NoC 163/10 Official Journal of the European Communities 4. 7. 90 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on advertising of medicinal products for human use 
COM(90) 212 final — SYN 273 
(Submitted by the Commission on 12 June 1990) 
(90/C 163/12) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100a 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas Council Directive 84/450/EEC (') has 
harmonized the laws, regulations and administrative 
provisions of the Member States concerning misleading 
advertising; 
Whereas all Member States have adopted further specific 
measures concerning the advertising of medicinal 
products; whereas there are disparities between these 
measures; whereas these disparities are likely to have an 
impact on the establishment and functioning of the 
internal market, since advertising disseminated in one 
Member State is likely to have effects in other Member 
States; 
Whereas Council Directive 89/552/EEC of 3 October 
1989 on the coordination of certain provisions laid down 
by law, regulation or administrative action in Member 
States concerning the pursuit of television broadcasting 
activities (*) prohibits the television advertising of 
medicinal products which are available only on medical 
prescription in the Member State within whose juris­
diction the television broadcaster is located; whereas this 
principle should be made of general application by prohi­
biting all advertising of medicinal products which are 
available only on prescription; 
Whereas advertising to the general public even of 
non-prescription medicinal products could affect public 
(') OJ No L 250, 19. 9. 1984, p. 17. 
(2) OJ No L 298, 17. 10. 1989, p. 23. health, if it was excessive and ill-considered; whereas 
advertising of medicinal products to the general public, 
where it is permitted, ought therefore to satisfy certain 
essential criteria which ought to be defined; 
Whereas, furthermore, distribution of samples free of 
charge to the general public for promotional ends must 
be prohibited; 
Whereas the advertising of medicinal products to persons 
qualified to prescribe or supply them contributes to the 
information available to such persons; whereas, never­
theless this advertising should be subject to strict 
conditions and effective monitoring, referring in 
particular to the work achieved within the framework of 
the Council of Europe; 
Whereas medical sales representatives have an important 
role in the promotion of medicinal products; whereas 
therefore certain obligations should be imposed upon 
them in particular the obligation to supply the person 
visited with a summary of product characteristics; 
Whereas persons qualified to prescribe medicinal 
products must be able to carry out these functions objec­
tively without being influenced by direct or indirect 
financial inducements; 
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 persons qualified to prescribe or supply 
medicinal products must have access to a neutral 
objective source of information about products available 
on the market; whereas it is nevertheless for the Member 
States to take all measures necessary to this end, in light 
of their own particular situation; 
Whereas advertising of medicinal products should be 
subject to effective, adequate monitoring; whereas 
reference in this regard should be made to the moni­
toring mechanisms set up by Directive 84/450/EEC; 
4. 7. 90 Official Journal of the European Communities NoC 163/11 
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, 
HAS ADOPTED THIS DIRECTIVE: 
CHAPTER I 
Scope, definitions and general principles 
Article 1 
1. This Directive concerns the advertising of medicinal 
products for human use in the Community. 
2. For the purposes of this Directive, 
— the definition of 'advertising' shall be that laid down 
in Article 2 of Directive 84/450/EEC, 
— the definition of 'medicinal product' shall be that laid 
down in Article 1 of Council Directive 
65/65/EEC O, 
— the definitions of the 'name of the medicinal product' 
and of the 'common name' shall be those laid down 
in Article 1 of Council Directive .../.. ./EEC, 
— the 'summary of product characteristics' shall be the 
summary approved by the competent authority which 
granted the marketing authorization in accordance 
with Article 4b of Directive 65/65/EEC. 
3. For the purposes of the application of this 
Directive, the advertising of medicinal products includes, 
in particular: 
— information of a commercial nature for health care 
professionals, in whatever form, which may promote 
the prescription or supply of medicinal products, 
— visits by medical representatives to persons allowed to 
prescribe or supply medicinal products, 
— any incitement to prescribe or supply medicinal 
products by the gift, offer or promise of any benefit 
or bonus, whether in money or in kind, including 
invitations to travel or to congresses. 
Article 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. 
(') OJ No L 11, 9. 2. 1965, p. 369/65. 2. All parts of the advertising of a medicinal product 
must be compatible with the particulars listed in the 
summary of product characteristics. 
3. The advertising of a medicinal product: 
— shall encourage the rational use of the medicinal 
product, by presenting it objectively and without 
exaggerating its properties, 
— shall not be misleading, within the meaning of 
Directive 84/450/EEC. 
CHAPTER II 
Advertising to the general public 
Article 3 
1. 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. 
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. 
No C 163/12 Official Journal of the European Communities 4.7.90 
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. 
Article 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; 
(f) 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'. 
CHAPTER III 
Advertising to health professionals 
Article 6 
1. Any advertising of a medicinal product to persons 
qualified to prescribe or supply 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. 
Article 7 
1. Any documentation relating to a medicinal product 
which is transmitted as part of the promotion of that 
product to persons qualified to prescribe or supply it 
shall include as a minimum the particulars listed in 
Ankle 6 (1). 
