CELEX: 51977PC0073
Language: en
Date: 1977-03-15
Title: Amendment to the proposal for a Council Directive on the approximation of the laws of Member States relating to veterinary medicinal products#Amendment to the proposal for a Council Directive on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products. (presented by the Commission to the Council pursuant to the second paragraph of article 149 of the EEC Treaty)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (77) 73
Vol. 1977/0029
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                               COM(77)73 final.
                                               Brussels , 15 March 1977 «
 Amendment to the proposal for a Council Directive on the approximation
 of the laws of Member States relating to veterinary medicinal products
  Amendment to the proposal for a Council Directive on the approximation
  of the laws of Member " States ■ relating to analytical , pharmaco-toxi cologi ca I
  and clinical standards and protocols in respect of the testing of
  veterinary 'medicinal products -
           (presented "by the Commission to ; the Council pursuant to
                 the second paragraph of article 149 of the EEC
                                      Treaty)
      COM ( 77 ) 73 final .
 ---pagebreak---                         EXPLANATORY MEMORANDUM
 13 Myy 1976 the Commission submitted to the Council two proposals
 for cli recti ver. relating to veterinary ne-.Jicmjl prr;du'.ts ( OJEC
 C / 15 < of 5 July 1976).
 According to Article 100 of the Treaty the Economi : and Social
 Committee and the European Parliament have each ad ipted an opinion
 on the two proposals , respectively on 23 October 1 '76 ( doc . CES 1066/ 76
 of 23 October 1976) and on 19 November 1976 ( doc . *1327/ 76 ( ASS 853 )
 of 24 November 1976 ). In the opinions a number of amendments have
 been proposed .
 The Commission has followed the opinions by amending ■♦'he proposals
 for directives in the following cases :
 I. Proposals for a Council Directive on the approximation of the laws
      of Member States relating to veterinary medicinal products :
      - Article 13
      - Arti c le 14
      -- Arti c le 15 .
      - Arti c le 33
      - Article A ~S
II . Proposal tor a Council Directive on the approximation of the laws
      of Member States relating to analytical , phamaco-ioxi cologi ca I
      and clinical standards and protocols in respect of the testing of
      voter i nary metfcir.al products :
      - Article ?.
 ---pagebreak---  Anondrront to the proposal for a Council Directive on the approximation
 of the laws of Member States relating to veterinary medicinal products
 1 . The eighth recital is amended as follows :
       " Whereas it is advisable , in order gradually to achieve freedom of
         movement of veterinary medicinal products , to facilitate the granting
         of marketing authorizations in the Member States for one and the
         same medicinal product ;"
 2 . The tenth recital is amended as follows :
      " Whereas , to achieve freedom of movement of veterinary medicinal
        products , further measures will prove necessary in the light of
        experience gained , especially within the said Committee ;"
3 . The first paragraph of Article 13 is amended as follows :
      " The person responsible for marketing shall adapt    the test method
        provided for in 9    of the second paragraph of Article 4 , in accordance
        with the advancement of technology and the progress of science if
        such adaptation allows    more reliable testing of the medicinal product .
4 . Article 14 is amended as follows :
     " 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 , in accordance with the provisions
          of Article 13 ."
5 . The second paragraph of Article 15 is amended as follows :
     " The Committee shall , when so requested by a Member State , examine
       questions relating to the implementation of Articles 10 , 26 and
        40 , in accordance with Articles 16 to 21 ."
6 . It^m 7 of the first paragraph of Article 33 is amended as follows :
     " if necessary , the delay;"
                                                 \
7. The second paragraph . of Article 43 is amended as follows :
     " The other provisions of this Directive shall be applied progressively ,
       within five years of its entry into force , to veterinary medicinal
       products placed on the market by virtue of previous provisions ."
 ---pagebreak--- Amfcn ; nent to the proposal for a Council Directive on the approximation
'i . The ninth recital is deleted-
2 . Article 2 is amended as follows :
     " The Pharmaceutical Committee set up by the Council Decision of
       20 May 1975 ( 75 / 320/ EEC ) may examine any question relating to the
       application of this Directive which is brought up by its chairman ,
       either on his own initiative or at the request of the representative
       of a Member State ."