Amendment to the proposal for a COUNCIL DIRECTIVE on the labelling of medicinal products for human use and on package leaflets
Date: 1991-07-18
Institutions: European Commission
Subjects: consumer protection, drug surveillance, labelling, medicinal product, pharmaceutical legislation, preparation for market

COMMISSION OF THE EUROPEAN COMMUNITIES 

C0M(91) 245 final  - SYN  229/230/231/273 

Brussels,  18 July  1991 

Amendment  to the proposal  for a 

COUNCIL DIRECTIVE 

SYN 229 

on  the wholesale  distribution 

of medicinal  products for human use 

Amendment  to the proposal  for a 

COUNCIL DIRECTIVE 

SYN 230 

on the  legal  status for  the supply 

of medicinal  products for human use 

Amendment  to the proposal  for a 

COUNCIL  DIRECTIVE 

SYN 231 

on  the  labelling of medicinal  products  for human use 

and on package  leaflets 

Amendment  to the proposal  for a 

SYN 273 

COUNCIL DIRECTIVE 

on advert ising 

of medicinal  products  for human use 

(presented  by  the Commission pursuant  to Article  149(3) 
of  the EEC-Treaty) 

•.'$§s$*ç 

PRE 

Amendment  to the proposal  for a 

COUNCIL  DIRECTIVE 

on  the wholesale  distribution 

of medicinal  products  for  human  use 

b 

• 2-

EffldMKTOKr MBBRrtMPBi 

At its plenary session on 12 June 1991 the European Parliament approved the 

Commission proposal on the wholesale distribution of medicinal products for 

human use (0CM(89)607 final, SXN 229 of 26 January 1990). 

Pursuant to Article 149(3) of the EEC Treaty, the Commission has decided to 

make 11 amendments to its proposal. 

First, the Commission has included Parliament's amendments concerning the 

public service obligations of wholesalers supplying pharmacies.  Since not 

all the Member States apply this system, it was found inappropriate to 

introduce it throughout the Community.  On the other hand, the new rules 

must allow the Member States which practise this system to retain it. 

Many of the amendments adopted by Parliament are designed to tighten up the 

obligations imposed on all wholesale distributors of medicinal products. 

The Commission feels that these obligations come under the guidelines on 

good distribution practices.  The Commission has accepted Parliament's 

amendment calling for these guidelines to be published within two years of 

adoption of the Directive and the amendment requiring all wholesale 

distributors of medicinal products to give an undertaking to comply with 

them. 

The Commission has not accepted the amendments stipulating that all 

wholesale distributors of medicinal products must have a pharmacist at 

their disposal.  This requirement would have posed serious problems in at 

least half the Member States and cannot be justified on public health 

grounds. 

3 

Amendment  to the proposal  for a 

-3-

COUNCIL DIRECTIVE 

on  the wholesale  distribution 

SYN 229 

of medicinal  products  for human use 

(Presented  by the Commission  in accordance with 

Article  149 paragraph  3 of  the EEC Treaty) 

Original  proposal 

Amended  proposal 

Titel  and visas unchanged 

First  recital  unchanged 

First recital  a (new) 

Whereas,  according  to Article  100a, 
the  c o m p ^ H nn  of  the  internal 
market must  h* based  on the highest 
possible  level  of  environmental, 
public 
consumer 
protection; 

health 

and 

Second recital 

Whereas  the  wholesale  distribution 
of medicinal  products  for human  use 
is  at  present  subject  to  different 
provisions  in  the  various  Member 
States;  whereas  many  operations 
involving  the wholesale distribution 
of  medicinal  products  may  cover 
simultaneously  several  Member 
States; 

Whereas  the  wholesale  distribution 
of medicinal  products  for human  use 
is  at  present  subject  to  different 
provisions  in  the  various  Member 
States;  whereas  many  operations 
involving  the wholesale distribution 
of medicinal  products cover and will 
increasingly  cover  simultaneously 
several  Member States; 

Third  recital  unchanged 

Fourth  recital 

supply 

medicinal 

Whereas  any  person  involved  in  the 
wholesale  distribution  of  medicinal 
products  should  be  in  possession  of 
a  speci al  authorization;  whereas 
gharmacists  and  persons  authorized 
to 
products 
djjrectly  to  the  public,  a nd _ w ho 
confine  themselves  to  this  actiyity, 
should  be  exempt  from  obtain 1jTQt_J,jTJs 
authorization;  whereas  1t  is  alwa)^ 
necessary  in  order  to  control  the 
Ç-ÇIPPJJ^.VÊ..- -Çll^J.D. _. °_f_ _d 1 strlbut jon  of 
medici nal  products,  that  Phaxmjxjsts^ 
and  persons  authorized  to  del 1ver 
medicinal  products  to  the  public 
lie e_p_  r e c o r ds 
transacti ons; 

s h o w i ng  __§I!_tr y 

Whereas  any  person  involved  in  the 
wholesale  distribution  of  medicinal 
products  should  be  in  possession  of 
a  speci fie  authorization;  whereas 
the  definition  of  distribution  does 
not  cover d j y_jd i n g  up,  p a cka g i nc; and 
presentation  operations  referred  to 

in  Article  16  of  Directive 
and  1n  the  amendments  thereto  or 
operations  1 Inked  to  direct  '.u<>p!y 
to_the  public; 

75/319 

Or Iginat  proposal 

Amended  proposal 

-A-

Fourth  recital  a  (new) 

with 

Whereas  it  is  necessary  to  lay  down 
uniform  rules  applicable  throughout 
a  view  to 
the  Community 
establishing 
fo r 
o b t a i n i ng 
arrangements 
with 
transport ,  personnel  and  premises, 
and  the  procedures  for  the  checks  to 
be carried  out  by  the Member  States; 

a u t h o r i z a ti on , 

the  conditions 

1n  connection 

Fifth  recital  unchanged 

Article  1 paragraph  1 and 2 unchanged 

Article  l(2a)(new) 

for 

wholesalers 

' p u b l ic 
shall 

For  the  purposes  of  this 
s e r v i ce 

2a. 
d i r e c t i ve 
include  the 
obligations' 
to 
obligation 
guarantee 
range  of 
a  constant 
medicinal  products  to meet  the  needs 
determined 
of 
territory  and  to  ensure  the  supply 
at  very  short  notice  of  the  products 
requested  throughout  the  territory 
In  question. 

a  geographically 

Articles  2,  3 and 4 unchanged 

r 

Original  proposaj_ 

Amended  proposai 

-5-

Article 5 (a) and  (b) unchanged 

Article 5 (c) 

(c)  they  must  undertake  to  fulfil 
the  obligations  incumbent  on 
them  under  the  terms  of 
Article 6. 

(c) they  must  undertake  to  comply 

sound 

with 
distribution 
practices  and  to establish  that 
they have the requisite means at 
their  disposal  to  apply  them in 
practice. 

