No C 116/24 Official  Journal  of the European  Communities 30.9.74 
ANNEX 
to the Opinion  of the Economic  and  Social  Committee 
The following  amendment,  tabled  in accordance  with  the  procedure  laid  down  in the  Rules 
of Procedure,  was  rejected  in discussion. 
Point  1.6. 
Amend  the second  sentence  to read: 
. . Despite  this,  the  Committee  considers  that  the  ceiling  proposed  by the  Commission 
should  be examined  in more  detail.  In some  Member  States  the levels  of aid  proposed  . . 
Result  of the vote: 
For: 26. 
Against:  29. 
Abstentions:  15. 
Opinion  on the 
— 'Amendment  to the proposal  for 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 proprietary  medicinal  products' 
— 'Amendment  to the proposal  for a Council  Directive  on the approximation  of the 
laws  of the Member  States  relating  to publicity  for proprietary  medicinal  products 
and to package  leaflets' 
— 'Amendment  to the proposal  for a Council  Directive  on the approximation  of the 
laws  of the Member  States  relating  to matter  which  may  be added  to proprietary 
medicinal  products  for colouring  purposes' 
The text  referred  to the  Committee  has  been  published  in Official  Journal  of the 
European  Communities  No  C 35 of 28 March  1974,  pages  68 and  69. 
A. LEGAL  BASIS  FOR  THE  OPINION 
On 18 February  1974,  the  Council  referred  the  abovementioned  proposal  to the 
Economic  and  Social  Committee  in accordance  with  Article  198  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 
121st  plenary  session,  held  in Brussels  on 26 and  27 June  1974. 
The full  text  of the Opinion  is as follows: 
30.9.74 Official  Journal  of the European  Communities No C 116/25 
THE  ECONOMIC  AND  SOCIAL  COMMITTEE: 
Having  regard  to the  request,  dated  19 February 
1974,  by  the  President  of the  Council  of the 
European  Communities  for  an  opinion  on  the 
'Amendment  to the proposal  for a Council  Directive 
on the  approximation  of the  laws  of the  Member 
States  relating  to analytical,  pharmaco-toxocological 
and clinical  standards  and  protocols  in respect  of the 
testing  of  proprietary  medicinal  products',  the 
'Amendment  to the proposal  for a Council  Directive 
on the  approximation  of the  laws  of the  Member 
States  relating  to the  publicity  for  proprietary 
medicinal  products  and  to package  leaflets'  and  the 
'Amendment  to the proposal  for a Council  Directive 
on the  approximation  of the  laws  of the  Member 
States  relating  to matter  which  may  be added  to 
proprietary  medicinal  products  for  colouring 
purposes'; 
Having  regard  to  Article  198  of  the  Treaty 
establishing  the European  Economic  Community; 
Having  regard  to the Decision  taken  by the Bureau  of 
the Economic  and  Social  Committee  on 26 February 
1974  entrusting  the Section  for Industry,  Commerce, 
Crafts  and  Services  with  the  preparation  of an 
opinion  and  a report  on the matter; 
Having  regard  to the  Opinion  delivered  by  the 
Section  for Industry,  Commerce,  Crafts  and  Services 
at its meeting  on  5 June  1974  (rapporteur  Mr 
Chabrol); 
Having  regard  to the supplementary  Opinion  of the 
Section  for the Protection  of the Environment,  Public 
Health  and  Consumer  Affairs  delivered  on 13 May 
1974; 
Having  regard  to the discussions  at its 121st  plenary 
session  held  on 26 and  27 June  1974,  sitting  of 27 
June  1974, 
HAS  ADOPTED  THE  FOLLOWING  OPINION 
unanimously: 
The Economic  and  Social  Committee  approves  the 
amendments  subject  to the comments  listed  below. 
1. The  Economic  and  Social  Committee  approves 
the Commission's  proposals  for  facilitating  the 
adaptation  of certain  provisions  to take  account  of 
technical  progress  by  means  of a flexible  and simplified  procedure.  It has  repeatedly  advocated 
such  a procedure,  especially  in connection  with 
Directives  for eliminating  technical  barriers  to trade. 
2. The  Committee  notes  that  in the  amendments 
to the  Directives  relating  to the  publicity  for 
proprietary  medicinal  products  and  to  package 
leaflets  and  to matter  which  may  be  added  to 
proprietary  medicinal  products  for  colouring 
purposes,  the powers  of the Standing  Committee  for 
Medicinal  Products  are  precisely  defined  and 
delimited.  In the case  of the  proposal  on analytical, 
pharmaco-toxicological  and  clinical  standards  and 
protocols  in respect  of the  testing  of proprietary 
medicinal  products,  however,  Article  3 (3) and  (4) 
expressly  states  that  the  Standing  Committee  for 
Medicinal  Products  'may  examine  any  question 
concerning  the operation  of this  Directive  raised  by 
its Chairman  either  on his own  initiative  or at the 
request  of a representative  of a Member  State'  and 
that 'any  amendments  needed  to adapt  the Annex  to 
this Directive  to technical  progress  shall  be adopted 
in accordance  with  the  procedure  laid  down  in 
paragraph  5'. 
