CELEX: 51989PC0607(03)
Language: en
Date: 1990-01-26
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE LABELLING OF MEDICINAL PRODUCTS FOR HUMAN USE AND ON PACKAGE LEAFLETS

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,                               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
Having regard to the Treaty establishing the European
                                                                       grounds connected with the labelling or package leaflet,
 Economic Community, and in particular Article 100a
thereof,
Having regard to the proposal from the Commission,                     HAS ADOPTED THIS DIRECTIVE:
In cooperation with the European Parliament,
                                                                                                CHAPTER I
Having regard to the opinion of the Economic and Social                                    Scope and definitions
Committee,
Whereas measures aimed at progressively establishing the                                         Article 1
internal market during the period up to 31 December 1992
need to be taken; whereas the internal market is to comprise           1.     This Directive deals with the labelling of medicinal
an area without internal frontiers in which the free movement          products for human use and leaflets inserted in packages of
of goods, persons, services and capital is ensured;                    such products.
Whereas Council Directive 6 5 / 6 5 / E E C o f 2 6 January 1965       2.     For the purposes of this Directive, the definition of
on the approximation of provisions laid down by law,                   'medicinal product' laid down in Article 1 of Directive
regulation or administrative action relating to medicinal              65/65/EEC shall apply. In addition to this:
products ( ] ), as last amended by Directive 89/341/EEC (2),           — 'name of the medicinal product' shall mean the name
establishes a list of particulars to be given on the immediate             given to a medicinal product, which may be an invented
packaging and the outer packaging of medicinal products for                name, a common name together with a trademark or the
human use; whereas this list should be supplemented and                    name of the manufacturer, or a scientific name together
details given of how labelling is to be presented;                         with a trade mark or the name of the manufacturer,
                                                                       — 'common name' shall mean the international
Whereas the Second Council Directive 75/319/EEC of 20
                                                                           non-proprietary name recommended by the World
May 1975 on the approximation of provisions laid down by
                                                                           Health Organization, or, if one does not exist, the usual
law, regulation or administrative action relating to
                                                                           common name,
proprietary medicinal products (3), as last amended by
Directive 89/341 /EEC (4), establishes a non-inclusive list of         — 'immediate packaging' shall mean the container or other
particulars to be included in package insert leaflets; whereas             form of packaging immediately in contact with the
this list should be supplemented and details given of how                  medicinal product;
such leaflets are to be presented;
                                                                       — 'outer packaging' shall mean the packaging into which is
                                                                           placed the immediate packaging,
Whereas the provisions on labelling and on package insert
leaflets should be united in a single legislative text;                — 'package leaflet' shall mean a leaflet containing
                                                                           information for the user which accompanies the
                                                                           medicinal product to which it refers.
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;                                          Article 2
(») OJ No 22, 9. 2. 1965, p. 369/65.                                   No part of this Directive shall be taken to authorize the
(2) OJ No L 142, 25. 5. 1989, p. 11.                                   marketing of a medicinal product for which an authorization
(3) OJ No L 147, 9. 6. 1975, p. 13.                                    in accordance with Community legislation has not been
(4) OJ No L 142, 25. 5. 1989, p. 11.                                   issued.
 ---pagebreak--- No C 58/22                               Official Journal of the European Communities                                       8. 3. 90
                          CHAPTER II                                                            Article 5
                Labelling of medicinal products                     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
                            Article 3                               hand, and (g) to (i) on the other hand, shall as far as possible
                                                                    appear in the same field of vision.
The following particulars shall appear on the outer
packaging of medicinal products or, where there is no outer         3.     The particulars listed in Article 3 shall appear in the
packaging, on the immediate packaging:                              official language or languages of the Member State where the
                                                                    product is put on the market. This provision shall not prevent
(a) the name of the medicinal product, including or followed        these particulars from being indicated in various languages,
    by the common name if the product contains only one             provided the information given is the same in all languages
    active ingredient;                                              used.
(b) a statement of the active ingredients expressed
    qualitatively and quantitatively per dosage unit or
    according to the form of administration for a given                                         Article 6
    volume or weight, using their common names;
                                                                    1.     Member States shall not prohibit or impede the placing
(c) the pharmaceutical form and the contents by weight, by          on the market of medicinal products within their territory on
    volume or number or doses of the product;                       the grounds that the labelling is incorrect, if such labelling
                                                                    complies with this Chapter.
