European Union - Article 2.2 of Directive 2001/ 83/EC on the Community code relating to medicinal products for human use aims to address the issue of the borderline products. The new legislation is applicable from 30 October 2005 through implementation in national legislation by Member States (1). The aim of the new provision is to clarify, from a legal point of view, the situation of certain borderline products for which there is uncertainty regarding which regulatory system should be applied. The intention of the new legislation is not to extend the definition of medicinal products currently covered by other legislative frameworks.
The Directive sets out clear rules for the classification of products:
(a) if a product falls clearly under the definition of other product categories, pharmaceutical legislation does not apply.
(b) If a product falls clearly under the definition of a medicinal product, pharmaceutical legislation will apply.
(c) If after due consideration of all relevant criteria and taking into account all characteristics of the product doubt remains whether a product falls within the definition of a medicinal product or of a product covered by other Community legislation, the pharmaceutical legislation will apply.
A workshop was recently organized between the Commission, Member States and industrial sectors for input on how to apply the new provision. It provided a unique opportunity to work on the clarifications needed concerning application of the legal framework and a definition/ delimitation of medicinal products, food/food supplements, cosmetics and medical devices. Discussion focused on a variety of issues, including:
• Implementing a consistent legal approach across the European Union; and
• The need to offer a detailed explanation of the term ‘modifying physiological functions’.
Member States insisted on the need to develop a ‘Commission-driven cooperation mechanism’ to overcome the sectorial approaches often prevailing at Member State and Community level.
A Commission report regarding the use of substances other than vitamins and minerals in food supplements is to be prepared by the Commission for 2007.
1. Workshop on borderline products and pharmaceuticals. 28/10/2004 http://www.eu.int
2. European Union. Official Journal L - 311 of 28/11/ 2004. http://www.eu.int