Article 6 (a) unchanged 

Article 6 (b) 

(b)  to  obtain  medicinal  products 
only  from  persons  who  are 
themselves  in possession of the 
authorization  referred  to  in 
Article  3(1) or who  are exempt 
f r om 
o b t a i n i ng 
authorization  under  the  terms 
of Article 3(2); 

t h is 

(b) to  obtain  medicinal  products 
only  from  persons  who  hold  an 
authorization  as  referred  to in 
Article  16  et  seg  of  Directive 
7 _5/_3  19/  E E C ,  or  who 

arc 

referred 

themse Ives  In  possession  of th<? 
to  in 
authorization 
Article  3(1)  or  who  are  exempt 
f r om 
o b t a i n i ng 
authorization  under  the  terms 
of Article 3(2) ; 

t h is 

Article 6 (c) unchanged 

Article 6 (d) 

(d)  to have an emergency plan which 
allows  participation  in  any 
action  of  withdrawal  from  the 
market ordered by the competent 
authorities or initiated by the 
manufacturer  of  the  medicinal 
product concerned; 

(d) to  accept  an  emergency  plan 
which  allows  participation  in 
any  action  of  withdrawal  from 
the  market  ordered  by  the 
competent  authorities  of  the 
Member State or initiated by the 
manu facturer/ importer  of  the 
medicinal  product concerned; 

Article 6 (e). (f) and  (g) unchanged 

è 

Original  proposal 

Amended propesai 

-G-

Art icle 7 

With  regard  to  the  supply  of  medicinal  products  to 
pharmacists  snd  persons  authorized  to  supply  medicinal 
products to the public, Member States shall not impose upon 
the  holder  of  an  authorization  referred  to  in Article 3 (1), 
which  has  beer  granted  by  another  Member  State,  any 
obligation strict :r than those .they impose on persons which 
they  have  themselves  authorized  to  carry  out  equivalent 

The  public  servi_çg_ o b_l  \g z 11 o n s 

imposed  by  certain  Hemberj;ta_ceT]on 
wholesalers  establish i ed  in  t ! i s i r 
territories  shall  not be affocted by 
this directive. 

Articles 8 and 9 unchanged 

Article  10 

t he  Commission  s h a ll 
g o od 
* *at 
j" 
c o m m i t t ee 

on 

p r a c t i c e s. 

p h a r m a c e u t i c al 

g u i d e l i n es 

If  a p p r o p r i a t e, 
T u T l i sh 
d i s t r i b u t i on 
case 
t he 
T T T I t l t u t ed 
D e c i s i on  7 5 / 3 2 0 / E E C1 
c o n s ul  t e d. 

by 

C o u n c il 
s h a ll 

be 

two  yoa^s 

a d o p ti on 

of 
Comm1 -s 1 on 

from 
^ii : ; 
s h a 11 

of 
t he 

W i t h in  a  p e r i od  of 
d a te 
t he 
d l r e c t l v e, 
p u b l i sh 
d i s t r i b u t i on 
t h is 
update 
It 
t he 
i n s t i t u t ed 
75/320/EEC. 

c o n s u lt 

s h a ll 

g u i d e l i n es 

p r a c t i c e s. 
p u b l i c a t i on 
f or 

t h is 

p h a r m a c e u t i c al 
by 

C o u n c il 

g o od 
on 
It 
shal1 
a n n u a l l y. 
purpose 
c o m m i t t ee 
D e c i s i on 

A r t i c l es  11  and  12  unchanged 

1-

Amendment  to the proposal  for a 

COUNCIL  DIRECTIVE 

on  the  legal  status  for  the  supply 

of medicinal  products  for  human  use 

9 

• 2-

ICTPT.AWA'Trar  WWyttAHmif 

At its plenary session on 12 June 1991 the European Parliament approval the 

Commission proposal concerning the legal status for the supply of medicinal 

products for human use (OOM(89)607 final, SÏN 230 of 26 January 1990). 

Pursuant to Article 149(3) of the EEC Treaty, the Commission has decide! to 

make 13 amendments to its proposal. 

In its opinion, Parliament proposed a system for the classification of 

medicinal products very different to the system envisaged by the 

Commission.  The Commission has decided to accept Pari 1 ament's suggestion 

and has therefore included all the amendments concerning the classification 

system.  The title of the proposal for a Directive has also been amended, 

as requested by Parliament.  As a result, the suggested amendments to 

Article 4 of the Commission's original proposal are no longer necessary 

since the classification criteria are now included in Article 3 of the 

amended proposal. 

The Commission has also accepted Parliament's amendments allowing a time 

limit of five years from the date of adoption of the Directive to draw up a 

list of the medicinal products available without medical prescription and a 

list of products available on medical prescription only. 

i 

i 

3  4 

-3-

Amendment  to the proposal  for a 

COUNCIL  DIRECTIVE 

on the  legal  status for supply 

of medicinal  products for human use 

SYN 230 

(Presented by the Commission  in accordance with 

Article  149 paragraph  3 of the EEC Treaty) 

Original  proposal 

Amended  proposal 

Titel 

Proposal  for  a  Council  directive 
concerning  the  legal  status  for the 
supply  of  medicinal  products  for 
human use. 

Proposal  for  a  Council  directive 
concerning  the  legal  status  for the 
supply  of  medicinal  products  for 
human use and their classification. 

Visas and  three first  recitals unchanged 

Fourth recital 

Whereas,  moreover,  persons  moving 
around within the Community have the 
right to carry a reasonable quantity 
of  medicinal  products  legitimately 
obtained  for  their  personal  use; 
whereas it must also be possible for 
a  person  established  in  one  Member 
State to receive from another Member 
State  a  reasonable  quantity  of 
medicinal  products  intended  for his 
personal  u s e;  whereas  it  is 
important therefore to harmonize the 
conditions  of  delivery  of  medicinal 
products to the public; 

Whereas,  moreover,  persons  moving 
around within the Community have the 
right to carry a reasonable quantity 
of  medicinal  products  legitimately 
obtained  for  their  personal  use; 
whereas it must also be possible for 
a  person  established  in  one  Member 
State to receive from another Member 
State  a  reasonable  quantity  of 
medicinal  products  intended  for his 
personal use; 

Fifth and sixth recitals unchanged 

> 

Qriginal  proposal 

Amended proposal 

-4-

Article 1 

1. 
This  Directive  concerns  the 
legal  status  for  the  supply  of 
medicinal products  for human use in 
the Community. 

1. 
This  Directive  concerns  the 
legal  status  for  the  supply  of 
medicinal products for human use and 
their  c l a s s i f i c a t i on  in  the 
Community as: 
- medicinal products subject to 

medical prescription. 

- medicinal products not subject 

to medical prescription. 

2.  For the purpose of this Council 
Directive,  the  definition  of 
'medicinal product' in Article  1 of 
Council  Directive  65/65/EEC  shall 
apply. 

2.  For the purpose of this Council 
Directive,  the  definition  of 
•medicinal  product'  set  out  in 
Article  1  of  Council  Directive 
65/65/EEC shall apply. 

In addition. 
'medical  prescription'  shall 
mean:  any prescription  emanating 
from  a  professional  qualified  to 
prescribe medicinal products. 

M 

nriginal  proposal 

Amended  proposal 

-5-

Article 2 

When a marketing authorization is 
granted,  the  competent  authority 
shall  specify  the  classification 
of the medicinal product: 
medicinal  product  subject  to 
medical prescription. 
medicinal  product  not  subject  to 
medical prescription. 

To  this  end  the  criteria  laid  down 
in Article 3(1) shall apply. 

2. The  competent  authorities  shall 
specify  the  subcategories  of 
medicinal products which can only 
be  s u p p l i ed  on  m e d i c al 
prescription.  In  this case thev 
s h a ll  usev  the  f o l l o w i ng 
classification: 

(a)medicinal  products  available  on 
renewable  or  non-renewable 
medical prescription. 

(b)medicinal products subject to 
special medical prescription. 
(c)medicinal  products  available  on 
restricted  medical  prescription 
reserved  for  certain  specialized 
areas. 

P 

/^ iff rna I- proposal 

Amended  proposa 

-6-

Article 3 

1  When  a  marketing  authorization  is  granted,  the 
competent  authority  shall  specify  the Jcgal  status  for  the 
supply of the medicinal product: 

—  medicinal  ponluct not subjca  to medical prescription, 

— medicinal  product  subjea  to  medical  prescription, 
to  in 

mentioning  one  of  the  categories  referred 
Anicic 2. 

To  this  end,  the  criteria  laid  down  in  Article 4  shall 
apply. 