(d) a list of the excipients;
                                                                    2.     Notwithstanding paragraph 1, Member States may
(e) the route and method of administration;                         require the following information to be provided on the outer
                                                                    packaging or, in the absence of such, on the immediate
(f) a special warning that the product must be stored out of
                                                                    packaging:
    reach of children;
                                                                    — price of the medicinal product,
(g) the expiry date in clear terms (month/year);
                                                                    — reimbursement         conditions     by     social     security
(h) special storage precautions, if any;                                organizations,
(i) special precautions for disposal of unused medicinal            — the legal status for supply to the patient, particularly
    products or waste materials derived from such products,             where a new medicinal product is concerned.
    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;
                                                                                             CHAPTER III
(k) the number of the authorization to put the medicinal
    product on the market;                                                                    User leaflet
(1) the manufacturer's batch number.
                                                                                                Article 7
                                                                    The inclusion in the packaging of medicinal products of a
                            Article 4                               package leaflet for the information of users shall be
                                                                    obligatory unless all the information required by Article 8 is
1.     The following particulars shall appear on immediate          directly conveyed on the outer packaging or on the
packagings placed in an outer packaging which complies              immediate packaging.
with the requirements laid down in Article 3:
— name of the medicinal product,
                                                                                                Article 8
— quantity of active constituents, using common names,
                                                                    1.     The leaflet shall include, usually in the following
— route and method of administration,                               order:
— expiry date,                                                      (a) for the identification of the medicinal product:
                                                                         — name of the medicinal product,
— batch number.
                                                                         — quantitative and qualitative composition in terms of
2.     Paragraph 1 shall not apply to immediate packagings                   active ingredients, using the common names,
containing a single dose which are too small to carry all the            — pharmaco-therapeutic group, if there exists a term
particulars listed in paragraph 1.                                           easily comprehensible for the patient,
 ---pagebreak---  8. 3. 90                                   Official Journal of the European Communities                                  No C 58/23
      — name and address of the holder of the marketing                 (f) a reference to the expiry date indicated on the label,
          authorization, and, where different, of the                       with:
          manufacturer;                                                     — a warning against using the product after this
                                                                                date,
 (b) the therapeutic indications;                                           — where appropriate, special storage precautions,
                                                                            — if necessary a warning against visible signs of
 (c) a list of information which is useful before taking a                      deterioration;
      medicinal product:
                                                                       (g) all other information compatible with the summary of
      — contra-indications,                                                 product characteristics of the product, useful for health
                                                                            education, and on condition that it is not of a
     — appropriate precautions for use,                                     promotional nature.
      — interactions with other medicinal products and other
                                                                       2.     Notwithstanding       point 1 (b),    the      competent
         forms of interaction (for example, alcohol, tobacco)
                                                                       authorities may decide that certain therapeutic indications
         which may affect the use of the medicine,
                                                                       will not be mentioned in the package leaflet, when the
     — special warnings,                                               dissemination of such information might have serious
                                                                       disadvantages for the patient.
     this list must:                                                   3.     The leaflet may include symbols or pictograms
     — take into account the particular condition of certain           designed to elaborate certain information mentioned in
         categories of users (e.g. children, pregnant or               paragraph 1.
         breastfeeding women, the elderly, persons with
         specific pathological conditions),
                                                                                                  Article 9
     — mention, if appropriate, potential effects on the
         ability to drive vehicles or to operate machinery,            The package leaflet must be written in clear and
                                                                       understandable terms for the patient, in the official language
     — refer to the excipients knowledge of which is                   or languages of the Member State where the medicinal
         important for a safe and effective use of the medicinal       product is put on the market. This provision does not prevent
         product;                                                      the leaflet being printed in several languages, provided that
                                                                       the same information is given in all the languages used.
(d) the necessary        instructions   for   proper    use,  in
       particular:
                                                                                                 Article 10
     — the usual dose and the maximum dose,
     — the method and route of administration,                         Member States shall not prohibit or impede the placing on
                                                                       the market of medicinal products within their territory on the
     — the frequency of administration, specifying if                  grounds that the package leaflet is not correct, if the package
         necessary the appropriate time at which the medicinal         leaflet complies with this Chapter.
         product should or must be administered,
     and, as appropriate, depending on the nature of the
     product
     — the duration of treatment, when it should be                                             CHAPTER IV
         limited,
                                                                                        General and final provisions
     — the action to undertake in the case of overdose
         (symptoms, emergency procedures, antidotes),
                                                                                                 Article 11
     — the course of action to take when a dose has not been
         taken,                                                        1.     One or more specimens or mock-ups of the outer
                                                                      packaging and the immediate packaging of a medicinal
     — the way the treatment should be stopped, if stopping
                                                                      product, together with the draft package leaflet, shall be
         the treatment may lead to withdrawal effects;
                                                                      submitted to the competent authorities of the Member State
                                                                      concerned.
