According to the official definition healthcare products are commodities designed to maintain, improve or restore general health. Therefore, you need to distinguish between medicinal and non-medicinal products.
Medicinal products are differentiated between prescription and non-prescription medication, the latter also being referred to as OTC (over the counter) products. Although they’re non-prescription products some of those OTC products are restricted to be sold in pharmacies only in order to ensure a sufficient information.
Commonly the term OTC products is not only used for non-prescription medicine but also for food supplements and some medicinal devices such as reading glasses or compresses. Often, this is referred to as the “market of self-medication” as the users usually bear the costs themselves. Occasionally, doctors recommend such products by prescription.
According to official definitions food supplements are non-medicinal products and hence legally defined as food. For further information please read our previous blog article about supplements.
Due to their dosage form and their resembling appearance food supplements and pharmaceuticals are often compared, although their effects and purposes are fundamentally different. Here are the most important key distinctions:
supplements are a group of food and hence subject to food law
non-medicinal products (like supplements) shall only be advertised with health and/or nutritional claims, but not with disease-related claims: Health claims
purpose of pharmaceuticals: healing/alleviation/prevention of diseases; purpose of supplements: addition to a healthy and balanced diet, maintenance of body functions
defined dosages for ingredients with pharmacological effects decide about a product’s classification as either supplement or drug
pharmaceutical companies require regulatory authorization
drugs are subject to official authorization procedures prior launch
supplements only need to be registered at the concerned federal office without being authorized
If you’re planning to launch an OTC health product, don’t hesitate to contact us.
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