3. The  Committee  would  draw  attention  to the 
danger  of giving  too wide  a definition  to the notion 
of 'technical  progress',:—  namely  that  this  would  not 
only  enable  direct  amendments  to be made  to the 
Directive  on standards  and  protocols,  but would  also 
enable  indirect  amendments  to be  made  to the 
provisions  of other  Directives  harmonizing  the very 
conditions  for the issue  of marketing  authorization. 
The procedure  of Article  100  of the  EEC  Treaty  is 
laid down  for such  indirect  amendments. 
4. The  Committee  realizes  how  difficult  it is to 
define  the meaning  of 'technical  progress';  this  will, 
however,  be able  to be defined  by the  Standing 
Committee  for Medicinal  Products  itself  in the course 
of its activity.  Nevertheless,  the Committee  considers 
that technical  progress  should  in particular  be 
assessed  in the light  of its direct  and  indirect  benefits 
for public  health. 
5. As  for the working  of the Standing  Committee 
for Medicinal  Products,  the Committee  considers  that 
the scientific  nature  of the  questions  it will  have  to 
discuss  and  their  effect  on the implementation  of the 
process  of authorizing  proprietary  medicinal  products 
and on  their  manufacture,  require  that  the 
appropriate  professional  bodies  concerned  be closely 
consulted. 
6. The  Committee  is surprised  that  — with  the 
exception  of Directive  No 65/65/EEC  of 26 January 
1965  — the Council  has  not  yet taken  decisions  on 
No C 116/26 Official  Journal  of the European  Communities 30. 9. 74 
all the  draft  Directives  concerning  authorization  to 
market  and  manufacture  medicinal  products.  It 
draws  attention  to its Opinions  on the  draft  Direc-
tives  in question,  and  requests  that  these  draft Directives  be swiftly  adopted  in order  to enable  a 
start  to be made  on achieving  a genuine  common 
market  for medicinal  products. 
Done  at Brussels,  27 June  1974. 
The Chairman 
of the Economic  and  Social  Committee 
Alfons  LAPPAS 
Opinion  on the  'Communication  from  the  Commission  to the  Council  on  the 
implementation  of the  "Guidelines  and  priority  measures  for  a Community  energy 
policy"  — Promotion  of the use of nuclear  energy' 
The text  referred  to the  Committee  has  been  published  in Official  Journal  of the 
European  Communities  No  C 44 of 19 April  1974,  pages  12 and  13. 
A. LEGAL  BASIS  FOR  THE  OPINION 
On 25 February  1974,  the  Council  referred  the  abovementioned  proposal  to the 
Economic  and  Social  Committee  in accordance  with  Article  170  of the  Treaty 
establishing  the European  Atomic  Energy  Community. 
B. OPINION  OF  THE  ECONOMIC  AND  SOCIAL  COMMITTEE 
The Economic  and  Social  Committee  prepared  its Opinion  on the above  matter  at its 
121st  plenary  session,  held  in Brussels  on 26 and  27 June  1974. 
The full  text  of the Opinion  is as follows: 
THE  ECONOMIC  AND  SOCIAL  COMMITTEE: 
Having  regard  to the letter  dated  25 February  1974, 
in which  the Council  of the European  Communities 
requested  the Committee  to deliver  an opinion  on the 
'Communication  from  the  Commission  to  the 
Council  on the  implementation  of the  "Guidelines 
and priority  measures  for  a Community  energy 
policy"  — Promotion  of the use of nuclear  energy'; 
Having  regard  to  the  Treaty  establishing  the 
European  Atomic  Energy  Community,  and  in 
particular  the second  sentence  of the first  paragraph 
of Article  170  thereof; Having  regard  to the Decision  taken  by its Bureau  on 
26 March  1974  instructing  the Section  for Energy  and 
Nuclear  Questions  to prepare  a report  and  an 
opinion  on the matter; 
Having  regard  to its Opinion  of 24 May  1973  on the 
'Proposal  for  a Directive  (Euratom)  amending  the 
Directives  laying  down  the basic  safety  standards  for 
the protection  of the  health  of workers  and  the 
general  public  against  the  dangers  of ionizing 
radiation'; 
Having  regard  to its Opinion  of 27 June  1973  on the 
'Second  Illustrative  Nuclear  Programme';