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Directive 2001/83/EC of the European Parliament and of the… Article 69

Article 69

1. In addition to the clear mention of the words "homeopathic medicinal product", the labelling and, where appropriate, the package insert for the medicinal products referred to in Article 14(1) shall bear the following, and no other, information: - the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5), - name and address of the registration holder and, where appropriate, of the manufacturer, - method of administration and, if necessary, route, - expiry date, in clear terms (month, year), - pharmaceutical form, - contents of the sales presentation, - special storage precautions, if any, - a special warning if necessary for the medicinal product, - manufacturer's batch number, - registration number, - "homeopathic medicinal product without approved therapeutic indications", - a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product. 2. Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show: - the price of the medicinal product, - the conditions for refunds by social security bodies. TITLE VI CLASSIFICATION OF MEDICINAL PRODUCTS

Read the full instrument → · Read this in context: TITLE V — LABELLING AND PACKAGE LEAFLET →

Other provisions in TITLE V — LABELLING AND PACKAGE LEAFLET

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 69 of Directive 2001/83/EC of the European Parliament and of the… (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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