1. Regulatory product definitions and examples
Regulatory classification of products is an essential process, dictated by specific legislative frameworks that vary according to the nature, composition, purpose and claims of the products concerned. This section examines the main product categories frequently concerned by the notion of borderline products (figure
1
), based on European regulations and applicable national specificities.
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Regulatory product definitions and examples
Bibliography
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(1) - PARLEMENT EUROPÉEN -
Directive 2001/83/CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain
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. – (version consolidée du 1
er
janvier 2025).
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