1.Medicinal products hall be subject 
to medical prescription where: 
-  thev  present  a  danger,  directly 
or  indirectly, even under normal 
conditions  of  use  if  taken 
without medical supervision or 
-  they are used frequently and to a 
very large extent under the wrong 
conditions  and  this  is likely to 
cause a direct or indirect danger 
to health or 

"  they  contain  substances  or 
preparations  based  on  substances 
whose effects and/pr side effects 
require more detailed research or 

- they are, with  certain exceptions, 

administered  parenterally or 

"  •  t h ev 

a re 

a d m i n i s t e r ed 

- 

p a r e n t e r a l lv  or 
t h ev 
c a u se 
dependence. 

a d d i c t i on 

a n d / or 

2.  All  medical  products  containing  a 
new  chemical 
£s 
and  classed, 
medical  p r e s c r i p t i o n. 
in  one  of  the  c a t e g o r i es  referred 
to 
in  A r t i c le  2. 

s h a ll  be  subject 

2.  Where  Member  States  specify  a 
subcategory  of  medicinal 
product 
s u b j e ct 
p r e s c r i p t i o n,  account  shall  be  taken 
of  the  following  elements: 

m e d i c al 

s p e c i al 

to 

a 

or 

r e l e v a nt 

the  p r e s e n ce 
the  medicinal 
in 
product  of  a  non-exempted  dosage 
of  a  substance  c l a s s i f i ed 
as  a 
n a r c o t ic 
p s y c h o t r o p ic 
the  meaning  of 
substance  within 
i n t e r n a t i o n al 
t he 
c o n v e n t i o ns 
( U n i t ed  N a t i o ns 
Conventions  of  1961  and  1971)  or 
t he 
t he 
if 
m e d i c i n al 
improperly  used,  give 
to 
r i s ks  of  medicinal  abuse. 
major 
cause  addiction  or  be  misused  for 
i l l e g al  purposes.or 

p o s s i b i l i ty 
p r o d u ct 

t h at 
c o u l d, 
r i se 

- 

A3 

Original propos»I 

Amended  proposal 

~r-

frhe  presence 
the  medicinal 
in 
product  of  a  substance  which, 
b e c a u se 
or 
i ts 
in 
properties,  could  be  included 
frhat  category  as  a  precautionary 
measure. 

n o v e l ty 

of 

thev 

s h a ll 

In  cases  where  Member  States 
2a. 
specify  a  subcategory  of  medicinal 
products  subject  to  limited  medical 
p r e s c r i p t i o n, 
take 
account  of  the  following  elements 
-  medicinal  products  which,  bv 
reason  of 
their  pharmacological 
characteristics  or  their  novelty 
or 
i n t e r e st  of  public 
in 
health,  are  reserved  for  use 
treatments  which  can  only  be 
carried  out  in  hospitals. 
-  medicinal  products  employed 

the 

in 

in 
i l l n e s s es  which 
in  a  hospital 
i n s t i t u t i on  w i th 
f or 
f a c i l i t i es 
w h e re 
b ut 

the  treatment  of 
require  diagnosis 
or 
o t h er 
a d e c u a te 
d i a g n o s i s. 
administration  and  follow-up  can 
be 
the 
h o s p i t al 
e s t a b l i s h m e n ts 
equipped  with  adecuate  diagnostic 
faci1  i t i e s. 
medicinal  products 
for  use  bv 
o u t - p a t i e n ts  which  could  produce 
severe  adverse  e f f e c ts  and  which 
t h e r e f o re 
supervised 
treatment. 

o ut  o u t s i de 
in 

c a r r i ed 
or 

c a ll 

for 

The  competent  authority 
least  annually  the 

shall 
3. 
l i st 
publish  at 
of  medicinal  products 
to 
medical  prescription,  specifying  the 
category  of  c l a s s i f i c a t i o n. 

subject 

3,  The  competent 

a u t h o r i ty 

l e a st  annually  the 

publish  at 
of  medicinal  products 
subject 
medical  prescription  specifying 
c a t e g o ry  of 
circulate 
professionals 

s h a ll 
l i st 
tc 
the 
and 
to  the  medical 

c l a s s i f i c a t i on 
l i st 

in  their  territory. 

this 

Original  proposal 

Amended proposa 

-8-

Article  4 

The  legal  status of supply of_ 

a medicinal  product  shall be 

set out  in the market ing 

authorization and  included jn_ 

the summary of  the product_ 

character 1st ics. 

1.  Mrdio'na! products  which  contain  substances  which 
arc  likely  to  present  a direct  or  indirea  danger  to  human 
health,  even  under  normal  conditions  of  use,  shall  not  be 
supplied  to  the  public  without  medical  prescription.  The 
following  criteria  shall  be  taken  into  consideration  in  this 
respect: 

(a)  potential  risks  appearing  during  the  preclinical  and 

clinical  tests  and trials; 

(b)  novelty  of  the  aaive  principle,  as  stared  in  Article  3, 

;-..:  ô:-ph2; 

(c)  possibility of serious side effects in normal conditions  of 

use; 

(d)  serious  risks  associated  with  contra-indications  and 

precautions  for  use; 

(c)  indications  requiring  a  medical  diagnosis  or  special 

medical  supervision; 

' f)  harmfulness  of constituents  under normal conditions of 
use, taking  into account  posology, pack  size or possible 
excessively  extended  treatment; 

(g)  parenteral  administration,  except  when  very long term 
illness  requires  an active  participation  by the  patient  in 
the  treatment  (for  example:  diabetes); 

(h)  important  risk of abuse, addiction or misuse for  criminal 

purposes. 

2.  Moreover,  medical  products  which  may  be  available 
without  prescription shall show a substantial safety in use in 
the  treatment  of  minor  ailments  or  symptoms,  usually 
capable  of  rapid  and  spontaneous  relief,  which  are  easily 
identifiable  by  users  and  do  not 
justify  a  medical 
consultation. 

: * < • * - .r  . . .^ 

M 

Original  proposal 

Amended proposal 

-9-

Article 5 

1.  Within  two  years  of  adoption  of  this  Directive,  the 
Member States shall communicate to the Commission and to 
the  other  Member  States,  the  list  of  medicines  which  are 
available  only  on  medical  prescription  on  their  territory, 
mentioning  the  category  of  classification. 

1. Unchanged 

2.  Each  year  Member  States  shall 
communicate to the Commission and to 
the other Member States  the changes 
that  have  been  made  to  the  list 
referred to in paragraph 1. 

2.  Each  year  Member  States  shall 
communicate to the Commission and to 
the  other  Member  States  the  list 
referred  to  in  paragraph  1 and  the 
changes that have been made thereto. 

3.  Within four years of adoption of 
this Directive, the Commission shall 
submit  a  report  to  the  Council  on 
the  application  of  this  Directive. 
This  report will  be accompanied, if 
necessary, by appropriate proposals. 

3.  Within five years of adoption of 
this Directive, the Commission shall 
draw  up  a  list  of  the  medicinal 
products  in all Member States which 
are  available  only  on  medical 
prescription.  The  list shall apply 
to all Member States. 

Within  five  years  of  adoption 
of  this  Directive,  the  Commission 
shall  draw  UP  a  list  of  the 
medicinal products in all the Member 
States  which  are  available  without 
This  list 
medical  prescription. 
shall  apply  to  all  the  Member 
States. 

Articles 6 and 7 unchanged 

Amendment  to the proposal  for a 

COUNCIL DIRECTIVE 

on  the  labelling of medicinal  products  for human use 

and on package  leaflets 

#• 

-2-

ECTIANATORy MBOtAMDOM 

At its plenary session on 12 June 1991 the European Parliament approved the 

Commission proposal on the labelling of medioijnal products for human use 

and on package leaflets (OOM(89)607 final, SYN 231 of 26 January 1990). 

Pursuant to Article 149(3) of the EEC Treaty, the Commission has decided to 

make 16 amendments to its proposal. 

