ARCHIVESHISTORIQUES
DELACOMMISSION
COLLECTION RELIEEDES
DOCUMENTS "COM"
COM(77)73
Vol.1977/0029

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COMMISSION OFTHEEUROPEAN COMMUNITIES
COM(77)73final.
Brussels,15March1977«
AmendmenttotheproposalforaCouncilDirectiveontheapproximation
ofthelawsofMemberStatesrelatingtoveterinarymedicinalproducts
AmendmenttotheproposalforaCouncilDirectiveontheapproximation
ofthelawsofMember "States ■relatingtoanalytical,pharmaco-toxi cologicaI
andclinicalstandardsandprotocolsinrespectofthetestingof
veterinary'medicinalproducts -
(presented "bytheCommissionto;theCouncilpursuantto
thesecondparagraphofarticle149oftheEEC
Treaty)
COM(77)73final.

EXPLANATORY MEMORANDUM
13Myy1976theCommissionsubmittedtotheCounciltwoproposals
forclirectiver.relatingtoveterinaryne-.Jicmjlprr;du'.ts(OJEC
C/15<of5July1976).
AccordingtoArticle100oftheTreatytheEconomi :andSocial
CommitteeandtheEuropeanParliamenthaveeachadiptedanopinion
onthetwoproposals,respectively on23October1'76(doc.CES1066/76
of23October1976)andon19November1976(doc.*1327/76(ASS853)
of24November1976).Intheopinionsanumberofamendments have
beenproposed.
TheCommissionhasfollowedtheopinionsbyamending ■♦'heproposals
fordirectivesinthefollowingcases:
I.ProposalsforaCouncilDirectiveontheapproximation ofthelaws
ofMemberStatesrelatingtoveterinarymedicinalproducts :
-Article13
-Article14
--Article15.
-Article33
-Article A~S
II.ProposaltoraCouncilDirectiveontheapproximation ofthelaws
ofMemberStatesrelatingtoanalytical,phamaco-ioxi cologicaI
andclinicalstandardsandprotocolsinrespectofthetestingof
voterinarymetfcir.alproducts:
-Article ?.

AnondrronttotheproposalforaCouncilDirectiveontheapproximation
ofthelawsofMemberStatesrelatingtoveterinarymedicinalproducts
1.Theeighthrecitalisamendedasfollows:
"Whereasitisadvisable,inordergraduallytoachievefreedomof
movementofveterinarymedicinalproducts,tofacilitatethegranting
ofmarketingauthorizations intheMemberStatesforoneandthe
samemedicinalproduct;"
2.Thetenthrecitalisamendedasfollows:
"Whereas,toachievefreedomofmovementofveterinarymedicinal
products,furthermeasureswillprovenecessaryinthelightof
experiencegained,especiallywithinthesaidCommittee;"
3.ThefirstparagraphofArticle13isamendedasfollows:
"Thepersonresponsibleformarketingshalladaptthetestmethod
providedforin9ofthesecondparagraphofArticle4,inaccordance
withtheadvancement oftechnology andtheprogressofscienceif
suchadaptationallowsmorereliabletestingofthemedicinalproduct.
4.Article14isamendedasfollows:
"Authorization shallbevalidforfiveyearsandshallberenewable
forfive-yearperiods,onapplication bytheholderatleastthree
monthsbeforethedateofexpiry,inaccordancewiththeprovisions
ofArticle13."
5.ThesecondparagraphofArticle15isamendedasfollows:
"TheCommitteeshall,whensorequestedbyaMemberState,examine
questionsrelatingtotheimplementation ofArticles10,26and
40,inaccordancewithArticles16to21."
6.It^m7ofthefirstparagraphofArticle33isamendedasfollows:
"ifnecessary,thedelay;"
\
7.Thesecondparagraph .ofArticle43isamendedasfollows:
"TheotherprovisionsofthisDirectiveshallbeappliedprogressively ,
withinfiveyearsofitsentryintoforce,toveterinarymedicinal
productsplacedonthemarketbyvirtueofpreviousprovisions."

Amfcn ;nenttotheproposalforaCouncilDirectiveontheapproximation
'i.Theninthrecitalisdeleted-
2.Article2isamendedasfollows:
"ThePharmaceutical CommitteesetupbytheCouncilDecisionof
20May1975(75/320/EEC)mayexamineanyquestionrelatingtothe
applicationofthisDirectivewhichisbroughtupbyitschairman,
eitheronhisowninitiativeorattherequestoftherepresentative
ofaMemberState."