Marketing authorisation for medicinal products for human use: additional conditions

To pursue the approximation begun by Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products with a view to achieving completely free movement of proprietary medicinal products within the European Community.

Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products.

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

Medicinal products may not be placed on the market of a Member State without authorisation from the competent authority of that Member State (see Directive 65/65/EEC - summary 1.5.2.1.1).

Applications for authorisation must be accompanied by various documents and particulars, including the manufacturer's control methods (sterility tests, stability tests, etc.) and the results of physico-chemical, biological or microbiological, pharmacological and toxicological tests and clinical trials. Member States must make sure that this information is accompanied by reports from experts possessing the necessary technical or professional qualifications when it is submitted to the competent authorities.

Authorisation will not be granted unless the conditions set out above are complied with.

Member States must verify that manufacturers and importers of medicinal products coming from non-member countries are able to comply with the provisions of Directive 65/65/EEC.

A Committee for Proprietary Medicinal Products has been set up to facilitate the adoption of a common position by the Member States with regard to decisions on the issuing of marketing authorisations and to promote thereby the free movement of medicinal products. This Committee comes under the European Agency for the Evaluation of Medicinal Products (summary 1.5.4.6).

Where the Committee acts, it deliberates and delivers a reasoned opinion on the matter within 90 days. In situations C and D, this deadline may be extended by 90 days.

An appeal may be made against the Committee's decision. The Committee has 60 days in which to adopt a definitive position.

The Commission draws up a draft decision on the application within 30 days. This draft is sent to the Member States and to the applicant. After the Standing Committee on Medicinal Products for Human Use has issued its opinion (summary 1.5.2.3), the Commission adopts a final decision which is addressed to the Member States concerned and to the person responsible for marketing the product. The Member States implement the decision within 30 days.

Medicinal products may not be manufactured without authorisation, even if they are intended for export. Authorisation is also required for imports from non-member countries into a Member State.

Authorisation must, in principle, be granted within 90 days from the date on which the competent authority receives the application.

The competent authority of the Member State concerned ensures, through repeated inspections, that the legal prescriptions regarding the medicinal products are being complied with.

The competent authority may limit the prohibition to supply the product, or its withdrawal from the market, to those batches which are the subject of dispute.

The Member States establish a system of pharmacovigilance to ensure the adoption of the relevant regulations concerning medicinal products authorised in the Community with due regard for information gathered on the undesirable effects of medicinal products under normal conditions of use. This information is gathered by a person responsible for pharmacovigilance under the person responsible for marketing.

4) deadline for implementation of the legislation in the member states

Directive 75/319/EEC: 21.11.1976
Directive 78/420/EEC: 03.05.1978
Directive 83/570/EEC: 31.10.1985
Directive 89/341/EEC: 01.01.1992
Directive 89/342/EEC: 01.01.1992
Directive 89/343/EEC: 01.01.1992
Directive 89/381/EEC: 01.01.1992
Directive 92/27/EEC: 01.01.1993
Directive 92/73/EEC: 31.12.1993
Directive 93/39/EEC: 01.01.199501.01.1998 for Article 1(7)

5) date of entry into force (if different from the above)

Directive 89/341/EEC: 31.12.1992: extension to existingmedicinal products
Directive 89/342/EEC: 31.12.1992: extension to immunological medicinal products
Directive 89/343/EEC: 31.12.1992: extension to radiopharmaceuticals
Directive 89/381/EEC: 31.12.1992: extension to existing medicinal products derived from human blood or human plasma
Directive 92/27/EEC: 01.01.1994: ban on medicinal products with non-conforming labels or leaflets.

6) references

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

Official Journal L 123, 11.05.1978Amended opinionOfficial Journal L 229, 15.08.1986

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

Official Journal L 142, 25.05.1989Amended opinionOfficial Journal L 176, 23.06.1989

Official Journal L 142, 25.05.1989Official Journal L 142, 25.05.1989Official Journal L 181, 28.06.1989Official Journal L 113, 30.04.1992Official Journal L 297, 13.10.1992Official Journal L 214, 24.08.1993

8) commission implementing measures

Manufacture

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use [Official Journal L 193, 17.07.1991] This Directive supplements Article 19a of Directive 75/319/EEC and deals mainly with personnel, premises and equipment, documentation, production, quality control, complaints and product recall and self-inspection.

Testing

Commission Directive 91/507/EEC of 19 July 1991 modifying the Annex to Council Directive 75/319/EEC on the approximation of the laws of the Member States relating to analytical, pharmatoxicological and clinical standards and protocols in respect of the testing of medicinal products [Official Journal L 270, 26.09.1991]

Marketing authorisation

Commission Regulation (EC) 541/95 of 10 March 1995 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 the examination of applications for variations to the terms of a marketing authorisation of medicinal products for human use and for veterinary use, with reference to Directives 75/319/EEC and 81/851/EEC.

It has been amended by the following measure:

Regulation (EC) 1146/98 - Official Journal L 159, 03.06.1998 (this Regulation is designed to improve the procedure with which pharmaceutical companies must comply in the event of variation of a marketing authorisation for human or veterinary medicinal products)

Commission Communication of 16 July 1998 on the Community marketing authorisation procedures for medicinal products [Official Journal C 229, 22.07.1998].

This document aims:

to determine more clearly the scope of the centralised procedure for issuing the Community marketing authorisation established by Regulation (EEC) 2309/93;
to clarify methods of access to the mutual recognition procedure established by Directives 93/39/EEC, 93/40/EEC and 93/41/EEC;
to provide the competent national authorities with interpretative elements in order to facilitate implementation of the different procedural phases.

Summary of Community decisions on marketing authorisations in respect of medicinal products:Official Journal C 163, 30.05.1997 (15 April - 15 May 1997);

Official Journal C 226, 25.07.1997 (15 June - 15 July 1997);

Official Journal C 292, 26.09.1997 (15 August - 15 September 1997);

Official Journal C 126, 24.04.1998 (15 March 1998 - 15 April 1998);

Official Journal C 200, 26.06.1998 (15 May - 15 June 1998);

Official Journal C 331, 29.10.1998 (15 September - 15 October 1998);

Official Journal C 24, 29.01.1999 (15 December 1998 - 15 January 1999);

Official Journal C 311, 29.10.1999 (15 August - 15 September 1999);

Official Journal C 95, 04.04.2000 (15 February - 15 March 2000);

Official Journal C 244, 25.08.2000 (15 June - 15 July 2000);

Official Journal C 2, 05.01.2001 (15 November - 15 December 2000: Bifril, Teoula, Zofepril and Zopranol);

Official Journal C 26, 26.01.2001 (15 December 2000 - 15 January 2001: Kétoprofène Ethypharm LP);

Official Journal C 53, 20.02.2001 (15 January - 15 February 2001: Glucophage).

These summaries include the decisions taken pursuant to Article 14 of Directive 75/319/EEC or Article 22 of Directive 81/851/EEC. An annexed list shows the names of the medicinal products, their pharmaceutical form, strength, route of administration, marketing authorisation holders, packaging and package sizes authorised for medicinal products in each of the Member States.

For further information, see the decisions on marketing authorisation pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93.

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