Labelling and package leaflets for medicinal products

1) OBJECTIVE

To give patients clear, precise information on medicinal products so that they use them correctly.

2) COMMUNITY MEASURE

Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets.

This Directive is repealed by the Community code relating to medicinal products for human use .

3) CONTENTS

The Directive supplements and clarifies:

• the list of particulars to be given on labelling in Directive 65/65/EEC, repealed by Directive 2001/83/EC;
• the list of particulars to be included in package leaflets and details of how such leaflets are to be presented in Directive 75/319/EEC, repealed by Directive 2001/83/EC.

The Directive repeals:

• Articles 13 to 20 of Directive 65/65/EEC;
• Articles 6 and 7 of Directive 75/319/EEC.

It applies to medicinal products for human use covered by Chapters II, III, IV and V of Directive 65/65/EEC.

Under the Directive, the following particulars must appear on the outer packaging of medicinal products:

• the name of the medicinal product (invented name, trade mark or name of the manufacturer), followed by the common name corresponding to the international non-proprietary name recommended by the World Health Organization or the usual common name;
• a statement of the active ingredients expressed qualitatively and quantitatively;
• the pharmaceutical form and the contents by weight, by volume or by number of doses;
• a list of excipients known to have an effect and included in the guidelines published pursuant to the Directive; in the case of injectable products, or of topical or eye preparations, all excipients must be stated;
• the method of administration;
• a warning that the medicinal product must be stored out of reach of children;
• a special warning if necessary;
• the expiry date;
• special precautions for storage and for disposal of unused medicinal products or waste derived from such products;
• the name and address of the holder of the authorization for placing the product on the market;
• the number of the authorization for placing the product on the market;
• the manufacturer's batch number;
• instructions on use.

By way of derogation, Member States may also require the labelling to indicate the price, the reimbursement conditions, the legal status for supply to the patient and other details for identification and authentication.

Limited labelling obligations are imposed on the immediate packaging because of its special nature.

It is obligatory to include a package leaflet with all medicinal products, unless all the information required is directly conveyed on the packaging.

The package leaflet repeats certain information which must appear on the packaging and also indicates:

• the pharmaco-therapeutic group of the product;
• the therapeutic indications;
• a list of information which is necessary before taking the medicinal product:

- contra-indications;

- precautions for use;

- undesirable side-effects if the product is taken at the same time as other medicinal products, alcohol or other substances;

- special warnings;

- the effects on driving ability;

- the list of excipients included in the guidelines published pursuant to the Directive.

This information must take account of categories of users such as children or pregnant women.

• the necessary instructions for proper use of the product, in particular:

- the dosage;

- the method and frequency of administration;

- the action to be taken if the product is not taken as prescribed;

- indication, if necessary, of the risk of withdrawal effects;

• the date on which the package leaflet was last revised.

The outer packaging and the package leaflet may include no promotional material.

The particulars required must be legible and comprehensible. The information on the label must also be indelible.

These particulars must be written in the official language or languages of the Member State where the product is placed on the market.

Member States may not prohibit the placing on the market of medicinal products, on grounds connected with labelling, if the labelling complies with the requirements of the Directive. The same applies to the package leaflet.

The mock-up of the packaging and the draft package leaflet, and any proposed changes to them, are submitted to the authorities competent for authorising marketing.

Certain exemptions may be granted when the product is not intended to be delivered for self-administration.

Where the labelling or package leaflet fail to comply with the provisions of the Directive, the competent authorities of the Member State may suspend the authorisation to place the product on the market.