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Marketing authorisation for medicinal products for human use: general conditions (basic directive)

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1) OBJECTIVE

To harmonise the marketing conditions for medicinal products.

2) COMMUNITY MEASURES

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products.

Amended by the following measures:

Council Directive 66/454/EEC of 28 July 1966;
Council Directive 75/319/EEC of 20 May 1975;
Council Directive 83/570/EEC of 26 October 1983;
Council Directive 87/21/EEC of 22 December 1986;
Council Directive 89/341/EEC of 3 May 1989;
Council Directive 89/342/EEC of 3 May 1989;
Council Directive 89/343/EEC of 3 May 1989;
Council Directive 92/27/EEC of 31 March 1992;
Council Directive 92/73/EEC of 22 September 1992;
Council Directive 93/39/EEC of 14 June 1993.

This Directive was repealed by theCommunity code relating to medicinal products for human use.

3) CONTENTS

The following text contains a consolidation of existing Directives concerning the marketing of medicinal products.

The provisions apply to proprietary medicinal products for human use intended to be placed on the market and to industrially manufacture medicinal products the marketing of which has been authorised in one Member State.

However, they do not apply to:

  • medicinal products prepared according to prescription, i.e. prepared in a pharmacy from a prescription intended for a specific patient;
  • medicinal products prepared in accordance with an official formula, i.e. prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patients by the pharmacy;
  • medicinal products intended for research and development trials;
  • intermediate products intended for subsequent processing by an authorised manufacturer.

No medicinal product may be placed on the market of a Member State without prior authorisation from the competent authority of the Member State concerned. The application for authorisation must be lodged with the competent authority of the Member State concerned and accompanied by a series of very specific items of information such as a description of the method of preparation, the therapeutic indications, contra-indications, secondary effects, etc.

When the competent authority authorises the marketing of a medicinal product, it will inform the person responsible for marketing that it approves the summary of the characteristics of the product. It will then send the European Agency for the Evaluation of Medicinal Products a copy of the authorisation accompanied by the summary of the characteristics of the product. It will also draw up an evaluation report regarding the results of the analytical, pharmaco-toxicological and clinical tests carried out on the medicinal product in question. This report will be regularly updated.

A marketing authorisation will be refused if it appears that the medicinal product is harmful under normal conditions of use, that it has no or very little therapeutic effect or that it does not have the stated composition in terms of quality and quantity. Authorisation will also be refused if the information requested is incomplete or not given.

The competent authorities of the Member States may refuse to grant marketing authorisation for a medicinal product for contraceptive purposes if their legislation prohibits the marketing of medicinal products used essentially for such purposes.

The authorisation must be granted within 210 days of the application being lodged.

If a Member State ascertains that an authorisation application made after 1 January 1995 is being examined by another Member State, it will await the evaluation report drawn up by this Member State pursuant to point 4 above. It will then recognise the decision of the other Member State within 90 days of receipt of the evaluation report or, if it believes that authorisation of the medicinal product in question could pose a risk to public health, it will apply the procedures provided for in Articles 10 to 14 of Council Directive 75/319/EEC.

As of 1 January 1998, if a Member State learns that the marketing of a medicinal product has been authorised by another Member State, it shall request from the latter the evaluation report referred to in point 4 above. It will then recognise the decision of the other Member State within 90 days or, if it believes that authorisation of the medicinal product in question could pose a risk to public health, it will apply the procedures provided for in Articles 10 to 14 of Council Directive 75/319/EEC.

The authorisation is valid for a period of five years renewable by five-yearly periods.

The marketing authorisation may be suspended or withdrawn on the same grounds as those invoked for refusal to grant marketing authorisation.

4) DEADLINE FOR IMPLEMENTATION OF THE LEGISLATION IN THE MEMBER STATES

5) DATE OF ENTRY INTO FORCE (if different from the above)

Directive 65/65/EEC: 03.02.1970

6) REFERENCES

Official Journal L 22, 09.02.1965
Amended opinions
Official Journal L 126, 12.07.1965
Official Journal L 229, 15.08.1986

Official Journal L 144, 05.08.1966

Official Journal L 147, 09.06.1975
Amended opinion
Official Journal L 229, 15.08.1986

Official Journal L 332, 28.11.1983
Amended opinion
Official Journal L 229, 15.08.1986

Official Journal L 15, 17.01.1987
Official Journal L 142, 25.05.1989
Amended opinion
Official Journal L 176, 23.06.1989

Official Journal L 142, 25.05.1989
Official Journal L 142, 25.05.1989
Official Journal L 113, 30.04.1992
Official Journal L 297, 13.10.1992
Official Journal L 214, 24.08.1993

7) FOLLOW UP WORK

The Commission adopted a communication on the implementation of the new marketing authorisation procedures for medicinal products for human and veterinary use in accordance with Council Regulation (EEC) No 2309/93 and Council Directives 93/39/EEC, 93/40/EEC and 93/41/EEC (Official Journal C 82, 19.03.1994).
In this communication, the Commission clarifies some technical points, firstly concerning medicinal products for human and veterinary use subject to the centralised procedure for marketing authorisation (particularly where list A is concerned), and, secondly, concerning transitional measures for the implementation of the new marketing authorisation procedures.

On 10 March 1995 the Commission adopted Regulation 541/95 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State [Official Journal L 55, 11.03.1995]. This Regulation lays down the procedure for examining applications for variations to the terms of marketing authorisations for medicinal products.
Regulation 541/95 was amended by Commission Regulation 1146/98 of 2 June 1998 [Official Journal L 159, 03.06.1998]. The Regulation was designed to improve the procedure to be followed by pharmaceutical companies in the event of variations to marketing authorisations for medicinal products for human use or for veterinary medicinal products.

On 16 July 1998 the Commission adopted a communication on the Community marketing authorisation procedures for medicinal products [Official Journal C 229, 22.07.1998]. This draft aims:

  • to give a clearer definition of the scope of the centralised procedure according to which the Commission issues marketing authorisations established under Regulation (EEC) 2309/93;
  • to clarify the conditions for use of the decentralised procedure established under Directives 93/39/EEC, 93/40/EEC and 93/41/EEC;
  • to provide the national competent authorities with the interpretations that are needed to facilitate the implementation of the different parts of this procedure.

8) COMMISSION IMPLEMENTING MEASURES

Directive 91/356/EEC- Official Journal L 193, 17.07.1991
Commission Directive of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use.

Summary of Community decisions on marketing authorisations in respect of medicinal products
15 April 1996 to 15 May 1996 -Official Journal C 188, 28.06.1996.
15 May to 15 June 1996 - Official Journal C 188, 28.06.1996
15 June to 15 July 1996- Official Journal C 216, 26.07.1996
15 November to 15 December 1996- Official Journal C 16, 16.01.1997
15 June to 15 July 1997- Official Journal C 226, 25.07.1997
15 August to 15 September 1997 - Official Journal C 292, 26.09.1997
Decisions taken pursuant to Article 14 of Directive 75/319/EEC.

Report - not yet published in the Official Journal
Homeopathic medicinal products, report of the Commission to the European Parliament and to the Council concerning the application of Directives 92/73 and 92/74 [COM(97) 362 final].

 
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