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 
on the wholesale distribution 
of medicinal products for human use SYN 229 
•.'$§s$*ç 
PRE Amendment to the proposal for a 
COUNCIL DIRECTIVE 
on the legal status for the supply 
of medicinal products for human use 
Amendment to the proposal for a 
COUNCIL DIRECTIVE SYN 230 
SYN 231 
on the labelling of medicinal products for human use 
and on package leaflets 
Amendment to the proposal for a 
COUNCIL DIRECTIVE 
on advert ising 
of medicinal products for human use SYN 273 
(presented by the Commission pursuant to Article 149(3) 
of the EEC-Treaty) 
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 
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Amendment to the proposal for a 
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 comp^Hnn of the internal 
market must h* based on the highest 
possible level of environmental, 
public health and consumer 
protection; 
Second recital 
Whereas the wholesale distribution Whereas the wholesale distribution 
of medicinal products for human use of medicinal products for human use 
is at present subject to different is at present subject to different 
provisions in the various Member provisions in the various Member 
States; whereas many operations States; whereas many operations 
involving the wholesale distribution involving the wholesale distribution 
of medicinal products may cover of medicinal products cover and will 
simultaneously several Member increasingly cover simultaneously 
States; several Member States; 
Third recital unchanged 
Fourth recital 
Whereas any person involved in the Whereas any person involved in the 
wholesale distribution of medicinal wholesale distribution of medicinal 
products should be in possession of products should be in possession of 
a speci al authorization; whereas a speci fie authorization; whereas 
gharmacists and persons authorized the definition of distribution does 
to supply medicinal products not cover d j y_jd i n g up, p a cka g i nc; and 
djjrectly to the public, and_who presentation operations referred to 
confine themselves to this actiyity, in Article 16 of Directive 75/319 
should be exempt from obtain 1jTQt_J,jTJs and 1n the amendments thereto or 
authorization; whereas 1t is alwa)^ operations 1 Inked to direct '.u<>p!y 
necessary in order to control the to_the public; 
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_ records showing __§I!_tr y 
transacti ons; 
-A-
Or Iginat proposal Amended proposal 
Fourth recital a (new) 
Whereas it is necessary to lay down 
uniform rules applicable throughout 
the Community with a view to 
establishing the conditions fo r 
obtaining authorizati on , 
arrangements 1n connection with 
transport , personnel and premises, 
and the procedures for the checks to 
be carried out by the Member States; 
Fifth recital unchanged 
Article 1 paragraph 1 and 2 unchanged 
Article l(2a)(new) 
2a. For the purposes of this 
directive 'public service 
obligations' shall include the 
obligation for wholesalers to 
guarantee a constant range of 
medicinal products to meet the needs 
of a geographically determined 
territory and to ensure the supply 
at very short notice of the products 
requested throughout the territory 
In question. 
Articles 2, 3 and 4 unchanged 
r 
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Original proposaj_ Amended proposai 
Article 5 (a) and (b) unchanged 
Article 5 (c) 
(c) they must undertake to fulfil (c) they must undertake to comply 
the obligations incumbent on with sound distribution 
them under the terms of practices and to establish that 
Article 6. 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 (b) to obtain medicinal products 
only from persons who are only from persons who hold an 
themselves in possession of the authorization as referred to in 
authorization referred to in Article 16 et seg of Directive 
Article 3(1) or who are exempt 7 _5/_3 19/ E E C , or who arc 
from obtaining this themse Ives In possession of th<? 
authorization under the terms authorization referred to in 
of Article 3(2); Article 3(1) or who are exempt 
from obtaining this 
authorization under the terms 
of Article 3(2) ; 
Article 6 (c) unchanged 
Article 6 (d) 
(d) to have an emergency plan which (d) to accept an emergency plan 
allows participation in any which allows participation in 
action of withdrawal from the any action of withdrawal from 
market ordered by the competent the market ordered by the 
authorities or initiated by the competent authorities of the 
manufacturer of the medicinal Member State or initiated by the 
product concerned; manu facturer/ importer of the 
medicinal product concerned; 
Article 6 (e). (f) and (g) unchanged 
è 
-G-
Original proposal Amended propesai 
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 
If appropriate, the Commission shall 
TuTlish guidelines on good 
distribution practices. j" **at 
case the pharmaceutical committee 
TTTItltuted by Council 
Decision 75/320/EEC1 
consul ted. shall be Within a period of two yoa^s from 
the date of adopti on of ^ii : ; 
dlrectlve, the Comm1 -s 1 on s h a 11 
publish guidelines on good 
distribution practices. It shal1 
update this publication annually. 
It shall consult for this purpose 
the pharmaceutical committee 
instituted by Council Decision 
75/320/EEC. 
