinal products are complied with . "     ( b ) The following paragraph is added :     " The officials representing the competent authority   shall report after each of the inspections mentioned   in the first paragraph on whether the manufacturer   complies with the principles and guidelines of good   manufacturing practice referred to in Article 27a .   The inspected manufacturer shall be informed of   the content of such reports . "    20 . The following Article is added :     " Article 38a    Member States shall take appropriate measures to   encourage veterinarians and other professionals   concerned to report to the competent authorities any   undesirable effect of veterinary medicinal products . "    21 . Article 39 is replaced by the following :     " Article 39    Member States shall take all measures necessary to   ensure that the competent authorities concerned   communicate the appropriate information to each   other , in particular regarding compliance with the   requirements adopted for authorization as referred to in   Article 24 ( 1 ) , or for authorization to place products   on the market , for the purpose of verifying compliance   with the provisions of Chapter VIII .    Upon reasoned request , Member States shall forthwith   communicate the reports referred to in the third   paragraph of Article 34 to the competent authorities of   another Member State . If , after considering the reports ,   the Member State receiving the reports considers that it   cannot accept the conclusions reached by the competent   authority of the Member State in which the report was   established , it shall inform the competent authorities   concerned of its reasons and may request further   information . The Member States concerned shall   attempt to reach agreement . If necessary , in the event of   serious differences of opinion , one of the Member   States concerned shall inform the Commission . "    22 . Article 42 is replaced by the following :     " Article 42    1 . Each Member State shall take all appropriate   measures to ensure that the Committee is informed   immediately of decisions granting marketing   authorization and of all decisions refusing or   withdrawing marketing authorization , cancelling a   decision refusing or withdrawing marketing   authorization , prohibiting supply or withdrawing a   product from the market , together with the reasons on   which such decisions are based .    2 . The person responsible for placing a veterinary   medicinal product on the market shall be obliged to   notify the Member States forthwith of any action taken   by him to suspend the marketing of a product or to   withdraw a product from the market , together with the   reasons for such action if it concerns the effectiveness of   the veterinary medicinal product or the protection of   public health . Member States shall ensure that this   information is brought to the attention of the   Committee .    3 . Member States shall ensure that appropriate   information about actions taken pursuant to   paragraphs 1 and 2 which may affect the protection of   health in third countries is forthwith brought to the   attention of the relevant international organizations ,   with a copy to the Committee . "    23 . The first paragraph to Article 43 is hereby   amended as follows :     ( a ) Points 1 and 2 are replaced by the following :     " 1 . Name of the veterinary medicinal product ,   which may be a brand name or a non-proprietary   name accompanied by a trade mark or the   name of the manufacturer , or a scientific name or   formula , with or without a trade mark , or the name   of the manufacturer .    Where the special name of a medicinal product   containing only one active ingredient   is a brand name , this name must be   accompanied in legible characters by the   international non-propriety name recommended by the   World Health Organization , where such names exist or ,   where no such name exists , by the usual   non-proprietary name .    2 . A statement of the active ingredients   expressed qualitatively and quantitatively per   dosage unit or according to the form of   administration for a particular volume or   weight , using the international non-proprietary   names recommended by the World Health Organization ,   where such names exist or , where no such names exist ,   the usual non-proprietary names . "     ( b ) Points 7 and 8 are replaced by the following :     " 7 . The withdrawal period , even if nil , in   the case of veterinary medicinal products administered   to food-producing animals .    8 . Expiry date , in plain language . "     ( c ) The following point is inserted :     " 9a . Special precautions for disposal of unused   product or waste material , if any . "    24 . In Article 48 , the first paragraph is   replaced by the following :     " The inclusion of a package insert in the packaging   of veterinary medicinal products shall be obligatory   unless all the information required by this Article can   be conveyed on the container and the external   packaging . Member States shall take all appropriate   measures to ensure that the insert relates solely to the   veterinary medicinal product with which it is included .   The insert shall be in the official language or languages   of the Member State in which the medicinal product is   marketed . "    25 . The second paragraph of Article 48 is hereby   amended as follows :     ( a ) Point ( e ) is replaced by the following :     " ( e ) the withdrawal period , even if this is nil ,   in the case of veterinary medicinal products   administered to food-producing animals ; "     ( b ) The following point is added :     " ( h ) special precautions for the disposal of   unused product or waste materials , if any . "    26 . The final paragraph of Article 48 is deleted .    27 . The following Chapter VIII is inserted :     " CHAPTER VIIIa    Distribution of veterinary medicinal products    Article 50a   1 . Member States shall take all appropriate   measures to ensure that wholesale dealing in veterinary   medicinal products is subject to the holding of an   authorization and to ensure that the time taken for the   procedure for granting this authorisation does not   exceed 90 days from the date on which the competent   authority receives the application .    