The Commission has accepted the two amendments clarifying the definitions 

of terms used in the proposal, the amendment stipulating that only the 

excipients that should be known about to ensure safe and effective use of 

the medicinal product need appear on the label and the amendment removing 

the obligation to indicate the name of the manufacturer, if other than the 

person responsible for placing the product on the market.  It has not 

included the other amendments on labelling, since care must be taken to 

avoid putting too much on the label and making it impracticable for 

manufacturers or incomprehensible for consumers. 

The Commission has included several of the amendments adopted by Parliament 

on small outer packaging. 

As regards the package leaflet, the Commission has included the amendments 

made by Parliament to bring the text of the proposal into line with the 

rules on labelling plus two other major additions:  details of the nature 

and expected effect of using the medicinal product and specification of the 

date on which the package leaflet was last revised. 

Finally, two amendments to the general guidelines have also been accepted. 

/\ 

- 3-

Amen<'<?:';r»l to the proposal  for a 

COUNCIL DIRECTIVE 

SYN 231 

on  the  labelling of medicinal products for human use 

and on package  leaflets 

(Presented by  the Commission  In accordance with 

Article  149 paragraph 3 of  the EEC Treaty) 

Original proposal 

Amended proposal 

Titels and visas unchanged 

Recitals unchanged 

CHAPTER I 

Scope and definitions 

Article 1 

1. 
This  Directive  deals  with  the labelling  of  medicinal 
products  lor  human  use and  leaflets  inserted in packages of 
such  products. 

1. 
This  Directive  deals  with  the labelling  of  medicinal 
products  lor  huma;? use and  leaflets  inserted  in packages  of 
such  products. 

2. 
For the purposes  of  this  Directive,  the definition of 
•medicinal  product'  laid  down  in  Article  1  of  Directive 
6.S/65/l-"l"C  shall  apply.  In addition  to this: 

2. 
l or the  purposes  ol  this  Directive,  the definition of 
'medicinal  prodtic:'  laid  down  in  Article  1  of  Directive 
65/6.5/I;IX'  shall  apply.  In addition  to this: 

-  "name  of  the  médicinal  product" 
shall  mean  the  name  given  to  a 
medicinal  product,  which  may be an 
invented  name  or a  common  chemical 
name  together  with  a  trademark  or 
the  name of the manufacturer; 

-  "name  of  the  medicinal  product" 
ohall  mean  the  name  given  to  a 
medicinal  product,  which may be an 
invented  name or a common  chemical 
name  together  with  a  trademark  or 
the  name  of  the  manufacturer;  in 
the  case  of an  invented  name,  this 
n.hj\l_l  not  bo  confused  with  the 
common  name; 

name' 

'common 
international 
shall  mean 
non-proprietary  name  recommended  by  the  Work! 
Health  Organisation, or. if one does not exist, the usual 
common  name, 

the 

—  'common 

name' 

international 
shall  mean 
nou-proprieiarv  u.ime  recommended  by  the  World 
Health  Organization, or, if one does not exist, the usual 
common  name. 

the 

'immediate packaging* shall mean the container or other 
form  ol  packaging  immediately  in  contact  with  tlte 
medicinal  product; 

—  'immediate  packaging" shall  mean the container or other 
form  of  packaging  immediately  in  contact  with  the 
medicinal  product; 

'outer  packaging' shall mean the packaging into  which is 
placed  the immediate  packaging, 

—  'outer  packaging" shall mean the packaging into which is 

placed  the immediate  packaging, 

leaflet'  shall  mean  a 

'package 
information 
medicinal  product  to which  it  refers. 

leaflet  containing 
for  the  user  which  accompanies  the 

—  'package 

leaflet*  shall  mean  a  leaflet  containing 
lo;  the  user  which  accompanies  the 

information 
medicinal  product  to which  it  refers. 

-  " l a b e l l i n g" 

t he 
p a r t i c u l a rs  p r o v i d ed  on  t he  o u t er 
or 

i m m e d i a te  p a c k a g i n g; 

9 ha  11  mean 

M 

-4-

Original  proposal 

Amended proposal 

Article 2 unchanged 

CHAPTER  II 

Labelling of medicinal  products 

Article 3 

T he 

f o l l o w i ng  p a r t i c u l a rs  shall  appear  on 

the  o u t er 

packaging  of  medicinal  p r o d u c ts  o r,  where  there  is  no  outer 

p a c k a g i n g,  on  the  i m m e d i a te  p a c k a g i n g: 

f o l l o w i ng  particulars  shall  appear  on 

The 
the  outer 
packaging  of  medicinal  products  o r.  where  there  is  no  outer 
p a c k a g i n g,  on  the  i m m e d i a te  packaging: 

(a)  the  name of  the m e d i c i n al  p r o d u c t,  i n c l u d i ng or  f o l l o w ed 
by  the  c o m m on  name  if  the  p r o d u ct  contains  o n ly  one 
active  i n g r e d i e n t; 

(a)  the name of  the medicinal  p r o d u c t,  i n c l u d i ng or  f o l l o w ed 
by  the  c o m m on  name  if  the  product  contains  only  one 
active  ingredient; 

(b)  a  statement 

of 

the  active 

expressed 
qualitatively  a nd  q u a n t i t a t i v e ly  per  dosage  unit  or 
according  to 
f or  a  given 
the  f o rm  of  a d m i n i s t r a t i on 
volume  or  w e i g h t,  using  their  c o m m on  names; 

ingredients 

(b)  a  statement 

of 

the  active 

expressed 
qualitatively  and  quantitatively  per  dosage  unit  or 
according  to  the 
for  a  given 
volume  or  w e i g h t,  using  their  c o m m on  names; 

f o rm  of  a d m i n i s t r a t i on 

ingredients 

(c)  the  pharmaceutical  f o rm  .snd the  contents  by  w e i g h t,  by 

(c)  the  pharmaceutical  f o rm  and  the  contents  by  weight,  bv 

volume  or  n u m b er  or  doses  of  the  p r o d u c t; 

volume  or  number  or  doses  of  the  p r o d u c t; 

d) a list of the excipients; 

(e)  the  route  and  m e t h od  of  a d m i n i s t r a t i o n; 

d) the  excipients  that  should  be 
known  about  to  en su re  an 
effective  use  of  the  medicinal 
product; 

(e)  the  route  and  m e t h od  of  a d m i n i s t r a t i o n; 

(f)  a  special  w a r n i ng  that  the  product  must  be  stored  out  of 

reach  ol  c h i l d r e n; 

(f)  a  special  w a r n i ng  that  the  product  must  In-  stou-d  m il  ot 

reach  ol  c h i l d r e n; 

(g)  the  expiry  date  in  clear  terms  ( m o n t h / y e a r ); 

(h)  special  storage  precautions,  if  a n y; 

(g)  the  e x p i ry  date  in  clear  terms  ( m o n t h,  vear). 

(h)  special  storage  precautions,  if  an\  ; 

(i)  special  precautious 

for  disposal  of  unused  medicinal 
products  or  waste  materials  derived  f r om  such  p r o d u c t s, 
if  a p p r o p r i a t e; 

j) the name and address of the person 
responsible 
for  placing  the 
medicinal  product  on  the  market 
and,  where  different,  of  the 
manufacturer; 

(i)  special  precautions 

for  disposal  of  unused  médicinal 
products  tu  waste  materials  derived  f r om  such  products, 
if  a p p r o p r i â t : '; 

j) the  name  and  address  of  the 
person  responsible  for  placing 
the  medicinal  produ  -  on  the 
market; 

(k)  the  number  of  the  a u t h o r i z a t i on  to  put  the  medicinal 

( k)  the  n u m b er  of  the  a u t h o r i z a t i on  to  put  the  m e d i c i n al 

p r o d u ct  on  the  m a r k e t; 

product  on  the  m a r k e t; 

(I) 

the  manufacturer's  batch  n u m b e r. 

