EU-Declaration of Excipients

EU-Declaration of Excipients

Guideline on the Excipients in the Label and Package Leaflet of Medicinal Products for Human Use

Volume 3B Guidelines, July 2003

Pursuant to Article 65 of European Council Directive 2001/83/EC

Annex: Excipients and Information for the Package Leaflet

www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003412.pdf

Explanatory Notes: The Annex is structured as follows:

Name: This is the name of the excipient using INN or PhEur nomenclature where possible, including a reference to E-numbers where relevant.

Route of administration: This is necessary because the information may depend upon the route of administration, e.g. for benzalkonium chloride the information relating to bronchospasm is relevant only for the respiratory route.

Threshold: It is accepted that excipients may only show an effect above a certain ‘dose’.

Except where otherwise stated, thresholds are expressed as Maximum Daily Doses of the excipient in question, taken as part of a medicinal product.

The threshold is a value, equal to or above which it is necessary to provide the information stated.

A threshold of ‘zero’ means that it is necessary to state the information in all cases where the excipient is present in the medicinal product.

Information for the Package Leaflet: The information is presented here in a simple form, in clear and understandable terms for the patient.

The text often refers to the term ‘per dose’ meaning dose of the medicinal product.

Since doses may be extremely variable, applicants must take into account the maximum single dose of the medicinal product, as defined in the SPC, Section 4.2.

For this reason the information sometimes contains the expression ‘up to x mg per dose’, for example.

If the pharmaceutical form is a solid form, e.g. tablet, capsule, suppository, powder in a sachet, it may be better to refer to the amount per tablet, capsule etc.