For the purposes of this Directive , wholesale dealing   shall include the purchase , sale , import , export , or   any other commercial transaction in veterinary medicinal   products , whether or not for profit , except for :     - the supply by a manufacturer of veterinary   medicinal products manufactured by himself ,     - retail supples of veterinary medicinal products by   persons permitted to carry out such supplies in   accordance with Article 50b .    Member States may also exclude supples of small   quantities of veterinary medicinal products from one   retailer to another .    2 . In order to obtain the authorization referred to in   paragraph 1 , the applicant shall have at his disposal   technically competent staff and suitable and sufficient   premises complying with the requirements laid down in   the Member State concerned as regards the storage and   handling of products .    3 . The holder of the authorization referred to in   paragraph 1 shall be required to keep detailed records .   The following minimum information shall be recorded   in respect of each incoming or outgoing transaction :     ( a ) date ;     ( b ) precise identity of the veterinary medicinal   product ;     ( c ) manufacturer's batch number , expiry date ;     ( d ) quantity received or supplied ;     ( e ) name and address of the supplier or recipient .    At least once a year a detailed audit shall be carried   out to compare incoming and outgoing supplies with   supplies currently held in stock , any discrepancies being   recorded .    These records shall be available for inspection by the   competent authorities for a period of at least three   years .    4 . Member States shall take all appropriate   measures to ensure that wholesalers supply veterinary   medicinal products only to persons permitted to carry   out retail activities in accordance with Article 50b , or to   other persons who are lawfully permitted to receive   veterinary medicinal products from wholesalers .    Article 50b    1 . Member States shall take all appropriate   measures to ensure that the retail supply of veterinary   medicinal products is conducted only by persons who   are permitted to carry out such operations by the   legislation of the Member State concerned .    2 . Any person permitted under the preceding   paragraph to sell veterinay medicinal products shall be   required to keep detailed records . The following   information shall be recorded in respect of each   incoming or outgoing transaction :     ( a ) date ;     ( b ) precise identity of the veterinary medicinal   product ;     ( c ) manufacturer's batch number ;     ( d ) quantity received or supplied ;     ( e ) name and address of the supplier or recipient ;     ( f ) where relevant , name and address of the   prescribing veterinarian and a copy of the   prescription .    At least once a year a detailed audit shall be carried   out , and incoming and outgoing products shall be   reconciled with products currently held in stock , any   discrepancies being recorded .    These records shall be available for inspection by the   competent authorities for a period of three years .    3 . Member States may limit the scope of the   record-keeping requirements referred to in   paragraph 2 . However , these requirements shall   always be applied in case of veterinary medicinal   products intended for administration to animals whose   flesh or products are intended for human consumption   and which are available only on veterinary prescription   or in respect of which a withdrawal period must be   observed .    4 . Not later that 1 January 1992 , Member States   shall communicate to the Commission a list of the   veterinary medicinal products which are available   without prescription . After having taken note of the   communication from the Member States , the   Commission shall examine whether suitable measures   should be proposed for drawing up a Community list of   such products .    Article 50c    Member States shall ensure that the owners or keepers   of food-producing animals can provide proof of   purchase , possession and administration of veterinary   medicinal products containing the substances set out in   Article 1 ( 5 ) ; Member States may extend the scope of   this obligation to other medicinal veterinary products .    In particular , Member States may require the   maintenance of a record giving at least the following   information :     ( a ) date ;     ( b ) identity of the veterinary medicinal product ;     ( c ) quantity ;     ( d ) name and address of the supplier of the   medicinal product ;     ( e ) identification of the animals treated . "    Article 2    1 . Member States shall take the necessary measures to   comply with this Directive not later than 1 January   1992 . They shall forthwith inform the Commission   thereof .    2 . By way of derogation from paragraph 1 , Member   States shall take the necessary measures to comply with   Article 27 ( f ) and the third paragraph of   Article 34 not later than two years after notification   of the Directive referred to in Article 27a .    3 . Where Member States adopt the provisions referred to   in paragrahs 1 and 2 , such provisions shall contain a   referece to this Directive or shall be accompanied by   such reference on the occasion of their official   publication . The methods of making such a reference   shall be laid down by the Member States .    4 . Request for authorization to place products on the   market lodged from the date set out in paragraph 1 must   comply with the provisions of this Directive .    5 . Within four years of the date set out in paragraph 1 ,   Article 1 shall , where relevant , be progressively   extended to existing veterinary medicinal products .    Article 3    This Directive is addressed to the Member States .    Done at Brussels , 13 December 1990 .    For the Council    The President    P. ROMITA    (1) OJ No C 61 , 10 . 3 . 1989 , p. 11 and OJ No   C 131 , 30 . 5 . 1990 , p. 16 .    (2) OJ No C 96 , 17 . 4 . 1990 , p. 104 and Decision   of 21 November 1990 ( not yet published in the   Official Journal ) .    (3) OJ No C 201 , 7 . 8 . 1989 , p. 1 .    (4) OJ No L 317 , 6 . 11 . 1981 , p. 1 .    (5) OJ No L 317 , 6 . 11 . 1981 , p. 16 .    (6) OJ No L 15 , 17 . 1 . 1987 , p. 34 .    (*) OJ No L 224 , 18 . 8 . 1990 , p. 1 .    (**) The phrase " an animal or a small number of   animals on a particular holding " also covers pets ,   and should be interpreted more flexibly for minor   or exotic animal species which do not produce food . "