Directive 65/65/EEC of
Official Journal 022 , 09/02/1965 p. 0369 - 0373
Danish special edition ....: Series-I (65-66) p. 17
English special edition...: Series-I (65-66) p. 20
Greek special edition ....: Chapter 13 Volume 1 p. 25
Spanish special edition...: Chapter 13 Volume 1 p. 18
Portuguese special edition Chapter 13 Volume 1 p. 18
Finnish special edition....: Chapter 13 Volume 1 p. 67
Swedish special edition...: Chapter 13 Volume 1 p. 67
Amended by 366L0454 (OJ 144 05.08.1966 p.2658) (SE SER1 I p.0168)
Derogation in 172B
Amended by 375L0319 (OJ L 147 09.06.1975 p.13)
Amended by 383L0570 (OJ L 332 28.11.1983 p.1)
See 387L0021 (OJ L 015 17.01.1987 p.36)
Amended by 387L0021 (OJ L 015 17.01.1987 p.36)
Amended by 389L0341 (OJ L 142 25.05.1989 p.11)
See 392L0027 (OJ L 113 30.04.1992 p.8)
Amended by 393L0039 (OJ L 214 24.08.1993 p.22)
Incorporated by 294A0103(52) (OJ L 001 03.01.1994 p.263)
THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY,
Having regard to the Treaty establishing the
Having regard to the proposal from the Commission;
Having regard to the Opinion of the European Parliament (1),
Having regard to the Opinion of the Economic and Social Committee (2),
Whereas the primary purpose of any rules concerning the production and distribution of proprietary medicinal products must be to safeguard public health;
Whereas, however, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community;
Whereas trade in proprietary medicinal products within the Community is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal feeding-stuffs or toilet preparations) ; and whereas such disparities directly affect the establishment and functioning of the common market;
Whereas such hindrances must accordingly be removed ; and whereas this entails approximation of the relevant provisions;
Whereas, however, such approximation can only be achieved progressively ; and whereas priority must be given to eliminating the disparities liable to have the greatest effect on the functioning of the common market;
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I Definitions and scope
For the purposes of this Directive, the following shall have the meanings hereby assigned to them;
1. Proprietary medicinal product: Any ready-prepared medicinal product placed on the market under a special name and in a special pack.
2. Medicinal product:
Any substance or combination of substances presented for treating or preventing disease in human beings or animals.
substance or combination of substances which may be administered to human
beings or animals with a view to making a medical diagnosis or to restoring,
correcting or modifying physiological functions in human beings or in animals
is likewise considered a medicinal product.
No 84, 4.6.1963, p. 1571/63. (2) OJ No 158, 16.10.1964, p. 2508/64. 3.
Any matter irrespective of origin which may be: - human, e.g.
blood and human blood products;
- animal, e.g.
whole animals, parts of organs, animal secretions, toxins, extracts, blood
- vegetable, e.g.
plants, parts of plants, vegetable secretions, extracts, etc;
- chemical, e.g.
elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis.
The provisions of Chapters II to V shall apply only to proprietary medicinal products for human use intended to be placed on the market in Member States.
CHAPTER II Authorisation to place proprietary medicinal products on the market
proprietary medicinal product may be placed on the market in a
In order to obtain an authorisation to place a proprietary medicinal product on the market as provided for in Article 3, the person responsible for placing that product on the market shall make application to the competent authority of the
The application shall be accompanied by the following particulars and documents:
1. Name or corporate name and permanent address of the person responsible for placing the proprietary product on the market and, where applicable, of the manufacturer.
2. Name of the proprietary product (brand name, or common name together with a trade mark or name of the manufacturer, or scientific name together with a trade mark or name of the manufacturer).
3. Qualitative and quantitative particulars of all the constituents of the proprietary product in usual terminology, but excluding empirical chemical formulae, with mention of the international non-proprietary name recommended by the World Health
Organisation where such name exists.
description of the method of preparation.
indications, contra-indications and side-effects.
pharmaceutical form, method and route of administration and expected shelf life
if less than three years.
methods employed by the manufacturer (analysis and assay of the constituents
and of the finished product, special tests, e.g. sterility tests, tests for the
presence of pyrogenic substances, the presence of heavy metals, stability
tests, biological and toxicity tests).
of: - physico-chemical, biological or microbiological tests;
and toxicological tests;
- clinical trials.
(a) a List of published references relating to the pharmacological tests, toxicological tests and clinical trials may be substituted for the relevant test results in the case of:
proprietary product with an established use, which has been adequately tested
on human beings so that its effects, including side-effects, are already known
and are included in the published references;
proprietary product, in which the combination of active constituents is
identical with that of a known proprietary product with an established use;
(iii) a new proprietary product consisting solely of known constituents that have been used in combination in comparable proportions in adequately tested medicinal products with an established use;
(b) In the case of a new proprietary product containing known constituents not hitherto used in combination for therapeutic purposes, references to published data may be substituted for the tests of such constituents.
or more specimens or mock-ups of the sales presentation of the proprietary
product, together with a package, leaflet where one is to be enclosed.