2. All the information contained in the documentation 
referred to in paragraph 1 shall be accurate, up-to-date, 
verifiable and sufficiently complete to enable the 
recipient to form his or her own opinion of the thera­
peutic value of the medicinal product concerned. 
3. Quotations as well as tables and other illustrative 
matter taken from medical journals or other scientific 
works for use in the documentation referred to in 
paragraph 1 shall be faithfully reproduced and the 
precise sources indicated. 
Article 8 
1. Medical sales representatives shall be given 
adequate training and shall have sufficient scientific 
knowledge to be able to provide precise and complete 
information about the medicinal products which they 
promote. 
2. During each visit, medical sales representatives shall 
provide the persons visited with the summaries of 
product characteristics in respect of each medicinal 
product which they present. 
3. Medical sales representatives shall transmit to the 
scientific service referred to in Article 12 (1), any infor­
mation about the use of the medicinal products they 
promote, especially about adverse reactions, that is 
reported to them by the persons they visit. 
Article 9 
1. In the course of promoting 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, with the exception of objects of an insignificant 
intrinsic value. 
4.7.90 Official Journal of the European Communities No C 163/13 
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 1 applies 
without prejudice to the regulations of the Member 
States concerning prices, profit margins and discounts. 
Article 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; 
(d) the samples shall be marked 'free medical sample — 
not for resale' or with another legend of analogous 
meaning; 
(e) the samples shall be accompanied by a copy of the 
summary of product characteristics; 
(f) no samples of medicinal products containing psycho­
tropic or narcotic substances within the meaning of 
international conventions may be supplied. 
CHAPTER IV 
Monitoring of advertising 
Article 11 
1. Member States shall ensure that there are adequate 
and effective methods to monitor advertising of 
medicinal products. Such methods shall include legal 
provisions under which persons or organizations 
regarded under national law as having a legitimate 
interest in prohibiting any advertisement inconsistent 
with this Directive may take legal action against such 
advertisement, or bring such advertisement before an 
administrative authority competent either to decide on 
complaints or to initiate appropriate legal proceedings. 
2. Under the legal provisions referred to in paragraph 
1, Member States shall confer upon the courts or admin­
istrative authorities powers enabling them: 
— to order the discontinuance, correction or withdrawal 
of any advertisement inconsistent with this Directive, — require either the publication of a corrigendum, or 
the publication in whole or in part and in a form 
which it shall deem adequate, of the decision 
ordering the discontinuance of an advertisement. 
3. Under the legal provisions referred to in paragraph 
1, Member States shall ensure that any decision taken in 
accordance with paragraph 2 shall state in detail the 
reasons on which it is based and shall be communicated 
in writing to the person concerned, mentioning the 
remedies available at law and the time limit allowed for 
the exercise of such remedies. 
4. This Article shall not exclude voluntary control of 
advertising of medicinal products by self-regulatory 
bodies and recourse to such bodies, if proceedings before 
such bodies are in addition to the judicial or adminis­
trative proceedings referred to in paragraph 1. 
Article 12 
1. The person responsible for marketing shall establish 
within his undertaking a scientific service in charge of 
information about the medicinal products which he 
places on the market. 
2. The person responsible for marketing shall: 
— make available to the bodies responsible for moni­
toring advertising of medicinal products a sample of 
all advertisements emanating from their undertaking 
together with a statement indicating the persons to 
whom it is addressed, the method of dissemination 
and the date of first dissemination, 
— ensure that advertising of medicinal products by his 
undertaking conforms to the requirements of this 
Directive, 
— verify that medical sales representatives employed by 
his undertaking have been adequately trained and 
fulfil the obligations imposed upon them by Article 8 
(2) and (3), 
— supply the bodies responsible for monitoring pharma­
ceutical advertising of medicinal products with the 
information and assistance these require to carry out 
their responsibilities, 
— ensure that the decisions taken by the bodies charged 
with monitoring advertising of medicinal products 
are immediately and fully complied with. 
Article 13 
1. Where the provisions of the Directive have not 
been observed, and a warning notice served on the party 
concerned has remained without effect, the competent 
authorities of a Member State may suspend the authori­
zation to market the medicinal product concerned, 
without prejudice to any other sanction which may be 
applied under national law. 
NoC 163/14 Official Journal of the European Communities 4. 7. 90 
2. All decisions taken pursuant to paragraph 1 shall 
state in detail the reasons on which they are based. A 
decision shall be notified to the party affected by it, who 
shall at the same time be informed of the remedies 
available at law and the time limit allowed for the 
exercise of such remedies. 
Article 14 
1 Member States shall take all the steps necessary to 
comply with this Directive with effect from 1 January 1992. They shall forthwith inform the Commission 
thereof. 
2. Measures taken in accordance with paragraph 1 
shall make express reference to this Directive. 
Article 15 
This Directive is addressed to the Member States.