(I) 

the  manufacturer's  batch  number. 

-5-

Original proposal 

Amended proposa I 

Art icle 4 

1. The  following  particulars  shall 
appear  on  immediate  packagings 
placed  in an outer packaging which 
complies  with  the  requirements 
laid down  in Article 3: 

—  name of  the medicinal  product, 

least 

At 
following 
the 
particulars  shall  appear  on 
immediate packagings placed  in ah 
outer  packaging  which  complies 
with  the  requirements  laid  down 
in Article 3: 

—  name of  the medicinal  product, 

—  quantity of  active constituents,  using common  names, 

—  quantity of  active constituents,  using common  names, 

—  route and  method of  administration, 

—  route and method of  administration, 

—  expiry date, 

—  batch  number. 

—  expiry  date, 

—  batch  number. 

2. Paragraph  1  shall  not  apply  to 
immediate  packagings  containing  a 
single dose which are too small to 
contain all the particulars  listed 
in paragraph 1. 

2. Immediate  packagings  which  are 
too  small  to  carry  all  the 
particulars  listed  in  Article  3 
shall  carry  at  least  the 
following particulars: 

- name of the medicinal product, 
-  r o u te 

m e t h od 

a nd 

of 

administration, 

- expiry date, 
- batch number, 
- contents  by weight, by  volume or 

by number of do3cs. 

3.  Immediate packagings other  than 

those referred  in paragraphs 

1 and 2 shall  carry the 

particulars  laid down  in Article 3. 

M 

•6-

Or iginal  proposal 

Amended proposal 

Ar t i cIe S and 6 unchanged 

CHAPTER  III 

User  leaflet 

Article 7 

The  inclusion  in  the  packaging  of 
medicinal  products  of  a  package 
leaflet  for  the  information  of  users 
shall  be  obligatory  unless  all  the 
information  required  by Article  8  is 
directly  conveyed  on  the  outer 
packaging  or  on  the  immediate 
packaging. 

The  inclusion  in  the  packaging  of 
medicinal  products  of  a  package 
leaflet  for the information of users 
shall  be  obligatory  unless  all  the 
information required by Article 8 is 
directly  conveyed  on  the  outer 
packaging  or  on  the  immediate 
packaging  or  unless  the  medicinal 
product  may  be  administered  only by 
a health professional. 

Article 8 

1. The leaflet shall include, usually 

in the following order: 

1.  The 

s h a ll  be  drawn  up 

l e a f l et 
a c c o r d a n ce  w i th 
p r o d u ct  c h a r a c t e r i s t i c s; 
c o n t a i n, 
f o l l o w i ng  o r d e r: 

u s u a l ly 

t he 

ir. 
summary  of 
s h a ll 

it 
in 

the 

a) for  the  identification 

of  the 

medicinal product: 

a) for  the  identification  of  the 

medicinal product: 

name of the medicinal product 
quantitative  and  qualitative 
composition  in  terms  of  active 
ingredients,  using 
names, 

common 

t he 

-  p h a r m a c o - t h e r a p e u t ic 

t h e re 
e x i s ts 
c o m p r e h e n s i b le 

a 
for 

g r o u p, 

if 
e a s i ly 

t e rm 

t he  p a t i e n t, 

name  of  the  medicinal  product 
in  accordance  with  Article 
3(a), 
f u ll 
and 
q u a n t i t a t i ve 
qualitative  composition  in 
terms of active  ingredients and 
excipients,  using  the  common 
names, 
pharmaceutical  form  and  contents 
by weight, by volume or by dosage 
units, 
pharmaco-therapeutic  group,  o^ 
type of action, if there exists a 
term  easily  comprehensible  for 
the  patient, 
indication  of 

-7-

Original proposal 

Amended proposal 

—  name  and  address  of  the  holder  of  the  marketing 
the 

and,  where  different, 

of 

authorization, 
manufacturer; 

—  name  and  address  of  the  holder  of  the  marketing 
the 

and.  where  different, 

of 

authorization, 
manufacturer; 

(b)  the  therapeutic  indications; 

•(b)  the  therapeutic  indications; 

(c)  a  list  of  information  which  is  useful  before  taking  a 

medicinal  product. 

—  contra-indications, 

—  appropriate  precautions  for  use, 

—  interactions  with  other  medicinal  products and  other 
forms  of  interaction  (for  example,  alcohol,  tobacco) 
which  may  affect  the  use  of  the  medicine, 

(c)  a  list  of  information  which  is  useful  before  taking  a 

medicinal  product: 

;—  contra-indications, 

—  appropriate  precautions  for  use, 

—  interactions  with  other  medicinal  products  and  other 
forms  of  interaction  (for  example,  alcohol,  tobacco) 
which  may  affect  the  use  of  the  medicine, 

—  special  warnings. 

this  list  must: 

—  special  warnings. 

this  list  must: 

—  take  into  account  the  particular  condition  of  certain 
(e.g.  children,  pregnant  or 
the  elderly,  persons  with 

categories  of  users 
breastfeeding  women, 
specific  pathological  conditions), 

—  mention, 

if  appropriate,  potential  effects  on 

the 

ability  to  drive  vehicles  or  to  operate  machinery, 

—  take  into  account  the  particular  condition  of  certain 
(e.g.  children,  pregnant  or 
the  elderly,  persons  with 

categories  of  users 
breastfeeding  women, 
specific  pathological  conditions), 

—  mention, 

if  appropriate,  potential  effects  on 

the 

ability  to  drive  vehicles  or  to  operate  machinery, 

—  refer 

to 

the  excipients  knowledge  of  which 

is 
important  for  a safe  and  effective  use of  the  medicinal 
product; 

—  refer 

to 

the  cxcipier.tN  knowledge  of  which 

is 
nnpon.:.::t  toi  a safe  and effective  useo*  ihe  medicinal 
product: 

d) the  necessary  instructions  for 

d) the  necessary  instructions  for 

proper use, in particular: 

proper use, in particular: 

the usual dose and maximum dose, 

the  usual  dose,  together  with 
wording  indicating  that  this 
does  not  apply  for  different 
doses being prescribed, and, if 
possible,  the  maximum  dose 
together  with  a  warning  that 
the  dose  and  therapeutic 
procedure  may  be  modified  by 
the prescriber; 

the 
administration, 

method 

and 

route 

of 

the  method  and 
administration, 

route  of 

-  the  frequency  of  administration, 
specifying 
if  necessary  the 
appropriate  time  at  which  the 
medicinal  product  should  or  must 
be administered; 

t he 
f r e q u e n cy 
administration,  specifying  if 
necessary  the  appropriate  time 
at  which  the medicinal  product 
should or must be administered; 

of 

and,  as  appropriate,  depending  on 
the nature of the product 

and,  as  appropriate,  depending  on 
the nature of the product 

Zi 

-8-

Or i g i'na I proposal 

Amended  proposal 

the duration of treatment, when it 
should be limited, 

the duration of treatment, when 
it should be limited, 

the  action  to  undertake  in  the 
case  of  overdose  (symptoms, 
emergency procedures, antidotes), 

the  nature  and  expected  effect 
of using the medicinal product, 

the  action  to undertake  in the 
case  of  overdose  (symptoms, 
emergency 
procedures  and 
antidotes  where  they  exist 
together  with  an  express 
recommendation  not  to use them 
except u"iu£r medical control), 

the course  of  action  to take when 
a dose has not been taken, 

the  course  of  action  to  take 
when a dose has not been taken, 

the  way  the  treatment  should  be 
stopped, if stopping the treatment 
may  lead to withdrawal effects; 

e) a  description  of  the  undesirable 
effects  which  can  occur  under 
normal  use  of  the  medicinal 
product,  with  indication  if 
possible  of  their  importance, and 
if  necessary  the  action  to  be 
taken  in  such  case;  if  the 
medicine  is  new,  the  patient 
should  be  expressly  invited  to 
communicate any undesirable effect 
which  is  not  mentioned  in  the 
leaflet  to  his  doctor  or  to  his 
pharmacist; 

