Entrepreneurial, what to choose? –problems with the legal classification of 'borderline' products

The average consumer does not consider the type or legal classification of a particular product when purchasing a particular product. The main factors influencing its choice are the effectiveness, price and positive opinions of other consumers. The situation of a manufacturer or importer planning to place a new product on the market is quite different. They face the problem of proper classification of a given product, which is not facilitated by both national and Community regulations. The issue of so-called borderline products has long been the subject of lively discussion. This problem concerns products which, because of their specific characteristics (in particular composition, pharmacological characteristics), are difficult to classify unequivocally and therefore the trader has repeated doubts as to the choice of the appropriate procedure.

This issue covers product groups such as medicinal products, medical devices, dietary supplements and cosmetics. For each of the abovementioned, the legislature provides for a different authorisation procedure, which is why it is so important to classify the product accordingly.

Although many products may meet the requirements of several types at the same time, the law does not allow double qualification and requires a precise definition of the product. The person placing the product on the market must therefore, on the basis of the applicable legislation and the state of the art, make an appropriate assessment of its product in order to best meet the definition contained in the various laws governing medicinal products, dietary supplements, medical devices, etc.

This is extremely important in view of the requirements for the marketing procedure, advertising and other obligations that the law imposes on individual products. The legislature has provided for the greatest requirements for medicinal products and, accordingly, under the Pharmaceutical Law, the provisions of that law apply to a product which meets both the criteria of a medicinal product and the criteria of another type of product, in particular a dietary supplement or a cosmetic product. The prioritisation of the classification of a product by that law is primarily based on consumer safety considerations. A product that has a significant impact on the human body should be thoroughly tested before being placed on the market, which is most closely ensured by the requirements of pharmaceutical law (e.g. clinical trials play an important role here). At the same time, as is clear from the case-law of the Court of Justice of the European Union, the mere effect of a product on the human body (having a physiological effect) does not automatically determine its classification as a medicine, the intensity and extent of that effect, in particular the therapeutic effects, will be relevant.

It is worth noting the definition of a medicinal product contained in this Act. It is a substance or mixture of substances presented as having the characteristics of preventing or treating diseases. Thus, the presentation of a product itself will affect its classification as a medicinal product, which relates in particular to the issue of advertising.

It is therefore the trader's responsibility. Inadequate classification may result in exposure to negative consequences on the part of the control authorities and may result in a loss of consumer confidence. It is therefore important to carefully examine the product, in particular in terms of its pharmacological properties (in the case of composition, national and Community regulations go with the aid of, for example, determining the permissible content of minerals and vitamins in dietary supplements) in order to properly qualify it.

Author: Ewa Majchrzak, KONDRAT Law Firm and Partners


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