Articles 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 
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Amendment to the proposal for a 
COUNCIL DIRECTIVE 
on the legal status for supply 
of medicinal products for human use 
(Presented by the Commission in accordance with 
Article 149 paragraph 3 of the EEC Treaty) SYN 230 
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 use; 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 
> 
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Qriginal proposal Amended proposal 
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 classification 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 
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nriginal proposal Amended proposal 
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 supplied on medical 
prescription. In this case thev 
shall usev the following 
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 
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/^ iff rna I- proposal Amended proposa 
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, 
mentioning one of the categories referred to in 
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 
" • thev are administered 
parenterallv or 
- thev cause addiction and/or 
dependence. 
2. All medical products containing a 
new chemical shall be subject £s 
medical prescription. and classed, 
in one of the categories referred to 
in Article 2. 2. Where Member States specify a 
subcategory of medicinal product 
subject to special medical 
prescription, account shall be taken 
of the following elements: 
the presence in the medicinal 
product of a non-exempted dosage 
of a substance classified as a 
psychotropic or a narcotic 
substance within the meaning of 
the relevant international 
conventions (United Nations 
Conventions of 1961 and 1971) or 
- the possibility that the 
medicinal product could, if 
improperly used, give rise to 
major risks of medicinal abuse. 
cause addiction or be misused for 
illegal purposes.or 
A3 
~r-
Original propos»I Amended proposal 
frhe presence in the medicinal 
product of a substance which, 
because of its novelty or 
properties, could be included in 
frhat category as a precautionary 
measure. 
2a. In cases where Member States 
specify a subcategory of medicinal 
products subject to limited medical 
prescription, thev shall take 
account of the following elements 
- medicinal products which, bv 
reason of their pharmacological 
characteristics or their novelty 
or in the interest of public 
health, are reserved for use in 
treatments which can only be 
carried out in hospitals. 
- medicinal products employed in 
the treatment of illnesses which 
require diagnosis in a hospital 
or other institution with 
a d e c uate facilities for 
diagnosis. but where 
administration and follow-up can 
be carried out outside the 
hospital or in establishments 
equipped with adecuate diagnostic 
faci1 ities. 
medicinal products for use bv 
out-patients which could produce 
severe adverse effects and which 
therefore call for supervised 
treatment. 
3. The competent authority shall 
publish at least annually the list 
of medicinal products subject to 
medical prescription, specifying the 
category of classification. 3, The competent authority shall 
publish at least annually the list 
of medicinal products subject tc 
medical prescription specifying the 
category of classification and 
circulate this list to the medical 
professionals in their territory. 
Original proposal -8-
Amended proposa 
Article 4 
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. 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. 
: *<•*-.r ...^ 
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. 
M 
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Original proposal 
Article 5 Amended proposal 
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 
medical prescription. This list 
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 
#• 
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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. 
/\ 
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Amen<'<?:';r»l to the proposal for a 
COUNCIL DIRECTIVE 
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) SYN 231 
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. 
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: 
- "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; 
'common name' shall mean the international 
non-proprietary name recommended by the Work! 
Health Organisation, or. if one does not exist, the usual 
common name, 
'immediate packaging* shall mean the container or other 
form ol packaging immediately in contact with tlte 
medicinal product; 
'outer packaging' shall mean the packaging into which is 
placed the immediate packaging, 
'package leaflet' shall mean a leaflet containing 
information for the user which accompanies the 
medicinal product to which it refers. 1. This Directive deals with the labelling of medicinal 
products lor huma;? use and leaflets inserted in packages of 
such products. 
2. lor 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 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; 
— 'common name' shall mean the international 
nou-proprieiarv u.ime recommended by the World 
Health Organization, or, if one does not exist, the usual 
common name. 
— '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, 
— 'package leaflet* shall mean a leaflet containing 
information lo; the user which accompanies the 
medicinal product to which it refers. 
- "labelling" 9 ha 11 mean the 
particulars provided on the outer 
or immediate packaging; M 
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Original proposal Amended proposal 
Article 2 unchanged 
CHAPTER II 
Labelling of medicinal products 
Article 3 
The following particulars shall appear on the outer 
packaging of medicinal products or, where there is no outer 
packaging, on the immediate packaging: 
(a) the name of the medicinal product, including or followed 
by the common name if the product contains only one 
active ingredient; 
(b) a statement of the active ingredients expressed 
qualitatively and quantitatively per dosage unit or 
according to the form of administration for a given 
volume or weight, using their common names; 
(c) the pharmaceutical form .snd the contents by weight, by 
volume or number or doses of the product; 
d) a list of the excipients; 
(e) the route and method of administration; 
(f) a special warning that the product must be stored out of 
reach ol children; 
(g) the expiry date in clear terms (month/year); 
(h) special storage precautions, if any; 
(i) special precautious for disposal of unused medicinal 
products or waste materials derived from such products, 
if appropriate; 
j) the name and address of the person 
responsible for placing the 
medicinal product on the market 
and, where different, of the 
manufacturer; 
(k) the number of the authorization to put the medicinal 
product on the market; 
(I) the manufacturer's batch number. The following particulars shall appear on the outer 
packaging of medicinal products or. where there is no outer 
packaging, on the immediate packaging: 
(a) the name of the medicinal product, including or followed 
by the common name if the product contains only one 
active ingredient; 
(b) a statement of the active ingredients expressed 
qualitatively and quantitatively per dosage unit or 
according to the form of administration for a given 
volume or weight, using their common names; 
(c) the pharmaceutical form and the contents by weight, bv 
volume or number or doses of the product; 
d) the excipients that should be 
known about to en su re an 
effective use of the medicinal 
product; 
(e) the route and method of administration; 
(f) a special warning that the product must In- stou-d mil ot 
reach ol children; 
(g) the expiry date in clear terms (month, vear). 
