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Reception Date
17.03.22
Category
PHARMACEUTICAL AND COSMETICS
Pharmaceuticals
Ministries & Departments
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
Responsible Departments
FOD Economie, KMO, Middenstand en Energie
Products & Services concerned
This draft pertains to the naming of medicinal products for human use authorised in Belgium.
Related EU Law
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In practice, the invented names proposed for medicinal products are often highly similar to the invented names of medicinal or other products that are already authorised. In addition, the authorities often find that a proposed invented name contains information that is confusing, incorrect, etc., regarding the quality or properties of the medicinal product in question. These kinds of invented names increase the risk of improper use (e.g. for the target population, indications or composition) of the medicinal products. An express normative provision setting the principle that the invented name of a medicinal product shall not create confusion with the invented name of other products, nor regarding the quality and/or other properties of the medicinal product, is necessary in the interest of public health.
The provision in question is an express normative provision stipulating that the invented name of a medicinal product shall not create confusion with other medicinal products, medical devices or food supplements. Nor shall the invented name of a medicinal product create confusion regarding its quality or other properties.
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