Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The labelling of excipients relevant to food allergies or food intolerances in the product information for medicinal products for human use in the EU ***

Dr. Sabine Schürmann (Abschlußjahr: 2020)

Summary
Language: English
Some excipients in medicinal products for human use are substances derived from foods or food ingredients that are relevant to food allergies or food intolerances. Medicinal products containing these excipients may therefore be potentially harmful to users suffering from food allergies or intolerances. For this reason, it is necessary that users are adequately informed about excipients relevant to food allergies and intolerances in the product information for medicinal products. This is particularly important as the prevalence and awareness of food allergies and intolerances seem to have increased over the last decades.
This thesis analyses the EU requirements for the labelling of excipients relevant to food allergies or intolerances in the product information for medicinal products and compares them with EU requirements for food labelling. Thereby, the focus is on general aspects and principles of labelling. The aim of this work is to identify similarities and differences in the labelling of pharmaceutical excipients and food ingredients relevant to food allergies or intolerances. Based on this, the advantages and disadvantages of the labelling of excipients and food ingredients are discussed as well as possible proposals to align the labelling of excipients with the labelling of food ingredients in order to improve excipient labelling and to create more consistent information for users.
Differences in the national implementation of labelling rules, the way information is provided, the nomenclature, and the completeness and transparency of information on food ingredients and excipients are revealed. Furthermore, the substances defined as allergens or triggers of intolerance reactions differ between medicinal products and foods. Consequently, users of medicinal products cannot rely on the fact that labelling of excipients relevant to food allergies or intolerances corresponds to the labelling of food ingredients.
The Annex to the European Commission guideline on "Excipients in the labelling and package leaflet of medicinal products for human use" (excipients guideline) lists specific substances and chemical groups of substances as excipients with a known effect. In contrast, Annex II to Regulation (EU) No. 1169/2011 on food information contains broader categories of food ingredients relevant to allergies and intolerances that consist of a basic material and products thereof. As a result, the substances listed in the Annex to the excipients guideline and those included in Annex II are not identical. In order to provide more consistent information to users, it is proposed to align the Annex to the excipients guideline with Annex II to Regulation (EU) No. 1169/2011. To this end, relevant categories from Annex II could be integrated into the Annex to the excipients guideline, using the Australian approach for the labelling of excipients relevant to food allergies or intolerances as a model.
Pages: 68
Annexes: 0, Pages: 0