(h) special storage precautions, if an\ ; 
(i) special precautions for disposal of unused médicinal 
products tu waste materials derived from such products, 
if appropriât:'; 
j) the name and address of the 
person responsible for placing 
the medicinal produ - on the 
market; 
(k) the number of the authorization to put the medicinal 
product on the market; 
(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, 
— quantity of active constituents, using common names, 
— route and method of administration, 
— 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. At least the following 
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, 
— route and method of administration, 
— expiry date, 
— batch number. 
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, 
- route and method 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 
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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: 
a) for the identification 
medicinal product: of the 
name of the medicinal product 
quantitative and qualitative 
composition in terms of active 
ingredients, using 
names, the common 
- pharmaco-therapeutic group, if 
there exists a term easily 
comprehensible for the patient, 1. The leaflet shall be drawn up ir. 
accordance with the summary of 
product characteristics; it shall 
contain, usually in 
following order: the 
a) for the identification of the 
medicinal product: 
name of the medicinal product 
in accordance with Article 
3(a), 
full quantitative and 
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 
authorization, and, where different, of the 
manufacturer; 
(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, 
— special warnings. — name and address of the holder of the marketing 
authorization, and. where different, of the 
manufacturer; 
•(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, 
— special warnings. 
this list must: 
— take into account the particular condition of certain 
categories of users (e.g. children, pregnant or 
breastfeeding women, the elderly, persons with 
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; this list must: 
— take into account the particular condition of certain 
categories of users (e.g. children, pregnant or 
breastfeeding women, the elderly, persons with 
specific pathological conditions), 
— mention, if appropriate, potential effects on the 
ability to drive vehicles or to operate machinery, 
— 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 
proper use, in particular: d) the necessary instructions for 
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 method and 
administration, 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; the frequency of 
administration, specifying if 
necessary the appropriate time 
at which the medicinal product 
should or must be administered; 
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 nature and expected effect 
of using the medicinal product, 
the action to undertake in the 
case of overdose (symptoms, 
emergency procedures, antidotes), 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 way the treatment should be 
stopped, if stopping the treatment 
may lead to withdrawal effects; 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, 
— i( necessary a warning against visible signs of 
deterioration; 
(g) all other information compatible with the summary of 
product characteristics of the product, useful for health 
education, and on condition that it is not of a 
promotional nature. e) a description of the undesirable 
effects which can occur when the 
medicinal product is used, with 
indication if possible of their 
importance, and if necessary the 
action to be taken in such case; 
the patient should be expressly 
invited to communicate any 
undesirable effect which is not 
mentioned in the leaflet to his 
doctor or to hi3 pharmacist; 
(f) a reference to the expirv date indicated on the label, 
with: 
— a warmm; against using the product after this 
date. 
— where appropriate, special storage precautions, 
— if neceNs.it » a warning against visible signs of 
deterioration; 
(g) all other inforn-.ation compatible with the summary of 
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 information needs relative to 
self-medication, 
— the readability of particulars on the labelling and 
leaflet. 
— utih/ation of bar codes for the identification of medicinal 
products. 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 information needs relative to 
sclf-medica:ion. 
— the readabii::\ of particulars on the labelline, .\nd 
leaflet. 
— utilization <•: bar codes for the identification of medicinal 
products. 
- excipient» that must be indicated 
on the packaging and warnings 
referring to them that must be 
carried on the packaging. 
h.r this purpose, the Commission shall consult the 
Committee for Proprietary Mcdicin.il Products instituted by 
Directive 75/319/EEC. For this purpose, ihe Commission shalf «.«insult in» 
Committee for Pr«ipnetarv Medicinal Products instituted r*. 
Directive 7.S/3H '-.EC. 
