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Key Facts

Belgium

Map of Belgium

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

-

Explanation

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.

Summary

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.

Notification Timeline

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Law is drafted in Belgium Belgium notifies the draft law 17.03.22 Draft law returns to Belgium Commenting Periode Ends 20.06.22 0 Member States & EC Responses 0 Detailed Opinions 0 Comments 2 External Stakeholders Responses

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Commenting Organisations

This section lists all organisations that have submitted comments on this notification. Each entry includes the organisation’s name, the number of contributions made, and a link to view their comments. Explore the list to understand which stakeholders are actively engaging in the consultation process.
Organisation Comments Date Total Contributions
BACHI Download 2022-06-20 4
pharma.be Download 2022-06-17 1
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