(f)  a  reference  to  the  expiry  date  indicated  on  the  label, 

with: 

—  a  warning  against  using  the  product  after 

this 

date, 

—  where  appropriate,  special  storage  precautions, 

the way the treatment should be 
if  stopping  the 
stopped, 
t r e a t m e nt 
to 
withdrawal effects; 

lead 

may 

e)  a  d e s c r i p t i on  of 

if 
and 

p o s s i b le  of 

e f f e c ts  which  can  o c c ur  when 
m e d i c i n al  p r o d u ct 
i n d i c a t i on 
i m p o r t a n c e, 
a c t i on 
t he  p a t i e nt 
i n v i t ed 
u n d e s i r a b le 
m e n t i o n ed 
d o c t or  or 

t he  u n d e s i r a b le 
t he 
is  u s e d,  w i th 
t h e ir 
t he 
in  such  c a s e; 
e x p r e s s ly 
any 
is  not 
to  h is 

in 
to  h i3  p h a r m a c i s t; 

e f f e ct  which 
l e a f l et 

t a k en 
s h o u ld  be 

c o m m u n i c a te 

if  n e c e s s a ry 

to  be 

t he 

to 

(f)  a  reference  to  the  expirv  date  indicated  on  the  label, 

with: 

—  a  w a r m m;  against  using  the  product  after 

this 

date. 

—  where  appropriate,  special  storage  precautions, 

— 

if  neceNs.it »  a  warning  against  visible  signs  of 

deterioration; 

— 

i(  necessary  a  warning  against  visible  signs  of 

(g)  all  other  inforn-.ation  compatible  with  the  summary  of 

deterioration; 

(g)  all  other  information  compatible  with  the  summary  of 
product  characteristics  of  the  product,  useful  for  health 
education,  and  on  condition 
is  not  of  a 
promotional  nature. 

that 

it 

product  characteristics  of  the  product,  useful  for  health 

education,  and  on  condition 

that 

it 

is  not  of  a 

promotional  n.:,;re. 

i) the date  on which  the package 

leaflet  was  last  revised 

ZH 

-9-

Original proposal 

Amended proposal 

Article 9 

The  package  leaflet  must  be  written 
in clear and understandable terms for 
the patient,  in the official language 
or  languages  of  the  Member  State 
where the medicinal product  is put on 
the market.  This  provision does not 
prevent  the  leaflet  being  printed  in 
several  languages,  provided  that  the 
same  information  is given  in all the 
languages used. 

The  package  leaflet must be written 
in  such  a  way  that  it  is  c 1 e ar , 
easily  legible  and  understandab'*> 
for the patient,  in the official language 
or  languages  of  the  Member  Sta.te 
where the medicinal product is put on 
the market.  This  provision does not 
prevent  the  leaflet  being  printed  in 
several  languages,  provided  that the 
same  information  is given  in all the 
languages used. 

Article 10 unchanged 

CHAPTER  IV 

General  and  final provisions 

Articles 11 and  12 unchanged 

Article 13 

As  necessary,  the  Commission  shall 
publish guidelines concerning: 

—  the formulation of certain warnings for certain categories 

of  medicinal  products, 

—  the 

particular 
self-medication, 

information 

needs 

relative 

to 

No  later  than  two  years  after  the 
adoption  of  this  Directive,  the 
•Commission  shall  publish  guidelines 
for the various  leaflet  sections, in 
particular concerning: 

—  the formulation of certain warnings tor certain catégorie* 

of  medicinal  products, 

—  the 

particular 
sclf-medica:ion. 

information 

needs 

relative 

to 

—  the  readability  of  particulars  on 

the  labelling  and 

—  the  readabii::\  of  particulars  on 

the 

labelline,  .\nd 

leaflet. 

leaflet. 

—  utih/ation of bar codes for the identification of  medicinal 

—  utilization <•: bar codes for the identification of  medicinal 

products. 

products. 

-  excipient» that must be indicated 
on  the  packaging  and  warnings 
referring  to  them  that  must  be 
carried on the packaging. 

this  purpose, 

h.r 
the 
Committee for  Proprietary  Mcdicin.il Products instituted  by 
Directive  7 5 / 3 1 9 / E E C. 

the  Commission  shall  consult 

this  purpose, 

For 
in» 
Committee  for  Pr«ipnetarv  Medicinal  Products  instituted r*. 
Directive  7.S/3H  '-.EC. 

ihe  Commission  shalf  «.«insult 

Articles  14, 15 and  16 unchanged 

zs 

Amendment  to  the  proposal  for a 

COUNCIL  DIRECTIVE 

on  advert ising 

of medicinal  products  for  human  use 

M 

-2-

EKPIflMPQEff  WtBBfflML 

At its plenary session on 12 June 1991 the European Parliament approved the 

Qaramission proposal on advertising of •medicinal products for human use 

(OOM(90)212 final, SYN 273 of 6 June 1990). 

Pursuant to Article 149(3) of the EEC Treaty, the Coitimission has decided to 

make 19 amendments to its proposal. 

The Commission has accepted the amendments prohibiting advertising to the 

general public of medicinal products which are habit-forming and/or 

addictive, of perforiiïtanoe-enhancing products or of medicinal products 

subject to reimbursement by the social security system.  It has also 

accepted the amendments prohibiting the distribution of free gifts and 

bonuses and making it compulsory to include an express instruction to read 

the label and the package leaflet carefully.  The other amendments on 

advertising to the general public have not been included:  the Commission 

feels that there is no need for a Community Directive to lay down the 

smallest details on the advertising of medicinal products, where such 

advertising is allowed. 

As regards advertising to health care professionals, the amended proposal 

includes the amendment omitting the exception for objects of an 

insignificant intrinsic value and incorporates the rules proposed by 

Parliament on the sponsorship of scientific congresses.  However, the 

Coramission could not accept the procedures advocated by Parliament to 

monitor this point.  As regards the measures to control free samples, the 

Commission felt that it was inappropriate to replace the cfuantitative limit 

which it had proposed by a time limit. 

Finally, the Commission has accepted none of the amendments on monitoring 

and penalties.  Since the rules proposed have been harmonized with the 

existing Coranunity legislation it saw no need to depart from them. 

•Cq 

-3-

Amendment  to the proposal  for a 

COUNCIL  DIRECTIVE 

on advert ising 

SYN 273 

of medicinal  products  for  human use 

(Presented  by  the Commission  in accordance with 

Article  149 paragraph  3 of  the EEC Treaty) 

Original  proposal 

Amended  proposal 

Titel  and visas unchanged 

Three  first  recitals unchanged 

Fourth  recital 

could 

products 

Whereas  advertising  to  the  general 
even  of  non-prescription 
public 
medicinal 
affect 
public  health,  if  it  was  excessive 
a nd 
advertising  of medicinal  products  to 
the  general  public,  where  it  is 
therefore  to 
permitted, 
satisfy  certain  essential  criteria 
which  ought  to be  defined; 

i l l - c o n s i d e r e d; 

w h e r e as 

ought 

Whereas  advertising  to  the  general 
public 
even  of  non-prescription 
medicinal  products  may affect  public 
health,  if  it  does  not  satisfy 
certain 
ought  to be  defined; 

criteria  which 

essential 

Fifth, sixth  and  seventh  recitals  unchanged 

Eighth  recital 

persons"  qualified 

W h e r e as 
to 
prescribe  medicinal  products  must  be 
able  to  carry  out  these  functions 
objectively  without  being  influenced 
by  direct  or  indirect  financial 
inducements; 

persons 

qualified 

W h e r e as 
to 
prescribe  medicinal  products  must be 
able  to  carry  out  these  functions 
objectively  without  being  influenced 
by direct  or  indirect  financial  - or 
other  -  inducements; 

