Transcript Excipients
Federal agency for medicines and health products EXCIPIENTS IN THE LABLE AND PACKAGE LEAFLET OF HOMEOPATHIC MEDICINAL PRODUCTS Patricia Bodart – 23 October 2012 (HMPWG, Gdansk) Excipients famhp/PRE/Homeo-Phyto 23/8/2012 2 “Excipients in the label and package leaflet of medicinal products for human use” “INTRODUCTION This is a Commission guideline pursuant to Article 65 of Directive 2001/83/EC. It contains warning statements relating to the presence of certain excipients in medicinal products. Homeopathic medicinal products authorised through a special simplified registration procedure are not addressed in this guideline since for these homeopathic products there are specific labelling requirements according to Article 69”. Excipients famhp/PRE/Homeo-Phyto 23/8/2012 CPMP/463/00 Final 3 “Directive 2001/83/EC relating to medicinal products for human use” “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); if the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name, Excipients famhp/PRE/Homeo-Phyto 23/8/2012 4 “Directive 2001/83/EC relating to medicinal products for human use” — 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”. Excipients famhp/PRE/Homeo-Phyto 23/8/2012 5 Summary pursuant to Art 65 of Directive 2001/83/EC Commission guideline concerning warning statements relating to the presence of certain excipients Excipients famhp/PRE/Homeo-Phyto 23/8/2012 Homeo Simplified registration Art 69 of Directive 2001/83/EC A special warning if necessary 6 Proposal Modifications of the guideline « Excipients » 1) Delete the last sentence of the 1st § This is a Commission guideline pursuant to Article 65 of Directive 2001/83/EC. It contains warning statements relating to the presence of certain excipients in medicinal products. Homeopathic medicinal products authorised through a special simplified registration procedure are not addressed in this guideline since for these homeopathic products there are specific labelling requirements according to Article 69. Excipients famhp/PRE/Homeo-Phyto 23/8/2012 7 Proposal Modifications of the guideline « Excipients » 2) Add a § concerning homeopathic medicinal products HOMEOPATHIC MEDICINAL PRODUCTS For homeopathic medicinal products authorised through article 16, this guideline is entirely applicable For homeopathic medicinal products authorised through the special simplified registration procedure, in accordance with article 69 of Directive 2001/83/EC, the presence of a package leaflet is not required. The excipients known to have a recognised action or effect should be at least declared on the labelling. Such excipients are listed in annex. However, the Competent Authority can require additional measures to ensure the safe use of those homeopathic medicinal products by patients with known sensitivity to one or more of the used excipients. The Competent Authority can for example require an insert leaflet containing further information. In this case a further statement “see leaflet for further information” must be mentioned on the labelling. Excipients famhp/PRE/Homeo-Phyto 23/8/2012 8 Conclusion Modifications of the guideline « Excipients » taking into account specific labelling requirement for homeopathic medicinal products authorised through a special simplified registration procedure Guideline applicable to all medicinal products including all homeopathic medicinal products Excipients famhp/PRE/Homeo-Phyto 23/8/2012 9