federal agency for medicines and health products excipients in the lable and package leaflet of...
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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)
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“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”.
CPMP/463/00Final
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“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,
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“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”.
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Summarypursuant to Art 65 of Directive
2001/83/EC
HomeoSimplified registration
Art 69 of Directive
2001/83/EC
A special warning if necessary
Commission guideline concerning warning statements
relating to the presence of certain
excipients
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Proposal
Modifications of the guideline « Excipients »
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ProposalModifications of the guideline « Excipients »
2) Add a § concerning homeopathic medicinal products
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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