M 

-A-

Or iginal proposal 

Amended  proposa I 

Ninth  recital 

of 

samples 

Whereas  it  should  be  possible  within 
certain  restrictive  •conditions  to 
medicinal 
p r o v i de 
products  free  of  charge  to  persons 
qualified  to  prescribe  or  'supply 
them  so  that  they  can  familiarize 
themselves  with  new  products  and 
acquire  experience  in  dealing  with 
them; 

of 

samples 

Whereas  it  should  be  possible  within 
certain  restrictive  conditions  to 
medicinal 
p r o v i de 
products  free  of  charge  to  persons 
qualified  to  prescribe  or  supply 
them  so  that  they  can  familiarize 
themselves  with  new  products  and 
acquire  experience  in  dealing  with 
them; 
of 
free 
medicinal  products  must,  of  course, 
not  be  sold; 

samples 

these 

Tenth  and eleventh  recital» unchanged 

Twelfth recital 

each 

undertaking 

which 
W h e r e as 
manufactures  or  imports  medicinal 
products  should  set  up  a  mechanism 
to  ensure 
information 
supplied  about  a  medicinal  product 
c o n f o r ms 
a p p r o v ed 
conditions  of  use, 

w i th 

that 

t he 

all 

that 

each 

undertaking 

which 
W h e r e as 
manufactures  or  imports  medicinal 
products  should  set  up  a  mechanism 
to  ensure 
information 
supplied  about  a  medicinal  product 
information 
c o r r e s p o n ds 
provided  in  the  summary  of  the 
characteristics  of  the  product,  as 
a p p r o v ed 
c o m p e t e nt 
authori ties ; 

t he 

the 

all 

to 

by 

CHAPTER I 

Scope, definitions and general  principles 

Article 1 unchanged 

Art icle 2 

1 
Any  advertising  of  a medicinal  product  in  respect  of 
which  a marketing  authorization  has  not been  granted  in 
accordance  with  Community  law  is  prohibited. 

1.  Any  advertising  of  a medicinal  product  in  respect of 
which  a marketing  authorization  has  not  been  granted  in 
accordance  with  Community  law  is  prohibited. 

*L\  All  parts  of  the  advertising  of  a 
medicinal  product  must  be  compatible 
with  the  particulars  listed  in  the 
summary  of  product  characteristics. 

3-« All  parts  of  the  advertising  of  a 
medicinal  product  must  conform  to 
the  particulars  ...  (rest  unchanged) 

& 

Orig nal  proposal 

Amended  proposal 

-5-

CHAPTER  M 

Adver t î s Ing to the genera I pub1ic 

Article  3 

1.  Member  Su  es shall  prohibit  the advertising  to the 
general  public  of: 

I.  Member  States  shall  prohibit  the advertising  to the 
general  public  of: 

—  medicinal  products  which  contain  psychotropic  or 
narcotic  substances,  within  the meaning  of  the inter 
national  conventions, 

—  medicinal  products  which  contain  psychotropic  or 
narcotic  substances,  within  the meaning  of  the inter 
national  conventions, 

—  other  medicinal  products  which  are only  available on 
prescription,  in  accordance  with  Council  Directive 
. . . / ..  ./EEC. 

—  other  medicinal  products  which  are only  available on 
prescription,  in  accordance  with  Council  Directive 
. . . / ..  ./EEC. 

-  medicinal  products  and  products 
which  are  habit-forming  and/or 
addictive, 

any performance-entrancing drug or 
product,  as  defined  by  the 
of  Europe  and  the 
Council 
International  Olympic  Committee, 

-  medicinal  products which 

are  reimbursed  by the social 

secur ity. 

2.  Member  States  shall  prohibit  the mention  in adver 
tising  to the general  public  of  therapeutic  indications  for 
which  self-medication  is not  suitable,  in  particular: 

2.  Member  States  shall  prohibit  the mention  in adver 
tising  to  the  general  public  of  therapeutic  indications for 
which  sclt'-mcdicaiion  is not suitable,  in  particular: 

—  tuberculosis, 

—  sexually  transmitted  diseases, 

—  other serious infectious  diseases, 

—  cancer, 

—  chronic  insomnia, 

—  diabetes and other  metabolic  illnesses. 

3.  The prohibition  referred  to in paragraph  1 shall not 
apply  to  vaccination  campaigns  approved  by  the 
competent  authorities  of  the  Member  States. 

4.  The prohibition  referred  in paragraph  2  shall  apply 
without  prejudice  to  Articles  2,  3  and  14  of  Directive 
89/552/EEC. 

5.  Member  States shall  prohibit  the free  distribution of 
medicinal  products  to  the  public 
for  promotional 
purposes. 

— 

tuberculosis, 

—  sexually  transmitted  diseases, 

—  other  serious  infectious  diseases, 

—  cancer, 

—  chronic  insomnia, 

—  diabetes  and other  metabolic  illnesses. 

3.  The prohibition  referred  to in paragraph  1 shall not 
apply 
to  vaccination  campaigns  approved  by  the 
competent  authorities  of  the  Member  States. 

4.  The prohibition  referred  in paragraph  2  shall  apply 
without  prejudice  to  Articles  2,  3  and  14  of  Directive 
89/552/EEC. 

5. Members States shall  prohibit 

the free distribution of 
medicinal  products  to the public 
for promotional purposes, 
as well  as  the offering of 
gifts or bonuses^ 

Or iginal  proposal 

Amended  proposal 

-6-

Article  4 

Without  prejudice  to  Article  3,  all  advertising  to  the 
general  public  of  a  medicinal  product  shall: 

Without  prejudice  to  Article  3,  all  advertising  to  the 
general  public  of  a  medicinal  product  shall: 

a) be  set  out  in  such  a  fashion  that 
it  is  clear  that  the  message  is 
an  advertisement,  and  that  the 
product  is  clearly  identified  as 
a medicinal  product, 

a)  be  set  out  in  such  a  fashion  that 
it  is  clear  that  the  message  ^ 
an  advertisement,  and  that  the 
product  is  clearly  P_resented. as a 
medicinal  product; 

(b)  include  the  following  minimum  information: 

(b)  include  the  following  minimum  information: 

followed  by 

—  the  name  of  the  medicinal  product,  incorporating 
the 
or 
medicinal  product  contains  only  one  active 
ingredient, 

the  common  name 

if 

—  the  name  of  the  medicinal  product,  incorporating 
or 
the 
medicinal  product  contains  only  one  active 
ingredient, 

the  common  name 

followed  by 

if 

—  the  information  necessary  for  correct  usage  of 
the  medicinal  product,  such  as  indications  for  use 
this,  an 
and  special  precautions,  or, 
express  invitation  to  read  the  package 
leaflet 
carefully. 

failing 

—  the  information  necessary  for  correct  usage  of 
the  medicinal  product,  such  as  indications  for  use 
and  special  precautions, 

an  express  invitation  to  read  the 
label  and  the  package  leaflet 
careful 1 y. 

