Ongoing Developments in the Area of Borderline Products
Scientific progress and the development of new types of products explain the rise in issues regarding the legal qualification of so-called “borderline” products. Borderline product issues usually arise with regard to products having combined characteristics of medicines and foods, of medicines and medical devices and/or medicines and cosmetics.
A new Directive (hereinafter the “Directive”) – which amends the directive establishing a Community code for human medicines) – is due to be implemented by the Member States by October 2005 amends the definition of “medicinal product” and introduces new principles to determine which of rules should apply in case of uncertainty. Firstly, the amended definition of “medicinal product” is now broader, to encompass, for instance, gene therapy and radiopharmaceutical products:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis (Article 1(2) of the Directive)[emphasis added]
Secondly, the Directive introduces a provision stating that if a product fits the definition of a medicinal product and, at the same time, the definition of another category of product (for instance a food), pharmaceutical rules apply, so, in this sense, prevails.
Separately, the summary of a European Commission workshop on the same topics released recently as well as other discussions announce further developments regarding borderline products.
In the area of foods, a draft regulation on nutrition and health claims made on foods is being discussed. Separately, it is worth noting that a draft regulation regarding the addition of vitamins and minerals and of certain other substances to foods is also under discussion.
In the area of medical devices, the European Commission foresees updating of existing guidelines. Further, the European Commission is considering whether to issue a communication on the legal principles and relevant methods with regard to the classification of products.
Other articles
KŠB Assisted with the Refinancing of the BigBoard Group, a leading player in the premium outdoor advertising market
Our team provided legal advice to BigBoard Praha, a leading player in the premium outdoor advertising market in the Czech Republic, in connection with its refinancing. Founded in 1993, the BigBoard Group is the largest provider of premium outdoor advertising in the Czech Republic, with an approximately 70% market share and annual turnover of around CZK 2 billion. Its advertising media cover key locations across the country, including the Prague metro and major transport hubs.
KŠB Assisted Sandberg Capital with a Majority Investment in HotelTime Solutions
The KŠB team provided legal advice to the investment group Sandberg Capital on the completion of a majority investment in HotelTime Solutions, one of the leading providers of cloud-based software for hotel operations management.
KŠB assisted Seyfor with the extension of its financing provided by Raiffeisenbank, Tatra banka and, newly, Slovenská sporiteľňa.
The KŠB team provided legal advice to its long-standing client Seyfor in connection with the continuation and expansion of its syndicated financing. The existing lending banks, Raiffeisenbank Czech Republic and Tatra banka, decided to continue supporting Seyfor’s growth, with Slovenská sporiteľňa joining the financing as a new lender.
