8. 3. 90 Official Journal of the European Communities No C 58/21 
Proposal for a Council Directive on the labelling of medicinal products for human use and on 
package leaflets 
COM(89) 607 final SYN 231 
(Submitted by the Commission on 26 January 1990) 
(90/C 58/05) 
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 measures aimed at progressively establishing the 
internal market during the period up to 31 December 1992 
need to be taken; whereas the internal market is to comprise 
an area without internal frontiers in which the free movement 
of goods, persons, services and capital is ensured; 
Whereas Council Directive 65/65/EECof26 January 1965 
on the approximation of provisions laid down by law, 
regulation or administrative action relating to medicinal 
products (]), as last amended by Directive 89/341/EEC (2), 
establishes a list of particulars to be given on the immediate 
packaging and the outer packaging of medicinal products for 
human use; whereas this list should be supplemented and 
details given of how labelling is to be presented; 
Whereas the Second Council Directive 75/319/EEC of 20 
May 1975 on the approximation of provisions laid down by 
law, regulation or administrative action relating to 
proprietary medicinal products (3), as last amended by 
Directive 89/341 /EEC (4), establishes a non-inclusive list of 
particulars to be included in package insert leaflets; whereas 
this list should be supplemented and details given of how 
such leaflets are to be presented; 
Whereas the provisions on labelling and on package insert 
leaflets should be united in a single legislative text; 
Whereas the provisions governing the information supplied 
to users should provide a high degree of consumer 
protection, in order that medicinal products be used correctly 
on the basis of complete and comprehensive information; 
(») OJ No 22, 9. 2. 1965, p. 369/65. 
(2) OJ No L 142, 25. 5. 1989, p. 11. 
(3) OJ No L 147, 9. 6. 1975, p. 13. 
(4) OJ No L 142, 25. 5. 1989, p. 11. Whereas the marketing of medicinal products whose 
labelling and package leaflets comply with the provisions of 
this Directive should not be prohibited or impeded on 
grounds connected with the labelling or package leaflet, 
HAS ADOPTED THIS DIRECTIVE: 
CHAPTER I 
Scope and definitions 
Article 1 
1. This Directive deals with the labelling of medicinal 
products for 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 
65/65/EEC shall apply. In addition to this: 
— 'name of the medicinal product' shall mean the name 
given to a medicinal product, which may be an invented 
name, a common name together with a trademark or the 
name of the manufacturer, or a scientific name together 
with a trade mark or the name of the manufacturer, 
— 'common name' shall mean the international 
non-proprietary name 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 for the user which accompanies the 
medicinal product to which it refers. 
Article 2 
No part of this Directive shall be taken to authorize the 
marketing of a medicinal product for which an authorization 
in accordance with Community legislation has not been 
issued. 
No C 58/22 Official Journal of the European Communities 8. 3. 90 
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 and 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 of children; 
(g) the expiry date in clear terms (month/year); 
(h) special storage precautions, if any; 
(i) special precautions 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; 
(1) the manufacturer's batch number. 
Article 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 carry all the 
particulars listed in paragraph 1. Article 5 
1. The particulars referred to in Articles 3 and 4 shall be 
easily visible, clearly comprehensible and indelible. 
2. The particulars listed in Article 3 (a) to (f) on the one 
hand, and (g) to (i) on the other hand, shall as far as possible 
appear in the same field of vision. 
3. The particulars listed in Article 3 shall appear in the 
official language or languages of the Member State where the 
product is put on the market. This provision shall not prevent 
these particulars from being indicated in various languages, 
provided the information given is the same in all languages 
used. 
Article 6 
1. Member States shall not prohibit or impede the placing 
on the market of medicinal products within their territory on 
the grounds that the labelling is incorrect, if such labelling 
complies with this Chapter. 
2. Notwithstanding paragraph 1, Member States may 
require the following information to be provided on the outer 
packaging or, in the absence of such, on the immediate 
packaging: 
— price of the medicinal product, 
— reimbursement conditions by social security 
organizations, 
— the legal status for supply to the patient, particularly 
where a new medicinal product is concerned. 
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. 
Article 8 
1. The leaflet shall include, usually in the following 
order: 
(a) for the identification of the medicinal product: 
— name of the medicinal product, 
— quantitative and qualitative composition in terms of 
active ingredients, using the common names, 
— pharmaco-therapeutic group, if there exists a term 
easily comprehensible for the patient, 
8. 3. 90 Official Journal of the European Communities No C 58/23 
— 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; 
(d) the necessary instructions for proper use, in 
particular: 
— the usual dose and the maximum dose, 
— the method and route of administration, 
— 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 
— the duration of treatment, when it should be 
limited, 
— the action to undertake in the case of overdose 
(symptoms, emergency procedures, antidotes), 
— 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; when the 
medicinal product 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, 
— if 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. 