Art icle 5 

The  advertising  of  a  medicinal  product  to  the  general 
public  shall  not  contain  any  material  which: 

The  advertising  of  a  medicinal  product  to  the  genera' 
public  shall  not  contain  any  material  which: 

(a)  gives  the  impression  that  a  medical  consultation  or 
surgical  operation  is  unnecessary,  in  particular  by 
offering  a  diagnosis  or  by  suggesting  treatment  by 
mail; 

(a)  gives  the  impression  that  a  medical  consultation  or 
surgical  operation  is  unnecessary,  in  particular  by 
offering  a  diagnosis  or  by  suggesting  treatment  by 
mail; 

b)  suggests  erroneously  that  the 
effects  of  taking  the  medicine 
are  guaranteed,  or  are  better 
than  another  treatment; 

b)  suggests 

effects 

that 
the 
of 
the 
medicine  are  guaranteed,  or  are 
better 
of 
the 
another  treatment; 

effects 

taking 

than 

(c)  suggests  that  the  normal  good  health  of  the  subject 
can  be  enhanced  by  taking  the  medicine,  or  that  it 
could  be  affected  by not  taking the medicine; 

(c)  suggests  that  the  normal  good  health  of  the  subject 
can  be  enhanced  by  taking  the  medicine,  or  thai  it 
could  be  affected  by not  taking  the  medicine; 

(d)  is directed  solely  or mainly  at children; 

(d)  is directed  solely  or  mainly  at children; 

(e)  refers  to  a  recommendation  by  scientists  or  health 

(e)  refers  to  a  recommendation  by  scientists  or  health 

professionals; 

professionals; 

(0  suggests  that  the  medicinal  product  is  a  foodstuff  or 

(0  suggests  that  the  medicinal  product  is  a  foodstuff  cr 

a cosmetic,  or  vice  versa; 

a  cosmetic,  or  vice versa; 

(g)  suggests  that  the  safety  or  efficacy  of  the  medicinal 

product  is due  to the  fact  that  it is 'natural'. 

(g)  suggests  that  the  safety  or  efficacy  of  the  median:! 

product  is due  to  the  fact  that  it is 'natural'. 

H 

Original  proposa I 

Amended proposa.l 

-7-

CHAPTER  111 

Advertising  to health professionals 

Ar t i cIe 6 

Anyi  advertising  of  a  medicinal 
product  to  persons  qualified  to 
prescribe  or  supply  such  products 
shall  include: 

—  the  particulars  listed  in  the  summary  of  product 

..._r ..-.;;;isticS, 

Any  advertising  of  a  medicinal 
product  to  persons  qualified  to 
prescribe or supply  or dispense  such 
products  shall  include: 

—  the  particulars  listed 

in  the  summary  of  product 

characteristics, 

—  the  legal  prescription  status of  the  medicinal  product, 

—  the  legal  prescription  status  of  the  medicinal  product, 

—  the  retail price of  the various  presentations, 

—  the  retail  price of  the various  presentations, 

—  if  appropriate,  conditions  of  coverage  by  the  social 

security systems. 

2.  The  advertising  of  a  medicinal  product  to  persons 
qualified  to  prescribe  or  supply  such  products  may, 
notwithstanding  paragraph  1,  include  only  the  name  of 
the  medicinal  product,  if  its sole  object  is to  recall  to  the 
latter. 

—  if  appropriate,  conditions  of  coverage  by  the  social 

security  systems. 

2. 
The  advertising  of  a  medicinal  product  to  persons 
qualified  to  prescribe  or  supply  such  products  may, 
notwithstanding  paragraph  1,  include  only  the  name  of 
the  medicinal  product,  if  its  sole  object  is to  recall  to  the 
latter. 

Articles 7 and 8 unchanged 

Art icle 9 

them, 

/*  In the course of promoting medicina} 
products  to  persons  qualified  to* 
prescribe 
be 
prohibited  to  give,  proffer  or 
promise  to  such  persons,  directly 
or  indirectly,  any  gifts,  pecuniary 
advantages  or benefits  in kind, with 
the . exception  of  objects  of  an 
insignificant  intrinsic, value. 

it  shall 

A» In  the  course  of  adverti sing 
medicinal 
products  to  persons 
qualified  to  prescribe  them,  it 
shall  be prohibited  to give, proffer 
or promise  to such persons, directly 
or  indirectly,  any  gifts,  pecuniary 
advantages  or  benefits  in  kind. 
(rest  deleted) 

& 

OrIginal  proposai 

Amended  proposal 

-8-

2 
Persons  qualified  to  prescribe  or  supply  medicinal 
products  shall  not  solicit  or  accept  any  inducement 
prohibited  under  paragraph  1. 

Persons  qualified  to  prescribe  or  supply  medicinal 
inducement 

2. 
products  shall  not  solicit  or  accept  any 
prohibited  under  paragraph  1. 

3 
The  prohibition  referred  to  in  paragraph  '  applies 
without  prejudice  to  the  regulations  of  the  vlember 
Sûtes  concerning  prices,  profit  margins  and  discounts. 

3. 
The  prohibition  referred  to  in  paragraph  " *pp!i:s 
without  prejudice  to  the  regulations  of  th*  vlember 
States  concerning  prices,  profit  margins  and  discounts. 

A r t i c le  9a  (new) 

1. The  provisions  of  Article  9  shall 
not  prevent  undertakings  which 
medicinal 
p r o d u ce 
p r o d u c ts 
o r g a n i z i ng 
congresses  intended  solely  for 
'  the,  further  scientific  training 

import 

f r om 

or 

of  health  care  professionals. 

2.  In  this  case,  the  hospitality 
extended  to  participants  must  be 
s u b o r d i n a te 
m a in 
scientific  objective  of  the  event 
it  is  provided. 
during  which 
S u ch 
be 
shall 
extended  only  to  health  care 
professional s. 

h o s p i t a l i ty 

t o-  the 

Art icle  10 

Where  medicinal  products  are  being 
promoted  to  persons  qualified  to 
free 
prescribe 
samples  shall  be  provided  to  such 
persons 
following 
on 
conditions : 

supply 

them, 

only 

the 

or 

Where  medicinal  products  are  being 
adverti sed  to  persons  qualified  to 
prescribe  or  supply  or  di spose  them, 
free  samples  shall  be  provided  to 
such  persons  only  on  the  following 
conditi ons: 

(a)  two  samples  at  the  most  may  be  provided  every  year 
to  any  person  qualified  to  prescribe  or  to  supply 
medicinal  products; 

(a)  two  samples  at  the  most  may  be  provided  every  year 
to  any  person  qualified  to  prescribe  or  to  supply 
medicinal  products; 

(b)  any  supply  of  samples  must  be  in  response  to  a 
written  request,  signed  and  dated, of  the  recipient; 

(b)  any  supply  of  samples  must  be  in  response  to  a 
written  request,  signed  and  dated,  of  the  recipient; 

(c)  the  samples  shall  be  identical  to  the  smallest  presen 

(c)  the  samples  shall  be  identical  to  the  smallest  presen 

tation  on  the  market; 

tation  on  the  market; 

d)  the  samples  shall  be  marked  "free 
medical  sample  -  not  for  resale" 
or 
of 
analogous  meaning; 

another 

legend 

with 

d,) the  samples 
and 

shall  be  marked, 
' free 
indelibly, 
clearly 
medical  sample  -  not  for  resale' 
or 
of 
analogous  meaning; 

another 

legend 

with 

» 

Or iginal  proposal 

Amended  proposal 

-9-

(e)  the  samples  shall  be  accompanied  by  a  copy  of  the 

(e)  the  samples  shall  be  accompanied  by  a  copy  of the 

summary  of product  characteristics; 

summary  of  product  characteristics; 

(0  no samples  of  medicinal  products  containing  psycho 
tropic  or  narcotic  substances  within  the  meaning  of 
international  conventions  may be supplied. 

(0  no samples  of  medicinal  products  conuining  psycho 
tropic  or  narcotic  substances  within  the  meaning  of 
international  conventions  may be supplied. 

CHAPTER  IV 

Monitoring of advertising 

Articles  11, 12, 13 and  14 unchanged 

w 

ISSN 02544475 

COM(91) 245 final 

DOCUMENTS 

EN 

05 

Catalogue number : CB-CO-91-324-EN-C 

ISBN 92-77-74649-1 

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