CELEX: 51989PC0607(02)
Language: en
Date: 1990-01-26
Title: PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING THE LEGAL STATUS FOR THE SUPPLY OF MEDICINAL PRODUCTS FOR HUMAN USE

8. 3. 90                                  Official Journal of the European Communities                                 No C 58/19
                  Proposal for a Council Directive concerning the legal status for the supply of medicinal
                                                       products for human use
                                                    COM(89) 607 final SYN 230
                                       (Submitted by the Commission on 26 January 1990)
                                                           (90/C 58/04)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                              for the supply of medicinal products in the Community or in
                                                                      the Member State concerned, while taking as a starting point
Having regard to the Treaty establishing the European                 the principles already established on this subject by the
Economic Community, and in particular Article 100a                    Council of Europe as well as the work of harmonization
thereof,                                                              completed within the framework of the United Nations,
                                                                      concerning narcotics and psychotropics,
Having regard to the proposal from the Commission,
In cooperation with the European Parliament,
                                                                      HAS ADOPTED THIS DIRECTIVE:
Having regard to the opinion of the Economic and Social
Committee,
                                                                                                 Article 1
Whereas measures aimed at progressively establishing the
                                                                      1.     This Directive concerns the legal status for the supply
internal market during the period up to 31 December 1992
                                                                      of medicinal products for human use in the Community.
need to be taken; whereas the internal market is to comprise
an area without internal frontiers in which the free movement
                                                                      2.     For the purpose of this Council Directive, the
of goods, persons, services and capital is ensured;
                                                                      definition of 'medicinal product' in Article 1 of Council
                                                                      Directive 65/65/EEC (J) shall apply.
Whereas the conditions for supply of medicines for human
use to the public vary appreciably from one Member State to           In addition,
another; whereas medicines on free sale in certain Member
States can only be obtained only on medical prescription in           — 'legal status for supply' shall mean: the conditions under
other Member States;                                                      which a medicinal product may be supplied to the
                                                                          public,
Whereas under the terms of Council Directive . . ., the
                                                                      — 'medical prescription' shall mean: any prescription
advertising and promotion to the general public of medicinal
                                                                          emanating from a doctor qualified to prescribe medicinal
products which are only available on prescription is
                                                                          products in the Community or from a health professional
prohibited; whereas, in view of the development of means of
                                                                          qualified to prescribe medicinal products under the terms
communication, the conditions of delivery of medicinal
                                                                          of the legislation of the Member State where the
products to the public should be harmonized;
                                                                          medicinal product is delivered.
Whereas, moreover, persons moving around within the
Community have the right to carry a reasonable quantity of
medicinal products legitimately obtained for their personal                                      Article 2
use; whereas it must also be possible for a person established
                                                                      Medicinal products which may only be available on medical
in one Member State to receive from another Member State a
                                                                      prescription shall be classified, at the time of granting the
reasonable quantity of medicinal products intended for his
                                                                      authorization for marketing, in one of the following
personal use; whereas it is important therefore to harmonize
                                                                      categories:
the conditions of delivery of medicinal products to the
public;                                                               (a) medicinal products on prescription, which may be
                                                                           renewed during a period of six months from the date of
Whereas, in addition, under the new system of registration of              the prescription, unless otherwise specified;
medicinal products in the Community, certain medicinal
products will be the subject of a Community marketing                 (b) medicinal products on prescription, which may not be
authorization; in this context, the legal status for the supply            renewed without the prescriber's express consent;
of medicinal products covered by a Community marketing                (c) medicinal products on special prescription, containing a
authorization needs to be fixed; whereas, it is important to               substance classified as a psychotropic or a narcotic
fix the criteria on the basis of which Community decisions                 substance within the meaning of the international
will be taken;                                                             conventions in force (conventions of the United Nations
                                                                           of 1961 and 1971);
Whereas it is therefore appropriate, in a first stage, to
harmonize the basic principles applicable to the legal status         (») OJ No 22, 9. 2. 1965, p. 369/65.
 ---pagebreak--- N o C 58/20                                  Official Journal of the European Communities                                    8. 3. 90
(d) medicinal       products     on    restricted     prescription,     (e) indications requiring a medical diagnosis or special
      reserved                                                              medical supervision;
      — for use in hospitals,
                                                                        (f) harmfulness of constituents under normal conditions of
      — to certain specialists.                                             use, taking into account posology, pack size or possible
                                                                            excessively extended treatment;
                                                                        (g) parenteral administration, except when very long term
                             Article 3                                      illness requires an active participation by the patient in
                                                                            the treatment (for example: diabetes);
1.      When a marketing authorization is granted, the
competent authority shall specify the legal status for the              (h) important risk of abuse, addiction or misuse for criminal
supply of the medicinal product:                                            purposes,
— medicinal product not subject to medical prescription,
                                                                        2.     Moreover, medical products which may be available
— medicinal product subject to medical prescription,                    without prescription shall show a substantial safety in use in
     mentioning one of the categories referred to in                    the treatment of minor ailments or symptoms, usually
     Article 2.                                                         capable of rapid and spontaneous relief, which are easily
                                                                        identifiable by users and do not justify a medical
To this end, the criteria laid down in Article 4 shall                  consultation.
apply.
2.      All medical products containing a new chemical entity
shall be subject to medical prescription, and classed in one of                                    Article S
the categories referred to in Article 2.
                                                                        1.     Within two years of adoption of this Directive, the
3.      The competent authority shall publish at least annually         Member States shall communicate to the Commission and to
the list of medicinal products subject to medical prescription,         the other Member States, the list of medicines which are
specifying the category of classification.                              available only on medical prescription on their territory,
                                                                        mentioning the category of classification.
4.      On the occasion of the 5-yearly renewal of the
marketing authorization or when new scientific elements are             2.     Each year, Member States shall communicate to the
communicated to them, the competent authorities shall                   Commission and to the other Member States the changes that
examine and, as appropriate, may amend the legal status for             have been made to the list referred to in paragraph 1.
the supply of a medicinal product, by applying the criteria
listed in Article 4.
                                                                        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
                             Article 4                                  accompanied, if necessary, by appropriate proposals.
1.      Medicinal products which contain substances which
are likely to present a direct or indirect danger to human
health, even under normal conditions of use, shall not be                                          Article 6
supplied to the public without medical prescription. The
following criteria shall be taken into consideration in this            Member States shall take the measures necessary to comply
respect:                                                                with this Directive before 1 January 1992. They shall
                                                                        forthwith inform the Commission thereof.
(a) potential risks appearing during the preclinical and
     clinical tests and trials;
                                                                        The provisions adopted pursuant to the first paragraph shall
(b) novelty of the active principle, as stated in Article 3,            make express reference to this Directive.
     paragraph 2;
(c) possibility of serious side effects in normal conditions of
     use;                                                                                          Article 7
(d) serious risks associated with contra-indications and
     precautions for use;                                               This Directive is adressed to the Member States.