2. Notwithstanding point 1 (b), the competent 
authorities may decide that certain therapeutic indications 
will not be mentioned in the package leaflet, when the 
dissemination of such information might have serious 
disadvantages for the patient. 
3. The leaflet may include symbols or pictograms 
designed to elaborate certain information mentioned in 
paragraph 1. 
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. 
Article 10 
Member States shall not prohibit or impede the placing on 
the market of medicinal products within their territory on the 
grounds that the package leaflet is not correct, if the package 
leaflet complies with this Chapter. 
CHAPTER IV 
General and final provisions 
Article 11 
1. One or more specimens or mock-ups of the outer 
packaging and the immediate packaging of a medicinal 
product, together with the draft package leaflet, shall be 
submitted to the competent authorities of the Member State 
concerned. 
2. All proposed modifications to the outer packaging, to 
the immediate packaging or to the package leaflet shall be 
submitted to the competent authorities of the Member State 
concerned. If the competent authorities have not opposed a 
draft modification within 90 days following the introduction 
of the request, the applicant may proceed to put the 
modification into effect. 
No C 58/24 Official Journal of the European Communities 8. 3. 90 
3. The competent authorities shall not allow a medicinal 
product to be placed on the market, if the packaging or the 
package leaflet do not comply with the provisions of this 
Directive or if they are not compatible with the particulars 
listed in the summary of the product characteristics referred 
to in Article 4b of Directive 65/65/EEC. 
4. The fact that the competent authorities do not refuse a 
marketing authorization for a reason associated with the 
labelling or the package insert, does not alter the general legal 
liability of the manufacturer or as appropriate the marketing 
authorization holder. 
Article 12 
1. When then provisions of this Directive are not 
observed, and an order addressed to the person concerned 
has remained without effect, the competent authorities of a 
Member State may suspend or revoke the authorization to 
place the medicinal product on the market, until the labelling 
and leaflet of the medicinal product in question has complied 
with the requirements of this Directive. 
2. AH decisions taken pursuant to paragraph 1 shall state 
in detail the reasons on which they are based. They shall be 
notified to the party concerned, who shall at the same time be 
informed of the remedies available to him under the laws in 
force and of the time limit allowed for the exercise of such 
remedies. 
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, 
— utilization of bar codes for the identification of medicinal 
products. 
For this purpose, the Commission shall consult the 
Committee for Proprietary Medicinal Products instituted by 
Directive 75/319/EEC. 
Article 14 
1. Articles 13 to 20 of Directive 65/65/EEC and 
Articles 6 and 7 of Directive 75/319/EEC are hereby 
repealed. 
2. References made to provisions which have been 
repealed shall be understood to refer to the present Directive, 
in accordance with the table of concordance given in the 
Annex. 
Article 15 
1. Member States shall take the measures necessary to 
comply with this Directive before 1 January 1992. They shall 
forthwith inform the Commission thereof. 
The provisions adopted pursuant to the first subparagraph 
shall make express reference to this Directive. 
2. From 1 January 1993, Member States shall refuse an 
application for marketing authorization or for the renewal of 
an existing authorization, when the labelling and the leaflet 
do not conform to the requirements of this Directive. 
Article 16 
This Directive is addressed to the Member States. 
8. 3. 90 Official Journal of the European Communities No C 58/25 
ANNEX 
TABLE OF CONCORDANCE 
Directive 65/65/EEC 
Article 13 
Article 14 
Article 15 
Article 16 
Article 17 
Article 18 
Article 19 
Article 20 first indent 
Article 20 second indent Present Directive 
Article 3 
Article 4, paragraph 1 
Article 4, paragraph 2 
— 
— 
Article 5, paragraph 3 
— 
Article 12, paragraph 1 
Article 12, paragraph 2 
Directive 75/319/EEC 
Article 6 first indent 
Article 6 second indent 
Article 6 third indent 
Article 6 fourth indent 
Article 6 fifth indent 
Article 7 Present Directive 
— 
Article 11, paragraph 3 
Article 8, paragraph 1 
— 
Article 7 
— 
Proposal for a Council Regulation (EEC) on the statistical classification of economic activities 
in the European Communities 
COM(90) final SYN 241 
(Submitted by the Commission on 1 February 1990) 
(90/C 58/06) 
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 the functioning of the internal market requires 
statistical standards applicable to the collection, 
transmission and publication of national and Community statistics in order to make available to enterprises, financial 
institutions, governments and all other operators in the 
Single Market reliable and comparable information; 
Whereas such information will be necessary for enterprises in 
order to assess their competitiveness and be useful for the 
Community institutions in the prevention of distortion of 
competition; 
Whereas only if the Member States use classifications of 
activities linked to the Community classification will it be 
possible to provide integrated statistical information with the 
reliability, speed, flexibility and degree of detail required for 
the management of the internal market;