The European Commission has published a review, open to comments until May 22 on the list of ingredients to be included in the labels of medicinal products and the way they should be reported. The review reflects the developments that have occurred since 2003, includes a list of ingredients that should be printed on the label and outlines the information for those that are to appear on the leaflet.
All of medicinal excipients for topical, parenteral and ophthalmologic should appear on the label. For topical products are meant those for external use, including transdermal patches, respiratory products administered via inhaler and those to be applied directly on the mucous membranes (oral, nasal, rectal, vaginal or ear). For all other drugs, excipients of labeling should be those who have recognized action.
The list of ingredients involved could include:
- Dyes, preservatives, adjuvants, stabilizers, thickeners, emulsifiers and flavorings;
- Ingredients of the outer covering of the products intended to be ingested or otherwise administered as capsules, soft capsules, coated tablets, suppositories;
- Ingredients of transdermal patches;
- Mixtures of excipients;
- Stabilizing the pH;
- Ingredients of the inks used to mark the doses;
- Diluents contained, for example, in herbal extracts or concentrates of vitamins
- Ingredients in mixtures of chemically related components (eg. Preservatives).
