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, 
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 the conditions for supply of medicines for human 
use to the public vary appreciably from one Member State to 
another; whereas medicines on free sale in certain Member 
States can only be obtained only on medical prescription in 
other Member States; 
Whereas under the terms of Council Directive . . ., the 
advertising and promotion to the general public of medicinal 
products which are only available on prescription is 
prohibited; whereas, in view of the development of means of 
communication, the conditions of delivery of medicinal 
products to the public should be harmonized; 
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, in addition, under the new system of registration of 
medicinal products in the Community, certain medicinal 
products will be the subject of a Community marketing 
authorization; in this context, the legal status for the supply 
of medicinal products covered by a Community marketing 
authorization needs to be fixed; whereas, it is important to 
fix the criteria on the basis of which Community decisions 
will be taken; 
Whereas it is therefore appropriate, in a first stage, to 
harmonize the basic principles applicable to the legal status for the supply of medicinal products in the Community or in 
the Member State concerned, while taking as a starting point 
the principles already established on this subject by the 
Council of Europe as well as the work of harmonization 
completed within the framework of the United Nations, 
concerning narcotics and psychotropics, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. This Directive concerns the legal status for the supply 
of medicinal products for human use in the Community. 
2. For the purpose of this Council Directive, the 
definition of 'medicinal product' in Article 1 of Council 
Directive 65/65/EEC (J) shall apply. 
In addition, 
— 'legal status for supply' shall mean: the conditions under 
which a medicinal product may be supplied to the 
public, 
— 'medical prescription' shall mean: any prescription 
emanating from a doctor qualified to prescribe medicinal 
products in the Community or from a health professional 
qualified to prescribe medicinal products under the terms 
of the legislation of the Member State where the 
medicinal product is delivered. 
Article 2 
Medicinal products which may only be available on medical 
prescription shall be classified, at the time of granting the 
authorization for marketing, in one of the following 
categories: 
(a) medicinal products on prescription, which may be 
renewed during a period of six months from the date of 
the prescription, unless otherwise specified; 
(b) medicinal products on prescription, which may not be 
renewed without the prescriber's express consent; 
(c) medicinal products on special prescription, containing a 
substance classified as a psychotropic or a narcotic 
substance within the meaning of the international 
conventions in force (conventions of the United Nations 
of 1961 and 1971); 
(») OJ No 22, 9. 2. 1965, p. 369/65. 
NoC 58/20 Official Journal of the European Communities 8. 3. 90 
(d) medicinal products on restricted prescription, 
reserved 
— for use in hospitals, 
— to certain specialists. 
Article 3 
1. When a marketing authorization is granted, the 
competent authority shall specify the legal status for the 
supply of the medicinal product: 
— medicinal product not subject to medical prescription, 
— medicinal product subject to medical prescription, 
mentioning one of the categories referred to in 
Article 2. 
To this end, the criteria laid down in Article 4 shall 
apply. 
2. All medical products containing a new chemical entity 
shall be subject to medical prescription, and classed in one of 
the categories referred to in Article 2. 
3. The competent authority shall publish at least annually 
the list of medicinal products subject to medical prescription, 
specifying the category of classification. 
4. On the occasion of the 5-yearly renewal of the 
marketing authorization or when new scientific elements are 
communicated to them, the competent authorities shall 
examine and, as appropriate, may amend the legal status for 
the supply of a medicinal product, by applying the criteria 
listed in Article 4. 
Article 4 
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 
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 active principle, as stated in Article 3, 
paragraph 2; 
(c) possibility of serious side effects in normal conditions of 
use; 
(d) serious risks associated with contra-indications and 
precautions for use; (e) 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, 
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. 
Article S 
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. 
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. 
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. 
Article 6 
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 paragraph shall 
make express reference to this Directive. 
Article 7 
This Directive is adressed to the Member States.