No C 299/12 Official  Journal  of the European  Communities 18.12.  76 
Opinion  on the proposals  for: 
— a Council  Directive  on the approximation  of the laws  of the Member  States  relating 
to veterinary  medicinal  products 
— a Council  Directive  on the approximation  of the laws  of the Member  States  relating 
to analytical,  pharmaco-toxicological  and  clinical  standards  and  protocols  in respect 
of the testing  of veterinary  medicinal  products 
The text  referred  to the  Committee  has  been  published  in Official  Journal  of the 
European  Communities  No  C 152  of 2 July  1976,  page  1. 
A. LEGAL  BASIS  FOR  THE  OPINION 
On 24 May  1976,  the Council  referred  the abovementioned  proposal  to the Economic 
and Social  Committee  in accordance  with  Article  100  of the  Treaty  establishing  the 
European  Economic  Community. 
B. OPINION  OF THE  ECONOMIC  AND  SOCIAL  COMMITTEE 
The Economic  and  Social  Committee  prepared  its opinion  on the above  matter  at its 
142nd  plenary  session,  held  in Brussels  on 27 and  28 October  1976. 
The full  text  of the opinion  is as follows: 
THE  ECONOMIC  AND  SOCIAL  COMMITTEE, 
Having  regard  to  the  Treaty  establishing  the 
European  Economic  Community,  and  in particular 
Article  100  thereof, 
Having  regard  to the request  made  by the Council  of 
the European  Communities  on 24 May  1976  for an 
opinion, 
Having  regard  to the decision  taken  by its bureau  on 
24 May  1976,  instructing  the Section  for Agriculture 
to prepare  the Committee's  work  on the matter, 
Having  regard  to previous  Committee  work  on the 
matter  and,  more  specifically,  its opinions  on the 
proposal  for  a Directive  on the  approximation  of 
laws,  regulations  and  administrative  provisions 
relating  to proprietary  medicinal  products  (*), the 
proposal  for a second  Directive  on the approximation 
of laws,  regulations  and  administrative  provisions 
relating  to proprietary  medicinal  products  (2), and  the 
proposal  for a third  Directive  on the approximation 
of laws,  regulations  and  administrative  provisions 
relating  to proprietary  medicinal  products  (3), 
(') OJ  No 158,  16. 10. 1964. 
(2) OJ  No 107,  19. 6. 1965. 
(3) OJ  No C 73, 22. 7. 1968. Having  regard  to the  report  submitted  by  the 
rapporteur,  Mr Chabrol, 
Having  regard  to the opinion  issued  by the Section 
for Agriculture  at its meeting  on 7 October  1976, 
Having  regard  to the discussions  at its 142nd  plenary 
session,  held  on 27 and  28 October  1976  (meeting  of 
28 October), 
HAS  ADOPTED  THE  FOLLOWING  OPINION 
by a unanimous  vote: 
The Committee  approves  the  two  proposals  for 
Directives. 
In the  light  of accumulated  experience  and  the 
advances  made  in scientific  knowledge  in this  field, 
the Committee  considers  that  such  Directives 
designed  to  approximate  Member  States'  laws 
relating  to pharmaceuticals  will  not  only  facilitate 
inter-Member  State  trade  in pharmaceuticals,  but also 
help to  protect  public  health  and  encourage 
coordination  of the requisite  supervisory  measures. 
18. 12. 76 Official  Journal  of the European  Communities No C 299/13 
Nevertheless,  a detailed  examination  of  the 
Commission's  proposals  has  prompted  the 
Committee  to make  the  specific  comments  set out 
below. 
SPECIFIC  COMMENTS 
1. Proposal  for  a Council  Directive  on  the 
approximation  of the  laws  of Member  States 
relating  to veterinary  medicinal  products 
1.1. Article  2 (2) 
The Committee  notes  that  the  Directive  is not  to 
apply  to 'medicated  feedingstuffs'.  It also  notes  that 
the Commission  is preparing  proposals  on  this 
matter,  and  that,  in addition,  for  the  time  being, 
partial  cover  at least  is provided  by Articles  2 (3) and 
3 (2). 
Nevertheless,  the Committee  trusts  that  Community 
measures  on medicated  feedingstuffs  will  be adopted 
as soon  as possible  and  without  too  much  delay  in 
relation  to  other  Directives  dealing  with  the 
veterinary  medicinal  products  sector.  This  will  avoid 
having  to take  troublesome  steps  to ensure  continuity 
in the rules  governing  this  sector. 
1.2. Article  4 (10) 
The Committee  recognizes  that  the text  proposed  by 
the Commission  seems  to accord  with  the importance 
of the  subject  matter  and,  as a result,  need  not  be 
amended.  The  Committee  is strengthened  in this 
belief  by the fact  that  this  provision  is made  explicit 
by the Annex  to the second  of the two  proposals  for 
Directives  under  discussion. 