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 
SYN 273 -3-
Amendment to the proposal for a 
COUNCIL DIRECTIVE 
on advert ising 
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 
Whereas advertising to the general Whereas advertising to the general 
public even of non-prescription public even of non-prescription 
medicinal products could affect medicinal products may affect public 
public health, if it was excessive health, if it does not satisfy 
and ill-considered; whereas certain essential criteria which 
advertising of medicinal products to ought to be defined; 
the general public, where it is 
permitted, ought therefore to 
satisfy certain essential criteria 
which ought to be defined; 
Fifth, sixth and seventh recitals unchanged 
Eighth recital 
Whereas persons" qualified to Whereas persons qualified to 
prescribe medicinal products must be prescribe medicinal products must be 
able to carry out these functions able to carry out these functions 
objectively without being influenced objectively without being influenced 
by direct or indirect financial by direct or indirect financial - or 
inducements; other - inducements; 
M 
-A-
Or iginal proposal Amended proposa I 
Ninth recital 
Whereas it should be possible within 
certain restrictive •conditions to 
provide samples of medicinal 
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; Whereas it should be possible within 
certain restrictive conditions to 
provide samples of medicinal 
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; these free samples of 
medicinal products must, of course, 
not be sold; 
Tenth and eleventh recital» unchanged 
Twelfth recital 
Whereas each undertaking which 
manufactures or imports medicinal 
products should set up a mechanism 
to ensure that all information 
supplied about a medicinal product 
conforms with the approved 
conditions of use, Whereas each undertaking which 
manufactures or imports medicinal 
products should set up a mechanism 
to ensure that all information 
supplied about a medicinal product 
corresponds to the information 
provided in the summary of the 
characteristics of the product, as 
approved by the competent 
authori ties ; 
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) 
& 
-5-
Orig nal proposal Amended proposal 
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: 
— 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. 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, 
— 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 
Council of Europe and the 
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: 
— 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. 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. 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^ 
-6-
Or iginal proposal Amended proposal 
Article 4 
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, 
(b) include the following minimum information: 
— the name of the medicinal product, incorporating 
or followed by the common name if the 
medicinal product contains only one active 
ingredient, 
— the information necessary for correct usage of 
the medicinal product, such as indications for use 
and special precautions, or, failing this, an 
express invitation to read the package leaflet 
carefully. 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 ^ 
an advertisement, and that the 
product is clearly P_resented. as a 
medicinal product; 
(b) include the following minimum information: 
— the name of the medicinal product, incorporating 
or followed by the common name if the 
medicinal product contains only one active 
ingredient, 
— 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: 
(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; 
(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; 
(d) is directed solely or mainly at children; 
(e) refers to a recommendation by scientists or health 
professionals; 
(0 suggests that the medicinal product is a foodstuff or 
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'. 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; 
b) suggests that 
the effects of taking the 
medicine are guaranteed, or are 
better than the effects of 
another treatment; 
(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; 
(e) refers to a recommendation by scientists or health 
professionals; 
(0 suggests that the medicinal product is a foodstuff cr 
a cosmetic, or vice versa; 
(g) suggests that the safety or efficacy of the median:! 
product is due to the fact that it is 'natural'. 
H 
-7-
Original proposa I Amended proposa.l 
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, 
— the legal prescription status of the medicinal product, 
— 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. 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 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. 
Articles 7 and 8 unchanged 
Art icle 9 
/* In the course of promoting medicina} 
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, with 
the . exception of objects of an 
insignificant intrinsic, value. 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) 
& 
-8-
OrIginal proposai Amended proposal 
2 Persons qualified to prescribe or supply medicinal 
products shall not solicit or accept any inducement 
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. 2. Persons qualified to prescribe or supply medicinal 
products shall not solicit or accept any inducement 
prohibited under paragraph 1. 
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. 
Article 9a (new) 
1. The provisions of Article 9 shall 
not prevent undertakings which 
produce or import medicinal 
products from organizing 
congresses intended solely for 
' the, further scientific training 
of health care professionals. 
2. In this case, the hospitality 
extended to participants must be 
subordinate to- the main 
scientific objective of the event 
during which it is provided. 
Such hospitality shall be 
extended only to health care 
professional s. 
Art icle 10 
Where medicinal products are being 
promoted to persons qualified to 
prescribe or supply them, free 
samples shall be provided to such 
persons only on the following 
conditions : 
(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; 
(c) the samples shall be identical to the smallest presen­
tation on the market; 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; 
(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
tation on the market; 
d) the samples shall be marked "free 
medical sample - not for resale" 
or with another legend of 
analogous meaning; d,) the samples shall be marked, 
clearly and indelibly, ' free 
medical sample - not for resale' 
or with another legend of 
analogous meaning; 
» 
-9-
Or iginal proposal Amended proposal 
(e) the samples shall be accompanied by a copy of the 
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. (e) the samples shall be accompanied by a copy of the 
summary of product characteristics; 
(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 
Office for Official Publications of the European Communities 
L-2985 Luxembourg