(e) a description of the undesirable effects which can occur
     under normal use of the medicinal product, with                  2.      All proposed modifications to the outer packaging, to
     indication if possible of their importance, and if               the immediate packaging or to the package leaflet shall be
     necessary the action to be taken in such case; when the          submitted to the competent authorities of the Member State
     medicinal product is new, the patient should be expressly        concerned. If the competent authorities have not opposed a
     invited to communicate any undesirable effect which is           draft modification within 90 days following the introduction
     not mentioned in the leaflet to his doctor or to his             of the request, the applicant may proceed to put the
     pharmacist;                                                      modification into effect.
 ---pagebreak--- No C 58/24                                Official Journal of the European Communities                                     8. 3. 90
3.      The competent authorities shall not allow a medicinal        — the readability of particulars on the labelling and
product to be placed on the market, if the packaging or the              leaflet,
package leaflet do not comply with the provisions of this
Directive or if they are not compatible with the particulars         — utilization of bar codes for the identification of medicinal
listed in the summary of the product characteristics referred            products.
to in Article 4b of Directive 65/65/EEC.
                                                                     For this purpose, the Commission shall consult the
4.      The fact that the competent authorities do not refuse a      Committee for Proprietary Medicinal Products instituted by
marketing authorization for a reason associated with the             Directive 75/319/EEC.
labelling or the package insert, does not alter the general legal
liability of the manufacturer or as appropriate the marketing
authorization holder.                                                                          Article 14
                                                                     1.     Articles 13 to 20 of Directive 65/65/EEC and
                            Article 12                               Articles 6 and 7 of Directive 75/319/EEC are hereby
                                                                     repealed.
1.      When then provisions of this Directive are not
observed, and an order addressed to the person concerned             2.     References made to provisions which have been
has remained without effect, the competent authorities of a          repealed shall be understood to refer to the present Directive,
Member State may suspend or revoke the authorization to              in accordance with the table of concordance given in the
place the medicinal product on the market, until the labelling       Annex.
and leaflet of the medicinal product in question has complied
with the requirements of this Directive.
                                                                                               Article 15
2.     AH decisions taken pursuant to paragraph 1 shall state
in detail the reasons on which they are based. They shall be         1.    Member States shall take the measures necessary to
notified to the party concerned, who shall at the same time be       comply with this Directive before 1 January 1992. They shall
informed of the remedies available to him under the laws in          forthwith inform the Commission thereof.
force and of the time limit allowed for the exercise of such
remedies.                                                            The provisions adopted pursuant to the first subparagraph
                                                                     shall make express reference to this Directive.
                            Article 13                               2.    From 1 January 1993, Member States shall refuse an
                                                                     application for marketing authorization or for the renewal of
As necessary, 'the Commission shall publish guidelines               an existing authorization, when the labelling and the leaflet
concerning:                                                          do not conform to the requirements of this Directive.
— the formulation of certain warnings for certain categories
    of medicinal products,
                                                                                              Article 16
— the particular          information   needs      relative    to
    self-medication,                                                 This Directive is addressed to the Member States.
 ---pagebreak--- 8. 3. 90                                  Official Journal of the European Communities                                   No C 58/25
                                                              ANNEX
                                                    TABLE OF CONCORDANCE
                             Directive 65/65/EEC                                       Present Directive
                          Article 13                                               Article 3
                          Article 14                                               Article 4, paragraph 1
                          Article 15                                               Article 4, paragraph 2
                          Article 16                                                          —
                          Article 17                                                          —
                          Article 18                                               Article 5, paragraph 3
                          Article 19                                                          —
                          Article 20 first indent                                  Article 12, paragraph 1
                          Article 20 second indent                                 Article 12, paragraph 2
                            Directive 75/319/EEC                                       Present Directive
                          Article 6 first indent                                              —
                          Article 6 second indent                                  Article 11, paragraph 3
                          Article 6 third indent                                   Article 8, paragraph 1
                          Article 6 fourth indent                                             —
                          Article 6 fifth indent                                   Article 7
                          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,                             statistics in order to make available to enterprises, financial
                                                                     institutions, governments and all other operators in the
Having regard to the Treaty establishing the European                Single Market reliable and comparable information;
Economic Community, and in particular Article 100a
thereof,
                                                                     Whereas such information will be necessary for enterprises in
Having regard to the proposal from the Commission,                   order to assess their competitiveness and be useful for the
                                                                     Community institutions in the prevention of distortion of
In cooperation with the European Parliament,                         competition;
Having regard to the opinion of the Economic and Social
Committee,                                                           Whereas only if the Member States use classifications of
                                                                     activities linked to the Community classification will it be
Whereas the functioning of the internal market requires              possible to provide integrated statistical information with the
statistical standards applicable to the collection,                  reliability, speed, flexibility and degree of detail required for
transmission and publication of national and Community               the management of the internal market;