The Committee  finds,  however,  that  practical 
difficulties  may  arise  in some  cases  in applying  this 
provision.  It could  have  been  replaced  by a reference 
to the Annex  to the second  proposal  for a Directive 
on the  approximation  of the  laws  of the  Member 
States  relating  to  analytical,  pharmaceutical, 
toxicological  and  clinical  standards  and  protocols  in 
respect  of the  testing  of proprietary  medicinal 
products. 1.3. Article  9 (2) 
In the  light  of how  industry  actually  operates  in 
practice,  the  Committee  considers  it excessively 
stringent  to provide  that  manufacturers  are  to be 
authorized  to have  certain  stages  of manufacture 
carried  out  by third  parties  only  in exceptional  and 
justified  cases. 
1.4. Article  13 
The Committee  puts  forward  the  following  new 
rendering  of the  last  part  of the  first  paragraph  of 
Article  13: 
'... if such  adaptation  allows  more  reliable  testing 
of the medicinal  product.' 
The Committee  further  suggests  that  the opening  part 
of the  second  and  third  paragraphs  be amended  to 
read: 
'The  person  responsible  for placing  the veterinary 
medicinal  product  on the market  shall  forthwith 
notify  the  competent  authorities  ...' 
1.5. Article  15 (2) 
The Committee  considers  that  Article  15 (2) should 
read: 
'2. The  Committee  shall,  when  so requested  by 
a Member  State,  examine  questions  relating  to the 
implementation  of Articles  10, 20, 33 and  39, in 
accordance  with  Articles  16 to 21.' 
1.6. Article  16 
The Committee  suggests  that  the last  part  of Article 
16 (1) should  be amended  to read: 
'... their  transmission  to one  or more  Member 
States.' 
1.7. Articles  18 and 19 
The Committee  considers  that  the  Committee  for 
Veterinary  Medicinal  Products  should  not  base  its 
decisions  solely  on  documentation.  When 
appropriate,  direct  consultations  should  take  place 
with  manufacturers  and/or  experts  appointed  by 
manufacturers. 
1.8. Article  33 (6) and  (7) 
With  a view  to bringing  the provisions  of Article  33 
more  into  line  with  practical  realities,  the items  listed 
No C 299/14 Official  Journal  of the European  Communities 18.12.  76 
in Article  33  (6)  and  (7)  might,  depending  on 
requirements,  be printed  on the containers  and  outer 
packages  of medicinal  products  or on the descriptive 
insert  which  it is compulsory  to pack  with  such 
products. 
This  is necessary  above  all where  one  is dealing  with 
medicinal  products  which  may  be administered  to a 
variety  of animals,  in which  case  waiting  periods  are 
liable  to differ  considerably. 
A provision  to this  effect  should,  therefore,  be added 
to Article  39. 
1.9. Article  41 
It is unfortunate  that  the proposal  does  not  contain 
any measure  to coordinate  (a) the  instructions  for 
using  the products  in question,  or (b) the conditions 
under  which  such  products  are supplied  to the public. 
This  situation  should  be  remedied  as soon  as 
possible. 
1.10.  Article  43 (2) 
The Committee  considers  that  15 years,  as proposed 
by the  Commission,  is too  long.  It would  be more 
realistic  to set a period  of 10 years. 2. 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 
2.1. Article  2 
The Committee  stresses  that  the  amendment 
procedure  proposed  here  is purely  administrative  in 
character  and  does  not  provide  for  the compulsory 
consultation  of experts. 
There  is a risk  of  'technical  progress'  being 
interpreted  too widely. 
This  difficult  concept  could  be  defined  by  the 
Standing  Committee  for Medicinal  Products  itself  in 
the course  of its work.  The  Committee  feels  that 
technical  progress  should  be assessed  in the light  of 
its direct  and  indirect  benefits  to public  health. 
The Standing  Committee  will  have  to discuss 
scientific  matters  which  will  have  an effect  on the 
authorization  of products  and  their  manufacture.  The 
Standing  Committee  should  therefore  engage  in close 
consultations  with  the  appropriate  trade  and 
professional  bodies. 
Done  at Brussels,  28 October  1976. 
The Chairman 
of the Economic  and  Social  Committee 
Basil  de FERRANTI 
Opinion  on the proposal  for a Council  Directive  on the harmonization  of provisions  laid 
down  by law,  regulation  or administrative  action  relating  to customs  debt 
The text  referred  to the  Committee  has  been  published  in Official  Journal  of the 
European  Communities  No  C 128  of 10 June  1976,  page  48. 
A. LEGAL  BASIS  FOR  THE  OPINION 
On 28 April  1976,  the Council  referred  the abovementioned  proposal  to the Economic 
and Social  Committee  in accordance  with  Article  100  of the  Treaty  establishing  the 
European  Economic  Community.