10. A document
showing that the manufacturer is authorised in his own country to produce
11. Any authorisation obtained in another
authorisation provided for in Article 3 shall be refused if, after verification
of the particulars and documents listed in Article 4, it proves that the
proprietary medicinal product is harmful in the normal conditions of use, or
that its therapeutic efficacy is lacking or is insufficiently substantiated by
the applicant, or that its qualitative and quantitative composition is not as
Authorisation shall likewise be refused if the particulars and documents submitted in support of the application do not comply with Article 4.
The competent authorities of Member States may refuse to authorise the placing on the market of a proprietary medicinal product for use as a contraceptive where the sale of proprietary products intended principally for such purposes is prohibited under their laws.
States shall take all appropriate measures to ensure that the procedure for
granting an authorisation to place a proprietary medicinal product on the
market is completed within 120 days of the date of submitting the application.
In exceptional cases this time limit may be extended for a further ninety days. The applicant shall be notified of such extension before the expiry of the initial time limit.
Member States shall take all appropriate measures to ensure that the holder of an authorisation furnishes proof that the controls have been carried out on the finished product in accordance with the methods described by the applicant pursuant to item 7 of the second paragraph of Article 4.
Authorisation shall not affect the civil and criminal liability of the manufacturer and, where applicable, of the person responsible for placing the proprietary medicinal product on the market.
shall be valid for five years and shall be renewed for five-year periods, on
application by the holder within the three months preceding expiry.
CHAPTER III Suspension and revocation of authorisation to market proprietary medicinal products
competent authorities of the Member States shall suspend or revoke an
authorisation to place a proprietary medicinal product on the market where that
product proves to be harmful in the normal conditions of use, or where its
therapeutic efficacy is lacking, or where its qualitative and quantitative
composition is not as declared. Therapeutic efficacy is lacking when it is established
that therapeutic results cannot be obtained with the proprietary product.
An authorisation shall also be suspended or revoked where the particulars supporting the application as provided for in Article 4 are found to be incorrect, or when the controls on the finished product referred to in Article 8 have not been carried out.
decisions taken pursuant to Articles 5, 6 or 11 shall state in detail the
reasons on which they are based. A decision 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
to place a proprietary product on the market and decisions to revoke authorisations
shall be published by each
CHAPTER IV Labelling of proprietary medicinal products
The following particulars shall appear on containers and outer packages of proprietary medicinal products:
1. Name of the proprietary product which may be a brand
name, or a common name together with a trade mark or name of the manufacturer,
or a scientific name together with a trade mark or name of the manufacturer.
2. Next to the name of the proprietary product, a
statement of the active constituents expressed qualitatively and quantitatively
per dose-unit or as a percentage, according to the pharmaceutical form. The
international non-proprietary names recommended by the World Health
Organisation shall be used wherever they exist.
3. Reference number for production identification
(manufacturer's batch number).
4. Number of the authorisation to place the proprietary
product on the market.
5. Name or corporate name and permanent address of the
person responsible for placing the proprietary product on the market and, where
applicable, of the manufacturer.
6. Method of administration.
7. Expiry date for proprietary products with a shelf life
of less than three years.
8. Special storage precautions, if any.
The pharmaceutical form and the contents by weight, by volume or by number of dose-units need only be shown on the outer packages.
the case of ampoules, the particulars required under the first paragraph of
Article 13 shall be given on the outer packages. However, on the actual
containers only the following particulars are required: - name of the
proprietary medicinal product;
of active constituents;
- expiry date.
As regards small single-dose containers, other than ampoules, on which it is impossible to give the particulars mentioned in
Article 14, the requirements of Article 13 shall apply only to the outer package.
In the case of narcotics, in addition to the particulars mentioned in Article 13, a special sign consisting of a double red line shall appear on both the outer package and the container.
Where there is no outer package, the particulars which should feature on such a package pursuant to the preceding Articles shall be shown on the container.
The particulars mentioned in items, 6, 7 and 8 of the first paragraph of Article 13 shall appear on the outer package and on the container of proprietary medicinal products in the language or languages of the country where they are being placed on the market.
The provisions of this Chapter shall not prevent the particulars required by rules other than those to which this Directive relates from being given on outer packages or on containers.
the provisions of this Chapter are not observed and an order addressed to the
person concerned has remained without effect, the competent authorities of the
Member States may suspend or revoke the authorisation to place the proprietary
medicinal product on the market.
decisions taken in pursuance of the preceding paragraph shall state in detail
the reasons on which they are based. A decision 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
CHAPTER V General and final provisions
An authorisation to market a proprietary medicinal product shall not be refused, suspended or revoked except on the grounds set out in this Directive.
Member States shall put into force the measures needed in order to comply with this Directive within eighteen months of its notification and shall inform the Commission forthwith.
Member States shall ensure that they communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
In the five years following the notification mentioned in Article 22, the rules for which provision is made in this Directive shall be applied progressively to proprietary medicinal products covered by an
authorisation to place on the market by virtue of previous provisions.
Directive is addressed to the Member States.
For the Council
M. COUVE DE MURVILLE
End of the document