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
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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”.
Excipients
famhp/PRE/Homeo-Phyto
23/8/2012
CPMP/463/00
Final
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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,
Excipients
famhp/PRE/Homeo-Phyto
23/8/2012
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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”.
Excipients
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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
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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
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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
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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
Excipients
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